Draft 2 Decree Detailing and guiding the implementation of some articles of Pharmaceutical Law

Draft 2 Decree Detailing and guiding the implementation of some articles of Pharmaceutical Law

DECREE
Detailing and guiding the implementation of some articles of Pharmaceutical Law
Pursuant to Government Organization Law no 76/2015/QH13 dated 19 June, 2015;
Pursuant to Pharmaceutical Law no 105/2016/QH13 dated 6 April 2016;
At the request of the Minister of Health,
The government hereby issues the Decree detailing and guiding the implementation of some articles of Pharmaceutical Law.
Chapter I
GENERAL PROVISIONS
Article 1. Scope of regulation

This Decree provides for certficate of pharmacy practice, pharmaceutical business operations, drug exportation, drug importation, marketing registration of medicinal materials, excipients, capsule shells; the assessment of drug manufacturing establishments residing abroad, powers, format, formalities pertaining to the recall of drug raw materials, handling measures of recalled drug raw materials, drug information, drug advertisement and drug price regulatory measures.
Article 2. Definition of terms
In this Decree the terms below shall be construed as follows:
1. Drug information is the collection, provision of information drug-related covering indications, contraindications, dosage, administration routes, adverse drug reactions, and other information pertaining to drug quality, safety and efficacy, conducted by responsible establishments with the aim of meeting the information requirements of entities, individuals practicing medicine, pharmacy or drug users.

2. Drug advertising is the act of introducing drugs performed by the pharmaceutical business establishment itself or in conjunction with, under financial sponsorship arrangements with, delegated to, another entity with a view to promoting the prescription, supply [and] usage of such drugs in a safe, rational, effective manner.
3. Drug introduction workshops for healthcare professionals are introduction sessions on drug products or drug related scientific symposia that are held, sponsored by a drug business establishment.
4. Drug introducers are personnel of a drug business establishment in the territory of Vietnam who are assigned the task of introducing drugs to health care personnel.
5. Health care personnel are persons who take part in the care and protection of people’s health.
6. Semi-finished products cover intermediate products (products which have undergone one or several processing steps and are in need to undergo one or several additional processing steps to become a finished products) and products awaiting packaging.

Chapter II
CERTIFICATE OF PHARMACY PRACTICE
Section I
DOSSIERS, FORMALITIES FOR THE ISSUANCE, REISSUANCE, CONTENT-MODIFICATION, REVOCATION OF AND TEMPLATE FOR CERTIFICATE OF PHARMACY PRACTICE
Article 3 Dossiers applying for certificate of pharmacy practice issuance
1. Dossiers applying for Certificate of pharmacy practice issuance should be prepared in accordance with the provisions of Article 24 of Pharmaceutical Law.
2. Application for Certificate of pharmacy practice issuance – Form 1 in Appendix 1 of this Decree.
3. Judicial resume. Applicants who are foreign nationals, Vietnamese nationals residing abroad must have a judicial resume or a written letter from the competent authority of the respective foreign country attesting that they have no criminal record, are not being pursued for criminal liability, that they are not subject to debarment from practice, debarment from conducting pharmacy-related work under a court order, a court ruling. The documents issued by the competent foreign authority must be consular officialized and notarized, authenticated.
4. Certificate of practice time shall be waived for application dossiers from applicants who have had their Certificate of pharmacy practice revoked under the provisions of clause 2, 3, 5, 8 and 9 Article 28 of Pharmaceutical Law.

5. Certificate of completion of a training course, refresher course on pharmacy professional knowledge shall be required of application dossiers from applicants who have had their Certificate of pharmacy practice revoked under the provisions of clause 6, 10 or 11 Article 28 of Pharmaceutical Law.
Article 4 Dossiers applying for Certificate of pharmacy practice re-issuance
1. Dossiers applying for Certificate of pharmacy practice re-issuance should be prepared in accordance with the provisions of Article 25 of Pharmaceutical Law
2. Application for re-issuance of Certificate of pharmacy to follow Form 2 in Appendix 1 of this Decree.
Article 5. Dossiers requesting content-modification of Certificate of pharmacy practice
1. Dossiers requesting content-modification of certificate of pharmacy practice should be prepared in accordance with the provisions of Article 26 of Pharmaceutical Law.
2. Application for content-modification of Certificate of pharmacy practice to follow Form 3 in Appendix 1 of this Decree.
3. Duplicate copy of documents demonstrating the changes incurred as follows:
a) Changes in personal information of the pharmacy practitioner: Duplicate copy of identity card or passport or household registry or confirmation, certification of the competent authority relevant to the changes in question.

b) Changes in the scope of professional practice: duplicate copy the corresponding professional qualification and certification of practice time at a relevant pharmaceutical establishment.
Article 6. Formalities for the issuance, re-issuance, content-modification, revocation of Certificate of pharmacy practice
1. Formalities for the issuance, re-issuance, content-modification, revocation of Certificate of pharmacy practice shall conform to the provisions of Article 27 of the Pharmaceutical Law.
2. In the case of content-modification, applicants must surrender the old Certificate of pharmacy practice upon receiving the modified new one.
3. The agency issuing Certificate of pharmacy practice shall issue certificate revocation decisions regarding the cases set out in Article 28 of Pharmaceutical Law. Individuals having their Certificate revoked must discontinue practice immediately upon receipt of the revocation decision. Within 10 days from the effective date of the decision, the concerned individuals must surrender their Certificate of pharmacy practice to the revoking agency.
4. The competent authority making conclusion on, and imposing sanctions against, violating cases stipulated in Clause 10 and 11 Article 28 of Pharmaceutical Law shall notify in writing the Certificate-issuing agency of its conclusions and actions. Within 7 days from receipt of such notification, the Certificate-issuing agency shall issue the revocation decision.
5. [The layout of] Certificate of pharmacy practice is prescribed in Template no 8a, 8b Appendix I of this Decree.

Section 2
TRAINING INSTITUTIONS, TRAINING PROGRAMS, REFRESHER COURSES ON PHARMACY PROFESSIONAL KNOWEDGE AND TEMPLATE FORM FOR CERTIFICATION OF COMPLETION OF TRAINING, REFRESHER COURSES
Article 7. Establishments providing training, refresher courses on pharmacy professional knowledge
1. Pharmacy specialty training schools shall hold training, refresher courses on pharmacy professional knowledge and issue completion certificates to practitioners having practice scope equivalent that of persons holding bachelor degree in medicine, pharmacy, traditional medicine, chemistry, biology.
2. University level training institutions having a faculty of traditional medicine [and] pharmacy shall hold training, refresher courses on pharmacy professional knowledge and issue course completion certificate to practitioner within the scope commensurate with bachelor degree, associate degree level in traditional medicine, pharmacy.
3. Medicine [and] pharmacy technical schools; other establishments mandated to provide pharmacy education shall hold training, refresher courses on pharmacy professional knowledge and issue course completion certificates to practitioners within the scope equivalent to technical school diploma level or lower.
4. Technician level training institutions having a traditional medicine [and] pharmacy department shall hold training, refresher courses on pharmacy professional knowledge and issue course completion certificates to practitioners within the scope equivalent to technical diploma in traditional medicine, pharmacy or lower.

Article 8. Holding training, refresher courses on pharmacy professional knowledge on pharmacy

1. Health Departments of provinces, central-affiliated cities shall be responsible to monitor and coordinate with the training establishments set out in Article 7 of this Decree in the provision of training, refresher courses [to pharmacy practitioners].
2. Trainers participating in pharmacy training, refresher courses shall comprise of trainers meeting the requirements of faculty of training establishments set out in Article 7 for the delivery of training contents in specialty knowledge; trainers with more than 05 years of managerial experience shall take part in the delivery of contents on pharmaceutical management and legal normative documents pertaining to pharmaceuticals; trainers of more than 05 years of experience in pharmacy practice and pharmaceutical business from manufacturing establishments, businesses, hospitals, pharmaceutical associations shall deliver contents related to practical skills.

Article 9. Programs, contents, duration of training, refresher courses on pharmacy professional knowledge
1. The content of training, refresher courses on professional knowledge shall cover 3 main components:
a) Professional knowledge of the discipline: relevant pharmaceutical updated knowledge; therapeutic guidelines; official reference literature newly; new methods of treatment; new approaches in therapeutics, drug usage, drug testing, drug storage, drug manufacture.
b) Legislation and regulations concerning pharmaceuticals;
c) Practical skills and techniques in pharmacy practice.
The Minister of Health shall set out the training program framework and to prescribe the training program and the final exam questionnaire for the evaluation of the pharmacy professional knowledge training, refresher courses.
2. Duration of training, refresher courses on pharmacy professional knowledge
a) Professional knowledge in the discipline: 24 hours for persons holding bachelor degree; 12 hours for persons holding associate degree, technical school diploma; 6 hours for persons of primary level of attainment and holding diplomas, certificates and other certifications.
b) Legislation and regulations concerning pharmaceuticals: 8 hours
c) Practical skills in pharmacy practice: 8 hours
3. Form of training: Training directly or online.

Article 10. Template for certificate of completion of training, refresher course on professional knowledge
[The layout of] certificate of completion of training, refresher courses on professional knowledge is prescribed in Form 4 Appendix 1 of this Decree.
Section 3
STANDARDIZATION OF PROFESSIONAL QUALIFICATIONS AND TITLES
Article 11. Professional qualifications and scope of practice
1. Cases to be issued certificate of pharmacy practice with practice scope corresponding to the qualifications set out in point h clause 1 Article 13:

a) Bachelor degree in pharmacy granted by domestic training institutions that clearly state “Pharmacist degree” or “Bachelor in pharmacy degree” or “bachelor level pharmacist” or “Senior pharmacist”;
b) Bachelor degree in pharmacy granted by foreign training institutions and Bachelor degree in pharmacy granted by domestic training institutions with no specific title stated as referred to in point a of this clause but are recognized by Hanoi Pharmacy School or HCMC School of Medicine and Pharmacy as equivalent to the one referred to in point a of this clause on the basis of the curriculum assessment or the result assessment of the final exam on professional knowledge according to Minister of Health’s specifications.
c) [Holders of] Bachelor degree in pharmacy that do not state the title referred to in point a of this clause, recognized as bachelor degree by Ministry of Education and Training [,] assessed by Hanoi School of Pharmacy and HCMC School of Medicine and Pharmacy as not equivalent to the one referred to in point a of this clause on the basis of curriculum assessment or the result assessment of final exam on professional knowledge according to with Minister of Health’s specifications, shall be allowed to practice within one of the following positions: Professional in-charge person of drug or drug raw material manufacturing establishment; Person in charge of drug quality assurance of drug manufacturing establishment; Professional in-charge person of establishments manufacturing medicinal materials, medicinal material drugs, traditional drugs; Professional in-charge person of establishments providing drug testing service; Professional in-charge person of establishments providing service of clinical trials on drugs.

2. Cases to be issued Certificate of pharmacy practice with practice scope corresponding to the qualifications set out in point b clause 1 Article 13 shall be as follows:
a) Bachelor degree in medicine granted by national training institutions that clearly state “Medical doctor degree” the professional title “General practitioner”.
b) Bachelor degree in medicine granted by foreign training institutions and Bachelor degree in medicine granted by domestic training institutions that do not specify the professional titles referred to in point a of this clause, assessed by HCMC School of Medicine and Pharmacy or Hanoi School of Medicine as equivalent to the one referred to in point a of this clause on the basis of curriculum assessment or the results of exams held by the aforementioned two schools according to the Minister of Health’s detailed regulations.
3. Cases to be issued Certificate of pharmacy practice with practice scope corresponding to the qualifications set out in point c clause 1 Article 13:
a) Bachelor degrees in traditional medicine, traditional pharmacy granted by domestic training institutions that clearly state “Medical doctor degree” in people’s medicine, oriental medicine specialty, traditional medicine, “Pharmacist degree” in oriental pharmacy, traditional pharmacy;

b) Bachelor degrees in traditional medicine granted by foreign training institutions and Bachelor degree in traditional medicine, traditional pharmacy granted by domestic training institutions that do not clearly sate the professional titles referred to in point a of this clause, assessed by Hanoi School of Pharmacy or HCMC School of Medicine [and] Pharmacy, Hanoi School of Medicine as equivalent to the one referred to in point a of this clause on the basis of curriculum assessment or the results of exams held by the afore mentioned schools according to the Minister of Health’s detailed regulations.
4. Cases to be issued Certificate of pharmacy practice with practice scope corresponding the qualifications set out in point d, đ clause 1 Article 13 shall be as follows:
a) Bachelor degree granted by domestic training institutions that clearly state “Engineer degree” or bachelor degree in chemistry, biology;

b) Bachelor degrees in biology or chemistry granted by foreign training institutions or bachelor degree in biology or chemistry granted by domestic training institutions that do not specify the name of the degree as referred to in point a of this clause [,] assessed by Hanoi School of Medicine or HCMC School of Medicine [and] Pharmacy as equivalent to the one referred to in point a of this clause on the basis of curriculum assessment or the results of exams held by the afore mentioned schools according to the Minister of Health’s detailed regulations.
5. Cases to be issued Certificate of pharmacy practice with practice scope corresponding to the qualifications set out in point e clause 1 Article 13:
a) Associate degree in pharmacy granted by do domestic training institutions that clearly state the title of “associate degree”;
b) Associate degree in pharmacy granted by foreign training institutions or Associate degree in pharmacy granted by domestic training institutions that are assessed by Hanoi School of Pharmacy or HCMC School of Medicine [and] Pharmacy as equivalent to the one referred to point a of this clause on the basis of curriculum assessment or the results of exams held by the afore mentioned two schools according the Minister of Health’s detailed regulations.

6. Cases to be issued certificate of pharmacy practice with practice scope corresponding to the qualifications set out in point g clause 1 Article 13 shall cover:
a) Technical school diploma in pharmacy granted by domestic training institutions;
b) Technical school diploma in pharmacy granted by foreign training institutions or domestic institutions that are assessed by Hanoi School of Pharmacy or HCMC School of Medicine [and] Pharmacy as equivalent to the one referred to in point a of this clause on the basis of curriculum assessment or the results of the exams held by the afore mentioned two schools according to the Minister of Health’s detailed regulations.
7. Cases to be issued certificate of pharmacy practice with practice scope corresponding to the qualifications set out in point h clause 1 Article 13 shall cover:
a) Technical school diploma that specify the title “physician assistant”, medical technical college diplomas granted by domestic training institutions;
b) Technical school diplomas, associate degrees in medicine granted by foreign training institutions or Technical school diplomas, associate degrees in medicine that are recognized by Ministry of Education and training.
8. Cases to be issued certificate of pharmacy practice with practice scope corresponding to the qualifications set out in point I clause 1 Article 13 shall cover:
a) Technical school diploma in tradition medicine, traditional pharmacy that clearly state the title “physician assistant”, associate degrees in traditional medicine, traditional pharmacy granted by domestic training institutions;

b) Technical school diploma in traditional medicine, traditional pharmacy granted by foreign training institutions or Technical school diplomas in traditional medicine, traditional pharmacy that are assessed by Hanoi School of Pharmacy or HCMC School of Medicine [and] Pharmacy as equivalent to the one referred to in point a of this clause on the basis of curriculum assessment or the results of exams held by the afore mentioned two schools according to the Minister of Health’s detailed regulations.
9. Cases to be issued certificate of pharmacy practice with practice scope corresponding to the qualifications set out in point 1 clause 1 Article 12 shall be provided for by the Minister of Health.
Section 4
ESTABLISHMENTS HOSTING PROFESSIONAL PRACTICE AND TEMPLATE FORM FOR PRACTICE TIME CERTIFICATION

Article 12. Practice-hosting establishments for pharmacy-professional-in-charge persons of establishments manufacturing drugs, drug raw materials
1. Pharmacy-professional-in charge persons of drug manufacturing establishments except the cases set out in clause 3 of this Article shall undertake professional practice at one of the following establishments: drug manufacturing establishments, pharmacy training schools of university level, associate level, drug testing establishments, pharmaceutical technology research institutions.
2. Pharmacy-professional-in charge persons of establishments manufacturing raw materials being pharmaceutical substances, excipients, capsule shells shall undertake professional practice at one of the following establishments: drug raw material manufacturing establishments, chemical manufacturing establishments, drug-, drug raw material-testing establishments, pharmacy training institutions of university level, associate level, research institutions of chemical technology, pharmaceutical technology.
3. Pharmacy-professional-in charge persons of establishments manufacturing vaccines, biological products and vaccine raw materials, biologic raw materials shall undertake professional practice at one of the following establishments: establishments manufacturing vaccines, biological products, testing establishments of vaccines biological products, vaccine, biologic-research institutions.

Article 13. Practice-hosting establishments for persons in charge of quality assurance of establishments manufacturing drugs, drug raw materials
1. Practice-hosting establishments for persons in charge of quality assurance of drug manufacturing drugs:
a) Persons in charge persons of quality assurance of drug manufacturing establishments except the cases set out in clause 3 of this Article shall undertake professional practice at one of the following establishments: drug manufacturing establishments, pharmacy training institutions of university level, associate level, drug testing establishments, pharmaceutical-technology research institutions;
b) Persons in charge of quality assurance of drug raw material-manufacturing establishments except the cases set out in clause 3 of this Article shall undertake professional practice at one of the following establishments: establishments manufacturing drugs, drug raw materials, drug testing establishments, pharmacy training institutions of university level, Pharmaceutical-technology research institutions, bioequivalence study centers;

2. Practice-hosting establishments for persons in charge of quality assurance of establishments manufacturing drug raw materials that are pharmaceutical substances, excipients, shell capsules except the cases set out in clause 3 of this Article shall be any of the following establishments: drug manufacturing establishments, pharmacy training institutions of university level, associate level, drug testing establishments, drug testing establishments, pharmaceutical-technology research institutions, chemical manufacturing establishments.
3. Practice-hosting establishments for persons in charge of quality assurance of establishments manufacturing vaccines, biological products and vaccine-, biologic-raw materials: vaccine-, biologic-manufacturing establishments, vaccine-, biologic-testing institutions, vaccine-, biologic-research institutions.
Article 14. Practice hosting establishments of pharmacy-professional-in charge persons and persons in charge of quality assurance of establishments manufacturing medicinal raw materials
1. Pharmacy-professional-in charge, the in charge persons of quality assurance of medicinal material-manufacturing establishments shall undertake professional practice at one of the following establishments: establishments manufacturing drugs, drug raw materials, training institutions of university level, associate level, technician level in pharmacy, traditional medicine, traditional pharmacy; research institutions of medicinal materials, traditional medicine; research institutions of chemical technology, pharmaceutical technology; hospitals’ traditional medicine departments, establishments delivering medical services in traditional medicine.
2. Pharmacy-professional-in charge persons, the in charge persons of quality assurance of household businesses, cooperatives manufacturing medicinal materials shall undertake professional practice at one of the following establishments: drug raw material manufacturing establishments, chemical manufacturing establishments, drug-, drug raw material-testing establishments, training institutions of university level, associate level, technician level in pharmacy, traditional medicine, traditional pharmacy; research institutions of medicinal materials, traditional medicine; research institutions of chemical technology, pharmaceutical technology; establishments delivering medical services in traditional medicine.
Article 15. Practice hosting establishments for pharmacy-professional-in charge persons of establishments wholesaling drugs, drug raw materials

1. Pharmacy-professional-in charge persons of drug wholesale establishments except the cases set out in clause 3 of this Article shall undertake professional practice at one of the following establishments: drug wholesale establishments; drug export import establishments, drug manufacturing establishments; drug-, drug raw material- testing establishments; pharmacy training institutions; pharmaceutical research institutions; pharmacy department of medical service establishments; establishments complying with good storage practice of pharmaceutical products; representative offices of foreign traders operating in the field of pharmaceuticals in Vietnam; pharmaceutical regulatory agencies.
1. Pharmacy-professional-in charge persons of drug raw material wholesale establishments shall undertake professional practice at one of the following establishments: drug raw material manufacturing establishments; chemical manufacturing establishments; drug-, drug raw material-testing establishments, pharmacy training institutions, research institutions of chemical technology, pharmaceutical technology; drug wholesale establishments, drug import export establishments; establishments providing storage service of drugs, drug raw materials; pharmaceutical regulatory agencies.
2. Pharmacy-professional-in charge persons of vaccine-, biologic-wholesale establishments shall undertake professional practice time at one of the following establishments: vaccine-, biologic-manufacturing establishments; vaccine-, biologic-wholesale establishments; vaccine-, biologic-storage service provider establishments; vaccine-, biologic-testing establishments; vaccine-, biologic-research institutions; vaccine-, biologic-regulatory agencies; vaccine-, biologic-using healthcare establishments.

3. Pharmacy-professional-in charge of establishments wholesaling medicinal materials, medicinal material drugs, traditional drugs shall undertake professional practice at one of the following establishments: drug wholesale establishments; drug storage service providing establishments; drug-, drug raw material-manufacturing establishments, drug-, drug raw material-testing establishments, training institutions of university level, associate level in pharmacy, traditional medicine; research institutions of medicinal materials, traditional medicine; hospitals’ traditional medicine departments, establishments providing medical services in traditional medicine.
Article 16. Practice hosting establishments for pharmacy-professional-in charge persons of establishments exporting, importing drugs, drug raw materials

1. Pharmacy-professional-in charge persons of establishments exporting, importing drugs, drug raw materials except cases set out in clause 2 and clause 3 of this Article shall undertake professional practice time at one of the following establishments: drug wholesale establishments; drug export import drugs; drug manufacturing establishments; drug-, drug raw material-testing establishments, pharmacy training institutions; pharmaceutical research institutions; pharmacy departments of medical service establishments; establishment meeting good storage practice of pharmaceutical products; representative offices of foreign traders operating in the field of pharmaceuticals in Vietnam; pharmaceutical regulatory agencies.
2. Pharmacy-professional-in charge persons of establishments exporting, importing vaccines, biological products shall undertake professional practice at one of the following establishments: manufacturing establishments; wholesale establishments; storage service providing establishments; vaccine-, biologic-regulatory agencies; vaccine-, biologic-using establishments.

3. Pharmacy-professional-in charge persons of establishments exporting, importing medicinal materials, medicinal material drugs, traditional medicine shall undertake professional practice at one of the following establishments: drug-, drug raw material- wholesale establishments; drug-, drug raw material-storage service providing establishments; drug-, drug raw material-manufacturing establishments; drug-, drug raw material-testing establishments, training institutions in pharmacy, traditional medicine; research institutions of medicinal materials, traditional medicine; hospitals’ traditional medicine departments, establishments providing medical services in traditional medicine.
Article 17. Practice hosting establishments for pharmacy-professional-in charge persons of drug retail establishments
1. Pharmacy-professional-in charge of drugstores shall undertake professional practice at one of the following establishments: drug wholesale establishments; drug export import establishments; drug manufacturing establishments; drug testing establishments; drugstores; pharmacy training institutions; pharmaceutical research institutions; pharmacy departments of medical service establishments; establishments meeting good storage practice of pharmaceutical products; establishments meeting good distribution practice of pharmaceutical products; representative offices of foreign traders operating in the field of pharmaceuticals in Vietnam; pharmaceutical regulatory agencies.

2. Pharmacy-professional-in charge persons of drug counters shall undertake professional practice at one of the following establishments: drug wholesale establishments; drug export import establishments; drug manufacturing establishments; drug-, drug raw material- testing establishments; drugstores; drug counters; district healthcare center; district clinics; pharmacy training institutions; pharmaceutical research institutions; pharmacy departments of medical service establishments; establishments meeting good storage practice of pharmaceutical products; establishments meeting good distribution practice of pharmaceutical products; representative office of foreign traders operating in the field of pharmaceuticals in Vietnam; pharmaceutical regulatory agencies.
3. Pharmacy-professional-in charge persons of drug cabinets of communes’ clinics shall undertake professional practice at one of the following establishments: drug wholesale establishments; drug export import establishments; drug manufacturing establishments; drug-, drug raw material- testing establishments; drugstores, drug counters; drug retail agents; commune clinic’s drug cabinets; medical service establishments; district health centers; district clinics; commune clinics; pharmacy training institutions; pharmaceutical research institutions; pharmaceutical departments of medical service establishments; establishments meeting good storage practice of pharmaceutical products; representative offices of foreign traders operating in the field of pharmaceuticals in Vietnam; pharmaceutical regulatory agencies.
4. Pharmacy-professional-in charge persons of establishments specializing in the retail of medicinal materials, medicinal material drugs, traditional drugs shall undertake professional practice at a pharmaceutical establishment or an establishment providing medical services in traditional medicine, except the cases set out in point c clause 2 Article 13 of Pharmaceutical Law
Article 18. Practice hosting establishments for pharmacy-professional-in charge persons of establishments providing testing services on drugs drug raw materials

1. Pharmacy-professional-in charge persons of establishments providing testing services on drugs, drug raw materials except the cases set out in clause 2 of this Article shall undertake professional practice at one of the following establishments: drug-, drug raw material-testing establishments; pharmacy training institutions; pharmaceutical research institutions; pharmaceutical regulatory agencies.
2. Pharmacy-professional-in charge persons of establishments providing testing services on vaccines, biological products shall undertake professional practice at one of the following establishments: drug testing establishments; drug raw material testing establishments; vaccine-, biologic- testing and control establishments; pharmacy training institutions; pharmaceutical research institutions; pharmacy departments of medical service establishments; establishments meeting good storage practice of pharmaceutical products covering vaccines, biological products; pharmaceutical regulatory agencies.
Article 19. Practice-hosting establishments for pharmacy-professional-in charge persons of establishments providing services of clinical trial on drugs, drug bioequivalence study

1. Pharmacy-professional-in charge persons of establishments providing services of clinical trial on drugs, drug bioequivalence study except the cases set out in clause 2 of this Article shall undertake professional practice at one of the following establishments: establishments providing services of drug bioequivalence study; services of clinical trial on drugs; drug-, drug raw material-testing establishments; pharmacology departments, clinical pharmacy departments of pharmacy training institutions; pharmaceutical research institutions; pharmacy departments of medical service establishments; hospitals, institutions operating inpatient beds; pharmaceutical regulatory agencies.
2. Pharmacy-professional-in charge persons of establishments providing services of clinical trial, bioequivalence study on medicinal material drugs, traditional drugs shall undertake professional practice at one of the following establishments: establishments providing services of drug bioequivalence study; services of clinical trial on drugs; drug-, drug raw material-testing establishments; pharmacology departments, clinical pharmacy departments of pharmacy training institutions; pharmacology, clinical pharmacy research institutions; pharmacy departments of medical service establishments; hospitals, institutions operating inpatient beds; pharmaceutical regulatory agencies.
Article 20. Practice-hosting establishments for in charge persons of clinical pharmacy functions of medical service establishments

1. Persons in charge of clinical pharmacy functions of medical service establishments shall undertake professional practice at one of the following establishments: establishments providing services of drug bioequivalence study; services of clinical trial on drugs; pharmacology departments, clinical pharmacy departments of pharmacy training institutions, medical training institutions; pharmacology, clinical pharmacy research institutions; clinical pharmacy divisions of medical service establishments’ pharmacy departments; National center for drug information and drug adverse reaction surveillance; Drug information and drug adverse reaction monitoring divisions under Drug administration.
2. Persons in charge of clinical pharmacy functions of establishments providing medical services in traditional medicine shall undertake professional practice at one of the following establishments: establishments providing services of drug bioequivalence study; services of clinical trial on drugs; pharmacology departments, clinical pharmacy departments of pharmacy training institutions, medical training institutions; pharmacology, clinical pharmacy research institutions; clinical pharmacy divisions of medical service establishments’ pharmacy departments; National center for drug information and drug adverse reaction surveillance; drug information and drug adverse reaction monitoring under Drug administration; hospitals, institutions with inpatient beds engaging in traditional medicine operations.

