Draft 2 Circular Promulgating nonprescription drug list
Promulgating nonprescription drug list
Pursuant to Pharma Law No. 105/2016/QH13 dated 6th April 2016;
Pursuant to Decree No. 63/2012/NĐ-CP dated 31st August 2012 by the Government stipulating role and mandate, authority and organization of Ministry of Health;
At the request of Director General of Drug Administration of Vietnam,
Minister of Health hereby promulgates the “Circular promulgating nonprescription drug list”.
Article 1. Scope
This Circular promulgates “nonprescription drug list” including:
1. List of pharmaceutical drugs.
2. List of medicinal material drugs.
Article 2. Definitions
1. Drug’s serious adverse reactions are harmful reactions leading to one of the following consequences:
b) Threat to life;
c) Hospitalization or prolonged hospital stay;
d) Severe or permanent sequelae;
đ) Birth defects in the fetus and other similar consequences.
2. Toxic medicinal materials are medicinal materials in the list of toxic medicinal materials used as drugs in Vietnam as promulgated by Minister of Health.
Article 3. Principles in developing “nonprescription drug list”
1. Nonprescription drug list is developed based on selection criteria for nonprescription drugs specified under Article 4 hereof.
2. Nonprescription drug list must be suitable with practical situation of drug use and supply in Vietnam and based on nonprescription drug categorization used in other countries.
3. Nonprescription drug list shall be revised and added to in order to meet practical situations of drug use and supply. When necessary, to ensure user’s safety, a drug may be removed from the nonprescription drug list in case it no longer meets the selection criteria set in Article 4 hereof.
4. The nonprescription drug list shall be reviewed and revised every 02 (two) years.
Article 4. Selection criteria for nonprescription drugs
A drug shall be included in the nonprescription drug list when it fully meets the following requirements:
1. It has low toxicity level, and as it is stored and administered into human body, it does not generate toxic decomposed products or serious adverse reactions already known or warned by World Health Organization and/or Vietnam’s and foreign competent authorities.
2. It has a wide dose range and is safe for different age groups with little effect on diagnosis and treatment of diseases that require clinical monitoring.
3. It is indicated for treatment of normal diseases where patients can treat themselves without necessary prescription and monitoring of medical examination and treatment practitioners.
4. Its route of administration and format are simple so that users can use themselves (mainly oral and topical) with strength and concentration suitable for self -treatment.
5. It has little interaction with other drugs and common food and beverages.
6. It has little ability to create drug dependence.
7. It has little risk of abuse or misuse affecting user’s safety.
Article 5. Application of “Nonprescription drug list”
1. Nonprescription drug list serves as a basis to separate prescription and nonprescription drugs.
2. Nonprescription drug list serves as a legal basis to develop and promulgate regulations and guidelines for nonprescription in drug registration, manufacture, export, import, circulation and distribution, advertisement and scope of operations for retail pharmacies. 3. For drugs with contraceptive indications within this List, drug retailers who hold university pharmacy degree or persons responsible for pharmaceutical expertise in retail pharmacies are responsible to provide counselling and drug inserts before dispatching or selling the drugs to users. In case there is no drug inserts enclosed, drug retailers must note down instructions for the patients by hand-writing, typing or printing and attaching such instructions on the drug’s containers, except for drugs distributed as part of family planning programs.
4. In case a drug has been categorized as a prescription drug and has been circulated for at least 5 consecutive years in Vietnam has sufficient evidence of meeting the selection criteria set under Article 4 hereof, it can be considered to be converted into a nonprescription drug.
5. In case there is a need to recommend for a change/ removal or addition to the nonprescription drug list specified hereunder to be in line with practical situation and to meet patients’ treatment need, pharmaceutical facilities, medical examination facilities, medical treatment facilities or drug registration applicants may send requests in writing using Form 1 attached herewith to Ministry of Health (Administration of Science, Technology and Training) or to Services of Health (SoHs) in provinces and cities under direct management of the central Government, so that the SoHs can combine, review and send recommendation for categorization to Ministry of Health (Administration of Science, Technology and Training).
Article 6. Execution
1. Upon effect of this Circular, legal drug retailers are allowed to retail without prescription drugs in the nonprescription drug list promulgated as part of this Circular, except for drugs that are currently categorized as prescription drugs on their labels (including package inserts), which shall be retailed upon prescription.
2. For drugs whose registration dossiers in Vietnam and/or import dossiers have been submitted to DAV before the effective date of this Circular but have not received an MA in Vietnam or an import
license, the facilities must categorize, revise and supplement documents related to drug categorization as specified herein before they can be granted with an MA in Vietnam or an import license.
3. For drugs that have been granted an MA or an import license in Vietnam before the effective date of this Circular, the following shall apply:
a) For drugs under the nonprescription drug list promulgated as part of Circular 23/2014/TT-BYT but not under the nonprescription drug list promulgated as part of this Circular, within 12 months after this Circular takes effect, facilities must categorize, update and supplement information on labels and package inserts relating to categorization of prescription drugs before they can be circulated in the market.
b) For drugs not under the nonprescription drug list promulgated in Circular 23/2014/TT-BYT but are under the nonprescription drug list promulgated in this Circular:
– From the effective date of this Circular, facilities are allowed to manufacture and import until the expiry date of the drugs with drug labels and categorization as approved, or
– Facilities can categorize, update and supplement on drug labels and package inserts information relating to drug categorization as stipulated in this Circular before the drugs are circulated in the market.
Article 7. Execution
1. This Circular takes effect from 1 January 2017.
2. Circular 23/2014/TT-BYT dated 30th June 2014 by Minister of Health promulgating nonprescription drug list shall expire its validity from the date this Circular takes effect.
3. In case any documents referenced to in this Circular are changed or revised, the changes/revisions shall apply.
– Office of the Government (Gazette, web page);
– Ministry of Justice (Agency of Examination of Legal Normative Documents, Department of Administrative Procedure Control);
– Sector-based health authorities (National Defense, Public Security, Postal-Telecommunication, Transport);
– MoH’s departments, administrations and directorates, MoH Inspectors, Vinapharm;
– SoHs of cities and provinces under direct management of the central government;
– MoH’s web page;
– Archived: VT, PC, QLD (02 copies).
Nguyễn Thị Kim Tiến
REQUEST FOR CHANGE/ REMOVAL/ ADDITIONS FOR NONPRESCRIPTION DRUG LIST
To: Drug Administration of Vietnam (Ministry of Health)
or Service of Health of [province/ city]
1. Name of organization making the proposal:
4. Proposal and reasons:
Pursuant to selection criteria for nonprescription drugs specified under Article 4, Circular No.…../2016/TT-BYT by Minister of Health promulgating nonprescription drug list, [name of organization making the proposal] would like to request change/ removal/ addition to the nonprescription drug list, i.e.:
[Specify your proposal].
Reasons for the proposal: [Specify].
5. Enclosed documents: [Specify (if any)]
Given the reasons mentioned above, we would like to kindly request Drug Administration of Vietnam – Ministry of Health/ Service of Health to consider the proposal of [name of organization making the proposal].
Thank you very much.
Head of the organization
( Signature & stamp )
Full name of the signatory.
Nonprescription drug list