Article 21. Practice hosting establishments for pharmacy-professional-in charge persons of establishments providing storage services of drugs, drug raw materials
1. Pharmacy-professional-in charge persons of establishments providing storage services of drugs, drug raw materials shall undertake professional practice at one of the following establishments: establishments meeting good storage practice of pharmaceutical products; drug wholesale establishments; drug manufacturing establishments; drug-, drug raw material-testing establishments; departments of pharmaceutical management or pharmaceutical manufacture or pharmaceutical engineering of pharmacy training institutions; pharmaceutical research institutions; pharmacy department of medical service establishments; representative offices of foreign traders operating in the field of pharmaceuticals in Vietnam; pharmaceutical regulatory agencies.
2. Pharmacy-professional-in charge persons of establishments providing storage services of vaccines, biological products shall undertake professional practice at one of the following establishments: establishments meeting good storage practice of pharmaceutical products including vaccines, biological products; drug wholesale establishments having vaccines, biological products within their operating scope; vaccine-, biologic-manufacturing establishments; vaccine-, biologic-testing and control establishments; departments of pharmaceutical management or pharmaceutical manufacture or pharmaceutical engineering of pharmacy training institutions; vaccine-, biologic-research insitutions; pharmacy departments of medical service establishments; representative offices of foreign traders operating in the field of pharmaceuticals in Vietnam; pharmaceutical regulatory agencies.

Article 22. Mentors for professional practice and Template form for certification of professional practice time
1. Mentors for professional practice must hold must hold professional qualifications equal to, or at a higher level than the practicing mentees and must be concurrently practicing in the discipline of such qualifications.
2. [The layout of] certificate of pharmacy practice is set out in Form no 5 in Appendix 1 of this Decree.
Article 23. Duration of professional practice required of persons holding post graduate specialty qualifications

1. Certificate of pharmacy practice applicants who hold post graduate specialty qualifications must have one of the qualifications set out in clause 1 Article 13 of Pharmaceutical Law.
2. Practice hosting establishments for persons holding post graduate specialty qualifications shall be in compliance with the Article … of this Decree.
3. The requirements regarding professional practice time of persons holding post graduate qualifications shall be regulated in accordance with each respective scope of practice as follows:
a) Practice time required of persons holding specialty qualifications in pharmaceutical formulation, pharmaceutical engineering, drug testing shall be reduced by 01 year for the positions of pharmacy-professional-in-charge person, person in charge of quality assurance of drug manufacturing establishments, professional-in-charge person of establishments providing drug testing services;
b) Practice time required of persons holding specialty qualifications in pharmacology, clinical pharmacy shall be reduced by 01 year for the positions of pharmacy-professional-in charge person of establishments providing services of drug bioequivalence study, establishments providing services of clinical trial on drugs, drug retail establishments, person in charge of clinical pharmacy function of medical service establishments;

c) Practice time required of persons holding specialty qualifications in medicinal materials, traditional medicine shall be reduced by 01 year for the positions of professional-in charge person of business establishments specializing in medicinal materials, traditional drugs, person in charge of clinical pharmacy function of establishments providing medical services in traditional medicine;
d) Practice time required of persons holding specialty qualifications in public health, infectious disease shall be reduced by 01 year for the positions of pharmacy-professional-in charge person of wholesale establishments, [establishments] providing storage services of vaccines, biological products;
đ) Practice time required of persons holding specialty qualifications in economic organization shall be reduced by 01 year for the positions of professional-in charge-person of wholesale establishments, retail establishments, [establishments] providing drug storage services.

Section 5
ISSUANCE OF CERTIFICATE OF PHARMACY PRACTICE THROUGH QUALIFYING EXAMINATION ROUTE
Article 24. Principles guiding the issuance of certificate of pharmacy practice through qualifying examination route
Ministry of Health shall issue Certificate of pharmacy practice [to applicants] through qualifying examination route on the following principles:
1. Unifying approach in issuing Certificate of pharmacy practice through qualifying examination route with a view towards further integration with and mutual recognition of certificate of pharmacy practice among countries.
2. Applicants obtaining Certificate of pharmacy practice through qualifying examination route must satisfy the requirements set out in Article 13 of Pharmaceutical Law. Certificate of pharmacy practice that are issued through qualifying exam route does not have a validity term specified unless specifically requested by applicants in order to have it recognized abroad.

3. Certificate of pharmacy practice issued through qualifying examination shall provide for an operating scope commensurate with the conditions the applicants qualify for.
4. Applicants of Certificate of pharmacy practice through qualifying examination route shall have the right to enter for examinations on several subject matters and to request for a Certificate with an operating scope commensurate with the conditions they qualify for.
5. Application for examination registration shall be prepared using Form no 6 in Appendix 1 of this Decree.

Article 25. Qualifying examination format, content and program
1. Examination shall be offered in online format.
2. The exam content shall be issued by Ministry of Health covering the following core contents:
a) General contents for pharmacy practitioners covering core knowledge of pharmacy university curriculum: pharmacology, pharma chemistry, formulation, medicinal materials, pharma economic management;
b) Exam contents practitioners in manufacturing sector: applicable to applicants who are the professionally in charge person, person in charge of quality assurance of manufacturing establishments. Test contents cover up to date knowledge regarding formulation technology, quality specifications, good pharmaceutical manufacturing practices;
c) Exam contents for practitioners in business sector of wholesale, retail, storage service covering up to date knowledge regarding good practices in wholesale, retail, storage services, therapeutic guidelines and system of legal normative documents pertaining to drug marketing;
d) Exam contents for practitioners in clinical pharmacy areas covering up to date knowledge regarding pharmacology, clinical pharmacy, therapeutic guidelines and drug information, information regarding drug adverse reactions.

e) Exam contents for practitioners in areas of clinical trial on drugs, drug bioequivalence study covering: core knowledge in drug analysis, drug testing, relevant good practices, relevant research methodologies.
3. Ministry of Health shall publicize the examination materials and program on the websites of Ministry of Health and Drug Administration at least 60 days before implementation date.
Article 26. Procedures, formalities for the issuance of Certificate of pharmacy practice through qualifying examination route
1. Registration for qualifying examination of Certificate of pharmacy practice
a) Applicants should register for Certificate of pharmacy practice’s qualifying examination on line, application dossier shall comprise of photocopy of the documents set out in Article… of Pharmaceutical Law;
b) The Health Department where the exam registration is made shall check the dossier, if found eligible, applicants shall be issued a code for the registration of online examinations;
c) Pharmacy training institutions of university level or traditional medicine [and] pharmacy training institutions shall hold and supervise the online examinations.
2. Exam results shall be announced electronically via a software application and stored in the database of the agency issuing exam-format certificate of pharmacy practice.

3. Ministry of Health shall base on the results of dossier examination by Health Departments and exam results to issue exam-format certificate of pharmacy practice within 10 days from the date the exam results are announced.

4. Applicants of exam-format Certificate of pharmacy practice who are already issued a Certificate of pharmacy practice under the format of merit evaluation of application dossier must surrender the latter upon receipt of the Certificate resulted from passing the qualifying examination.
Article 27. Council for Certificate of pharmacy practice issuance and examination holding establishments

1. The Council for the issuance of exam-format certificate of pharmacy practice shall be set up by the Minister of Health, with members representatives of regulatory authorities, representatives of pharmacy training institutions, medical training institutions, representatives of trade associations.
2. The Council for the issuance of exam-format certificate of pharmacy practice shall be tasked with advising the Minister of Health on exam contents, exam programs and the evaluation of dossiers applying for exam-format certificate of pharmacy practice.
3. Training institutions of university level in pharmacy, traditional medicine [and] pharmacy shall hold qualifying examinations for certificate of pharmacy practice.
Article 28. Managing Certificate of pharmacy practice issued through qualifying examination route
1. Holders of exam-format certificate of pharmacy practice shall be allowed to practice in accordance with the practice scope stated in the Certificate [,] which is valid countrywide.
2. Holders of exam-format certificate of pharmacy practice shall have the rights and responsibilities of practitioners set out in Article 31 and Article 32 of Pharmaceutical Law.
3. Holders of exam-format certificate of pharmacy practice shall be given priority in hiring and in the assessment of legibility for working overseas or taking overseas business trips.

CHAPTER III
CONDUCTING PHARMACEUTICAL BUSINESSES
Section 1
DOSSIERS, FORMALITIES FOR THE ISSUANCE, RE-ISSUANCE, MODIFICATION, REVOCATION OF CERTIFICATE OF SATISFACTION OF CONTIDIONS FOR CONDUCTING PHARCEUTICAL BUSINESS
Article 29. Dossiers for the issuance, re-issuance, modification, revocation of Certificate of satisfaction of conditions for conducting pharmaceutical business
1. Dossiers for the issuance, re-issuance, modification, revocation of Certificate of satisfaction of conditions for conducting pharmaceutical business shall be prepared in accordance with the provisions of Article 38 of Pharmaceutical Law.
2. Application for the issuance, re-issuance, modification, revocation of Certificate of satisfaction of conditions for conducting pharmaceutical business shall be prepared using the form no 7a, 7b and 7c respectively in Appendix 1 of this Decree.
3. Technical documents relevant to the pharmaceutical business establishments referred to in point b clause 1 and point b clause 2 Article 38 of Pharmaceutical Law shall be as required as follows:
a) Establishments manufacturing drugs, drug raw materials: technical documents registering for the assessment of Good manufacturing practice for drugs according to Minister of Health’s specifications or Certificate of compliance with good manufacturing practices for drugs, drug raw materials.

b) Establishments importing, exporting drugs, drug raw materials, establishments providing storage services of drugs, drug raw materials: technical documents registering for the assessment of Good storage practice of drugs, drug raw materials or Certificate of compliance with good storage practice for drugs, drug raw materials.
c) Establishments wholesaling drugs, drug raw materials: technical documents registering for the assessment of Good distribution practice for drugs according to Minister of Health’s specifications or Certificate of compliance with Good distribution practice for drugs, drug raw materials.
d) Establishments retailing drugs: technical documents registering for the assessment of Good retail practice for drugs according to Minister of Health’s specifications or Certificate of compliance with Good pharmacy practice; [technical documents required of] establishments specializing in the retail of medicinal materials, medicinal material drugs, traditional drugs shall be in compliance with Article 46 of this Decree.
đ) Establishments providing drug-, drug raw material-testing services: technical documents registering for the assessment of Good laboratory practice or certificate of compliance with Good laboratory practice for drug quality control.
e) Establishments providing services of clinical trial on drugs: technical documents registering for the assessment of Good clinical practice of clinical trials on drugs or Certificate of compliance with Good clinical practice of clinical trials on drugs.

g) Establishments providing services of drug bioequivalence study: technical documents [registering for] the assessment of Good [laboratory] practice or certificate of compliance with Good laboratory practice for the bio fluid analysis phase and Good clinical practice for the clinical study phase.
Where the bioequivalence study service providing establishment only meets Good laboratory practice for bio fluid analysis it must contract a good-practice-compliant clinical trial service provider for the conduct of clinical study phase of the drug bioequivalence study.
Article 30. Dossiers for the issuance, re-issuance, modification, revocation of Certificate of satisfaction of conditions for conducting pharmaceutical business with respect to establishments operating in narcotic raw materials, psychotropic raw materials, drug precursors, narcotic drugs, combination drugs containing narcotic pharmaceutical substances, combination drugs contain psychotropic pharmaceutical substances, combination drugs containing precursors, radioactive drugs

1. Dossiers for the issuance, re-issuance, modification of Certificate of satisfaction of conditions for conducting pharmaceutical business shall be prepared in accordance with the provisions of Article 38 of Pharmaceutical Law.
2. Application for the issuance, re-issuance, modification of Certificate of satisfaction of conditions for conducting pharmaceutical business shall be prepared using the form no 7a, 7b and 7c in Appendix 1 of this Decree.
3. Technical documents corresponding to the respective pharmaceutical business establishments shall be required as follows:
a) Establishments manufacturing narcotic raw materials, psychotropic raw materials, drug precursors: Certificate of compliance with Good manufacturing practice of drug raw materials.
b) Establishments manufacturing narcotic drugs, psychotropic drugs, precursor drugs: Certificate of compliance with Good manufacturing practice of drugs corresponding to the each of the dosage forms that are registered for manufacture; layout plan of a separate warehouse meeting the principles, standards of Good storage practice for drugs dedicated to the preservation of narcotic drugs, psychotropic drugs, precursor drugs; duplicate copy of professional qualifications; and documentation proving practice time of the inventory manager and the key personnel responsible for record keeping, reporting regime.
c) Establishments manufacturing radioactive drugs: Certificate of compliance with Good manufacturing practice corresponding to each of the dosage forms that are registered for manufacture; Certificate of compliance with standards of radiation safety, nuclear safety and the security of radioactive sources, nuclear materials, nuclear equipment; layout of a separate warehouse meeting the standards of Good storage practice for drugs dedicated to the preservation of radioactive drugs; duplicate copy of professional qualifications and documentation proving practice time of the inventory manager, the key personnel responsible for record keeping, reporting regime, the person supervising the research, production, analysis, testing processes and responsible for record keeping, reporting regime, the official performing work related to the manufacture of radioactive drugs.

d) Establishments manufacturing combination drugs containing narcotic pharmaceutical substances, combination drugs containing psychotropic pharmaceutical substances, combination drugs containing precursors: Certificate of compliance with Good manufacturing practice corresponding to each of the dosage forms that are registered for manufacture; duplicate copy of professional qualifications and documentation proving practice time of the inventory manager and the key personal responsible for record keeping, reporting regime.
đ) Establishments exporting, importing narcotic raw materials, psychotropic raw materials, drug precursors, narcotic drugs, psychotropic drugs, precursor drugs: duplicate copy of Certificate of satisfaction of conditions for conducting pharmaceutical business that were issued with the business scope of export, import drugs, drug raw materials; the establishments’ undertaking of not violating the provisions of point b clause 1 Article 53 of this Decree; layout plan of a separate warehouse meeting the principles, standards of Good storage practice for drugs dedicated to the preservation narcotic drugs, psychotropic drugs, precursor drugs; Certificate of satisfaction of conditions for conducting drug business with operating scope: distributing drugs at the establishments 03 places of business in the Northern, Central and Southern regions; documents describing the software application for the tracking of warehouse receipts, storage, issues of narcotic drugs, psychotropic drugs and precursor drugs; duplicate copy of professional qualifications and documentation proving practice time of the inventory manager and the key personnel responsible for record keeping, reporting regime.

e) Establishments exporting, importing radioactive drugs: Certificate of compliance with standards of radiation safety, nuclear safety and the security of radioactive sources, nuclear materials, nuclear equipment; layout plan of a separate warehouse meeting standards of Good storage practice dedicated to the preservation of radioactive drugs; duplicate copy of professional qualifications and documentation proving practice time of the inventory manager, the key personnel responsible for record keeping, reporting regime.
g) Establishments exporting, importing combination drugs containing narcotic pharmaceutical substances, combination drugs containing psychotropic pharmaceutical substances, combination drugs containing precursors: shall be in accordance with the provisions of point b clause 3 Article 29 of this Decree.
h) Establishments wholesaling narcotic drugs, psychotropic drugs, precursor drugs: layout plan of a separate warehouse meeting the principles, standards of Good storage practice for drugs or a dedicated area within the warehouse meeting the principles, standards of Good storage practice for the preservation of narcotic drugs, psychotropic drugs, precursor drugs; detailed information on the establishment’s distribution system; duplicate copy of professional qualifications and documentation proving practice time of the inventory manager.

i) Establishments wholesaling radioactive drugs: Certificate of compliance with standards of radiation safety, nuclear safety and the security of radioactive sources, nuclear materials, nuclear equipment; layout plan of a separate warehouse meeting the standards of Good storage practice or a dedicated area for the preservation of radioactive drugs; duplicate copy of professional qualifications and documentation proving practice time of the inventory manager, the key personnel responsible for record keeping, reporting regime.
k) Establishments wholesaling combination drugs containing narcotic pharmaceutical substances, combination drugs containing psychotropic pharmaceutical substances, combination drugs containing precursors: shall be in conformance with the provisions of point c clause 3 Article 29 of this Decree.
l) Establishments retailing narcotic drugs, psychotropic drugs, precursor drugs, combination drugs containing narcotic pharmaceutical substances, combination drugs containing psychotropic pharmaceutical substances, combination drugs containing precursors: shall be in conformance with the provisions of point d clause 3 Article 29 of this Decree.

Section 2
GEOGRAPHIC AREAS, BUSINESS SCOPE OF RETAIL ESTABLISHMENTS BEING DRUG COUNTERS, DRUG CABINETS
Article 31. Geographic areas covered by drug counters, commune clinics’ drug cabinets and scope of business
1. Drug counters shall be set up at communes of townships, districts, cities under a province, in ethnic minority areas, mountainous areas, island, areas of extreme economic-social hardship.
2. At ward level under districts, townships, where there is not yet present a drugstore or drug counter to serve every 2000 residents, business establishments that already own a GSP warehouse shall be allowed to set up an additional GPP-compliant drug counter at the ward of such communes, townships, districts, cities of provinces (where there is no GSP-compliant business present in the province GDP-compliant businesses shall be allowed to do so).
3. Commune clinic’s drug cabinets shall be set up at communes, townships under communes, districts, cities under provinces.
4. Business scope of drug counters, drug cabinets of commune clinics
a) Business scope of drug counters is provided for under clause 1 Article 48 of Pharmaceutical Law. Drug counters that are not yet GPP-compliant shall only be allowed to retail drugs on the list of non prescription drugs issued by the Minister of Health;
b) Business scope of commune clinic’s drug cabinets is provided for under clause 1 Article 49 of Pharmaceutical Law.

Section 3
IMPLMENTATION ROADMAP OF GOOD PRACTICES FOR DIFFERENT TYPES OF PHARMACEUTICAL BUSINESS ESTABLISHMENT
Article 32. Implementation roadmap of Good manufacturing practice for drug raw materials, excipients
1. Establishments that manufacture raw materials being pharmaceutical substances must implement Good manufacturing practice of drug raw materials.
2. By 01 January 2021 all establishments manufacturing raw materials that are excipients must comply with good manufacturing practice for drug raw materials.

Article 33. Implementation roadmap of Good practice for drug retail establishments
1. Commune clinic’s drug cabinets
a) With respect to commune clinics’ drug cabinets, establishments that are issued Certificate of satisfaction of conditions for drug business before 01 January 2017, by 31 December 2020 must comply with Good retail practice for drugs;
b) With respect to commune clinics’ drug cabinets, newly set up establishments, applying for Certificate of satisfaction of conditions for drug business as of 01 January 2017 must comply with good retail practice for drugs;
2. Establishments specializing in the retail of medicinal materials, medicinal material drugs and traditional drugs:
a) With respect to the type of establishment specializing in the retail of medicinal materials, medicinal material drugs, traditional drugs, establishments that are issued Certificate of satisfaction of conditions for drug business before 01 January 2017, by 31 December 2020 must comply with good retail practice for drugs;
b) With respect to the type of establishment specializing in the retail of medicinal materials, medicinal material drugs, traditional drugs, newly set up establishments applying for Certificate of satisfaction of conditions for drug business as of 01 January 2017 must comply with good retail practice for drugs.

Section 4
AMBULATORY DRUG RETAIL OUTLETS
Article 34. Establishments operating ambulatory drug retail outlets
1. Establishments operating ambulatory drug retail outlets must register the ambulatory retail operations with Health Departments with the following information:
a) Geographic areas covered by the ambulatory retail operations and name of the corresponding professional-in charge persons.
b) List of drugs to be ambulatory-retailed.
3. Establishments operating ambulatory drug retail shall be responsible for the operating conditions, the origin and quality integrity of the drugs to be retail ambulatory and must rotate the stock of drugs, ensuring the rule that the same drugs should not be retailed ambulatorily for more than 90 days.
4. Establishments operating ambulatory drug retail outlets shall be entitled to preferential treatment and assistance from local funding allocated by the local authorities in accordance with relevant provisions for investment incentives.

Article 35. Conditions required for operating ambulatory drug retail outlets
1. Professional-in charge persons of ambulatory retail operations must possess a certificate of practice as required of drug retail establishments in line with the respective business scope.
2. The drug ambulatory retail outlets must be clearly indicated by a sign stating the name, address of the establishment holding the ambulatory retail operations, the name of the professional-in charge person, operating geographic areas.
Article 36. Scope of ambulatory drug retail operations
1. The list of drugs to be ambulatory retailed must be appropriate considering the professional qualifications of the professional-in-charge person and storage conditions.

2. Directors of relevant Health Departments shall approve the list of drugs to be ambulatory retailed.
Article 37. Procedures, formalities for the registration of ambulatory drug retail operations
1. Establishments operating ambulatory drug retail shall register for setting up ambulatory retail outlets with the Health Department of the locality where the operations are to be conducted.
2. Registration dossiers shall comprise:
a) Certificate of satisfaction of conditions for conducting pharmaceutical business of the establishments operating ambulatory drug retail;
b) Certificate of pharmacy practice of the professional-in charge of the ambulatory retail outlets;
c) Operating geographic areas of each of the ambulatory retail outlets;
d) List of drugs to be retailed at each of the ambulatory retail outlets;
đ) Photography of cabinets, counters for the storing of ambulatory retail drugs;
e) Procedures for the control, monitoring, issuing, receiving of drugs for the ambulatory retail outlets.
3. Within 20 days from the date of dossier receipt, Health Departments shall issue a registration certificate for ambulatory retail outlet operations or a response on the reasons of rejection.

Article 38. Rights and responsibilities of professional-in charge persons of ambulatory drug retail operations
The professional-in charge-person of ambulatory drug retail operations shall have the rights and responsibilities set out for pharmacy practitioners, ambulatory drug retail operations shall be conducted according to the rights and responsibilities set out for drug retail establishments under the provisions of Article 42 Pharmaceutical Law.
Section 5
TRADING AND IMPORTING MEDICINAL MATERIALS, TRADITIONAL DRUGS
Article 39. General conditions for conducting business in medicinal materials, traditional drugs
1. Establishments that manufacture, export, import, wholesale, retail and provide storage service of medicinal materials, traditional drugs must possess a certificate of satisfaction of conditions for drug business covering within its business scope medicinal materials, traditional drugs. 2. Eligibility criteria for Certificate of satisfaction of conditions for drug business covering medicinal materials, traditional drugs in scope:

a) The professional-in charge person of the establishment must possess a suitable certificate of practice according to the provisions of Article 15, 16, 17, 18, 19 and 22 of Pharmaceutical Law;

b) The establishment must fulfill the conditions required of the respective types of business operations as set out in clause 1 Article 33 of Pharmaceutical Law.
Article 40. Conditions required of establishments manufacturing medicinal materials, traditional medicinals
1. Physical facilities:

a) Compliance with good manufacturing practice for medicinal materials, traditional medicinals (GMP for medicinal materials, traditional medicinals). Establishments manufacturing medicinal materials, traditional medicinals must possess manufacturing plants, storage facilities for finished products, storage facilities for input raw materials meeting the required standards at a minimum.
b) The Minister of Health shall set out specific requirements for manufacturing establishments of medicinal materials, traditional medicinals that have not met the standards of good manufacturing practice for medicinal materials, traditional medicinals in line with the set out implementation roadmap for good manufacturing practice for drug raw materials.
2. Personnel:
a) The persons in charge of quality assurance must possess as certificate of pharmacy practice as set out in point a clause 3 Article 15 of Pharmaceutical Law;
b) Of the personnel involved in manufacturing medicinal materials, traditional medicinals there must be at least 01 person holding one of the professional qualifications, certificates, certifications set out in point a, c, e, g clause 1 Article 13 of Pharmaceutical Law and being regularly trained, kept updated of professional knowledge concerning the manufacture, formulation of medicinal materials, traditional medicinals.

Article 41. Conditions required of establishments importing, exporting, providing storage services of medicinal materials, traditional medicinals
1. Physical facilities must include a warehouse meeting good storage practice for medicinal materials, traditional medicinals (GSP for medicinal materials, traditional medicinals). The warehouse for the storage of medicinal mateerials, traditional medicinals must be at least 500 m2 as required.
2. Personnel: The inventory manager of medicinal materials, traditional medicinals must hold one of the professional qualifications, certificates, certifications set out in point a, b, c, e, g, h, i, k, l clause 1 Article 13 of Pharmaceutical Law and be regularly trained, kept updated of professional knowledge pertaining to medicinal materials, traditional medicinals.
Article 42. Conditions required of establishments wholesaling medicinal materials, traditional medicinals

1. Physical facilities must be in compliance with the standards of good distribution practice for medicinal materials, traditional medicinals (GDP for medicinal materials, traditional medicinals). The warehouse for the storage of medicinal materials, traditional medicinals must be at least 300 m² as required.
2. Personnel: The inventory manager of medicinal materials, traditional medicinals must hold one of the professional qualifications, certificates, certifications set out in point a, b, c, e, g, h, i, k, l clause 1 Article 13 of Pharmaceutical Law and be regularly trained, kept updated of professional knowledge pertaining to medicinal materials, traditional medicinals.
Article 43. Conditions required of establishments specializing in the retail of medicinal materials, traditional medicinals 1. Physical facilities:
a) A fixed place of business, with an area commensurate with the business scale, of a minimum 25 m2 , separate; located in a high and dry, well ventilated, safe area, away from polluting sources, with measures for fire and explosion prevention and fighting in place; there must be a display area, storage area for medicinal materials;
b) Adequate equipment in place for the storage of drugs away from adverse impacts of lighting, heat, humidity, pollution, insect infestation, comprising: cupboards, counters, shelving, racks that are sturdy, smooth-finished, easy to clean, convenient for sale display, storage of drugs; Thermometer, hygrometer, dehumidifier for the control of ambient temperature, humidity at the medicinal material retail outlets, lighting system, ventilator; Storage equipment suitable with the storage conditions stated on [product] labeling. Storage ambient temperate to be maintained a below 300C, humidity not above 75%.
2. Personnel:
a) Adequately staffed with personnel suitably qualified for the tasks assigned to them, of which there must be at least one person holding one of the professional qualifications, certificates set out in point a, b, c, e, g, h, i, k, l clause 1 Article 13 of Pharmaceutical Law; b) All personnel must be regularly trained, kept updated with professional knowledge [and] the state regulatory requirements regarding the storage, management of medicinal materials.
3. Retail establishments shall only sell medicinal materials, traditional medicinals that are purchased from establishments qualified for conducting business in medicinal materials; that have known origin and are packaged, labelled according to Ministry of Health’s specifications; they shall not sell unprocessed toxin-containing medicinal materials according to Ministry of Health’s specifications.

Article 44. Conditions required of establishments manufacturing traditional drugs
Establishments manufacturing traditional drugs, except traditional medicinals [,] must fulfill the following conditions:
1. Physical facilities meeting the standard of good manufacturing practice of traditional drugs (GMP for traditional drugs). Establishments manufacturing traditional drugs must possess manufacturing plants, finished product storage facilities, input raw material storage facilities meeting the required standards at a minimum.
2. Personnel:
a) The person in charge of quality assurance must possess a certificate of pharmacy practice as stipulated in Article 13 of Pharmaceutical Law;
b) The person in charge of manufacturing traditional drugs must hold one of the professional qualifications, certificates, certifications set out in point a clause 1 Article 13 of Pharmaceutical Law or a bachelor degree in traditional pharmacy.
Article 45. Conditions required of importing establishments, exporting establishments, establishments providing storage service for traditional drugs
1. Physical facilities must include a warehouse meeting good storage practice of drugs. The warehouse for traditional drugs must be of a minimum 500 m2 as required.
2. Personnel: The inventory manager of traditional drugs must hold one of the professional qualifications, certificates, certifications outline in point a, c, e.g. clause 1 Article 13 of Pharmaceutical Law and be regularly trained, kept updated of professional knowledge pertaining to traditional drugs.

Article 46. Conditions required of establishments wholesaling traditional drugs
1. Physical facilities must be in compliance with the standards of good distribution practice of drugs. Warehouse for the storage of medicinal materials, traditional medicinals must be at a minimum 30 m2 as required.
2. Personnel: The inventory manager of traditional drugs must hold one of the professional qualifications, certificates, certifications outline in point a, c, e, g clause 1 Article 13 of Pharmaceutical Law and be regularly trained, kept updated of professional knowledge pertaining to traditional drugs.

Article 47. Conditions required of establishments specializing in the retail of traditional drugs, medicinal material drugs
1. Physical facilities must be in compliance with the standards of good retail practice of medicinal materials, traditional drugs (GPP).
2. Personnel: The key personnel must hold one of the professional qualifications, certificates, certifications outline in point a, c, e, g and h clause 1 Article 13 of Pharmaceutical Law and be regularly trained, kept updated of professional knowledge pertaining to traditional drugs and medicinal material drugs.

Article 48. Importing medicinal materials, traditional drugs
1. Medicinal material shall only be imported after being licensed for importation and shall be imported not in excess of the quantity stated in the import license.
2. Traditional drugs having a registration number for marketing in Vietnam shall be allowed to be imported according to the provisions of clause 1 Article 60 of Pharmaceutical Law.
3. Traditional drugs having not yet a registration number for marketing in Vietnam shall be allowed to be imported and shall only be imported not in excess of the quantity stated in the import license in accordance with the provisions of clause 2 Article 60 of Pharmaceutical Law.
4. Criteria, dossiers. Formalities, timeframe for import licensure of traditional drugs having not yet a registration number for marketing in Vietnam shall be as regulated.

Article 49. Dossiers, formalities, timeframe for import licensure of medicinal materials

1. Dossier for import licensure of medicinal materials a) Import purchase order as per Ministry of Health set out template. With respect to entrusted importation, the entrusted import agent’s name must be stated on the import purchase order; b) The manufacturer’s quality specification table and test method table for the medicinal materials, or photocopy of the quality standards from relevant pharmacopoeial monographs; c) With respect to medicinal materials containing narcotic, psychotropic, drug precursor active ingredients an Inventory report must be enclosed in the submission, following the Ministry of Health’s template form.

2. Powers, formalities in the issuing of Import license for medicinal materials Businesses shall submit the dossier to Ministry of Heath (Traditional Medicine [and] Pharmacy Administration). Within 20 working days from receipt a valid dossier Ministry of Heath (Traditional Medicine [and] Pharmacy Administration) shall review [the case and] issue the import license. In case of refusal Ministry of Heath (Traditional Medicine [and] Pharmacy Administration) shall issue a written response clearly stating the reasons of the refusal.

Section 6
LICENSURE PROCEDURES, FORMALITIES FOR CONDUCTING BUSINESS IN CONTROLLED DRUGS AND DRUGS ON THE LIST OF RESTRICTED RETAIL
Article 50. Licensure procedures, formalities for conducting business in narcotic drugs, psychotropic drugs, precursor drugs and combination drugs containing narcotic pharmaceutical substances, combination drugs containing psychotropic pharmaceutical substances, combination drugs containing precursors, radioactive drugs

1. Business establishments operating in narcotic drugs, psychotropic drugs, precursor drugs and combination drugs containing narcotic pharmaceutical substances, combination drugs containing psychotropic pharmaceutical substances, combination drugs containing precursors, radioactive drugs shall only be allowed to conduct operations related to narcotic drugs, psychotropic drugs, precursor drugs and combination drugs containing narcotic pharmaceutical substances, combination drugs containing psychotropic pharmaceutical substances, combination drugs containing precursors, radioactive drugs in strict adherence with the business scope stated on the establishments’ Certificate of satisfaction of conditions for drug business.
2. Every year, before 31 March, manufacturing, exporting, importing establishments must submit their forecast regarding their business demand in, utilization of, narcotic raw materials, psychotropic raw materials, drug precursors, narcotic drugs, psychotropic drugs, precursor drugs of the year to Ministry of Health (Drug Administration). Within 10 working days from receipt of a valid submission, Ministry of Health (Drug Administration) shall review [the case and] respond to the respective establishments. The establishments’ application dossiers for import licensure and dossiers requesting for permit to domestic purchase shall only be considered after the approval of the demand forecast.
3. Establishments operating in, utilizing narcotic drugs, psychotropic drugs, precursor drugs shall only be allowed to purchase, sell, dispense, use the drugs after the dossiers requesting permit for domestic purchase of such drugs have been approved.

4. Retail establishments shall only be allowed to retail drugs on the list of retail-restriction drugs according to Minister of Health’s specifications after obtaining a written approval to do so by the relevant local Health Department. The Minister of Health on the basis of disease structure and supply capacity of provinces, centrally-affiliated cities shall provide guidance to Health Departments in their consideration for approval of the retail of drugs on the restricted retail list by the [requesting] retail establishments.
SECTION 7
SECURITY MEASURES, TO ENSURE NON DIVERSION OF CONTROLLED DRUGS, CONTROLLED DRUG RAW MATERIALS
Article 51. General requirements

1. Establishments operating in narcotic drugs, psychotropic drugs, precursor drugs must develop and comply with specific standard operating procedures (SOP) for the handling of narcotic drugs, psychotropic drugs, precursor drugs in the management of their export, import, purchase, sales, storage, delivery and receiving, transport, disposal operations. Standard operating procedures must be constructed in such as way so as to ensure safety, [drug] diversion prevention; every transfer step must be documented, signed off in order to clearly identify the responsibility of each individual involved in the transactions.
2. Establishments operating in combination drugs containing narcotic pharmaceutical substances, combination drugs containing psychotropic pharmaceutical substances, combination drugs containing precursors must have SOPs in place guiding their operations in accordance with the provisions of clause 2 of this Article. These SPOs can be formulated separately or generally to also cover other drugs.
3. Establishments operating in narcotic drugs, psychotropic drugs, precursor drugs and combination drugs containing narcotic pharmaceutical substances, combination drugs containing psychotropic pharmaceutical substances, combination drugs containing precursors, radioactive drugs must be in alignment with the development plan of pharmaceutical industry. The Minister of Health shall depending on the prevailing social economic situations of each particular period formulate a zoning plan for business establishments operating in narcotic drugs, psychotropic drugs, precursor drugs and combination drugs containing narcotic pharmaceutical substances, combination drugs containing psychotropic pharmaceutical substances, combination drugs containing precursors, radioactive drugs, radioactive isotopes and define their scope of business with a view to assuring safety, preventing diversion, eliminating abuses.
Article 52. Requirements for manufacturing establishments
1. Establishments manufacturing narcotic drugs, psychotropic drugs, precursor drugs must fulfill the requirements set out in Article 54 of this Decree and the following requirements:
a) Be in compliance for at least 02 years with the principles, standards of Good manufacturing practice for pharmaceutical products [,] appropriate to each of the respective dosage forms;

b) Have in place a separate warehouse meeting the principles, standards of Good storage practice for pharmaceutical products for the storage of narcotic drugs, psychotropic drugs, precursor drugs commensurate with their business scope but with an minimum floor space of 100m2 and a minimum volume of 300m³. The warehouse must have doors, secure locks, and measures put in place to ensure safety, prevent diversion;
c) The inventory manager of narcotic pharmaceutical substances, semi-finished products containing narcotic pharmaceutical substances, narcotic drugs must hold a bachelor degree in pharmacy and have at least 02 years of practice at a drug manufacturing establishment;
d) The inventory manager of narcotic pharmaceutical substances, psychotropic pharmaceutical substances, drug precursors, precursor drugs must hold a bachelor degree in pharmacy, if graduated from a pharmacy technical school or a pharmacy college he or she must be delegated the responsibility in writing by the head of the establishment. The term of each delegation period shall not be longer than 12 months;
đ) The key person responsible for record keeping, report regime must be hold a bachelor degree in pharmacy and have at least 02 years of practice at a drug manufacturing establishment;

e) The pharmacy-professional-in charge person, individuals directly involved in manufacturing operations, the inventory manager, the key person responsible for record keeping, reporting regime of narcotic drugs, psychotropic drugs and precursor drugs must be trained in legal normative documents pertaining to the management of narcotic drugs, psychotropic drugs and precursor drugs by Ministry of Health’s designated training institutions. Other individuals involved in the manufacturing of narcotic drugs, psychotropic drugs and precursor drugs must receive introductory training, kept updated of relevant legal normative documents and standard operating procedures; training records must be retained at the establishments’ premises.
2. Establishments manufacturing combination drugs containing narcotic pharmaceutical substances, combination drugs containing psychotropic pharmaceutical substances, combination drugs containing precursors must fulfill the requirements set out in Article 51 of this Decree and the following requirements:
a) In compliance for at least 02 years the principles, standards of Good manufacturing practice for pharmaceutical products [,] appropriate to each of the respective dosage forms; b) The inventory manager of raw materials-, semi-finished products- containing narcotic pharmaceutical substances must hold a bachelor degree in pharmacy and have at least 02 years of practice at a drug manufacturing establishment;
c) The inventory manager of raw materials-, semi-finished products- containing psychotropic pharmaceutical substances, raw materials-, semi-finished products- containing precursors must hold a bachelor degree in pharmacy, if graduated from a pharmacy technical school or a pharmacy college he or she must be delegated the responsibility in writing by the head of the establishment. The term of each delegation period shall not be longer than 12 months;
d) The key person responsible for record keeping, reporting regime must hold a bachelor degree in pharmacy and have at least 02 years of practice at a drug manufacturing establishment;

đ) The pharmacy-professional-in charge person, the inventory manager, the key person responsible for record keeping, reporting regime must be trained in relevant normative legal documents pertaining to the regulation of narcotic drugs, psychotropic drugs and precursor drugs by Ministry of Health’s designated training institutions. Other indivivuals involved in the manufacturing of combination drugs containing narcotic pharmaceutical substances, combination drugs containing psychotropic pharmaceutical substances, combination drugs containing precursors must receive introductory training in, kept updated of relevant legal normative documents and standard operating procedures; training records must be retained at the establishments’ premises.
3. Establishments manufacturing radioactive drugs must fulfill the requirements of Article 51 of this Decree and the following requirements:
a) Be in compliance with standards of good manufacturing practice (GMP) appropriate to the types of radioactive drug set out by Ministry of Health and [licensed to operate] by Ministry of Health.
b) Be in compliance with standards of Radiation safety, Nuclear safety and security of radioactive sources, nuclear materials, nuclear equipment in accordance with Ministry of Science and Technology’s regulations.

c) Have a dedicated warehouse meeting standards of good storage practice for pharmaceutical products for the storage of radioactive drugs and must have in place measures to ensure radiation safety, radioactive drug security and be licensed by Administration of radiation and nuclear safety to store radioactive substances. Where the establishment does not have a dedicated warehouse radioactive drugs must be stored in a separate areas, with radiation safety and security ensured as required.
d) The inventory manager must hold a bachelor degree in pharmacy and in possession of a training certificate on radioactive pharmacy, bachelor degree in radioactive chemistry, bachelor in radiation medicine/nuclear medicine specialty and in possession of a training certificate in radiation safety issued by Administration of radiation safety of Ministry of Science and Technology, [and] have at least 1 year practice at a radioactive drug manufacturing establishment.
đ) The key person in charge of record keeping, reporting regime must hold a pharmacy technical diploma or higher level qualifications and have at least 01 year of practice at a drug manufacturing establishment.
e) The person supervising research, production, analysis, testing processes and in charge of record keeping, reporting must hod a bachelor degree in radioactive chemistry, bachelor degree in radiation medicine/nuclear medicine specialty or be a pharmacist of university level with training in radioactive pharmacy and at least 02 year practice at a radioactive drug manufacturing establishment; he/she must be in possession of a training certificate in radiation safety issued by Administration of radiation safety of Ministry of Science and Technology.
g) Personnel performing work related to the manufacture of radioactive drugs of radioactive drug manufacturing establishments must be suitably qualified in the discipline [,] with academic attainment of university or post graduate level in areas covering radioactive chemistry, analytical chemistry, radiopharmaceutical chemistry, nuclear physics, radioactive technique, he or she must thoroughly master the knowledge regarding mechanisms, processes in radioactive drug manufacturing and be complete the training course for radiation safety for workers working in the manufacture, formulation of radioactive substances
Article 53. Requirements for exporting, importing establishments
1. Establishments exporting, importing narcotic drugs, psychotropic drugs, precursor drugs must fulfill the requirements set out in Article 51 of this Decree and the following requirements:
a) Have at least 05 year experience in drug exporting, drug importing;
b) For 05 years up to the date of applying for the supplementation of the operations of exporting, importing narcotic drugs, psychotropic drugs, precursor drugs, the import, export establishment has not been trading in drugs that are concluded by relevant state regulatory authorities as seriously in breach of quality standards nor has it been involved in falsifying or tampering with documents, materials, legal papers from Vietnam or foreign competent authorities; nor has it used a fake seal or forged a signature or a seal of an importing establishment, a manufacturing establishment or any of the establishments related to drug export, import dossiers;

c) Have a dedicated warehouse meeting the principles, standards of Good storage practice for pharmaceutical products for the storage of narcotic drugs, psychotropic drugs, precursor drugs commensurate with the establishment’s business scale but not smaller than 100m² in floor space and of not less than 300 m³ in volume. The warehouse must have doors with secure locks, and measures in place to ensure safey, prevent drug diversion;
d) Have at least 03 places of business meeting the principles, standards of Good distribution practice in 03 regions, the North, the Central and South;
đ) Have in place a software system for the tracking of warehousee receipts, preservation, issues of narcotic drugs, psychotropic drugs and precuror drugs;
e) The inventory manager, the person in charge of reporting, the professional-in charge person must hold a bachelor degree in pharmacy and have at least 02 year practice at a drug manufacturing, tradiding establishment;
g) The pharmacy-professional-in charge person, invidivuals directly involved in the operations of exporting, importing, inventory management, the person in charge of reporting on narcotic drugs, psychotropic drugs, precursor drugs must be trained by Ministry of Health’s designated training institutions on normative legal documents pertaining to the regulation of narcotic drugs, psychotropic drugs and precursor drugs. Other individuals participating in the trading of narcotic drugs, psychotropic drugs, precursors drugs must receive introductory training in, kept updated of relevalnt legal normative documents and standard operating procedures; training records must be retained at the etablishments’ premises.
2. Establishments exporting, importing combination drugs containing narcotic pharmaceutical substances, combination drugs containing psychotropic substances, combination drugs containing precursors must fulfill the conditions required for business operations set out in Article 51 of this Decree and the following requirements:

The pharmacy-professional-in charge person, the inventory manager, the person in charge of reporting must be trained by Ministry of Health’s designated training institutions on normative legal documents pertaining to the regulation of narcotic drugs, psychotropic drugs and precursor drugs. Other individuals participating in the trading of narcotic drugs, psychotropic drugs, precursors drugs must receive introductory training in, kept updated of relevalnt legal normative documents and standard operating procedures; training records must be retained at the etablishments’ premises.
3. Establishments exporting, importing radioactive drugs, radioactive isotopes must fulfill the requirements set out in Article 51 of this Decree and the following requirements:
a) Be in compliance with standards of Radiation safety, Nuclear safety and security of radioactive sources, nuclear materials, nuclear equipment in accordance with Ministry of Science and Technology’s regulations.
c) Have a dedicated warehouse meeting standards of good storage practice for pharmaceutical products for the storage of radioactive drugs, radioactive isotopes and have in place measures to ensure radiation safety, radioactive drug security [and] be licensed by Administration of radiation and nuclear safety to store radioactive substances. Where the establishment does not have a dedicated warehouse radioactive drugs must be stored in a separate areas, with radiation safety and security ensured as required.
c) The inventory manager must hold a bachelor degree in pharmacy and in possession of a training certificate on radioactive pharmacy, bachelor degree in radioactive chemistry, bachelor in radiation medicine/nuclear medicine specialty and in possession of a training certificate in radiation safety issued by Administration of radiation safety of Ministry of Science and Technology, [and] have at least 1 year practice at a radioactive drug manufacturing, trading establishment.

d) The key person in charge of record keeping, reporting regime must hold a pharmacy technical school diploma or higher level qualifications and have at least 01 year of practice at a drug manufacturing establishment.
Article 54. Requirements for wholesale establishments
1. Establishments wholesaling narcotic drugs, psychotropic drugs, precursor drugs must fulfill the requirements set out in Article 51 of this Decree and the following requirements:
a) Have a warehouse meeting the principles, standards of Good storage practice for pharmaceutical products for the storage of narcotic drugs, psychotropic drugs, precursor drugs. The warehouse must have secure locks [and] measures in place for safety protection, diversion prevention. It there is no dedicated warehouse available, narcotic drugs, psychotropic drugs, precursor drugs must be stored at a separate area in a warehouse meeting Good storage practice for pharmaceutical products;
b) Be capable of adequately and timely supplying drugs to retail establishments, drug using establishments in the province catchment area.
c) The inventory manager for narcotic drugs, psychotropic drugs, precursor drugs must hold a bachelor degree in pharmacy and have at least 02 year practice at a drug trading company;

d) The pharmacy-professional-in charge person, the inventory manager of narcotic drugs, psychotropic drugs and precursor drugs must be trained in legal normative documents pertaining to the regulation of narcotic drugs, psychotropic drugs and precursor drugs by Ministry of Health’s designated training institutions. Other individuals participating in the wholesale of narcotic drugs, psychotropic drugs, precursors drugs must receive introductory to, kept updated of relevalnt legal normative documents and standard operating procedures; training records must be retained at the etablishments’ premises.
2. Establishments wholesaling combination drugs containing narcotic pharmaceutical substances, combination drugs containing psychotropic substances, combination drugs containing precursors must fulfill the conditions required for business operations set out in Article 51 of this Decree and the following requirements:
The pharmacy-professional-in charge person, the inventory manager must be trained in legal normative documents pertaining to the regulation of narcotic drugs, psychotropic drugs and precursor drugs by Ministry of Health’s designated training institutions. Other individuals participating in the wholesale of combination drugs containing narcotic pharmaceutical substances, combination drugs containing psychotropic active substances, combination drugs containing precursors must receive introductory training in, kept updated of relevant legal normative documents and standard operating procedures; training records must be retained at the etablishments’ premises.
3. Establishments wholesaling radioactive drugs, radioactive isotopes must fulfill the requirements set out in Article 51 of this Decree and the following requirements:
a) Be in compliance with standards of Radiation safety, Nuclear safety and security of radioactive sources, nuclear materials, nuclear equipment in accordance with Ministry of Science and Technology’s regulations.
b) Have a dedicated warehouse meeting standards of good storage practice for pharmaceutical products for the storage of radioactive drugs, radioactive isotopes and must have in place measures to ensure radiation safety, radioactive drug security and be licensed by Administration of radiation and nuclear safety to store radioactive substances. Where the establishment does not have a dedicated warehouse radioactive drugs must be stored in a separate areas, with radiation safety and security ensured as required.

c) The inventory manager must hold a bachelor degree in pharmacy and in possession of a training certificate on radioactive pharmacy, bachelor degree in radioactive chemistry, bachelor in radiation medicine/nuclear medicine specialty and in possession of a training certificate in radiation safety issued by Administration of radiation safety of Ministry of Science and Technology, [and] have at least 1 year practice at a radioactive drug manufacturing, trading establishment.
d) The key person in charge of record keeping, reporting regime must hold a pharmacy technical diploma or higher level qualifications and have at least 01 year of practice at a drug manufacturing establishment.
Article 55. Requirements for retail establishments
1. Establishments retailing narcotic drugs, psychotropic drugs, precursor drugs must fulfill the requirements set out in Article 54 of this Decree and the following requirements:
a) Be a drugstore meeting the principles, standards of Good pharmacy practice;
b) Be registered with Health Department at the locality;
c) The drugstore’s owner, professional-in charge person must directly manage and retail narcotic finished products;
d) The person who manages and retails psychotropric drugs, precursors drugs must hold a technical school diploma or associate degree in pharmacy;

đ) The pharmacy-professional-in charge person, other invididuals participating in the retail or narcotic drugs, psychotropic drugs, precursor drugs must receive introductory training in, kept updated of relevant legal normative documents and standard operating procedures; training records must be kept at the establishments’ premises.
2. Establishments retailing combination drugs containing narcotic pharmaceutical substances, combination drugs containing psychotropic pharmaceutical substances, combination drugs containing precursors must fulfill the requirements set out in Article 54 of this Decree and the following requirements:
a) Be a drugstore meeting the principles, standards of Good pharmacy practice;

b) Have a tracking registrer, conduct inventory check, prepare annual reports of quantity purchased, received, in stock, 6 months’ customer addresses according to Minister of Health’s specifications;
c) The pharmacy-professional-in charge person, other individuals partipating in the retail of combination drugs containing narcotic pharmaceutical substances, combination drugs containing psychotropic pharmaceutical substances, combination drugs containing precursors must receive introductory training in, kept updated of relevant legal normative documents and standard operating procedures; training records must be kept at the establishments’ premises.
3. Establishments retailing drugs on the restricted retail list according to the Minister of Health must fulfill the requirements set out in point d clause 1 Article 33 of Pharmaceutical Law and must have a tracking register, conduct inventory check, prepare annual reports on the quantity purchased, sold and in stock, 6 months’ customer addresses according to Minister of Health’s specifications.
Article 56. Requirements regarding the delivery, receipt, transport of narcotic raw materials, psychotropic raw materials, drug precursors, narcotic drugs, psychotropic drugs and combination drugs containing narcotic pharmaceutical substances, combination drugs containing psychotropic pharmaceutical substances, combination drugs containing precursors, radioactive drugs

1. Requirements regarding the delivery, receipt, transport of narcotic raw materials, psychotropic raw materials, drug precursors, narcotic drugs, pyschotropic drugs and combination drugs containing narcotic pharmaceutical substances, combination drugs containing psychotropic pharmaceutical substances, combination drugs containing precursors:
a) The person delivering, receiving narcotic raw materials, psychotropic raw materials, drug precursors, narcotic drugs, psychotropic drugs, precursor drugs must hold a technical school diploma or associate degree in pharmacy.
b) Narcotic raw materials, psychotropic raw materials, drug precursors, narcotic drugs, psychotropic drugs, precursor drugs and combination drugs containing narcotic pharmaceutical substances, combination drugs containing psychotropic substances, combination drugs containing precursors mus be packaged, sealed and secured by safety protection measures, to avoid losses during transport; despatching orgin, receiving destination, name of drugs, drug quantity should be clearly indicated on the packaging.
c) The establishment’s head must delegate in writing to an employee holding a technical school diploma or associate degree in pharmacy the responsibility of transporting narcotic raw materials, pyschotropic raw materials, drug precursor raw materials, narcotic drugs, psychotropic drugs, precursor drugs. The responsible person must carry with him/her such delegation letter, his/her identity card (or legal personal identification papers), sales invoices or warehouse release forms; be responsible organoleptically as to the drug category, quantity, quality during transportation and deliver them in full to the receiving party.

d) Where the business establishment contracts out the transport of narcotic raw materials, psychotropic raw materials, drug precursor raw materials, narcotic drugs, psychotropic drugs, precursor drugs: the contracting and the contracted parties must enter into a written agreement clearly specifying the conditions regarding storage, transport, delivery and receipt of narcotic drugs, psychotropic drugs, precursor drugs according to relevant requirements. The contracted party must satisfy those conditions during transportation, preventing drug diversion.
The contracting and contracted parties shall be accountable for any associated issues arising during transportation of narcotic raw materials, psychotropic raw materials, drug precursor raw materials, narcotic drugs, psychotropic drugs, precursor drugs.

2. Requirements regarging the delivery, receipt, transport of radioactive drugs:
a) Esstablishments participating in the delivery, receiving process must be in possession of a license for transport and storage of radioactive drugs issued by Administration of radiation safety of Ministry of Science and Technology.
b) The person delivering, receiving radioactive drugs and radioactive isotopes must be in possession of a training certificate in radiation safety.
c) During the transfer, the delivering person, the receiving person must cross check the name of the radioactive drugs, the type of radioactive isotopes, the radioactivity at the time of preparation, quantity, batch number, expiry date, radiation dose measured on the container surface, the drug quality from organoleptic viewpoint and there must be an accompanying quality certificate.
d) The delivery and receipt of radioactive drugs and radioactive isotopes must be documented by a handover minutes.
đ) Entities involved in the delivery, receipt of radioactive drugs and radioactive isotopes must be in possession of permits neccessary for radiation work involving the delivery, receipt transactions in accordance with the guidelines on the declaration, radiation work licensure and radiation worker certification issued by Ministry of Science and Technology.
e) The transport of radioactive drugs, radioactive isotopes must be carried out safely in strict adherence with the guidelines for safe transport of radioactive materials issued by Ministry of Science and Technology.

g) The head of etablishments manufacturing, trading, using radioactive drugs and radioactive isotopes must delegate in writing to an employee holding a pharmacy technical school diploma or higher level qualifications and in possession of training certificate in radiopharmaceutical chemistry the responsibility of transporting radioactive drugs, radioactive isotopes; The person responsible for the transport must carry with him/her such delegation letter, identity car (or legal personal identification papers), certificate of training in radiation safety, sales invoices or warehouse release forms; be responsible organoleptically as to the drug category, quantity, quality during transportation and deliver them in full to the receiving party.
Article 57. Requirements regarding the storage of narcotic drugs, psychotropic drugs, precursor drugs and combination drugs containing narcotic pharmaceutical substances, combination drugs containing psychotropic substances, combination drugs containing precursors at the drug using establishments
1. The inventory manager managing narcotic drugs at the establishments’ pharmacy department must hold a bachelor degree in pharmacy. If graduated from a pharmacy technical school or college he/she must have the responsibility delegated to in writing by the head of the establishment. The term of each delegation period shall not be longer than 12 months.
2. Narcotic drugs, psychotropic drugs, precursor drugs at the pharmacy department must be stored in warehouses meeting the principles, standards of “good storage practice of pharmaceutical products”; hospitals’ pharmacy deparments must prepare to implement the principles of “Good storage practice of pharmaceutical products” (GSP) in strict accordance with the roadmap set out by Ministry of Heath, [and] have in place measures for safety protection, diversion prevention.

Warehouses, cupboards for the storage of narcotic drugs, pyschotropic drugs, precursor drugs must be secured with locks. If there is no separate warehouses, cupboards availabe, narcotic drugs may be stored together with pyschotropic drugs and precursor drugs but they have to be kept separate to avoid confusion

Combination drugs containing narcotic pharmaceutical substances, combination drugs containing psychotropic substances, combination drugs containing precursors must be stored in a separate areas.
3. Narcotic drugs, psychotropic drugs, precursor drugs stocked in out-of-hours service drug cupboards, emergency drug cupboards must be kept separate in a designated drawer or section guarded by the on-duty nurse and dispensed according to medical orders, cupboards must be securely locked. The head of the establishment must stipulate in writing the quantity, type of narcotic finished products, psychotropic finished porducts, finished precursor drugs to be stocked in out-of-hours service drug cupboards, emergency drug cupboards. At the change of shift, the outgoing drug keeper from the old shift must handover the drugs and the register to the incoming drug keeper of the new shift.
4. Narcotic drugs, psychotropic drugs, precursor drugs stocked in education-labor-social centers, centers providing compulsory treatment of addiction to opium-form substances by alternative drugs [must be] managed, dispensed and kept record of by a person holding a bachelor degree in pharmacy. If such person is graduated from pharmacy technical schools or pharmacy colleges the job must be delegated to him/her in writing by the head of the establishment. The term of each delegation period shall not be longer than 12 months.

5. Psychotropic drugs of commne clinics must be kept in securely locked counters, cupboards, with measures for safety protection, diversion prevention in place.
Article 58. Regulations regarding the storage of radioactive drugs, radioactive isotopes at healthcare establishments, Medicine – Pharmacy specialized research, training institutions
a) Physical facilities: Radioactive drugs, radioactive isotopes must be stored in warehouses compying with the provisions of good storage practice for radioactive drugs (GSP-radioactive drug section) and legislation on radiation safety; hospital’s pharmacy departments must prepare to implement the principles of “Good storage practice for radioactive drugs ” (GSP- radioactive drug section) in strict adherence to Ministry of Health’s set out roadmap and [the protocol for] storage of radioactive substances of Ministry of Science and Technology. Warehouses, storage cupboards for radioactive isotopes must be securely locked, suitably equipped for radiation safety and security protection, to counter to radiation exposure to the environment.
b) Inventory manager: university-level pharmacist or technician pharmacist having been trained in radiation safety and delelated the job to him/her (in writing by the establishments, the term of each delegation period not longer than 12 months).

Businesses shall send application dossiers to Ministry of Health (Drug Administration). Within 10 working days from receipt of a valid dossier, Ministry of Health (Drug Administration) shall review [the case and] issue the import license. If the application is rejected, Ministry of Health (Drug Administration) shall provide a written response to the applying business stating the rejection reasons.
Article 59. Requirements for compounding narcotic drugs, psychotropic drugs, precursor drugs and combinationation drugs containing narcotic pharmaceutical substances, combination drugs containing psychotropic pharmaceutical substances, combination drugs containing precursors at hospitals
Hospital compoudning narcotic drugs, psychotropic drugs, precursor drugs and combination drugs containing narcotic pharmaceutical substances, combination drugs containing psychotropic pharmaceutical substances, combination drugs containing precursor must fulfill the following contidions:
1. Physical facilities of the compounding area:
a) Compounding room: fitted with anti-dust ceiling, floor and walls of cleanable, disinfectable as necessary, materials. The room must built in a well ventilated, separate, safe, away-from-polluting-source area. The floor area should at at a minimum 10m². Layout of functions should be in a one-directional pattern;
b) There is a sink for handwashing and washing of compounding tools;
c) There are adequate tools available for drug compouding, storing and testing.
2. Compouding personnel:
a) The person supervising, in charge of record keeping, reporting regime, quality control of drugs after compounding must hold a pharmacist degree;
b) The person managing narcotic drugs after compounding must hold a pharmacist degree;
c) The peson managing psychotropic drugs, precursor drugs after compouding mst hold a pharmacy technical school diploma or associate degree in pharmacy.
3. Packaging, labelling, storing drugs

a) Narcotic drugs, psychotropic drugs, precursor drugs after compounding must be packaged, labelled immediately to avoid confusion. Labelling must indicate the following information: Establishment’s name, drug name, dosage form, active ingredient, strength or concentration or strength, compounding person, supervising person, compounding date, drug expiry date;
b) Narcotic drugs, psychotropic drugs, precursor drugs and combination drugs containing narcotic pharmaceutical substances, combination drugs containing psychotropic pharmaceutical substances must be stored in a separate cupboards; fitted with measures, equipment to ensure safety, prevent diversion.
4. Operating scope:
a) Hospitals qualified for compounding shall be allowed to purchase narcotic pharmaceutical substance, psychotropic pharmaceutical substances, drug precursors from export, import establishments set out in Article 53 of this Decree;
b) Drugs compounded by hospitals shall only be sold, dispensed according to presciptions to inpatients and outpatients of the same hospitals;
c) Hospitals shall only compound drugs for which the formula, compounding procedures, quality specifications are approved by its head. The head of the hospitals shall be responsible for the safety and efficacy of the drugs compounded by his/her hospital;
d) Compounding injectable drugs is not allowed.

Article 60. Requirements regarding compounding radioactive drugs at hospitals:
Hospitals with the mandate of delivering medical services by nuclear medicine techniques must be licensed by Ministry of Health and the regulatory agency for radiation safety for compouding radioactive drugs and radioactive isotopes for their own use and must fulfill the following requirements:
1. Physical facilities: Must be commensurate with guidelines of good compouding practice for radioactive drugs issued by Ministry of Health.
2. Personnel:
a) The compounding person must be a pharmacist of technical school level or higher, technician, holder of bachelor degree in radioactive chemistry and a training certificate in radiation safety and radioactive pharmacy;

b) The person supervising, in charge of record keeping, reporting regime, quality control of radioactive drugs after compounding must hold a bachelor degree in radioactive chemistry, bachelor degree in radiation medicine/nuclear medicine specialty or be a pharmacist of university level with training in radiopharmaceutical chemistry.
3. Operating scope:
a) Compounded drugs shall only be sold, dispensed per prescriptons to patients treated or diagnosed at the compounding establishment;
b) Radioactive drugs, radioactive isotopes after compounding must stored in special radiation shieding lead containers, with distinct marking symbol; there must be measures equipment available to ensure radiation safety protection and security of radiation sources.
3. Operating scope:
a) Compounded drugs shall only be sold, dispensed per prescriptions to patients treated or diagnosed at the compounding establishment;
b) Compounding shall only be undertaken of drugs for which the formula, compounding procedures, quality specifications are approved by the head of the establishments, the latter shall be responsible for the safety and efficacy of the drugs.

Article 61. Regulations regarding compounding narcotic drugs, psychotropic drugs, precursor drugs and combination drugs containing narcotic pharmaceutical substances, combination drugs containing psychotropic pharmaceutical substances, combination drugs containing precursors at medicine – pharmacy specialized research, training institutions
Medicine – pharmacy specialized research, training institutions compounding narcotic drugs, psychotropic drugs, precursor drugs and combination drugs containing narcotic pharmaceutical substances, combination drugs containing psychotropic pharmaceutical substances, combination drugs containing precursors must fulfill the following conditions and requirements:
1. Physical facilities of compounding area:
a) Compounding room: fitted with anti-dust ceiling, floor and walls of cleanable, disinfectable as necessary, materials. The room must built in a well ventilated, separate, safe, away-from-polluting-source area. The floor area should at at a minimum 10m². Layout of functions should be in a one-directional pattern;
b) There is a sink for handwashing and washing of compounding tools;
c) There are adequate tools available for drug compouding, storing and testing.
2. Compounding personnel: the person supervising the compounding, in charge of record keeping, reporting regime, quality control of drugs after compounding and in charge of record keeping, reporting regime must hold a pharmacist degree;
b) The person managing narcotic drugs after compounding must hold a pharmacist degree;

c) The peson managing psychotropic drugs, precursor drugs after compouding mst hold a pharmacy technical school diploma or associate degree in pharmacy.
3. Packaging, labelling, storing drugs
a) Narcotic drugs, psychotropic drugs, precursor drugs after compounding must be packaged, labelled immediately to avoid confusion. Labelling must indicate the following information: Establishment’s name, drug name, dosage form, active ingredient, strength or concentration or strength, compounding person, supervising person, compounding date, drug expiry date;
b) Narcotic drugs, psychotropic drugs, precursor drugs must be stored in a separate drawer or section of a securely locked cupboard; fitted with measures to ensure safety, prevent diversion. Combination drugs containing narcotic pharmaceutical substances, combination drugs containing psychotropic pharmaceutical substsances, combinations drugs containing precursors must be stored in dedicated areas; fitted wtih measures, equipment to ensure safety, diversion prevention.
4. Operating scope:
a) Esablishments qualified for compounding shall be allowed to purchase narcotic pharmaceutical substances, psychotropic pharmaceutical substances, drug precursors from export import establishments as set out in Article 53 of this Decree;
b) Compounded drugs shall only be used for the purpose of teaching and scientific study of the establishments themselves.

Article 62. Regulations regarding compounding, utilization of radioactive drugs and radioactive isotopes at medicine – pharmacy specialized research, training institutions
1. Medicine – pharmacy specialized research, training institutions in possession of a certification of research, training in radioactive drugs, radioactive isotopes shall be allowed to compound, utilize radioactive drugs for the purpose of teaching and scientific study; there must be a pharmacist or pharmaceutical chemistry officer trained in radiopharmaceutical chemistry to supervise or perform the compounding and be responsible for recordkeeping protocol as regards the register of compoundings, the register for the tracking of receipts and issues of radioactive drugs and reporting in accordance with the provisions of this Decree.
2. Radioactive drugs, radioactive isotopes after compounding must be packaged, labelled immediately to avoid confusion Labeling information must conform to Minister of Health’s specifications.
3. Radioactive drugs, radioactive isotopes must be stored in dedicated cupboards; fitted with equipment, measures for safety protection, prevention of diversion and radiation exposure.
Article 63. Regulations regarding the disposal of narcotic raw materials, psychotropic raw materials, drug precursors and combination drugs containing narcotic pharmaceutical substances, combination drugs containing psychotropic pharmaceutical substances, combination drugs containing precursors, radioactive drugs

1. Raw materials, semifinished products containing narcotic active substances; raw materials, semifinished products containing psychotropic active substances; raw materials seminfinished products containing precursors, narcotic drugs, psychotropic drugs and precursor drugs that are past their expiry date, are substandard, sample drugs past their retention date, returned drugs from therapeutic departments and returned drugs from cases of deceased patients must be disposed of, the following steps must be undertaken to dispose of unwanted drugs:
a) A written letter requesting for the disposal of drugs to be sent to the forecast reviewing agency. The request letter must state clearly the drug name, strength-concentration, quantity, disposal method. Drug disposal shall only be carried out after being approved by the forecast reviewing agency;
b) Decision by the head of the establishment to form a drug disposal board. The board should be made up of at least 03 persons, of which one must be an in charge officer of the establishment;
c) Prepare a minutes of drug disposal and file it at the establishment’s premises;
d) After the drug disposal is completed, a report on the disposal must be sent to the forecast reviewing agency (with the drug disposal minutes enclosed).

2. Overrun products, defective products containing narcotic, psychotropic active substances and drug precursors from production lines that are in need of disposal should be gathered and disposed in accordance with the requirements in point b and point c clause 1 of this Article.
3. Primary packaging of narcotic drugs, psychotropic drugs, precursor drugs no longer in use at manufacturing, trading establishments must be gathered and disposed of in accordance with the requirements in point b and point c clause 1 of thi Article.
4. Primary packaging of drugs, comprising: empty bottles, ampoules, vials of container drugs, psychotropic drugs and precursor drugs no longer in use at the establishment must be disposed of according to the requirements in point b and point c clause 1 of this Article.
5. The disposal of narcotic drugs, psychotropic drugs, precursor drugs, combination drugs containing narcotic pharmaceutical substances, combination drugs containing psychotropic substances must be carried out separately from other drugs’; safety of humans, animals must be absolutely ensured and environment pollution avoided in accordance with environment protection legislation.
6. Radioactive drugs that are no longer usable must be disposed of and returned to state of radioactive waste.

7. Radioactive waste originating from radioactive drugs must be tightly managed, gathered together and ensured of causing no harm to humans and environment, ensuring that the radiation dose radiation workers and members of the public are exposed to does not exceed to the dose limits set out by the Minister of Science and Technology regarding the control and safety assurance of occupational radiation and non-occupational radiation.
8. The treatment of radioactive waste must be undertaken in compliance with the regulatory provisions for the management of radioactive waste and used radioactive sources of Ministry of Health and Technology.
Article 64. Requirements regarding dispensing, using narcotic drugs, psychotropic drugs, radioactive drugs
1. Pharmacy departments shall dispense drugs to therapeutic departments according to Requisition form for narcotic drugs, psychotropic drugs and precursor drugs as set out by the Minister of Health and directly dispense drugs to outpatients..
2. The head of pharmacy depatment or the university-graduated pharmacist who is delegated the responsibilty in writing by the first shall approve with his/her signature Requisition forms for narcotic drugs, psychotropic drugs and precursor drugs from therapeutic departments, examination wards and the out-of-hours pharmacy shifts.
3. The head of therapeutic departments, head of examination wards shall approve with his/her signature Requisition forms for narcotic drugs, psychotropic drugs and precursor drugs for his/her own department, ward.

4. At therapeutic departments, examination wards, upon receiving narcotic drugs, psychotropic drugs and precursor drugs from pharmacy deparments, the nurse assigned with the task must cross check the drugs’ name, strengths, concentration, quantity before injecting or distributing to patients and must directly dispense them to patients.
5. For unwanted narcotic drugs, psychotropic drugs and precursor drugs left over from patients who are transferred to other hospitals or deceased, the therapeutic deparments must prepare paperwork for returning them to pharmacy department. The head of pharmacy department shall make decisions regarding whether to put them to use again or dispose of them depending on actual situations and document the decision for filing at the deparment.

6. Pharmacy department must monitor and keep full records of the quantity of narcotic drugs, psychotropic drugs and precursor drugs received, issued, in stock in accordance with Minister of Health’s specifications.
7. Psychotropic drugs supporting public mental health programs at health clinics of communes, wards, townships must be managed, dispensed, kept records of by a person holding professional qualifications of pharmacist assistant level or higher or physician assistant level or higher.
8. Pharmacy department of general hospitals operating a Nuclear medicine department shall dispense radioactive drugs, radioactive isotopes to Nuclear medicine department and shall not dispense drugs directly to patients.
The head of Pharmacy department or a person graduated from Pharmacy university with training certificate in radiopharmaceutical chemistry who is delegated the responsibility by the department head shall approve with his/her signature the requisition form of radioactive drugs, radioactive isotopes for the pharmacy department’s out-of hours shifts.
9. The head of Nuclear medicine department or a university graduated pharmacist with training certificate in radioactive pharmacy/holder of bachelor degree in radioactive chemistry/medical doctor specializing in nuclear medicine who is delegated the responsibility in writing by the department head shall approve with his/her signature the requisition form of radioactive drugs, radioactive isotopes and radioactive substances for drug production of the department.

At the Nuclear medicine department after receiving drugs from Pharmacy department, the university graduated pharmacist with training certificate in radioactive pharmacy/holder of bachelor degree in radioactive chemistry/medical doctor specializing in nuclear medicine who is assigned the task must cross check the name of the drugs, name of radioactive isotopes, calibrated radioactivity of the measuring date, type of carrier substances, expiry date, quantity of drugs before putting into storage, compounding or administering to patients.
Unused radioactive drugs, radioactive isotopes left over from patients being transferring to toher hospitals or deceased patients must be kept at the Nuclear medicine department and safely stored. The Nuclear department’s head shall depending on actual situations decide whether to put them back to use or dispose of them according to relevant regulations.
The Nuclear department must monitor and keep records of the quantity of radioactive drugs, radioactive isotopes, carrier substances that are received, kept in stock using the template form set out by the Minister of Health.
10. The Nuclear medicine specialist making the diagnostic/therapeutic requisition and prescribes radioactive drugs, radioactive isotopes to patients shall be responsible for the prescribed indications, dosage, administration route, execution mode, result evaluation, handling of complications (if any) in the course of administeing radioactive drugs, radioactive isotopes.

The nuclear medicine specialist may delegate the introducing of radioactive drugs, radioactive isotopes into the patient’s body to a nurse who have been trained in the specialty of nuclear medicine.
11. The radiopharmaceutical chemistry officer: shall be responsible for receiving from supplying sources, storing for the use of his/her unit, dispensing radioactive drugs, radioactive isotopes. He/she shall excecute medical orders of compounding, extracting marking radioractive drugs of medical doctors when there are requisitions for radioactive drugs to support diagnostic/therapeutic purposes.
12. The radiation safety officer: shall monitor, inspect, ensure radiation safety in the establishment that uses radioactive for disease diagnosing [and] treating.

13. The head of Nuclear medicine unit shall be have direct, total responsibility over all aspects of the operations in the unit’s utilization of radioactive drugs, radioactive isotopes for disease diagnosing [and] treating.
Article 65. General provisions regarding the authorization required for domestic purchase of narcotic drugs, psychotropic drugs, precursor drugs, narcotic raw materials, psychotropic raw materials, drug precursors
1. Business establishments, establishments using narcotic drugs, psychotropic drugs, precursor drugs shall only be allowed to purchase, sell, dispense, use narcotic drugs, psychotropic drugs, precursor drugs after the domestic purchase order has been approved by the competent authority.
2. Exporting, importing establishments, manufacturing establishments, establishments authorized to compound narcotic drugs, psychotropic drugs, precursor drugs, combination drugs containing narcotic pharmaceutical substances, combination drugs containing psychotropic substances, combination drugs containing precursors shall only be allowed to purchase, sell narcotic raw materials, psychotropic raw materials after the domestic purchase order has been approved by the competent authority.

3. The head of establishment shall be responsible for the quantity of narcotic drugs, psychotropic drugs, precursor drugs, narcotic pharmaceutical substances, psychotropic pharmaceutical substances, drug precursor requested to be approved for domestic purchase.
Article 66. Dossiers, formalities, powers in authorizing domestic purchase of narcotic drugs, psychotropic drugs, precursor drugs, narcotic raw materials, psychotropic raw materials, drug precursors
1. Dossiers applying for approval of domestic purchase:
a) Domestic purchase order according to Minister of Health’s specifications;
b) Report on the usage of drugs according to Minister of Health’s specifications;
c) Officinal note providing the rationale of the request for domestic purchase and undertaking that purchased drugs would be used for the correct intended purposes.
2. Powers in authorizing domestic purchase:
a) Ministry of Health (Drug Administration):
– Issue permits for domestic purchase of narcotic raw materials, psychotropic raw materials, drug precursors to manufacturing establishments, hospitals, research, testing establishments, Medicine – pharmacy training institutions;
– Issue permits for domestic purchase of narcotic drugs, psychotropic drugs, precursor drugs to exporting, importing establishments as set out in Article 53 of this Decree;

– Issue permits for domestic purchase of narcotic drugs, psychotropic drugs, precursor drugs to establishments that are outside the Health sector regulatory purview but in need of purchasing Issue license for domestic purchase of narcotic drugs, psychotropic drugs, precursor drugs to support scientic research of which the protocol has been aproved by the state competent health regulatory agency;
– Issue permits for domestic purchase of narcotic drugs, psychotropic drugs, precursor drugs to Military Health Administration – Ministry of National defense.
b) Health Department of provinces, centrally-affiliated cities shall issue permits for domestic purchase of narcotic drugs, psychotropic drugs, precursor drugs to wholesale establishments, in-sector and off-sector medical service establishments (except for units under Ministry of National defense and Ministry of Transport), research institutions, Medicine – pharmacy specialized training institutions. Depending of each particular locality, Health Department may devolve to the Health clinic of districts, precints, townships or Medical center of districts, precints, townships (if there are university graduated pharmacist available) to issue permits for domestic purchase of narcotic drugs, psychotropic drugs, precursor drugs for health clinics of communes, wards, townships.
c) Military Health Administration – Ministry of National defense shall issue permtis for domestic purchase of narcotic drugs, psychotropic drugs, precursor drugs to hospitals, units affiliated to Ministry of National defense.
d) Healthcare Administration – Ministry of Transport shall issue permits for domestic purchase of narcotic drugs, psychotropic drugs, precursor drugs to hospitals, units affiliated to Ministry of Transport.
3. Licensure formalities and time limit:
Establishments shall send application dossiers to the competent agency set out in clause 2 of this Article. Within 10 working days from receipt of a valid dossier, the competent agency shall review [and] issue the permit for domestic purchase. If the application is rejected, the competent agency shall issue a written response to the applying establishment stating the rejection reasons.

Chapter IV
DRUG EXPORTATION, DRUG IMPORTATION
Section I
CRITERIA, DOSSIERS, FORMALITIES, TIME LIMITS REGARDING EXPORT LICENSURE FOR DRUGS, DRUG RAW MATERIALS
Article 67. General provisions
1. The exportation of drugs shall be undertaken in accordance with the provisions of clause 4 and 5 Article 60 of Pharmaceutical Law.
2. Traders manufacturing, exporting, entrusting agents to export on their behalf, being being entrusted to export on others’ behalf, drugs, drug raw materials shall be responsible for the intellectual property rights associated with the exported drugs, drug raw materials in accordance with Pharmaceutical Law, Commerce Law, Intellectual property Law and prevailing applicable regulations.
3. Non-trader organizations, individuals shall be allowed to entrust an agent on the basis of a legal contractual agreement the exportation of drugs to meet their own demand, except for medicinal materials belonging to the list of controlled precious, rare, endemic species, breeds, drug raw materials being psychotropic pharmaceutical substances, narcotic substances, drug precursors on the list issued by the Minister of Health or the list of radioactive substances issued by the Government.
4. License for exporting drugs, drug raw materials shall be valid for a maximum 01 year from signing date.
Article 68. Criteria, dossiers, formalities, time limit for export licensure of narcotic drugs, psychotropic drugs, precursor drugs, combination drugs containing narcotic pharmaceutical substances, combination drugs containing psychotropic substances, combination drugs containing precursors already licensed for marketing in Vietnam

1. Criteria: drugs to be exported must meet the following criteria:
a) Drugs for which a certificate of registration for marketing in Vietnam has been issued;
b) Drugs that have been licensed for importation by the competent health authority of the importing country.
2. Application dossier for export licensure:
a) Export manifest in conformance with Minister of Health’s specifications;

b) Original copy of import license issued by the competent health authority of the importing country. If the import license is not yet expressed in Vietnamese or English, a notarized translated Vietnamese or English version must be submitted in the dossier.
3. Formalities and time limit for export licensure:
Businesses shall send application dossiers to Ministry of Health (Drug Administration). Within 10 working days from receipt of a valid dossier Ministry of Health (Drug Administration) shall review [and] issue the export license. If the application is rejected, Ministry of Health (Drug Administration) shall issue a written response to the applying establishment stating the rejection reasons.
Article 69. Criteria, dossiers, formalities, time limit for export licensure of narcotic drugs, psychotropic drugs, precursor drugs, combination drugs containing narcotic pharmaceutical substances, combination drugs containing psychotropic substances, combination drugs containing precursors not yet licensed for marketing in Vietnam
1. Criteria: drugs to be exported must meet the following criteria:
a) Drugs for which there is not yet a certificate of registration for marketing in Vietnam;
b) Drugs that have been licensed for importation by the competent health authority of the importing country.

2. Application dossier for export licensure:
a) Export manifest in conformance with Minister of Health’s specifications;
b) Original copy of import license issued by the competent health authority of the importing country. If the import license is not yet expressed in Vietnamese or English, a notarized translated Vietnamese or English version must be submitted in the dossier;
c) Duplicate copy (stamped with certifying seal of the importing establishment) of the marketing license at the importing country (if applicable);
d) Written attestation of the manufacturing establishment and exporting establishment that the drugs to be exported are manufactured in conformance with the import license issued by the importing country’s competent health authority.
3. Formalities and time limit for export licensure:
Businesses shall send application dossiers to Ministry of Health (Drug Administration). Within 10 working days from receipt of a valid dossier Ministry of Health (Drug Administration) shall review [and] issue the export license. If the application is rejected, Ministry of Health (Drug Administration) shall issue a written response to the applying establishment stating the rejection reasons.

Article 70. Criteria, dossiers, formalities, time limit for export licensure of radioactive drugs, radioactive isotopes, toxic drugs, drugs containing pharmaceutical substances on the list of drugs banned from use in some particular fields, sectors, not yet licensed for marketing in Vietnam
1. Criteria: drugs to be exported must meet the following criteria:
a) Drugs for which there is not yet a certificate of registration for marketing in Vietnam;
b) Drugs that have been licensed for importation or licensed for marketing by the competent health authority of the importing country (in the case of radioactive drugs, radioactive isotopes).
2. Application dossier for export licensure:
a) Export manifest in conformance with Minister of Health’s specifications;

b) Original copy of import license issued by the competent health authority of the importing country. If the import license is not yet expressed in Vietnamese or English, a notarized translated Vietnamese or English version must be submitted in the dossier; or duplicate copy of license for marketing at the importing country or duplicate copy of certificate of pharmaceutical product issued by the importing country’s competent authority;
c) Written attestation of the manufacturing establishment and exporting establishment that the drugs to be exported are manufactured in conformance with the import license issued by the importing country’s competent health authority.
3. Licensure formalities and time limit:
Businesses shall send application dossiers to Ministry of Health (Drug Administration). Within 10 working days from receipt of a valid dossier Ministry of Health (Drug Administration) shall review [and] issue the export license. If the application is rejected, Ministry of Health (Drug Administration) shall issue a written response to the applying establishment stating the rejection reasons.
Article 71. Criteria, dossiers, formalities, time limit for export licensure of medicinal materials on the list of controlled precious, rare, endemic species, breeds
1. Criteria: Medicinal materials on the Ministry of Health-issued list of controlled precious, rare, endemic species, breeds 2. Application dossier for medicinal material export licensure

a) Export manifest order in conformance with Minister of Health’s specifications; b) The manufacturer’s quality specification table and test method table for the medicinal materials, or photocopy of the quality standards from relevant pharmacopoeial monographs; c) Written attestation from the exporting establishments regarding the sustainable cultivation and exploitation of medicinal materials. 2. Powers, formalities in export licensure for medicinal materials: Businesses shall send application dossiers to Ministry of Health (Administration of traditional medicine & pharmacy). Within 10 working days from receipt of a valid dossier Ministry of Health (Administration of traditional medicine & pharmacy) shall review [and] issue the export license. If the application is rejected, Ministry of Health (Administration of traditional medicine & pharmacy) shall issue a written response to the applying establishment stating the rejection reasons.
Article 72. Criteria, dossiers, formalities for export licensure of drug raw materials being psychotropic pharmaceutical substances, narcotic pharmaceutical substances, drug precursors or radioactive substances for drug manufacture

1.Criteria: drug raw materials that have been licensed for importation by the importing country’s competent health authority.
2. Application dossier for export licensure:
a) Export manifest in conformance with Minister of Health’s specifications;
b) Original copy of import license issued by the competent health authority of the importing country. If the import license is not yet expressed in Vietnamese or English, a notarized translated Vietnamese or English version must be submitted in the dossier;
c) Duplicate copy (stamped with certifying seal of the importing establishment) of the marketing license at the importing country for the drug containing the raw materials being requested to export (if applicable);

d) Written attestation of the manufacturing establishment and exporting establishment regarding the conformance to the import license issued by the importing country’s competent health authority of the raw materials to be exported.
3. Formalities and time limit for export licensure:
Businesses shall send application dossiers to Ministry of Health (Drug Administration). Within 10 working days from receipt of a valid dossier Ministry of Health (Drug Administration) shall review [and] issue the export license. If the application is rejected, Ministry of Health (Drug Administration) shall issue a written response to the applying establishment stating the rejection reasons.
Article 73. Criteria, dossiers, formalities time limit for export licensure of drugs not intended for commercial purposes (also known as non-commercial drugs)

1. Criteria: the drugs to be exported should meet all of the following criteria:
a) Drugs that are gifts, donations from organizations, individuals in Vietnam sent to organizations, individuals in a foreign country; drugs that are part of belongings of diplomatic missions, international organizations to Vietnam, or diplomatic missions, organizations of Vietnam to a foreign country and individuals working in these missions, organizations (where there are provisions for concessions, exemption from customs formalities the international treaty of which Vietnam is party to shall apply); drugs that are part of personal baggage of travelers exiting the country brought out as cargo, accompanied carry-on baggage;
b) Drugs that are exported through non commercial channel solely for personal use in disease treatment of the applying individual or their family members, [or] individuals working in the organization applying for the non commercial drug export;
c) Individuals, organizations applying for drug exportation through non commercial channel shall be responsible for the origin and quality of the drugs being exported via non commercial channel;
d) Drugs exported via non commercial channel must have labels clearly indicating the drug name, active ingredient name, strength, concentration, expiry date;
đ) They must satisfy the regulatory requirements of destination country;
e) They are not drug raw materials, do not belong to the list of drug prohibited from exportation for the manufacture of drugs for human use;
g) Export quantity limit:

– Quantity of narcotic drugs shall not exceed the quantity prescribed in the accompanying doctor’s prescription and shall not exceed the quantity of a 07 day course based on the directions for use.
– Quantity of psychotropic drugs shall not exceed the quantity prescribed in the accompanying doctor’s prescription and shall not exceed the quantity of a 10 day course based on the directions for use.
– Other drugs shall be allowed to be exported via non commercial channel with no restriction on quantity and number of dispatches or times of exporting as personal accompanied baggage.
2. Application dossier for export licensure:
a) Export application dossier for drugs meeting the requirements of point g clause 1 of this Article shall comprise:
– Drug prescription, medical exam booklet: Prescription by a Vietnamese physician, outpatient medical exam booklet following the form set out by the Minister of Health regarding prescribing protocols for outpatient service; Drug prescriptions, medical exam booklets from a foreign national physician must be written in English or Vietnamese, if written in other languages they must be translated into Vietnamese and must cover the following: patient’s name, age; drug name, strength or concentration and units of volume; drug quantity (or number of days’ supply); dosage; physician’s full name, signature; physician’s address (address of the physician’s place of practice: hospital, physician ‘clinic).
b) Export application dossier for drugs not meeting the requirements of point g clause 1 of this Article shall comprise:
– Application form following the template set out by the Minister of Health;
– Valid copy of Identification card or passport of the person exporting drugs via non commercial channel (original copy of identification card, passport must be presented when undertaking customs procedures);
– Drug prescription, medical exam booklet: in accordance with requirements set out in point a of this clause.
3. Formalities and time limit for export licensure:
a) Organizations, individuals shall undertake export customs formalities directly at the port of entry in the case of export drugs meeting the requirements of point g clause 1 of this Article;

b) In the event the drugs applied for exportation by an individual applicant do not meet the requirements set out point g clause 1 of this Article, the individual applicant should send an application dossier to the Health Department of the same locality of the port of arrival processing his/her entry formalities or the Health Department of the locality of his/her residency or legal temporary residency. Within 7 working days from receipt of a valid dossier, Health Department shall consider the case for export licensure. If the application is rejected, Health Department shall issue a written response clearly stating the rejection reasons.
c) In the event the drugs applied for exportation by an organization do not meet the requirements set out in point g clause 1 of this Article, the organization applicant should send an application dossier to Ministry of Health (Drug Administration). Within 7 working days from receipt of a valid dossier, Ministry of Health (Drug Administration) shall consider the case for export licensure. If the application is rejected, Ministry of Health (Drug Administration) shall issue a written response clearly stating the rejection reasons.
Section 2
CRITERIA, DOSSIERS, TIME LIMITS REGARDING IMPORT LICENSURE FOR DRUGS, DRUG RAW MATERIALS
Article 74. General provisions

1. The importation of drugs shall be undertaken in accordance with the provisions of Article 60 of Pharmaceutical Law.
2. Importation for the manufacture of drugs for human use of drugs and drug raw materials on the List of drugs and drug raw materials prohibited from import, prohibited from production enclosed in Appendix 2 of this Decree is prohibited.
3. The Minister of Heath shall be tasked with the formulation of regulations on expiry dates of imported drugs, imported drug raw materials.
4. General provisions for organization, individuals involved in the importation of drugs, drug raw materials:
a) Fulfill the requirements set out in clause 1 Article 43 and clause 1 Article 44 of Pharmaceutical Law;

b) Businesses in possession of Certificate of satisfaction of conditions for conducting drug business and a valid permit to conduct radiation work issued by the competent agency shall be allowed direct importation of radioactive drugs, radioactive isotopes.
c) Traders shall be allowed to entrust an agent to import drugs on their behalf in accordance with the operating scope set out in Certificate of satisfaction of conditions for conducting drug business, except for medicinal materials on the list of precious, rare, endemic species, breeds, controlled drugs, drug raw materials being narcotic pharmaceutical substances, narcotic pharmaceutical substances, drug precursors on the list issued by the Minister of Health or radioactive substances on the list issued by the Government.
d) Non-trader organizations, individuals shall be allowed to entrust an agent on the basis of a legal contractual agreement the importation of drugs to meet their own demand except for medicinal materials belonging to the list of controlled precious, rare, endemic species, breeds, drug raw materials being psychotropic pharmaceutical substances, narcotic substances, drug precursors on the list issued by the Minister of Health or the list of radioactive substances issued by the Government.
đ) Representative office of foreign traders operating in drugs and drug raw materials in Vietnam, Vietnamese traders in possession of Certificate of satisfaction of conditions for conducting drug business shall be allowed to import drugs in support of drug registration for marketing activities (including drugs for testing, validating purposes as part of drug registration requirements).

e) Establishments mandated to conduct research, testing work, drug manufacturing establishments shall be allowed to import or entrust an agent to import on their behalf drugs, drug raw materials and reference standards in support of their own research, testing work..
g) Medical service establishments of provinces, cities, sectoral healthcare services and organizations of Vietnam shall be allowed to receive donation drugs from charities non governmental organizations, individual foreign nationals, Vietnamese residing oveseas.
h) Businesses operating GPP “Good pharmacy practice” standard-compliant drugstore chain shall be allowed to import drugs belonging to the list of rare drugs, drugs imported to meet hospitals’ therapeutic demand in special cases for sales at GPP-compliant drugstore in their system.
i) Representative office in Vietnam of manufacturing etablishments, registrant establishments, establishments holding marketing license of drugs subject to clinical trials shall be allowed to import drugs for the service of clinical trials according to the trial protocol approved by Ministry of Health.
k) Representative office in Vietnam of manufacturing establishments, registrant establishments, establishments holding marketing license of drugs subject to bioavailability study, boequivalence study, establishments contracted for the conduct of bioavailability study, bioequivalence study shall be allowed to import drugs for the service of bioeavailability study, bioequivalence study.

l) Traders shall be allowed to import primary packaging components.
m) At the point of drug importation (customs clearance formalities being undertaken at customs office), the foreign companies that supply the importing traders in Vietnam the drugs for which there is already a certificate of registration for marketing in Vietnam and the cases set out in article 79, 80 and 85 of this Decree must fulfill one of the following conditions:
– Have a representative office in Vietnam, be in possession of a certificate of incorcopration in home country, hold a certificate of satisfaction of conditions for conducting drug business or equivalent papers issued by the competent health regulatory authority of the home country and a certificate for the fulfillment of 1 year tax obligations by the home country’s tax authority.

– In possession of a still valid license to operate in drugs, drug raw materials in Vietnam issued before 31 December 2016
5. Intellectual property rights associated with drugs, drug raw materials:
Traders manufacturing, importing, supplying, entrusting-, being entrusted the importation of, drug, drug raw materials shall be responsible for the intellectual property rights associated with the drugs, drug raw materials they manufacture, import, supply, import via an entrusted agent in accordance with the provisions of Pharmaceutical Law, Commerce Law, Intellectual Property Law and prevailing regulations.
6. Quality control testing for imported vaccine, antibody containing sera:
Vaccines, antibody containing sera used in disease prevention and treatment, with or without a certificate of marketing registration, shall be transferred to the businesses’ storage according to relevant requirements after customs clearance and shall only be put to use after being given a written certification by the National Institute for Control of Vaccine and Biological that the imported vaccine lots, antibody containing sera lots for disease prevention and treatment meet quality and safety standards based on test animals.
7. Imported drugs in support of state health program, aid donation drugs, humanitarian assistance drugs; imported drugs for the service of clinical trials, to be used as sample for drug registration, in support of research, testing, validating work; drugs imported for exhibitions, trade fair displays must be used for the intended purposes, to the intended target and not to be circulated in the market.

8. The head of state health programs, head of recipient entities receiving the aid donation, humanitarian assistance drugs must carry out necessary measures to ascertain the drug quality, safety, efficacy and be fully responsible for the quality, the safe, effective and rational use of the drugs.
9. The Minister of Health shall set out the details regarding sector-specific dossiers required for customs clearance of imported drugs, drug raw materials, validation test dossiers for vaccines, antibody containing sera and testing timelines corresponding to the respective drug types.
10. The Minister of Health shall be tasked with the formulation of import quantity limit for drug import dossiers meeting eligibility and technical criteria.
11. Validity term of drug import license:
Drug import license shall have a maximum validity of 01 year from signing date. Raw material import license shall have a maximum validity of 02 years from signing date.
Article 75. General provisions regarding import licensure for drugs, drug raw materials

1. The import manifest of the drugs, drug raw materials for which import licensure is sought shall be prepared in 03 copies using the form applicable to each type of drug in accordance with Minister of Health’s specifications. After approval, 02 duplicate copies shall be filed at the licensing agengy, 01 duplicate copy sent to the importing establishment. The duplicate copy intended for the importing establishments shall be stamped with “Duplicate for the business” for the latter to undertake clearance formalities at port of entry Customs. The Minister of Health shall be tasked with the formulation of detailed templates for import manifest and constituent documentation of the import application dossier.
2. Dossier, documentation accompanying the import manifest should be prepared on an A4 format paper, firmly bound into 01 volume. Dossier [documents] should be arranged according to the order of the index, with dividing tabs between sections. Divided sections should be consecutively numbered for ease of reference and stamped with the importing establishment’s seal on the first page of each section of the entire dossier and there should be a cover page indicating: the importing entity’s name, the manifest number, manifest preparation date, manifest type.
3. Language of application dossier for drug import licensure:
Application dossier for import licensure must be prepared in Vietnamese or English, except the following contents that may be written in other Latin-alphabet languages:
a) Drug’s brand name, generic name or international nonproprietary name;
b) Drug components’ international nonproprietary name or scientific name, drug’ quantitative composition when it is not possible to translate them into Vietnamese or the Vietnamese version would be devoid of meaning;
c) Name and address of drug’s manufacturing establishment, franchised/licensed drug’s manufacturing establishment.
4. With regards to drugs that are imported according to the provisions of Article 76 and 77 of this Decree, a separate manifest should be prepared for each of the drugs, except for the drugs that have in common all the following elements, they may then be grouped into one import licensure application dossier:
a) Drug name;
b) Dosage form;
c) One unit dose formula (for unit-dose-form drugs) or the same strength (for multi-dose-form drugs);
d) Manufacturer.

Article 76. Criteria, dossiers, time limit for import licensure of drugs containing pharmaceutical substances not yet licensed for marketing in Vietnam or already licensed for marketing in Vietnam but the supply of which fails to adequately meet therapeutic demand
1. Criteria: The drug must satisfy one of the following criteria:
a) Chemo pharmaceutical drugs, therapeutic biologicals of which there are less than 03 drugs having a still valid certificate of registration for marketing, that are of the same technical group according to drug tendering regulations and of the same active ingredients, similar dosage form.
b) Pharmaceutical substances for which there are already multiple certificates of registration for marketing issued in Vietnam but of which there are not more than 03 drugs with a still valid one [, that] belonging to the same technical group according to the provisions for drug tendering and having the same active ingredients, similar dosage form, being currently marketed. Drugs subject of an importation licensure that have a projected wholesale price lower than the average one of those currently marketed. Depending on the prevailing developments of each particular period, the Minister of Health shall formulate specific criteria for price consideration.
c) Vaccines, biologicals with expired certificate of registration for marketing in Vietnam, for which a renewal/re-registration dossier has been submitted, of which there are less than 03 drugs of the same use being licensed for marketing.

2. Application dossier for import licensure:
a) Import manifest in conformance with Minister of Health’s specifications;
b) Pharmaceutical product certificate;
c) Quality specification and quality control test method of the drug.
d) Drug labels and package insert stamped with the seal of the importing business, comprising: 01 set of original labels enclosed with the original package insert of the drug as it is actually marketed in the origin country; 02 sets of labels planned for marketing in Vietnam enclosed with the package insert in Vietnamese;
đ) Clinical trial dossier in the case of the drugs set out in clause 1 and clause 2 Article 89 of Pharmaceutical Law.;
e) Data on the drug stability study at storage conditions of ACTD-prescribed zone 4b for the drugs coming from countries where ACTD-prescribed zone 4b storage conditions are not yet ensured.
3. Licensure formalities and time limit:
Businesses shall send aplication dossiers to Ministry of Health (Drug Administration). Within 20 working days from the date of receipt of a valid dossier, Ministry of Health (Drug Administration) shall examine the dossier as prescribed in clause 2 of this Article and issue an import license for eligible cases. If the application is rejected, Ministry of Health (Drug Administration) shall issue a written response to the concerned business clearly stating the rejection reasons.

Article 77. Criteria, dossiers, time limit for import licensure of drugs not yet licensed for marketing in Vietnam containing medicinal materials that are used for the first time in Vietnam or have been used for drug manufacture in Vietnam but the supply of such drugs fail to adequately meet therapeutic demand
1. The drug to be imported must fulfill one of the following criteria:
a) Containing medicinal materials that are used for the first time in Vietnam. The medicinal materials for the first time used in Vietnam are not part of the consituent components of a drug that already has a registration number for marketing in Vietnam.
b) The drug contains medicinal materials that are components of not more than 03 drugs having a still valid certificate for marketing registration [that are] of the same grouping under drug tendering provisions.
2. Application dossier for import licensure:
a) Import maniest in conformance with the Ministry of Health’s specifications;
b) Certificate of pharmaceutical product;
c) Quality specification and quality control test method of the drug.
d) Drug labels and package insert stamped with the seal of the importing business, comprising: 01 set of original labels enclosed with the original package insert of the drug as it is actually marketed in the origin country; 02 sets of labels planned for marketing in Vietnam enclosed with the package insert in Vietnamese;
đ) Clinical trial dossier in the case of the drugs set out in clause 1 and clause 2 Article 89 of Pharmaceutical Law.;
e) Data on the drug stability study at storage conditions of ACTD-prescribed zone 4b for the drugs coming from countries where ACTD-prescribed zone IVb storage conditions are not yet ensured;
3. Licensure formalities and time limit:
Businesses shall send aplication dossiers to Ministry of Health (Administration of traditional medicine&pharmacy). Within 20 working days from the date of receipt of a valid dossier, Ministry of Health (Administration of traditional medicine&pharmacy) shall examine the dossier as prescribed in clause 2 of this Article and issue an import license for eligible cases. If the application is rejected, Ministry of Health (Drug Administration) shall issue a written response to the concerned business clearly stating the rejection reasons.

Article 78. Criteria, dossiers, time limit for import licensure of drugs not yet licensed for marketing in Vietnam in need for the emergency service of national defense, security, epidemic prevention and combatting, mitigation of national disasters, calamities’ consequences
1. Criteria: the drug to be imported must satisfy one of the following criteria:
a) Drugs that are approved by the Minister of National Defense to support national defense emergency requirements;
b) Drugs that are approved by the Minister of Public Security to support security emergency requirements;
c) Drugs that are approved by the Minister of Health to support the emergency demand of disease prevention and combatting, mitigation of national disasters, calamities’ consequences.
2. Application dossier for import licensure:
a) Import manifest in conformance with Minister of Health’s specifications;
b) Original copy of the approval letter from the Minister of National Defense, Minister of Public Security, Minister of Health referred to in point 1 of this Article. The approval letter must reflect the following contents: active ingredient, dosage form; strength, concentration, packaging form, manufacturer, manufacturing country.
3. Licensure formalities and time limit:

Businesses shall send application dossiers to Ministry of Health (Drug Administration). Within 05 working days from the date of receipt of a valid dossier, Ministry of Heath (Drug Administration) shall review the case for import licensure. If the application is rejected, Ministry of Health (Drug Administration) shall issue a written response to the concerned business stating clearly the rejection reasons.
Article 79. Criteria, dossiers, time limit for import licensure of drugs not yet licensed for marketing in Vietnam meeting special therapeutic requirements, rare drugs
1. Criteria: the drug to be imported must satisfy one of the following conditions:
a) It must be on the list of rare drugs issued by the Minister of Health and [the supply of] drugs that are similar to it, possible replacement of it, still fails to adequately cover therapeutic demand. The Minister of Health shall be tasked with the formulation of specific criteria for making decision [on this case] factoring in the prevailing social economic situations;
b) It must meet the rare drug criteria prescribed by the Minister of Health but not yet included in the existing Minister of Health’s issued List of rare drugs, [the supply of] drugs that are similar to it, possible replacement of it, still fails to adequately cover therapeutic demand. The Minister of Health shall be tasked with the formulation of specific criteria for making decision [on this case] factoring in the prevailing social economic situations;
c) [For which] there are demands for the special therapeutic service of medical service establishments. The Minister of Health shall be tasked with the formulation of specific criteria for making decision [on this case] factoring in the prevailing social economic situations.
2. Application dossier for import licensure:

a) Import manifest in conformance with Minister of Health’s specifications;
b) Officer letter from the relevant medical service etablishment confirming the necessity and irreplaceability of the drug that are subject of the import application with respect to the drugs in support of special therapeutic demands according to the Minister of Health’s speficifications, with the List of drugs subject of the import application enclosed;
c) Certificate of pharmaceutical product;
d) Drug labels and package insert stamped with the seal of the importing business, comprising: 01 set of original labels enclosed with the original package insert of the drugs as they are being marketed in the origin country or photocopy of the original labels and package insert of the drug as it is actually marketed in the origin country; 02 sets of labels planned for marketing in Vietnam enclosed with the package insert in Vietnamese;
đ) Report on the drug usage projected by the medical treatment establishment in conformance with Minister of Health’s specifications;
e) Undertaking by the importing estabilishment regarding its accountability over the quality of the imported drugs.
g) In the event that the importing establishment cannot provide the documentation required under point c,d of this Clause while the drugs are neccessitated for the disease prevention and treatment operations, the discretion over the case shall be assigned to the Minister of Health.
3. Licensure formalities and time limit:
Businessses shall send application dossier to Ministry of Health (Drug Administration). Within 15 working days from the date of receipt of a valid dossier, Ministry of Health (Drug Administration shall review the case for import licensure. If the application is rejected, Ministry of Health (Drug Administration) must issue a written response clearly stating the rejection reasions.

Article 80. Criteria, dossiers, formalities, time limit for import licensure of vaccines, antibody containing sera not yet licensed for marketing in Vietnam in support of special therapeutic demand of medical treatment establishments, immunization service establishments
1. Criteria: the drug to be imported must satisfy the following criteria:
a) Vaccine, antibody containing sera having been marketed for more than 05 years at the manufacturing country. In the case the drug is not marketed at the manufacturing country, the importing business must explain the reasons and provide evidence of the drugs being marketed in reference countries;
b) Of which there are not more than 03 drugs of the same use with a still valid certificate of marketing registration.
2. Application dossier for import licensure:
a) Import manifest in conformance with Minister of Health’s specifications;
b) Projection/forecast of vaccines, antibody containing sera of the medical treatment establishment, immunization service establishment in accordance with the Minister of Heath’s specifications;
c) Certificate of pharmaceutical product;
d) Drug labels and package insert stamped with the seal of the importing business, comprising: photocopy of the original labels and package insert of the drug as it is actually marketed in the origin country; 02 sets of labels planned for marketing in Vietnam enclosed with the package insert in Vietnamese;

đ) Written attestation from the manufacture company and the supply company regarding the quality integrity of the vaccines, antibody containing sera supplied to Vietnam in conformance with the Minister of Health’s stipulations.
3. Licensure formalities and time limit:
Businesses shall send application dossiers to Ministry of Health (Drug Administration). Within 15 working days from the date of receipt of a valid dossier, Ministry of Health (Drug Administration) shall review the case for import licensure. If the application is rejected, Ministry of Health (Drug Administration) shall issue a written response to the concerned business clearly stating the rejection reasons.

Article 81. Criteria, dossier, formalities, timeline for import licensure of drugs of the same trade name, active ingredient composition, strength or concentration, dosage form with a brand name drug already licensed for marketing in Vietnam, manufactured by the brand name drug manufacturer itself or a delegated manufacturer, priced lower than the brand name drug being marketed in Vietnam
1. Criteria: the drug to be imported must satisfy all of the following criteria:
a) Have the same trade name, active ingredient composition, strength or concentration, dosage form with a brand name drug already licensed for marketing in Vietnam;
b) Are manufactured by the brand name [comparator] drug itself or by a delegated manufacturer;
c) Have a projected wholesale price lower than the brand name comparator drug. Depending on the prevailing developments of each particular period, the Minister of Health shall formulate specific criteria for price consideration.
2. Application dossier for import licensure:
a) Import manifest in conformance with Minister of Health’s specifications;
b) Attestation rom the importing business regarding quality integrity and selling price of the drug to be imported in accordance with the Minister of Heath’s specifications;
c) Certificate of pharmaceutical product;
d) Drug labels and package insert stamped with the seal of the importing business, comprising: 01 set of labels enclosed with the package insert of the actual drug to be imported to Vietnam; 02 sets of Vietnamese-translated supplementary labels and package insert;

3. Licensure formalities and time limit:
Businesses shall send application dossiers to Ministry of Health (Drug Administration). Within 10 working days from the date of receipt of a valid dossier, Ministry of Health (Drug Administration) shall review the case for import licensure. If the application is rejected, Ministry of Health (Drug Administration) shall issue a written response to the concerned business clearly stating the rejection reasons.
Article 82. Criteria, dossiers, formalities, time limit for import licensure of drugs not yet licensed for marketing in Vietnam or for the service of State health programs
1. Criteria:
a) Drugs that are approved by the Government or the competent state regulatory authority for the service of State health programs.
b) The unit assigned with executing the state health programs shall carry out neccessary measures to ensure the quality integrity, safety and efficacy of the drugs to be imported.
2. Application dossier for import licensure:

a) Import manifest in conformance with Minister of Health’s specifications;
b) Original copy of the letter from the state competent regulatory authority regarding the importation of drugs for the service of State health programs;
c) Documentation demonstating [the fulfillment] of the requirements of point b Clause 1 of this Article.
d) With regards to vaccines, anbibody containing sera, apart from documentation specified in point a, b and c of this clause, the following documents shall aso be required (except for vaccines, antibody containing sera imported under awarded contracts of national or international tenders in Vietnam):
– Certification of the home country’s competent authority perrmitting the marketing or exportation of the vaccines, antibody containing sera;

– Quality control certificate from a national quality testing agency or other competent agencies of the home country for the import lots (the version stamped with importing business’s seal).
3. Licensure formalities and time limit:
Businesses shall send application dossiers to Ministry of Health (Drug Administration). Within 15 working days from the date of receipt of a valid dossier, Ministry of Health (Drug Administration) shall review the case for import licensure. If the application is rejected, Ministry of Health (Drug Administration) shall issue a written response to the concerned business clearly stating the rejection reasons.
Article 83. Criteria, dossiers, formalities for import licensure of aid donation, humanitarian assistance drugs not yet licensed for marketing in Vietnam
1. Criteria: the drugs to be imported must satisfy all of the following criteria:
a) They must be licensed for marketing at the home country. As regards vaccines, antibody containing sera, they must be on the List of vaccines, biologicals recommended for use by World Health Organization;

b) They must be approved by the Minister of Health or Chair of People’s Committee of provinces, centrally-affiliated cities to be received as aid donation, humanitarian assistance;
c) They must not belong to the list of narcotic drugs, psychotropic drugs and drug raw materials prohibited from importation for the manufacture of drugs for human use;
d) They must have a known orign and the recipient esablishment of the aid donation, humanitaria assistance drug must ensure its quality integrity, safe, effective use. Vaccines, antibody containing sera lots donated must be accompanied by a quality control certificate of the home country’s national quality control, and must be tested for quality control by the National institute for control of vaccines and biologicals after importation;
đ) They must be packaged in suitable container closure, indicating: drug name, active ingredient, strength, concentration, dosage form, packaging form, enclosed with package insert and a detailed listing for each package unit;
e) In special cases, with regards to donated drugs for the service of research programs that do not satisty the requirements set out in point a, b, c, d and đ of this clause, the Minister of Health shall have discretion over the receipt of the donations on the basis of relevant legal, technical documents of the research program.
2. Application dossier for import licensure:
a) Official letter requesting an import license from the recipient establishment of the aid donation, humanitarian assistance;

b) List of the aid donation, humanitarian assistance drugs in conformance with Minister of Health’s specfications;
c) Original copy of the letter from the Minister of Health, or Chair of People’s Committee of provinces, centrally-affiliated cities regarding the approval of the receipt of aid donation, humanitarian assistance drugs by the recipient establishment;
d) Certificate of pharmaceutical product or attestation of the donating agency that the drugs are being marketed in the donating country;
đ) Quality control certificate from a national quality testing agency or the competent agency of the home country for the lots of vaccine, antibody containing sera to be imported;
e) Sample of supplementary labels and package insert in Vietnamese.
3. Licensing powers:
a) Ministry of Health (Drug Administration) shall issue import licenses for aid donation, humanitarian assistance drugs that are new drugs, vaccines, antibody containing sera;

b) Health Department of provinces, centrally affiliated cities shall issue import licenses for aid donation, humanitarian assistance drugs for the drugs other than those specified in point a of this Article for establishments at their locality.
4. Licensure formalities and time limit:
Recipient establishments of the aid donation, humanitarian assstance shall send application dossiers to the competent agency. Within 15 working days from the date of receipt If the application is rejected, the competent agency shall issue a written response to the concerned establishment clearly stating the rejection reasons.
Article 84. Criteria, dossiers, time limit for import licensure of drugs in support of clinical trials, bioequivalence studies, bioavailability studies, as sample for drug registration, testing, and scientific research
1. Criteria: the drugs to be imported must satisfy one of the following criteria:
a) Drugs to be used in clinical trials according to Ministry of Health-approved trial protocols;
b) Drugs to be used in bioequivalence studies, bioavailability studies according to protocols approved at the Ministry of Health-delegated technical specialty agency;
c) Drugs to be used as sample in application dossiers for drug registration number;
d) Drugs to be used in testing, controls of drugs;

đ) Drugs to be used in scientific research projects approved by competent authorities.
2. Application dossiers for import licensure:
a) Import manifest in conformance with Minister of Health’s specifications;
b) Approval letter by the relevant competent authority;
c) Written undertaking regarding the use of drugs in accordance with intended pirposes by the importing establishments.
3. Licensure formalities and time limit:
Businesses shall send application dossiers to Ministry of Health (Drug Administration). Within 15 working days from the date of receipt of a valid dossier, Ministry of Health (Drug Administration) shall review the case for import licensure. If the application is rejected, Ministry of Health (Drug Administration) shall issue a written response to the concerned business clearly stating the rejection reasons.
Article 85. Criteria, dossiers, time limit for import licensure of drugs for display at exhibitions, trade fairs
1. Criteria: the drugs to be imported must satisfy all of the following criteria:
a) Drugs to be displayed at medicine, pharmaceutical-related exhibitions, trade fairs;
b) The drugs must be re-exported in full after completion of the exhibitions, trade fair and not to be marketed in Vietnam.
2. Application dossier for import licensure:

a) Import manifest in accordance with Minister of Health’s specifications;
b) Written undertaking from the importing establishment that the drugs are to be used for the intended purposes and re-exported upon comletion of the exhibitions, trade fairs.
3. Licensure formalities and time limit:
Businesses shall send application dossiers to Ministry of Health (Drug Administration). Within 15 working days from the date of receipt of a valid dossier, Ministry of Health (Drug Administration) shall review the case for import licensure. If the application is rejected, Ministry of Health (Drug Administration) shall issue a written response to the concerned business clearly stating the rejection reasons.
Article 86. Criteria, formalities, time limit for import licensure of drugs not intended for commercial purposes (also known as non-commercial drugs)
1. Criteria: the drugs to be imported must satisfy all of the following criteria:
a) Drugs that are gifts, donations from overseas organizations, individuals sent to organizations, individuals in Vietnam; drugs that are part of the belongings of diplomatic missions, international organizations to Vietnam or diplomatic missions, Vietnam organizations abroad and individuals working at these missions, organizations (where there are provisions for concessions, exemption from customs formalities the international treaty of which Vietnam is party to shall apply); drugs that are part of personal baggage of travelers exiting the country brought in as cargo, accompanied carry-on baggage;
b) The drugs must be licensed for marketing at the home country;
c) Drugs that are imported solely for personal use in disease diagnosis, treatment of the applying individual or his/her family members, individuals working in organizations that apply for such drugs to be imported via non commercial channel. Drugs imported via non commercial channel shall not be sold on the market or used for any other illegal purposes;
d) Individuals, organizations applying for drugs to be imported via non commercial channel shall be accountable for the origin and quality of the drugs so imported;

đ) The drugs to be imported must be packaged in suitable container closure, indicating: drug name, active ingredients, concentration, strength, dosage form, packaging form, expiry date;
e) They must not be drug raw materials, not on the list of drugs banned from importation for the manufacture of drugs for human use;
g) Import quantity limits:
– Quantity of narcotic drugs shall not exceed the quantity prescribed in the accompanying doctor’s prescription and shall not exceed the quantity of a 07 day course based on the directions for use.
– Quantity of psychotropic drugs shall not exceed the quantity prescribed in the accompanying doctor’s prescription and shall not exceed the quantity of a 10 day course based on the directions for use.
– For other drugs the drug total value of each importation shall not exceed 100USD (calculated using interbank exchange rate) and the number of importation per year shall not exceed 03 times for each organization, individual.
2. Application dossier for import licensure:
a) Import application dossier for drugs meeting the requirements of point g clause 1 of this Article shall comprise:

– Drug prescription, medical exam booklet: Prescription by a Vietnamese physician, outpatient medical exam booklet following the form set out by the Minister of Health regarding prescribing protocols for outpatient service; Drug prescriptions, medical exam booklets from a foreign national physician must be written in English or Vietnamese, if written in other languages they must be translated into Vietnamese and must cover the following: patient’s name, age; drug name, strength or concentration and units of volume; drug quantity (or number of days’ supply); dosage; physician’s full name, signature; physician’s address (address of the physician’s place of practice: hospital, physician ‘clinic).
b) Import application dossier for drugs not meeting the requirements of point g clause 1 of this Article shall comprise:

– Application form following the template set out by the Minister of Health;
– Valid copy of identification card or passport of the person importing drugs via non commercial channel (original copy of identification card, passport must be presented when undertaking customs procedures);
– Drug prescription, medical exam booklet: in accordance with requirements set out in point a of this clause.
3. Formalities and time limit for import licensure:
a) Organizations, individuals shall undertake import customs formalities directly at the port of entry for the drugs meeting the requirements of point g clause 1 of this Article;
b) In the event the drugs applied for importation by an individual applicant do not meeting the requirements set out point g clause 1 of this Article, the individual applicant should send an application dossier to the Health Department of the same locality of the port of arrival processing his/her entry formalities or the Health Department of the locality of his/her residency or legal temporary residency. Within 7 working days from receipt of a valid dossier, Health Department shall review the case for import licensure. If the application is rejected, Health Department shall issue a written response clearly stating the rejection reasons;

c) In the event the drugs applied for importation by an organization do not meet the requirements set out in point g clause 1 of this Article, the organization applicant should send an application dossier to Ministry of Health (Drug Administration). Within 7 working days from receipt of a valid dossier, Ministry of Health (Drug Administration) shall review the case for import licensure. If the application is rejected, Ministry of Health (Drug Administration) shall issue a written response clearly stating the rejection reasons.
Section 3
CRITERIA, DOSSIERS, FORMALITIES, TIME LIMIT FOR IMPORT LICENSURE OF CONTROLLED DRUGS
Article 87. Criteria, dossiers, formalities, time limit for import licensure of narcotic drugs, psychotropic drugs, precursor drugs, combination drugs containing narcotic pharmaceutical substances, combination drugs containing psychotropic pharmaceutical substances, combination drugs containing precursor, radioactive substances for drug manufacture already licensed for marketing in Vietnam
1. Criteria: drugs, drugs raw materials to be imported that are already issued a certificate of registration in Vietnam.
2. Application dossier for import licensure:
a) Import manifest in conformance with Minister of Health’s specifications;
b) Drug usage report in conformance with Minister of Health’s specifications;

c) Permit for conducting radiation related work issued by Administration of Radiation and Nuclear safety – Ministry of Science and Technology (applicable to the importation of radioactive drugs and radioactive substances).
3. Licensure formalities and time limit:
Businesses shall send application dossiers to Ministry of Health (Drug Administration). Within 10 working days from the date of receipt of a valid dossier, Ministry of Health (Drug Administration) shall review the case for import licensure. If the application is rejected, Ministry of Health (Drug Administration) shall issue a written response to the concerned business clearly stating the rejection reasons.

Article 88. Criteria, dossiers, formalities, time limit for import licensure of narcotic drugs, psychotropic drugs, precursor drugs, combination drugs containing narcotic pharmaceutical substances, combination drugs containing psychotropic pharmaceutical substances, combination drugs containing precursor, radioactive drugs not yet licensed for marketing in Vietnam
1.Criteria: The criteria set out in clause 1 Article 79 of this Decree shall apply.
2. Application dossier for import licensure:
a) Documents prescribed in point a, b, c, d and đ clause 2 Article 79 of this Decree;
b) Drug usage report in conformance with Minister of Health’s specifications.
3. Licensure formalities and time limit:
Businesses shall send application dossiers to Ministry of Health (Drug Administration). Within 20 working days from the date of receipt of a valid dossier, Ministry of Health (Drug Administration) shall review the case for import licensure. If the application is rejected, Ministry of Health (Drug Administration) shall issue a written response to the concerned business clearly stating the rejection reasons.

Article 89. Criteria, dossiers, formalities, time limit for import licensure of controlled drug raw materials not yet licensed for marketing in Vietnam
1.Criteria: drug raw materials to be imported for which there is not yet a certificate of registration for marketing in Vietnam
a) Drug raw materials to be imported that are psychotropic pharmaceutical substances, narcotic pharmaceutical substances, narcotic substances, drug precursors, radioactive substances for drug manufacture;
b) Drug raw materials to be imported that are toxic raw materials for the manufacture of drugs on the List of toxic drugs prescribed by the Minister of Health;
c) Drug raw materials that are pharmaceutical substances on the list of substances banned from use in some particular fields, sectors in Appendix 3.
2. Application dossier for import licensure:
a) Import manifest in conformance with Minister of Health’s specifications;
b) Quality specification table and test method table for excipients, capsule shells, primary packaging components with regards to the drugs following manufacturer’s quality specifications and test methods or photocopy of the quality standards from the relevant pharmacopoeial monographs if the raw materials do not follow quality standards of Europe, UK, US, International, Japan pharmacopoeias;
c) Drug usage report in conformance with Minister of Health’s specifications.
3. Licensure formalities and time limit:

Businesses shall send application dossiers to Ministry of Health (Drug Administration). Within 20 working days from the date of receipt of a valid dossier, Ministry of Health (Drug Administration) shall review the case for import licensure. If the application is rejected, Ministry of Health (Drug Administration) shall issue a written response to the concerned business clearly stating the rejection reasons.
Section 4
CRITERIA, DOSSIERS, FORMALITIES, TIME LIMIT FOR IMPORT LICENSURE OF DRUG RAW MATERIALS BEING PHARMACEUTICAL SUBSTANCES NOT YET LICENSED FOR MARKETING IN VIETNAM, EXCIPIENTS, CAPSULE SHELLS, PRIMARY PACKAGING COMPONENTS

Article 90. Criteria, dossiers formalities, time limit for import licensure of drug raw materials being pharmaceutical substances not yet licensed for marketing in Vietnam to be used as samples for drug registration, testing, research
1. Criteria: drug raw materials that are pharmaceutical substances to be imported must satisfy one of the following criteria:
a) Drug raw materials to be used as samples in drug registration dossier;
b) Drug raw materials to be used in testing, research at drug manufacturing establishments or establishments mandated for drug testing;
c) Drug raw materials to be used in scientific reasearch projects approved by the competent authorities.
2. Application dossier for import licensure:
a) Import manifest in conformance with Minister of Health’s specifications;
b) Letter from the importing establishment explaining the purpose of use of the drug raw materials and guaranteeing to use them for the intended purposes.
3. Licensure formalities and time limit:
The importing establishments shall send application dossiers to Ministry of Health (Drug Administration). Within 15 working days from the date of receipt of a valid dossier, Ministry of Health (Drug Administration) shall review the case for import licensure. If the application is rejected, Ministry of Health (Drug Administration) shall issue a written response to the concerned business clearly stating the rejection reasons.

Article 91. Criteria, dossiers, formalities, time limit for import licensure of drug raw materials being pharmaceutical substances not yet licensed for marketing in Vietnam to be used for displays at exhibitions, trade fairs
1. Criteria: drug raw materials being pharmaceutical substances not yet licensed for marketing in Vietnam [,] must satisfy all of the following criteria:
a) Drug raw materials to be used as displays at medicine-, pharmaceutical-related exhibitions, trade fairs;
b) The drug raw materials must be re-exported in full at the completion of the relevant exhibitions, trade fairs and must not be marketed in Vietnam.
2. Application dossiers for import licensure:
a) Import manifest in conformance with Minister of Health’s specifications;
b) Written undertaking from the importing establishment that the drug raw materials are to be used for the intended purposes and re-exported upon completion of the exhibitions, trade fairs.
3. Licensure formalities and time limit:
The importing establishments shall send application dossiers to Ministry of Health (Drug Administration). Within 15 working days from the date of receipt of a valid dossier, Ministry of Health (Drug Administration) shall review the case for import licensure. If the application is rejected, Ministry of Health (Drug Administration) shall issue a written response to the concerned business clearly stating the rejection reasons.

Article 92. Criteria, dossiers, formalities, time limit for import licensure of drug raw materials being pharmaceutical products not yet licensed for marketing in Vietnam for the manufacture of export intended drugs

1. Criteria: raw materials being pharmaceutical substances not yet licensed for marketing in Vietnam for the manufacture of export-intended drugs, drugs not for marketing in Vietnam.
2. Application dossier for import licensure:
a) Import manifest in conformance with Minister of Health’s specifications;
b) Written undertaking from the importing establishment that the drug raw materials are to be used for the intended purposes and re-exported upon completion of the exhibitions, trade fairs.
3. Licensure formalities and time limit:
The importing establishments shall send application dossiers to Ministry of Health (Drug Administration). Within 15 working days from the date of receipt of a valid dossier, Ministry of Health (Drug Administration) shall review the case for import licensure. If the application is rejected, Ministry of Health (Drug Administration) shall issue a written response to the concerned business clearly stating the rejection reasons.
Article 93. Criteria, dossier, formalities, time limit for import licensure of drug raw materials being pharmaceutical substances not yet licensed for marketing in Vietnam for the production of drugs in the service of national defense, security, epidemic prevention and combatting, mitigation of natural disasters’, calamities’ consequences

1. Criteria: drug raw materials being pharmaceutical substances not yet licensed for marketing in Vietnam to be imported for the production of the following drugs:
a) Drugs that are approved by the Minister of National Defense to support national defense emergency requirements;
b) Drugs that are approved by the Minister of Public Security to support security emergency requirements;
c) Drugs that are approved by the Minister of Health to support the emergency demand in the disease diagnosis, treatment.
2. Application dossiers for import licensure:
a) Import manifest in conformance with Minister of Health’s specifications;
b) Approval letter of the competent authorities.
3. Licensure formalities and time limit:
Businesses shall send application dossiers to Ministry of Health (Drug Administration). Within 05 working days from the date of receipt of a valid dossier, Ministry of Health (Drug Administration) shall review the case for import licensure. If the application is rejected, Ministry of Health (Drug Administration) shall issue a written response to the concerned business clearly stating the rejection reasons.

Article 94. Criteria, dossiers, formalities, time limit for import licensure of excipient, capsule shell, primary packaging components for drug manufacture, drug manufacturing research
1. Criteria: excipients, capsule shells, primary packaging components for the manufacture of drugs already licensed for marketing in Vietnam or for drug manufacturing research.
2. Application dossier for import licensure:
a) Import manifest in conformance with Minister of Health’s specifications;
b) Quality specification table and test method table for excipients, capsule shells, primary packaging components with regards to the drugs following manufacturer’s quality specifications and test methods or photocopy of the quality standards from the relevant pharmacopoeial monographs if the raw materials do not follow quality standards of Europe, UK, US, International, Japan;
c) Written undertaking from the importing establishment that the reference standards, excipients, capsule shells, primary packaging components are to be used for manufacturing research at the establishment, not to be marketed (applicable to drug imports for manufacturing research);
d) With respect to importation of primary packaging components for drug manufacture, the dossier must include one of the following documents:
– Certificate of GMP compliance of the establishment manufacturing the primary packaging materials issued by the competent health authority or pharmaceutical regulatory agency;
– Certificate of satisfaction of conditions for manufacturing primary packaging materials issued by the competent health authority or pharmaceutical regulatory agency of the home country; Written certification from pharmaceutical regulatory authorities of countries member ofThe International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human use, ICH), Europe Union, EU, Pharmaceutical Inspection Co-operation Scheme, PIC/S certifying the manufacture of packaging materials for pharmaceutical products, food products; Drug Master File (DMF) accepted by US Food and Drug Administration, USFDA enclosed with the link where the information is posted on USFDA website;

– Certificate of conformity to ISO 15378 (Primary packaging materials for medicinal products – Particular requirements for application of ISO 9001:2008 with reference to Good Manufacturing Practices (GMP)) issued by a certification body accredited by an international conformity assessment and accreditation organization;
– Certificate of conformity to ISO 13485 (Medical Devices – Quality management systems – Requirements for regulatory purposes) with regards to primary packaging components being medical devices for drug prepackaging (catridge, injection pump) issued by a certification body accredited by an international standard conformity assessment and accreditation organization; – Certificate of conformity to ISO 9001 (Quality management systems – Requirements) with regards to drug packaging raw materials for shape forming in line packaging;
– Internationally accredited certification bodies referred to in this point shall comprise: Bureau Veritas, TÜV (Technischer Überwachungs Verein), SQS (Swiss Association for Quality and Management Systems), SGS (Société Générale de Surveillance), IQnet (The International Certification Network), BSI (The British Standards Institution), DQS (German Registration for Management Systems), GTÜ (Gesellschaft für Technische Überwachung), International Certification Management GmbH;
3. Licensure formalities and time limit:
The importing establishments shall send application dossiers to Ministry of Health (Drug Administration). Within 15 working days from the date of receipt of a valid dossier, Ministry of Health (Drug Administration) shall review the case for import licensure. If the application is rejected, Ministry of Health (Drug Administration) shall issue a written response to the concerned business clearly stating the rejection reasons.

CHAPTER V
MARKETING REGISTRATION FOR MEDICINAL MATERIALS, EXCIPIENTS, CAPSULE SHELLS AND ASSESSMENT OF MANUFACTURING FACILITIES IN FOREIGN COUNTRIES

Article 95. Subjects of application and marketing registration requirements for medicinal materials, excipients, capsule shells
1. Medicinal materials, capsule shells that are part of the list issued by the Minister of Health referred to in clause 5 of this Article must be registered for marketing prior to them being marketed in Vietnam or have their quality specifications declared in accordance with clause 2 Article 68 of Pharmaceutical Law, except the following cases:
a) Medicinal materials, excipients, capsule shells for the manufacture according to registration dossier of drugs already licensed for marketing in Vietnam;
b) Medicinal materials, excipients, capsule shells not yet licensed for marketing in Vietnam that are licensed for import and imported not in excess of the quantity accorded in the import license as regulated to be used as samples for registration, testing, drug research, display at exhibitions, trade fairs; for export-intended drug production, to meet the requirements national defense, security, epidemic prevention and combatting, mitigation of natural disasters’, calamities’ consequences.
2. Medicinal materials, excipients, capsule shells to be registered for marketing or have their quality specifications declared must satisfy the following criteria:
a) Guaranteed safety, efficacy;
b) Compliant with quality standards provided for under Article 102 and Article 103 of Pharmaceutical Law.

3. Registrants of medicinal materials, excipients, capsule shells shall be the following:
a) Establishments engaging in the manufacture, wholesale, exportation, importation of drugs, drug raw materials in Vietnam;
b) Foreign establishments trading in drugs, drug raw materials that have a representative office.
4. Establishments manufacturing medicinal materials, excipients, capsule shells must fulfill the conditions in terms of physical, technical facilities and human resources in accordance with the provisions of point a clause 1Article 33 of Pharmaceutical Law and relevant legislation. The implementation roadmap for the principles, standards of Good manufacturing practice for drug raw material manufacturing establishments, certificate of satisfaction of conditions for business as regards establishments manufacturing excipients, capsule shells, establishments manufacturing, processing medicinal materials shall be regulated by the provisions of clause 2 Article 116 of Pharmaceutical Law.
5. The list of medicinal materials, excipients, capsule shells requiring registration includes:
a) Medicinal materials containing toxicity for drug manufacture;
b) New medical materials not yet used as components in medicinal material drugs being marketed in Vietam;

c) Excipients following internal specifications formulated by the manufacturer that are not drawn from or included in Vietnam pharmacopoeia, national standards for drugs, drug raw materials or required the adoption of foreign pharmacopoeias in Vietnam according to Ministry of Health’s regulations;
d) Capsule shells used in the manufacture of drugs of hard-shell capsule dosage form.
6. Ministry of Health shall issue the list of medicinal materials containing toxicity used for drug manufacture referred to in point a clause 5 of this Article and implementation roadmap for the registration of medicinal materials, excipients, capsule shells.
Article 96. Format of registration for medicinal materials, excipients, capsule shells.

1. Medicinal materials, excipients, capsule shells shall be registered under one of the following format:
a) Issuance of Certificate of marketing registration;
b) Renewal of Certificate of marketing registration;
c) Modification, supplementation of Certificate of marketing registration.
2. Certificate of marketing registration shall be issued to medicinal materials excipients, capsule shells in the following cases:
a) Medicinal materials, excipients, capsule shells for which no certificate of marketing registration has been issued;
b) Medicinal materials, excipients, capsules for which a certificate for marketing registration has been issued but have undergone changes with respect to processing or manufacturing facilities, except for changes in secondary packaging facilities, facilities, location from which the products are released;
c) Medicinal materials, excipients, capsule shells with an expired certificate of marketing registration that are not allowed to be renewed.
3. Modification, supplementation of certificate of marketing registration for medicinal materials, excipients, capsule shells that have been issued in Vietnam but have undergone changes while it is still valid, except the case specified in point b clause 2 of this Article.
4. Renewal of certificate of marketing registration for medicinal materials, excipients, capsule shells upon its expiry date covering changes in administrative dossier if applicable at the time of renewal registration.

Article 97. Application dossiers for certificate of marketing registration issuance for medicinal materials, excipients, capsule shells
1. Application dossier
a) Application for certificate of marketing registration issuance;
b) Authenticated duplicate copy of the still-effective Certificate of satisfaction of conditions for pharmaceutical business of establishments manufacturing, wholesaling, exporting, importing drugs, drug raw materials in Vietnam (with regards to Vietnamese registrant establishments).
Authenticated duplicate copy of the still-effective Certificate of representative office of foreign owned establishments trading drugs, drug raw materials (with regards to foreign owned registrant establishments);
c) Legal documents, papers pertaining to the manufacturing establishment in accordance with the provisions of clause 4 Article 95 of this Decree.
d) Samples of medicinal materials’, excipients, capsule shells’ labels: 02 (two) label mockups;
đ) Other documents pertaining trading and marketing (if applicable);
2. Quality dossier:
a) Quality specifications;
b) Test methods;
c) Test results.
3. Dossier demonstrating the safety profile of new medicinal materials, new excipients and capsule shells containing new components, including toxicology evaluation report.

Article 98. Application dossier for certificate of marketing registration renewal of medicinal materials, excipients, capsule shells
1. Administrative dossier
a) Application for renewal of certificate of marketing registration;

b) Authenticated duplicate copy of still-effective Certificate of satisfaction of conditions for pharmaceutical business of establishments manufacturing, wholesaling, exporting, importing drugs, drug raw materials in Vietnam (with regards to Vietnamese registrant establishments).
Authenticated duplicate copy of still-effective Certificate of representative office of foreign owned establishments trading drugs, drug raw materials (with regards to foreign owned registrant establishments);
c) Legal documents, papers pertaining to the manufacturer in accordance with the provisions of clause 4 Article 95.
d) Post marketing report of the medicinal materials, excipients, capsule shells.
2. Quality dossier
a) Duplicate copy of qualify specifications and test methods of the medicinal materials, excipients, capsule shells;
b) Test results.
Article 99. Application dossiers for modification, supplementation of Certificate of marketing registration for medicinal materials, excipients, capsule shells

1. Application for the modification, supplementation of certificate of marketing registration with duplicate copy of the certificate enclosed.
2. Documentation pertaining to the contents to be modifed, supplemented.
Article 100. Powers, formalities, time limits for the issuance, renewal, modification, supplementation of certificate of marketing registration for medicinal materials, excipients, capsule shells
1. The Minister of Health shall issue, renew, modify, supplement certificates of marketing registration for medicinal materials, excipients, capsule shells on the basis of dossier examination, the advice of the Advisory council for the issuannce marketing registration certificate for drugs, drug raw material.
2. Application dossiers for the issuance renewal, modification, supplementation of certificate of marketing registration for medicinal materials, excipients, capsule shells shall be submitted to Ministry of Health.
Application for the renewal of certificate of marketing registration for medicinal materials, excipients, capsule shells shall be submitted approximately 06 months prior to the certificate expiry date.
3. Time limits for the issuance, renewal or modification, supplementation of certificate of marketing registration for medicinal materials, excipients, capsule shells:

a) Not longer than 06 months from the date of receipt a complete dossier for the issuance of certificate of marketing registration for medicinal materials, excipients, capsule shells;
b) Not longer than 03 months from the date of receipt of a complete dossier for the renewal, modification, supplementation of certificate of marketing registration for medicinal materials, excipients, capsule shells;
c) If the application for issuance, renewal, modification, supplementation of certificate for marketing registration for medicinal materials, excipients, capsule shells is rejected or if the case does not yet meet the eligility criteria for the respective application there must be a written response clearly stating the rejection reasons.
3. The validity term of certificate of marketing registration for medicinal materials, excipients, capsule shells shall be 05 years from issuance or renewal date.

4. The Minister of Health shall specify the details regarding dossiers, formalities for for the issuance, renewal, modification, supplementation of certificate of marketing registration for medicinal materials, excipients, capsule shells.
Section 2
PROVISIONS FOR THE ASSESSMENT OF MANUFACTURING FACILITIES IN FOREIGN COUNTRIES
Article 101. Assessment of manufacturing conditions of foreign establishments manufacturing drugs, drug raw materials
1. Foreign establishments manufacturing drugs, drug raw materials that are registered for marketing, use in Vietnam must comply with Good manufacturing practices.
2. The establishment registering the drugs, drug raw materials shall be responsible to ensure that imported drugs that are manufactured at foreign manufacturing facilities complying with Good manufacturing practices.
3. The establishments registering the drugs shall be responsible for registering the conformity assessment of Good manufacturing practices of the foreign facilities manufacturing drugs, drug raw materials with respect to the drugs/drug dosage forms, drug raw materials registered for marketing in Vietnam.

4. In the event that the registered drugs are manufactured at several different manufacturing facilities (different locations), the registration of conformity assessment shall made for all of the manufacturing facilities involved in the manufacture of such drugs.
5. The manufacturing establishment of the drugs, drug raw materials may directly register the conformity assessment of Good manufacturing practice.
6. The establishments registering the assessment shall be responsible to cover the assessment cost according to applicable provisions of the laws.
7. The drug registrant establishment, the manufacturing establishments must promptly report on the cases stipulated in clause 1 Article 105 of this Article.
Article 102. Format of conformity assessment and scope of application
1. The format of mutual recognition of Good manufacturing practices shall apply to:
a) Manufacturing establishments belonging to countries that are party to Mutual recognition treaties/conventions/agreements regarding Good manufacturing practice inspection results.
b) Manufacturing establishments belonging to EU/EEA member countries, Switzerland, Japan, United State, Australia.
2. Format of documentary evaluation pertaining to manufacturing conditions shall apply to:

a) Manufacturing establishments belonging to PIC/S member countries.
b) Manufacturing establishments not belonging to EU, PIC/S member countries butt have been inspected, assessed and certified of conformity to EU, PIC/S-GMP standards by regulatory authorities.
3. Format of on-site inspection shall apply to:
a) Manufacturing establishments not belonging to clause 1 and 2 of this Article;
b) Manufacturing establishments owning substandard drugs (01 lot in level 1 breach of quality or 02 lots in level 1 breach of quality);

c) Manufacturing establishments of which drug registration dossiers or dossiers registering conformity assessments are found to have signs of tampering, of figures or contents in the dossiers being falsified.
Article 103. Dossiers registering conformity assessments of Good manufacturing practice
1. Registration dossier under mutual recognition format:
a) Registration form;
b) Certificate of good manufacturing practice or Good manufacturing practice inspection report or Manufacturing license providing adequate information on dosage forms. These documents should not be older than 3 years from issuance date.
c) Master file on the manufacturing facilities.
2. Registration dossier under format of documentary evaluation regarding manufacturing conditions.
a) Registration form;
b) Certificate of good manufacturing practice or Good manufacturing practice inspection report or Manufacturing license providing adequate information on dosage forms. These documents should not be older than 3 years from issuance date;
c) Master file on the manufacturing facilities;

d) List of Good manufacturing practice inspections conducted by the pharmaceutical regulatory authority of the relevant home country or pharmaceutical regulatory authority of other countries within 03 years prior to the date of registration for conformity assessment of the facilities and duplicate copy of most recent Good manufacturing practice inspection report;
đ) List of drugs planned to supply to Vietnam;
e) Duplicate copy of batch release procedures for the products to be marketed in Vietnam;
g) If the drugs registered for marketing or planned to be registered for marketing are injectable drugs, infusion drugs (sterile drugs) or biological drugs: period quality monitoring reports should be enclosed.
3. Registration dossier under on-site inspection format
a) Registration form;
b) Certificate of good manufacturing practice or Good manufacturing practice inspection report or Manufacturing license providing adequate information on dosage forms. These documents should not be older than 3 years from issuance date;
c) Master file on the manufacturing facilities;
d) List of Good manufacturing practice inspections conducted by the pharmaceutical regulatory authority of the relevant home country or pharmaceutical regulatory authority of other countries within 03 years prior to the date of registration for conformity assessment of the facilities and duplicate copy of most recent Good manufacturing practice inspection report;
đ) List of drugs planned to supply to Vietnam.

Article 104. Conducting conformity evaluation, assessment and result announcing
1. Ministry of Health shall be responsible for conducting the conformity evaluation, assessment and announce in writing the assessment results:
a) Within 30 days from the date of dossier receipt in the case of mutual recognition;
b) Within 45 days from the date of dossier receipt in the case of documentary evaluation;

c) Within 60 days from the date of dossier receipt in the case of documentary evaluation for facilities manufacturing sterile drugs, biological drugs;
d) Within 6 months from the date of dossier receipt in the case of on-site inspection.
2. The Minister of Health shall announce, update the list of, recognized manufacturing facilities, with as enclosure information pertaining to assessed dosage forms, or products.
3. The Minister of Health shall provide for the procedures, formalities for conformity assessments, periodic assessments, recognition of foreign manufacturing facilities conforming to Good manufacturing practice.
Article 105. Change control and period assessments
1. Registrant /manufacturing establishments must promptly report the following cases:
a) A manufacturing facility inspected and assessed as non conformity to good manufacturing practice by the home country’s or EU, PIC/S member countries’ pharmaceutical regulatory authorities;
b) Discontinuation of production at a manufacturing facility that has been assessed for conformity or change in manufacturing facilities;
c) Repair, major changes in structure, building and plant layout, manufacturing process; facility expansion;
d) Change in key manufacturing equipment;
đ) Major changes in amenities impacting operational environment or the system itself: change of design, operational rationale…;
e) Changes in professional-in charge persons; quality-in charge persons;
g) Production, trial production of vaccines or other products on certified vaccine production lines;

h) Major changes in manufacturing process, quality control procedures for vaccines, biologicals.
2. Periodic assessments:
a) Not later than 06 months after the expiry of the certificate, the registrant/manufacturing establishments must submit a dossier for re-assessment;
b) After the submission of the re-assessment/assessment dossier, the registrant/manufacturing establishment shall proceed with the submission of registration dossier for a new, for renewal of, certificate of registration for marketing of drugs, drug raw materials.
3. Registration dossier for periodic assessment:
a) Registration form;
b) Certificate of good manufacturing practice or Good manufacturing practice inspection report or Manufacturing license providing adequate information on dosage forms. These documents should not be older than 3 years from issuance date;
c) Report on the supply status of the drugs to Vietnam and quality, safety of the drugs supplied to Vietnam;
d) Report on the periodic assessment of in year product quality regarding the drug, group of drugs supplied to Vietnam.

4. Drug manufacturing establishments not belonging to PIC/S, EU member countries, within 6 years from the most recent assessment, must have production lines of drugs marketed in Vietnam re-assessed at least once.
CHAPTER VI
POWERS, FORMAT, FORMALITIES FOR THE RECALL OF DRUGS RAW MATERIALS,
TREAMENT OF RECALLED DRUG RAW MATERIALS
Article 106. Cases warranting drug raw material recall
The cases for drug raw material recall are provided for in clause 2 Article 62 of Pharmaceutical Law, specifically:
1. Drug raw materials that are used for incorrect purposes;
2. Drug raw materials that are manufactured not for purpose of human use;
3. Drug raw materials of which the certificate of marketing registration is issued based on falsified documentation;
4. Drug raw materials that are produced at drug raw material manufacturing facilities not meeting regulated conditions;
5. Drug raw materials that are produced at drug raw material manufacturing facilities meeting regulated conditions but not at the correct address according to the one recorded in registration dossier;
6. Drug raw materials that are not produced according to the registered manufacturing process;

7. Drug raw materials that contain pharmaceutical substances warned by the World Health Organization, the competent authorities of Vietnam or the origin country as not safe, effective for human use;
8. Drug raw materials that are subject of recall notification by the pharmaceutical regulatory authority of a foreign country;
9. Drug raw materials, medicinal materials of packaging materials and packaging form of which do not meet the quality assurance requirements for drug raw materials, medicinal materials;
10. Drug raw materials, medicinal materials that do not meet quality standards for drug manufacture;
11. Drug raw materials for which evidence of in-process and batch release quality controls;
12. Drug raw materials, medicinal materials that do not satisfy the requirements regarding drug labeling according the provisions of Article 61 of Pharmaceutical Law and other relevant legislation;
13. Medicinal materials that are if unknown sources, origins.
Article 107. Format and scope of drug raw material recalls
1. Recall format:
a) Voluntary recalls are recalls carried out on the initiative of drug registrant establishments, drug manufacturing establishments, importing establishments or entrusted import agents.

b) Mandatory recalls are recalls carried out at the request of competent state regulatory authorities that are provided for under Article 62 of Pharmaceutical Law and Article 106 of this Decree.
2. Scope and timeframe for recalls:
a) Drug raw materials shall be recalled from al business establishments, manufacturing establishments using such drug raw materials.
b) Where the raw materials do not satisfy quality standards due to deficiencies in the course of storage, transport, distribution, the recall may only be effected on a part of the impaired lot of raw materials.

c) The recall of drug raw materials must be completed within 30 days from the date the recall decision becomes available.
d) The recall of finished drug products that are produced from recalled drug raw materials shall be performed in accordance with legislation on drug recalls.
Article 108. Responsibilities over drug raw materials recalls
1. Manufacturing establishments, importing establishments, entrusted import agents of recalled drug raw materials shall have the following responsibilities:
a) Cease the business operations involving the recalled drug raw materials;
b) Lead, coordinate with concerned organizations, individuals in making announcements about drug raw materials to be recalled and conducting the recall, taking back the recalled drug raw materials;
c) Handle the recalled drug raw materials;
d) Cover the costs of recall, cost of handling the recalled drug raw materials, pay damages in accordance with legislation;

đ) Report to Ministry of Health about the drug raw material recall and recall results;
e) In voluntary recalls the business operations involving the recalled drug raw materials must be suspended and Ministry of Health informed before the head of the establishment issue the recall decisions. The time limit for issuing recall decisions should not be more than 48 hours from the time Ministry of Health’s opinion becomes available.
2. Establishments distributing the recalled drug raw materials shall have the following responsibilities:
a) Cease the trading, distributing of the recalled drug raw materials;
b) Announce and conduct the recall, take back the recalled drugs returned by manufacturing establishments, users;
c) Return the recalled drug raw materials to the establishments supplying them;
d) Cover the costs of recall, treatment of the recalled drug raw materials and pay damages in accordance with legislation if at fault.
3. Manufacturing establishments using recalled drug raw materials shall have the following responsibilities:
a) Cease the use of recalled drug raw materials;
b) Return the recalled drug raw materials to the establishments supplying them;
c) Conduct the recall of intermediate products, pre-packaging products, finished drug products made of recalled drug raw materials, except when the recalled drug raw materials can be corrected and reused.

4. Ministry of Health shall have the following responsibilities:
a) Depending on the seriousness of the quality breach, safety risks, Ministry of Health shall issue a decision to recall the violative drug raw material. The time limit for issuing recall decision is no longer than 48 hours from the time the conclusion that the drug raw materials fall into the cases warranting recall.
b) Review assessment reports and respond to voluntary recall proposals, proposed plans of remedial actions, recycling the recalled raw materials of the manufacturing, trading establishments;
c) Inspect, supervise the organization and execution of recall operations of drugs, drug raw materials; handle the violating establishments in accordance with legislation;
d) Publicize information regarding the recalled drug raw materials on Ministry of Health’s web port in the case of recalled drug raw materials requiring destruction.

Article 109. Treatment of recalled drug raw materials
1. Treatment of recalled drug raw materials:
a) Drug raw materials shall be disposed of in cases of recall set out in clause 2, 3 and 13 Article 106 of this Decree.
b) Drug raw materials can be reworked, recycled in cases of recall of clause 12 Article 106 of this Decree.
c) Drug raw materials can be recycled or re-exported for recycling or redeployed for non-human use purposes or destroyed in the event that the manufacturing establishment/the establishment responsible for the recall does not or cannot carry out the recycling, re-export or redeployment.
2. Correcting, recycling raw material materials:
a) Establishments that own the recalled drug raw materials wishing to correct, recycle or re-export them must send a written proposal to Ministry of Health with the proposed plan of remedial measures or recycling procedures attached;
b) The correction, recycling of drug raw materials shall only be carried out an approval letter from Ministry of Health is obtained.
3. Disposal of drug raw materials:
a) The person in charge of the unit owning the drug raw materials requiring disposal must issue a decision to for a Council for drug raw material disposal. The Council must be made up of at least 03 persons, of whom there must be the person in charge of the unit and the professional in charge person

b) The disposal of drug raw materials must be carried out in such a way so as to ensure long term safety for humans, animals and avoid environment pollution in accordance with environment protection legislation.
c) The violating drug raw material business establishment shall be responsible for the cost of drug raw material disposal.
d) The disposal of drug raw materials used in the manufacture of narcotic drugs, psychotropic drugs, radioactive drugs must be performed in strict adherence to regulations for the disposal of those drugs.
CHAPTER VII. DRUG INFORMATION, DRUG ADVERTISEMENT
Section 1
GENERAL PROVISIONS
Article 110. Subjects of application and requirements for drugs to be eligible for information, advertisement dissemination
1. Drugs that are allowed to have information about them disseminated to healthcare professionals comprise:
a) Drugs for which there is a still effective certificate of registration for marketing in Viettnam shall be allowed to have drug information activities about them carried out under the forms set out in Article 120 of this Decree.
b) Drugs that have not been issued a certificate of registration for marketing in Vietnam but are the subject of an import license shall be allowed to have drug information activies about them carried out under the forms set out in clause 3 Article 120 of this Decree.

2. Drugs meeting the requirements set out in Clause 2 Article 79 of Pharmaceutical Law can be advertised to the public in accordance with the provisions of this Decree. Drugs on the List of non prescription drugs can be advertised on audio press, visual press in accordance with the provisions of this Decree.

Article 111. Basis for and scope of content of drug information, drug advertisement requested to be confirmed
1. The establishment named as registrant on Certificate of registration for drug marketing in Vietnam or the Representative office in Vietnam of the registrant establishment may request for the confirmation of the drug information, drug advertisement regarding the drugs it registered.
2. The drug importing establishment may request for the confirmation of drug information, drug advertisement regarding the drugs it imported in the cases referred to in point b Clause 1 Article 110 of this Decree.
3. The establishment requesting the confirmation of drug information, drug advertisement contents shall not be subject to [any] penalties in relation to its activities in drug information, drug advertisement at the time of submission of request for content confirmation.
Article 112. Requirements regarding content presentation of drug information, drug advertisement
1. Drug information, drug advertisement contents must be presented in Vietnamese language. The utterances, wordings of drug information, drug advertisement contents must be concise, common, in accordance with the provisions of Article 18 of Advertisement Law.

2. The smallest font used in drug information, drug advertisement content should be sufficiently large to be readable under normal conditions and should not be smaller than that equivalent to Vntime or Times New Roman 12 font type on A4 sized paper.
Article 113. Information, graphics not to be used in drug information, drug advertisement
1. Contents that are not related to the drugs or potentially misleading as regards the drug composition, activity, indications, origins;
2. Contents that may be interpreted as: this drug is number one drug; this drug is the best of all; using this drug is the best option available; using this drug does not require physician’s prescription; this drug is completely harmless; this drug has no contraindications; there is no undesirable reactions from the use of this drug; there is no harmful effects from the use of this drugs;
3. Words, wordings such as radical cure, eliminate, specialized in the cure of, leading, premier league, first ever, choice, high quality, 100% guaranteed, safe, rid, cut away, stop in its track, immediately alleviate, promptly alleviate, alleviate on the spot, peace of mind, not to worry, no worries and words, wordings denoting similar meaning.
4. Phrasings that imply inference about the drug’s action, indications, efficacy;
5. Listing of every constituent components of the drugs with the intent to over claim the drugs’ uses or create confusions as to the activity individual components versus the drugs’;
6. Indications not to be included in drug advertisement contents:
a) Indications for the treatment of tuberculosis, leprosy;
b) Indications for the treatment of venereal communicable diseases;
c) Indications for the treatment of insomia;
d) Indications of aphrodisiac properties;
đ) Indications for the treatment of cancer, tumors;
e) Indications for the treatment of diabetis or similar metabolism disorders;

g) Indications for the treatment of virus causing hepatitis, new emergent diseases.
7. Certifications that are not yet recognized by Ministry of Health;
8. Test results of drugs, drug raw materials.
9. Results of pre clinical studies;
10. Results of clinical trials or bioequivalence studies not yet recognized by Ministry of Health;
11. Take advantage of title, position, reputation, correspondences, testimonials from organizations, individuals for the use of drug promotion, advertising;
12. Take advantage of the drugs’ origin, raw materials for the use of drug information dissemination, advertising;
13. Graphics that are potentially misleading as to the drugs’ activity or over descriptive of pathological condition, drugs’ activity;
14. Pictures, name, logos of healthcare professionals;
15. Pictures of animals, plants belonging to the list of protected endangered, precious, rare animals;
16. Phrasings, words of anecdotal, word-of-mouth nature, nature to recommend the use of the drugs.
17. Objectionable graphics, not appropriate with Vietnam good custom and tradition.

Article 114. Requirements regarding samples of drug information, drug advertisement constituting the dossier requesting for content confirmation of drug information, drug advertisement
1. Samples of drug information, drug advertisement shall be considered as a request for content confirmation of a drug information, drug advertisement, including:
a) Sample of drug information, drug advertisement of a drug lot
b) Sample of drug information, drug advertisement for two or more drugs of the same active ingredients and route of administration from the same manufaturer but of different strengths or dosage forms.
2. Sample of drug information, drug advertisement may be proposed to be placed on one or more suitable different media in accordance with the provisions of this Decree.
3. The establishment requesting for content confirmation of drug information, drug advertisement must pay dossier evaluation fees at the [office of] agency receiving the dossier in accordance with legislation on fees and charges.
Article 115. Changes in content of drug information, drug advertisement after issuance of content confirmation certificate
1. The establishment shall not unilaterally change the content of the drug information, drug advertisement after being issued a content confirmation certificate. Changes in, supplementation to, the content of drug information, drug advertisement post confirmation shall be considered as new contents, except for the cases stipulated in Clause 2 of this Article. The establishment must undertake to request for content confirmation of the drug information, drug advertisement anew from the start in accordance with the provisions of Article 129,130,131 of this Decree.

2. Changes in the name, address of the manufacturing establishment, importing establishment or distribution establishment, the persons portrayed in the advertisement without any other information changes to the content of the drug information, drug advertisement shall require a request for confirmation of changed contents in accordance with the provisions of Article 133 of this Decree.

Article 116. Reissuance of certificate of confirmation of drug information, drug advertisement content
The establishment requesting for content confirmation of drug information, drug advertisement may request for reissuance of the confirmation certificate in the following cases:
1. Certificate of confirmation is lost or damaged;
2. Content of confirmation is erroneously recorded due to the fault of the competent state regulatory authority.
Article 117. Validity of certificate of confirmation of drug information, drug advertisement content
1. Certificate of confirmation of drug information, drug advertisement content shall automatically lapse in the following cases:
a) Certificate of drug registration for marketing in Vietnam, drug import license expires.
b) Certificate of marketing registration of the drug is revoked.
c) Changes in information on the approved label sample or package insert regarding to the safety, efficacy of the drug.
2. Certificate of drug advertisement content confirmation shall automatically lapse in the following cases:

a) The cases that are set out in point a, b and c clause 1 of this Article;
b) The drug involved is the subject of a restriction-in-use or use-under-physician’s supervision advisory issued by the competent state regulatory authority.
c) The drug contain an active ingredient or medicinal materials that is removed from the List of non prescription drugs issued by the Minister of Health.
3. The drug information dissemination, drug advertisement shall be suspended when the drugs involved is suspended from being marketed according to a Decision of the competent authority. The suspension period for information dissemination, drug advertisement [activities] shall be dependent on the marketing suspension period of the drugs.
Article 118. Suspension of content confirmation for drug information, drug advertisement
1. Dossiers requesting for content confirmation of drug information, drug advertisement shall be suspended in the following cases:
a) The establishment requesting for content confirmation of drug information, drug advertisement or the establishment registering the drug for which the confirmation is sought is under a period of sanctions administered by the competent authority for violations related to drug information, drug advertisement.

b) In the course of reviewing the dossier, the receiving agency discovers inconsistencies requiring closer examination of the package insert, in the interest of user safety.
2. Upon discovering any issues enumerated in Clause 1 of this Article, the receiving agency shall respond in writing [to the establishment] cleartly stating the reasons of the confirmation suspension.
Section 2
DRUG INFORMATION 

Article 119. Forms of drug information eligible for a waiver of content confirmation
1. Drug information directed to drug users shall be disseminated under one of the following forms:
a) Information provision to users in the form of Ministry of Health’s approved user instruction package insert.
b) Counseling, advising patients on the use of drugs by healthcare professionals.
c) Counceling, advising patients on the use of drugs by drug retailers, pharmacist delivering clinical pharmacy service at drugstores.
d) Dissemination of information pertaining to the drugs’ quality, safety, efficacy to the community in the form of public notices of pharmaceutical state regulatory authorities.
2. Various forms of reports, updates of information pertaining to the quality, safety, efficacy of marketed drugs to competent authorities, comprising:
a) Ministry of Health receiving information pertaining to drugs’ quality, safety, efficacy reported by pharmaceutical trading establishments, drug registrant establishments, National center for drug information and surveillance of drug adverse reactions, drug testing establishments.
b) National center for drug information and surveillance of drug adverse reactions, regional center for drug information and surveillance of drug adverse reactions receiving information pertaining to drug adverse effects, drug related errors, counterfeit drug suspicion, substandard drugs and information pertaining to drugs’ therapeutic efficacy reported by medical practitioners, drug trading establishments.

c) National center for drug information and surveillance of drug adverse reactions, to receive information pertaining to drugs’ quality, safety, efficacy collected and reported by regional centers.
Article 120. Form of drug information requiring submission of dossiers requesting for content confirmation of drug information
Drug information directed to healthcare professionals:
1. Drug information disseminated through “Drug introducers”.
2. Drug information publications.
3. Workshops, conferences, drug introduction events.
Article 121. Requirements for information materials for the introduction of drugs to healthcare professionals
1. Information materials for drug introduction to healthcare professionals must fulfill the requirements set out in Article 113 and Article 122 of this Decree.

2. Information materials for drug introduction to healthcare professionals must have the wording “Materials for medical exam, treatment practitioners” printed on top of every page. Materials composing of multiple pages must be consecutively numbered, the top page must indicate clearly where to find detailed information on the product (specific page number) and printed clearly: (a) Number of Certificate of content confirmation for the materials of Drug Administration – Ministry of Health XNTT/XX/QLD-TT, date … month … year…, (b) the date the information material is printed: date … month … year… .
3. Drug information materials should only provide information on the drug, information not related to the drugs should not be included.
4. Information about the drugs must have its supporting references clearly footnoted, citations from supporting literatures must be annotated as such. Citations must convey the information correctly, without inferences or redaction aiming to create misunderstandings as to the drugs’ safety, efficacy.
Article 122. Requirements regarding the content of healthcare professionals-directed drug information materials
The drug information materials must cover in full the following contents:
1. Drug name: either brand name or generic name may be used.
2. Active ingredient composition.
a) For pharmaceutical drugs: International nonproprietary name should be used.
b) For drugs of medicinal material sources: Vietnamese name should be used (if there is not yet a Vietnamese name for it the native name of the origin country, in conjunction with its Latin name, should be used);
3. Dosage form;
4. Uses, indications;
5. Dosage;
6. Administration;
7. Side effects and adverse reactions;
8. Contraindications and precautions;
9. Drug interactions;
10. Manufacturer’s name and address.

Article 123. Workshops, conferences, drug introduction events for healthcare professionals
Drug information for the introduction of drugs in workshops, conferences, events must fulfill the following requirements:
1. Drug name: either brand name or generic name may be used.
2. Active ingredient composition.
a) For pharmaceutical drugs: International nonproprietary name should be used
b) For drugs of medicinal material drugs, traditional drugs: Vietnamese name should be used (if there is not yet a Vietnamese name for it the native name of the origin country, in conjunction with its Latin name, should be used);
3. Strength/Active ingredient concentration;
4. Dosage form;
5. Information, study reports on:
a) Pharmacodynamics;
b) Pharmacokinetics;
c) Clinical information: Indications, dosage, administration, contraindications, warnings, precautions, side effects, adverse reactions and mitigation actions;
d) Information pertaining to formulation, formulas, storage methods, expiry date, packaging form;
đ) Information on drug classification: narcotics, psychotropics, prescription drugs, non prescription drugs;

e) Other relevant information;
g) Manufacturer’s name and address.
6. Drug information must be presented by speakers who are knowledgeable officials in the specialty, familiar with the drugs being introduced.
Article 124. Drug displays at medical conferences, symposia

1. Entities organizing, hosting medical conferences, symposia wishing to display, introduce drugs at conferences, symposia must inform in writing the local Health Department of their intention prior to holding them.
2. The conduct of drug information activities, drug advertising activities in conjunction with drug displays at the conference, symposium venue must strictly adhere to the provisions regulating drug information, drug advertising of this Decree and relevant legislation.
Section 3
DRUG ADVERTISEMENT
Article 125. Drug advertising media
1. Advertising on books, newspapers, magazines, flyers.
2. Advertising on panels, banners, posters, transport media, adverting objects.
3. Advertising on audio press, visual press.
4. Advertising on electronic newspapers, electronic bulletin, advertising display monitors.
5. Advertising drugs at workshops, conferences, events.
6. Advertising drugs on other advertising media in accordance with applicable legislation.

Article 126. Content of drug advertisement
1. The content of drug advertisement must be consistent with the following documents
a) Label samples and package insert approved by Ministry of Health;
b) The drug monograph written in Vietnam National Formulary;
c) Drug related documentation, guidance for industry issued or recognized by Ministry of Health.
2. Drug advertisement content must cover the following mandatory information:
a) Drug name;
b) Composition of pharmaceutical substances or medicinal materials recorded in the approved package insert. Vietnamese name (if applicable) should be used for medicinal materials.
c) Indications;
d) Administration;
đ) Dosage;
e) Contraindications and/or warnings for specific populations (pregnant women, nursing mothers, children, elderly patients, patients with chronic conditions).
g) Precautions and things to avoid, to pay attention to in the course of medication;
h) Side effects and adverse reactions;
i) Manufacturer’s name and address

k) Reminder “Read the instructions for use carefully before use”;
l) The bottom of the first page of the advertisement content must be printed with: Number of Certificate of content confirmation for the advertisement by Drug Admistration– Ministry of Health: XXXX/XNQC-QLD, date … month … year The docuement is printed on Date … month … year … .
m) With regards to advertisement content covering multiple pages, the document must be page numbered and the number of pages it contains indicated on the first page, location where to find the product’s detailed information should also be indicated.

n) Information about the drugs must have its supporting references clearly footnoted, citations from supporting literatures must be annotated as such. Citations must convey the information correctly, without inferences or redaction aiming to create misunderstandings as to the drugs’ safety, efficacy.
3. Advertisement contents for audio, visual press: must cover all the information set out in point a,b,c,e,i and k Clause 2 of this Article of which the content in pointin point a, b, c, e and k must be distinctly and amply pronounced. If the drug contains more than 03 active ingredients depending on the airtime available, the name of the primary active ingredient should be read out, or should also the name of vitamins, minerals, medicinal materials in general.
4. Content of advertisement on electronic newspapers, eletronic bulletin, advertising deplay monitors:
a) Content of audio advertisement: advertisement content must be presented in the same way with audio press, specified in clause 3 of this Article.
b) Content of non audio advertisement: must cover all the information specified in in Clause 2 of this Article;
If the advertisement content covers several pages or storyboard frames, the pages or frames must must be projected consecutively, with inbetween pauses sufficiently long for viewers to read all the information presented; the page, frame displaying the product information must be still standing, not moving, for viewers to digest fully the information about the product.

Advertising in this form requires the ad content to be exclusively about one product, not to be cross advertised among serveral products concurrently so as to prevent misunderstanding.
6. Content of outdoors advertisement: must cover the information set out in point a, b, i, k and l clause 2 of this Article. If the advertisement presents information related to the uses, activity, indications of the drug it must also include all of the information enumerate in in clause 2 of this Article.
Article 127. Sponsorships for drug information, drug advertisement activities
1. Organizations, individuals shall have the right to provide funding, in kind sponsorship to workshops for healthcare professionals on a voluntary, transparent manner with no conditions attached.
2. The sponsors’ drug introduction activities at the workshops, conferences, events and radio broadcasting programs, television programs must be carried out in strict adherence to applicable regulations on direct to public advertising prescribed in this Decree and relevant legislation.

Section 4
DOSSIERS, PROCEDURES, FORMALITIES AND POWERS FOR THE ISSUANCE OF CERTIFICATE OF CONFIRMATION OF DRUG INFORMATION CONTENT, DRUG ADVERTISEMENT CONTENT
Article 128. Powers to issue certificate of content confirmation for drug information, drug advertisement
Minister of Health of a Ministry of Health-delegated unit shall have the powers to issue certificates of content confirmation for drug information, drug advertisement in accordance with the provisions of this Decree.

Article 129. Dossiers, procedures, receiving formalities for dossiers requesting the confirmation of drug information content to be disseminated at drug introduction workshops for healthcare professionals
1. Establishments prior to holding drug introduction workshops for healthcare professionals must submit a dossier to the Health Department where the workshop venue is located requesting the latter to confirm the drug information content for the workshop.
2. The dossier shall comprise:
a) Letter requesting confirmation of the drug information content for drug introduction workshop (form 1a – Appendix 4);
b) Workshop venue, workshop program (proposed);
c) Content of each of the presentations, name and academic title of speakers;
d) Materials proposed to display, disseminated at the workshop;
đ) Materials pertaining to the drug to be presented at the workshop;
e) Reference literature (if applicable).
2. All the component documents of the dossier must be stamped across the margins with one impression of the seal of the requesting establishment.
3. Upon receipt of a complete, valid dossier according to the provisions of Clause 2 of this Article, within 15 working days, Health Department shall issue the certificate confirming the content of drug information to be disseminated at the drug introduction workshop to healthcare professionals (form 2a – Appendix 4).

4. If the dossier requesting content information of drug information for dissemination at drug introduction workshop to healthcare professionals is found to be incomplete, not yet valid according to the provisions of this Decree, within 15 working days, Health Department shall inform the establishment so the latter can revise, supplement or complete the dossier accordingly.
5. Where Health Department issues a follow up notice requesting dossier revision, supplementation:
a) The follow up notice must specify in detail: which documents should be supplemented, which contents should be revised, supplemented.
b) The requesting establishment must respond according to what are required in the follow up notice and submit the revised, supplemented workshop information content to Health Department. If the revision, supplementation correctly answers the follow up requirement, within 10 working days, Health Department shall issue the certificate confirming the drug information content for dissemination at the drug introduction workshop to healthcare professionals.
6. The establishment requesting for content confirmation of drug information for dissemination at drug introduction workshop for healthcare professionals shall be responsible for informing the dossier-receiving Health Department at least 02 days in advance the actual venue and time of the workshop.

Article 130. Dossiers, procedures, receiving formalities for receiving dossiers requesting confirmation of drug advertisement content to be used at the public workshops, conferences, events for the public
1. Establishments requesting for the confirmation of drug advertisement content to be disseminated at workshops, conferences, events for the public shall submit application dossiers at the receiving agency according to the provisions of Article 128 of this Decree.
2. The dossier shall comprise:

a) Letter requesting confirmation of the drug advertisement content for dissemination at workshops, conferences, events (form 1b – Appendix 4);
b) Workshop venue, workshop program (proposed);
c) Content of each of the presentations, name and academic title of speakers;
d) Materials proposed to display, disseminated at the workshop;
đ) Materials pertaining to the drug to be presented at the workshop;
e) Reference literature (if applicable)
All the component documents of the dossier must be stamped across the margins with one impression of the seal of the requesting establishment.
2. If the dossier is not yet valid, within 05 working days from the date of receipt of the dossier based on the incoming receipt stamp of the receiving agency, the latter shall issue a follow up notice requesting the establishment to revise, supplement the dossier as appropriate. The time limit for the requesting establishment to respond to the follow up notice is 90 days from the notice date. Past this timeline the dossier requesting for confirmation of advertisement content becomes void.
3. Within 15 working days from the receipt date of a complete valid dossier based on the incoming receipt stamp on the dossier of the receiving agency, the latter shall issue a confirmation certificate using form 2c in Appendix 4 of this Decree. If the request is declined, the receiving agency must respond in writing stating the reason of the declination.

5. At least 02 days in advance before proceeding with advertising, the establishment that was issued the certificate of confirmation of drug advertisement content for dissemination at workshops, conferences, events for the public must inform in writing the Health Department where the workshop is to take place the format, time and location of the advertisement, with as enclosure the certificate confirming the advert content, the approved advert sample or script for the latter to audit, inspect as necessary;
In the event that the location, time of the workshop, conference, event is changed compared to the information in the certificate confirming the advert content, the establishment must inform Health Department at the locality where the workshop is to be held at least 02 days in advance.
Article 131. Dossiers, procedures, formalities for dossier receipt, evaluation and issuance of certificate confirming the content of drug information, drug advertisement
1. Establishments before disseminating drug information, drug advertisement must submit a dossier requesting for the confirmation of drug information, drug advertisement content to the relevant authority stipulated in Article 128 of this Decree
2. The dossier shall comprise:
a) Letter requesting for confirmation of the content of drug information, drug advertisement (form 1c, 1d – Appendix 4);

b) Proposed format, content of drug information, drug advertisement;
c) Reference materials, supporting the information content, advertisement content;
d) Duplicate copy of label sample, packaged insert approved by Ministry of Health;
đ) Duplicate copy of Marketing license or duplicate copy of Decision to issue Registration number issued by the competent authorities;
e) Duplicate copy of Certificate of satisfaction for drug business or License for formation of representative office in Vietnam of the foreign company;
g) If the advertisement is to be placed on radio broadcasting, television channels the advert script, video clip, audio clip must be submitted. The script must be descriptive of each of the graphic, the narrative, and the music portions;

3. Dossiers should be presented on A4 sized paper, stamped across the margins with one impression of the dossier preparing establishment’s seal. Large sized outdoors advertisements may be presented on A3 sized paper. The documents enumerated in point d, đ and e of Clause 2 of this Article shall only be required in photocopy stamped with the seal of the establishment registering the information, advertisement.
4. Proposed content of drug information, advertisement or script must be submitted in 02 duplicate copies. At the end of the process, 01 copy shall be filed at the dossier receiving agency, 01 copy stamped as received by the receiving agency and attached to the certificate confirming the drug advertisement content and given to the requesting establishment.
5. The receiving agency shall not review the registered contents of information, advertisement that are not relevant to the drug involved.
6. Upon receipt of a valid, complete dossier in accordance with the provisions of this Decree, within 15 working days, the dossier receiving agency shall issue a certificate confirming the drug advertisement content (form 2b, 2c – Appendix 4) to the requesting establishment.
7. If the dossier registering drug information, drug advertisement is not yet complete according to the provisions of this Decree, within 15 working days, the dossier receiving agency shall issue a written follow up notice to the establishment registering the information, the drug advertisement for the latter to revise, supplement, complete the dossier.
8. When there is a follow up notice from the dossier receiving agency requesting revision, supplementation:

a) The follow up notice requesting revision, supplementation shall call out in specific details: which documents to supplement, which contents to revise, supplement;
b) The establishment must respond with the revision, supplementation according to what was requested in the follow up notice and submit to the receiving agency the revised, supplemented information content, drug advertisement content. If the follow up submission meet the requirements, within 15 working days, the dossier receiving agency shall issue the certificate confirming the advertisement content to the dossier submitting establishment.
c) Within 03 months from the date the receiving agency issue the follow up notice, if the registering establishment does not respond with the requested revision, supplementation such dossier shall become void.
9. The procedures of dossier registration and appraisal shall be undertaken anew from the start in the following cases:
a) The establishment requesting for confirmation of information content, advertisement content does not correctly respond to the specific requirements of revision, supplementation of the follow up notice.
b) The establishment requesting for confirmation of information content, advertisement fails to respond with the required revision, supplementation past 03 months from the date the dossier receiving agency issues the follow up notice.
With respect to the case specified in point a of this clause, the receiving agency shall issue a notice to the requesting establishment informing the latter that it is not allowed to disseminate the registered information, advertisement.

10. In the event that drug information, drug advertisement is disseminated before content confirmation by the competent agency or the content disseminated is different from what has been confirmed, the dossier receiving agency shall send a written warning to the drug registrant establishment and stop receiving, processing the establishment’s dossiers registering drug information, advertisement content for a period from 3 to 12 months depending on the specifics of the case as follows:

a) Stop receiving, processing dossiers registering drug information, drug advertisement for 03 months for first time infringement.
b) Stop receiving, processing dossiers registering drug information, drug advertisement for a period from 3 to 6 months for cases with 2 infringing acts in a year.
c) Stop receiving, processing dossiers registering drug information, drug advertisement for a period from 6 to 12 months for cases with 3 infringing acts in a year.
Article 132. Dossier, procedures, formalities for dossier receipt, evaluation and re-issuance of a certificate confirming the content of drug information, drug advertisement
1. The dossier prepared in 01 volume;
2. A valid dossier shall comprise:
a) Letter requesting the re-issuance of the certificate confirming drug information/drug advertisement content (form 1e in Appendix 4 of this Decree);
b) Duplicate copy of the drug information content/drug advertisement content approved by Ministry of Health.
3. The establishment requesting for re-issuance of the certificate confirming drug information content/drug advertisement content shall send the dossier to the dossier receiving agency in person or by post;
4. Within 15 days from the receipt date of a complete, valid dossier, the dossier receiving agency shall re-issue the certificate confirming drug information content/drug advertisement content if the dossier qualifies (Mẫu 2b, 2c in Appendix 4 of this Decree), or issue a written notice informing the Certificate re-issuance request is declined stating the reasons.

Article 133. Formalities for the confirmation of changes in content of drug information, drug advertisement
1. The establishment holder of a certificate confirming drug advertisement content shall send a letter requesting for change to the receiving agency. The requesting letter msut call out the changes and the underlying rationale.
2. After 15 from the date the establishment sends the requesting letter, if the dossier receiving agency does not respond in writing, the establishment shall proceed with the changes as requested. If the dossier receiving agency issues a written refusal, the refusal letter must clearly state the reasons of the refusal.
Chapter VIII
DRUG PRICE REGULATORY MEASURES
Article 134. Declaration, re-declaration and posting of drug price

1. Drug price declaration is the act that the drug business establishment reports to state regulatory authorities the drug’s import price, cost price, projected wholesale price, projected retail price before marketing the drug.
2. Drug price re-declaration is the act that the drug business establishment reports to state regulatory authorities the drug’s import price, cost price, suggested wholesale price, suggested retail price when there are changes in the prices declared.
3. Drug price posting is the act that the drug business establishment publicize the drug’s wholesale price, retail price at the transaction place or retail place by way of printing, writing or sticking the retail price on the packaging containing the drug or the drug outer packaging; publicizing can be done on a board, on paper or by other means.

4. Types drug price to be declared:
a) Suggested import price is the cost to be paid for purchasing the imported drug at the first port of entry of Vietnam that is determined on estimations and declared by the drug manufacturing establishment or the delegated registrant establishment to the regulatory authorities at the submission of drug registration dossiers or redeclared when there is a need to adjust the import price making it higher than the price declared, or last redeclared;
b) Actual import price is the customs value of the imported drug as recorded in the customs value declaration form;
c) Cost price of domestically produced drugs: is the total cost price, calculated by expenses of raw materials, direct consumables (+) direct labor expenses (+) overhead expenses (+) cost of finances (loan interest paid if any) plus (+) management expenses (-) expenses allocated to other secondary products (if any);
d) Wholesale price is the selling price between drug business etablishments or the selling price of a trade trading establishment to medical service establishments;
đ) Suggested wholesale price is the suggested selling price of a domestic manufacturing establishment, importing establishment, import agent, the establishment that contacts out the drug manufacture, to drug trading establishments or medical service establishments and is declared, redeclared to the drug price regulatory authority;
e) Suggested retail price is the suggested selling price of a domestic manufacturing establishment, importing establishment, import agent and drug trading business establishment direct to the consumers;

g) Retail price is the price at which the drug is sold directly to the consumers at retail establishments.
5. Drug price shall be declared, posted in Vietnamese currency on the smallest package unit. For import price, the declaration, re-declaration must be supported by information about the exchange rate at which the foreign currency is converted into Vietnam Đong at the point of declaration. The foreign currency exchange rate applicable shall be the one the drug trading businesses actually use in bank transactions either regarding loan repayment or currency purchase, where the drug trading business has yet to repay the bank, the selling rate at the point of price calculation of the commercial bank where the loan was secured or the currency purchased shall be used.
Article 135. Dossiers, formalities, procedures in drug price declaration, re-declaration
1. Procedures, formalities for drug price declaration of foreign drugs imported to Vietnam

a) When submitting a dossier for a new registration of a foreign drug, the establishment manufacturing the foreign drug (or the delegated drug registrant establishment if applicable) shall undertake to declare the suggested import price of the drug arriving at Vietnam port of entry. When submitting a dossier for re-registration, if the imported price is adjusted making it higher than the still-effective suggested price declared, redeclared earlier, the foreign drug manufacturing establishment (or the delegated drug registrant establishment if applicable) shall undertake to redeclare the suggested import price;
b) When the drug has been issued a registration number (or an import license in the case of drugs having not yet a registration number), the drug importing establishment shall undertake to declared for following types of price before placing the first lot of drug product on the Vietnam market: Actual import price at Vietnam port of entry; Suggested wholesale price; Suggested retail price (if the establishment has retail business registered). The subsequent import consignments do not require price re-declaration by the importing establishment unless the prices are adjusted upward);
c) With regards to drugs imported via entrusted import agents, the import agent shall undertake the declaration in accordance with the provisions of point b clause 1 of this Clause. When there is change in registration number, if the wholesale price is adjusted making it higher than the still-effective suggested wholesale price declared, redeclared previously the importing establishment or the import agent shall undertake to redeclare the suggested wholesale price.
2. Procedures, formalities in price declaration for domestically produced drugs
a) When the drug has been issued a registration number, the domestic manufacturing establishment (or the delegated drug registrant establishment if applicable) shall undertake to declare the following types of price before placing the drug on the market for the first time: Cost price; Suggested wholesale price; Suggested retail price (if the establishment has retail business registered). The subsequent lots of drug do not require price re-declaration by the domestic manufacturing establishment or the delegated drug registrant establishment unless the prices are adjusted upward;
b) For of drugs that are contract-manufactured domestically, the establishment that contacts out the drug manufacture shall undertake price declaration.
c) When there is a change in registration number, if the wholesale price is adjusted upward making it higher than the still-effective suggested wholesale price previously declared, redeclared, the domestic manufacturing establishment (or the delegated drug registrant establishment if applicable) or the establishment contracting out the drug manufacture shall undertake to redeclare the suggested wholesale price.

3. Drug business establishments shall undertake to redeclare drug prices to the drug price regulatory authority when there is a need to adjust the prices upward making them higher than those declared or last redeclared in the following cases:
a) Upward adjustment of import price for foreign drugs imported to Vietnam (when there is a change to the import price, calculated in foreign currency);
b) Upward adjustment of wholesale price or retail price (if applicable) of foreign drugs imported to Vietnam;
c) Upward adjustment of wholesale price or retail price (if applicable) of domestically produced.
4. Dossiers for drug price declaration:
The dossier for drug price declaration shall be prepared in 02 sets: 01 set to be sent to Drug Administration – Ministry of Health, 01 to be filed at the establishment. The dossier for price declaration shall be compiled as follows:
a) Drug price declaration with the submission of new registration of imported drug:
– Drug price declaration table.
b) Drug price declaration before placing the drug on the market:
– Drug price declaration table.
c) Drug price declaration of drugs produced in Vietnam before placing them on the market for the first time:
– Drug price declaration table.
5. Dossiers for drug price re-declaration:

The dossier for drug price redeclaration shall be prepared in 02 sets: 01 set to be sent to Drug Administration – Ministry of Health or Health Department, 01 to be filed at the establishment. The dossier for drug price re-declaration shall comprise the following:
a) Import price re-declaration for foreign drugs imported to Vietnam:
– Letter regarding the drug price re-declaration;
– Drug price re-declaration table;

b) Re-declaration of wholesale price, retail price (if applicable) of foreign drugs imported to Vietnam:
– Letter regarding the drug price re-declaration;
– Drug price re-declaration table.
c) Re-declaration of wholesale price, retail price (if applicable) of domestically produced drugs:
– Letter regarding the drug price re-declaration;
– Drug price re-declaration table.
If electronic declaration is used, there must be still 01 original copy [of the dossier] filed at the establishment and the electronic version sent to the drug price regulatory authority.
6. The declared, redeclared suggested wholesale prices shall be reviewed and if not yet found unreasonable shall be publicized on Drug Administration’s website. Other importing establishments or import agents and domestic manufacturing establishments, if the suggested wholesale prices they are planning to declare are not higher than the declared, re-declared wholesale prices publicized on Drug Administration’s website, they are then not required to declare their prices. If their prices are higher than the suggested wholesale prices publicized on Drug Administration’s website, such other importing establishments, import agents and domestic manufacturing establishments shall undertake to redeclare the drug prices, or declare the trading establishment’s price levels.

7. The Minister of Health shall specify the requirements regarding dossiers, procedures, formalities for [on line] drug price declaration, re-declaration and the deployment of the online drug price declaration system.
Article 136. Powers, responsibilities of state regulatory authorities over drug price, trading establishments in the implementation of drug price declaration, re-declaration regulations
1. Powers in receiving dossiers for drug price declaration, re-declaration:
a) Drug Administration – Ministry of Health shall receive:
– Drug price declaration dossiers for foreign drugs imported to Vietnam.
– Drug price re-declaration dossiers for foreign drugs imported to Vietnam.
– Drug price declaration for domestically produced drugs.
b) Health Department of provinces, centrally affiliated cities shall receive the Drug price declaration dossiers for domestically produced drugs from establishments having manufacturing facilities in the respective locality.
c) The State regulatory authority over drug price (Drug Administration – Ministry of Health and Health Department of provinces, centrally affiliated cities shall issue a dossier receipt within the working day of the price-declaration, re-declaration dossier submission by trading establishments.

2. Responsibilities of the drug price regulatory authority:
The State regulatory authority over drug price shall not undertake to approve the drug prices that are self-declared by establishments but rather it shall review the prices declared, redeclared based on the principles prescribed by Ministry of Health in conjunction with Ministry of Finance, it shall publicize on Ministry of Health’s website the declared, redeclared price levels that are not yet found unreasonable, to the trading establishments that have the declared, redeclared price levels found not reasonable, it shall send a written notice requesting them to review the declared, redeclared price levels and state the reasons of the request:
a) Regarding drug declaration cases:
Not later than 45 days from the receipt of a complete price declaration dossier in accordance with relevant regulations, if the declared price levels are found not reasonable, a written notice shall be sent to the business establishment requesting for revision of the price levels declared and stating the reasons of the request.
b) Regarding drug re-declaration cases:
Not later than 30 days from the receipt of a complete price re-declaration dossier in accordance with relevant regulations, if the declared price levels are found not reasonable, a written notice shall be sent to the trading establishment requesting for revision of the price levels declared and stating the reasons of the request.
c) Ministry of Health shall take the lead in conjunction with Ministry of Finance to formulate the principles guiding the review of prices as declared by drug trading establishments so as to judge the reasonableness of the prices declared, redeclared factoring in the following fundamental factors:
– Import expenses, total cost price, market circulation expenses, determined according to prevailing provisions of the laws.
– Market price of the drugs in domestic market, regional market and global market.
– Fluctuations in price of inputs such as raw materials, consumables, exchange rates other particular expenses.
– Other factors associated with the assurance of the drug market stabilization and the securing of supply in support of medical services for the people.

3. The state regulatory authority over drug price, the competent person in the course of inspection, control of drug price, if finding a drug trading establishment in violation of drug price regulations shall proceed as follows:
Handle the case, refer the case to the competent authority for actions according the Government regulations on sanctions for administrative offences in relation to drugs, cosmetics, and medical equipment and devices and relevant legislation pertaining to violations of drug price regulations.
While the case is being referred to the competent authority for their actions, depending on the nature and seriousness of the offenses (multiple violations or on multiple products or multiple violative acts against drug price regulations), the drug price regulatory authority shall consider and administer the following measures:
a) Suspension of the receipt, review of drug registration dossiers, business registration dossiers of foreign businesses operating in drugs and drug raw materials in Vietnam, dossiers registering drug information, drug advertisement, in the case of manufacturing establishment or delegated drug registrant establishments, in the following cases:
– Not declaring, not redeclaring drug prices; incomplete declaration of drug prices according to regulations;
– Not reviewing and adjusting the declared price after receiving written notice to the effect from drug price regulatory authority;
– Selling drugs at a price higher than the still effective declared, redeclared price;
– Not informing customers the effective declared, redeclared drug price.
b) Suspension of receiving, reviewing dossiers for the importation of drugs not yet having a registration number, in the case of importing establishments or import agents in the following cases:

– Not declaring, not redeclaring drug prices; incomplete declaration of drug prices according to regulations;
– Not reviewing and adjusting the declared price after receiving written notice to the effect from drug price regulatory authority;
– Selling drugs at a price higher than the still effective declared, redeclared price;
– Not informing customers the effective declared, redeclared drug price.

c) Establishments that sell drugs at a price higher than that the effective declared, redeclared prices without undertaking to redeclare it in accordance with the regulations shall be sanctioned by the measures enumerated in point a, b clause 3 Article 136 of this Decree, they are at the same time requested to adjust the selling price appropriately, not higher than the declared, redeclared price that is still effective up to the point of price increase.
4. Ministry of Health shall form an Interdisciplinary working group for the review of price declaration, price re-declaration by establishments, making policy recommendations, to provide input in the handling of cases declaring, redeclaring unreasonable drug prices. Members of the Interdisciplinary working group shall be: representative of Ministry of Health (Drug Administration – lead agency, Department of Planning-Finance), representative of Ministry of Finance (Pricing regulation Administration, Corporate finance Administration) and representative of Ministry of Industry and Trade (Domestic Market Department).
5. Health Department of provinces, centrally affiliated cities shall form an Interdisciplinary working group for the review of price declaration, price re-declaration by domestic manufacturing establishments having manufacturing facilities at the locality, establishments, to provide timely input in the handling of cases declaring, redeclaring unreasonable drug prices. Members of the Interdisciplinary working group shall be: representative of Health Department – lead agency, representative of Finance representative of Department of Industry and Trade.

6. Rights and responsibilities of drug trading establishments:
a) Drug trading establishments shall have the right to determine the price of the drugs they trade, at the same time they shall be responsible for fulfilling all requirements regarding price declaration, price redeclaration, price posting and other regulations pertaining to the management of drug price of this Decree and relevant legal normative documents; they shall be responsible before the laws regarding the drug price they declare, redeclare, the price they post and the data, reports, information on drug price they provide.
b) In the event that the drug price state regulatory authority has opinions regarding the drug price declared, redeclared by a trading establishment, within 30 days from receipt of the opinions in writing from the state regulatory authority, the trading establishment shall have the right to give feedback, to respond to the state regulatory authority’s opinions, past this timeline if the establishment does not respond, the price declaration, redeclarion dossier shall become void and the establishment shall have to comply to the regulatory authority’s opinions regarding the establishment’s declared, redeclared drug price.
c) In the course of trading in drugs:
– Importing establishments, domestic manufacturing establishments, import agents, establishment that contract out the manufacture of drugs, shall have to provide their customers, in paper form or by printing on sales invoices, with information regarding the effective suggested wholesale price, suggested retail price (if applicable) that they have declared, redeclared.

– The drug wholesale establishment shall base on the suggested wholesale price provided by drug supplying establishments and information regarding declared, redeclared drug prices publicized on Ministry of Health’s web portal to determine the price of the drugs they sell [at a level] not higher than the effective suggested wholesale price that was declared, redeclared by importing establishments, domestic manufacturing establishments, import agents or establishments that contract out the drug manufacture.
– In the event that the price at which the establishment sell their drugs is lower than the prices that were declared, redeclared, the provisions of antidumping legislation shall be complied with.
7. Period reporting on drug price re-declaration:

Before the 10th every month, Department of Health shall inform to Ministry of Health (Drug Administration – Ministry of Healthộ Y tế) in paper format report and via email (at email address: quanlygiathuoc@dav.gov.vn) the status of drug price re-declaration of domestic manufacturing establishments having manufacturing facilities in the local jurisdiction for the review, consolidation of information and publication on Ministry of Health’s web portal.
Article 137. Drug price posting
1. Price posting at wholesale establishments
Drug wholesale establishments shall undertake to post the wholesale price of each type of drugs at the place of transaction or the drug selling place of the pharmaceutical trading establishments for customers, competent regulatory authorities to see and recognize them easily, by means of: making the price public on boards, in papers or other suitable means. The posted wholesale price of the wholesale establishment shall not be higher than the suggested wholesale price declared, redeclared to the drug price state regulatory authority by manufacturing, importing establishments.
2. Price posting at retail establishments

Drug retail establishments shall undertake to post the retail price of each of the type of drugs at the retail establishment by means of: printing, writing down, or sticking the retail price on the packaging containing the drugs or the drugs’ outer packaging; or making the price public on boards, in papers or other suitable means for customers, competent state regulatory authorities to see and to recognize easily, ensuring that the content of drug’s original labels are not hidden and drugs are not sold at a price higher than that posted.
3. Posting drug price at retail establishments in medical service establishments
a) Retail establishments in medical service establishments shall perform the posting of retail price in accordance with the provisions of clause 2 of this Article.
b) The retail price of drugs sold by retail establishments in medical service establishments shall be [set] in accordance to the provisions for maximum retail markups prescribed by Ministry of Health on the following principles:
– Retail price at retail establishments covers the purchase price recorded on invoices and retail markup; the retail price of a drug shall not be higher that of a drug of the same type on the market (being a drug of the same drug name, strength, dosage form, manufacturer and manufacturing country).
– With regards to the drug products that are on the tender list of the hospital itself: The drug purchase price by the drug retail establishment shall not be higher than the winning bid price of the same product at the time.

– With regards to the drug products that are not on the tender list of the hospital or the drug products suppliers refuse to sell at the winning bid price because market fluctuations have pushed the price to a level higher than the winning bid price: The Director of the hospital shall make decision and be responsible regarding the list of drugs and their purchase price.- With regards to the drug products that are not on the tender list of the hospital or the drug products suppliers refuse to sell at the winning bid price because market fluctuations have pushed the price to a level higher than the winning bid price: The Director of the hospital shall make decision and be responsible regarding the list of drugs and their purchase price.- The maximum retail markup shall be determined based on the purchase price of the smallest package unit, and decreasing with the purchase price increasing in such a way that that still enables the retail establishment to cover for expenses necessary for its operations.c) The Director of medical service establishments shall be responsible for the implementation of drug price regulations by retail establishments operating in the establishment under his/her management.4. The Minister of Health shall formulate specific provisions for the operational organization and maximum retail markups for retail establishments operating in medical service establishments.

Article 138. Drug tendering
1. The procurement of drugs that are funded by the state budget, health insurance fund, revenue from the service delivery of medical service establishments and other lawful revenue streams of public healthcare establishments shall be undertaken by way of tendering in accordance with the provisions of the Law on Tender and relevant legislation regulating drug tendering.
2. The procurement of drugs for national stockpile shall be undertaken by way of tendering in accordance with the provisions of the Law on Tender and relevant legislation regulating drug tendering and national stockpile.
3. The procurement of drugs for the service of national target programs, national defense, security, epidemics combatting, mitigation of natural disasters, calamities’ consequences shall be undertaken by way of tendering in accordance with the provisions of the Law on Tender and relevant legislation regulating drug tendering and the production and supply of public goods and services.
4. The procurement of drugs that are funded by the state budget, health insurance fund, revenue from the service delivery of medical service establishments and other lawful revenue streams of public healthcare establishments shall be undertaken in strict adherence to the following principles:
a) Tenderers shall not offer imported drugs that belong to the list issued by the Minister of Health on the basis of technical criteria grouping when there are domestically produced drugs that satisfy the therapeutic, price and supply availability requirements.

b) Priority shall be given to the procurement of generic drugs, biosimilars for the first time produced in Vietnam [and] licensed for marketing in Vietnam; medicinal materials drugs, traditional drugs that are manufactured from domestically sourced medicinal materials, drugs the production of which involves the use of pharmaceutical substances, excipients, capsule shells or primary packaging components that are manufactured by Good manufacturing practice-compliant domestic establishment; fresh medicinal materials; medicinal materials, traditional drugs that are manufactured as part of national, ministerial and provincial-level mandated science and technology missions.
c) Priority shall be given to the purchase of medicinal material drugs, traditional medicinals that are manufactured by Ministry of Health-prequalified establishments meeting the competency, experience, reputation criteria. The Minister of Health shall set out criteria, dossiers, procedures for the self-selection of suppliers meeting the competency, experience, reputation criteria for the supply [of drugs] to medical service establishments
d) Tenderers shall not offer imported medicinal materials that belong to the Minister of Health-issued list when there are medicinal materials that are cultivated, harvested domestically meeting the therapeutic, price and supply availability requirements.
The determination of a reasonable price shall be based on the winning bid prices of medicinal materials that are domestically cultivated, harvested and winning bid prices of imported medicinal materials.
d) Priority shall be given to the purchase of drugs on the List of national products.

5. The Ministeer of Health shall take the lead, in conjunction with Ministry of Planning and Investment, The Minister of Finance to provide specific guidelines for the tendering of the drugs stipulated in clause 4 of this Article.
Article 139. Cases subject to drug price negotiations
1. The procurement of drugs that are funded by the state budget, health insurance fund, revenue from the service delivery of medical service establishments and other lawful revenue streams of public healthcare establishments shall be undertaken by way of price negotiation when one of the following criteria is satisfied:
a) Drugs, of which there are one 01 to 02 manufacturers on the basis of technical criteria grouping;
b) Brand name drugs, drugs that are still under patent protection;
c) Drugs that are on the list of rare drugs issued by Ministry of Health;
d) Drugs of uncommon strength;
đ) Other specific categories: narcotic drugs, psychotropic drugs and precursors and vaccines, therapeutic biologics.
2. The Ministry of Health based on the criteria in paragraph 1 of this Article to issue a list of drugs to which price negotiation can be conducted.
Article 140. Price stabilization measures
1. Cases warranting price stabilization measures
a) When there are unusual fluctuations in the price of drugs on the List of essential drugs, occuring in the following situations:
– Buying prices or selling prices in the market increase or decrease excessively in an unreasonable fashion in relation to the levels of increase or decrease resulting from the effects of price forming underlying factors, which are calculated according to policy regimes, technical-economic norms or price calculation methods issued by the state competent authority;

– Purchasing price or selling price on the market increases or decreases unreasonablyin time of natural disasters, fires, epidemics, enemy inflicted destruction, economic-financial crisis, temporary supply-demand imbalances;
b) When market price volatility impacts social economic stability, creating adverse imacts to production and people’s life.
2. Drug price stabilization measures
Operations aiming to achieve price stabilization for the drugs on the List of essential drugs according to the provisions of the Law on Price shall cover:
a) Regulate supply and demand of domestically produced drugs and imported drugs, exported drugs; among regions, localities in country through the [regulation] of drug circulation;
b) Control of drugs in stock; taking inventory of quantity, volume of products on hands;
c) Price registration;
d) Monitoring price forming input factors;
3. Execution of drug price stabilization measures
Ministry of Health shall take the lead, in conjunction with Ministry of Finance, and relevant ministries and provincial level People’s committees to deploy drug price stabilization measures in accordance with the implementation guiding documents of the Law on Price and this Decree.

Article 141. Drug price State regulatory authority
Drug Admistration under Ministry of Health shall be the agency supporting the Minister of Health in the delivery of state regulatory functions over the prices of medicinal material drugs, chemo pharmaceutical drugs.
Adinistration of Traditional Medicine&Pharmacy shall be the agency supporting the Minister of Health in the delivery of state regulatory functions over the prices of medicinal materials, traditional drugs.
Chapter IX
IMPLEMENTATION PROVISIONS

Article 142. Transitional provisions
…
Article 143. Entry into force
1. This Decree shall take effect from 01 January 2017.
2. …
Article 144. Deployment responsibilities
1. The Minister of Health shall be responsible for providing guidance for, and organize the deployment of this Decree.
2. Ministers, Heads of ministerial level agencies, Heads of Government-affiliated agencies, Chairs of People’s Committees of provinces, centrally-affiliated cities shall be responsible for the implementation deployment of this Decree./.

Recipients:
– The Party’s Central committee;
– Prime Minister, Vice Ministers of the Government;
– Ministries, Ministerial level agencies,
Government affiliated agencies;
– People’s Councils, People Committee of provinces, centrally affiliated cities;
– Central office and Committees of the Party;
– Office of the President;
– Ethnic Council and Committees of National Assembly;
– Office of National Assembly;
– Supreme People’s Court;
– Supreme Procuracy;
– Central offices of mass organizations;
– National Academy of Public Administration;
– VPCP: BTCN, TBNC, PCN, BNC,
Government web portals, Steering Committee 112,
Press Secretary of Prime Minister,
Bureaus, Administration, affiliated units, Official Gazette;
– File: Mail and correspondences, VX.

PP. THE GOVERNMENT
THE PRIME MINISTER
Nguyễn Xuân Phúc

Decree detailing pharmacy Law