Draft 1 Circular Guidance for announcing drugs belonging to the list of brand name drugs
CIRCULAR
Guidance for announcing drugs belonging to the list of brand name drugs
Pursuant to Pharmaceutical Law No. 105/2016/QH13 dated 6 April 2016;
Pursuant to Decree No. … / 2017 / ND-CP dated … May … 2017 of the Government detailing the implementation of some articles of Pharmaceutical Law;
Pursuant to Decree No. 63/2012/ND-CP of 31 August 2012 of the Government regulating the functions, duties, powers, organizational structure of Ministry of Health;
At the request of the Director of the Drug Administration,
Minister of Health hereby issue the circular guiding the announcement of drugs belonging to the list of brand name drugs.
Chapter I
GENERAL PROSIVIONS
Article 1. Scope of regulation, subjects of applicability
1. This Circular provides specific guidance regarding the announcement of drugs belonging to the list of brand name drugs.
2. This Circular applies to institutions, organizations and individuals owning the drugs that are marketed in Vietnam under the provisions of clause 1 of this Article.
Article 2. Definition of terms
In this Circular, the following terms shall be construed as follows:
1. Brand name drug means drugs that for the first time are licensed for marketing on the basis of available data on the drug’s quality, safety and effectiveness.
2. Patent means a form of protection of exclusive rights granted for an invention, which is a technical solution under the form of a product or a process, to solve an identified problem by the application of the laws of nature.
Chapter II
GUIDELINES FOR ANNOUNCING DRUGS BELONGING TO THE LIST OF BRAND NAME DRUGS
Article 3. Dossier required for a drug to be announced as belonging to the List of brand name drugs
1. Letter requesting Ministry of Health to announce a brand name drug using Template form in Appendix 1 enclosed with this Circular.
2. Patent for the drug issued by one of the competent intellectual property authorities listed under Article 6 of this Article with one of the following categories in its scope of protection:
a. An active ingredient with regard to a drug containing a single active ingredient;
b. A group or combination of active ingredients with regard to a drug containing more than one active ingredients;
c. A pharmaceutical product or a preparation or a dosage form with regard to injection drugs, infusion drugs, drugs for eye conditions, mist spray drugs, drug implants, subdermal patches, drugs in gel form;
d. Pharmaceutical product with regard to a drug containing an active ingredient known in other field which is used for the first time in healthcare;
e. Processes of manufacturing, fractionation, isolation, purification of an active ingredient with regard to a drug containing an active ingredient which is a known natural product.
The patent must be accompanied by the parts on background art and explanation of the claims defining the scope for protection.
3. Documents pertaining to the licensing or ownership transfer of patent’s rights in the case the establishment manufacturing the drug or the establishment holding the product’s license is not the owner of the patent for the active ingredient, enclosed with an affidavit from the establishment certifying the authenticity of the document.
4. Documents certifying that the manufacturing establishment is delegated by the patent’s owner to manufacture the drug according to the claims defining the patent’s scope of protection referred to in clause 2 of this Article.
5. Documents regarding the information on the drug subject of the request for brand name drug announcement, comprising:
a) Certificate of pharmaceutical product (CPP) or Free sale certificate (FSC) or Marketing authorization (MA) or Import license or Official letter correcting, adjusting information of Drug Administration for the drug, issued to the owner by the competent authority.
b) Documents demonstrating the drug’s safety and effectiveness with respect to requests for brand name drug announcement of drugs containing an active ingredient which is a known natural product:
+ Substantiating documents regarding the clinical trial data of the drug as well as figures pertaining to the drug’s quality, safety, effectiveness.
+ Documents pertaining to the manufacturing process of the drug according to the Patent that was issued for it.
c) In the case of changes in manufacturer, documentation demonstrating that the drug that is manufactured at the new manufacturing establishment has the same technical standards with the one manufactured at the old establishment.
6. Other relevant documents (as applicable).
7. Papers, documents that are issued by foreign competent authorities must be consular officialized according to the regulations on consular officialization; if authenticated duplicate copies are submitted the authentication must be done in accordance with legislation on authentication. For the papers, documents issued by foreign competent authorities that are not in Vietnamese or English language, a Vietnamese or English notarized translation version must be submitted along with the original or a valid duplicate copy.
Where an establishment submits information regarding a patent for an invention that is searchable, ascertainable through patent databases of Intellectual property authorities’ websites, the establishment must indicate clearly the search address, name of the relevant intellectual property authority and search code.
Article 4. Procedures for receiving, examination of dossiers requesting for a drug to be announced as belonging to the list of brand name drugs
1. The establishment requesting for brand name drug announcement must submit 01 set of application dossier to Ministry of Health.
2. Within 90 days from receipt of a complete application dossier from the establishment, Ministry of Health shall make decision regarding the announcement of the drug as belonging to the list of brand name drugs. If the drug is yet to be announced, Ministry of Health shall issue a written notification to the effect, stating the reasons.
3. The List of brand name drugs shall be published on Ministry of Health’s web portal.
Article 5. Provisions for the announcement that a drug belongs to the list of brand name drugs
1. If the establishment’s application dossier is for the announcement of a new drug, such drug shall be announced in the list of brand name drug if:
a) The documentation required under Article 3 of this Circular are satisfactorily submitted and the drug’s manufacturing establishment is located in an ICH member country or Australia.
b) Availability of documentation demonstrating that the drug is licensed for marketing for the first time in the manufacturing country in the case of manufacturing establishments not belonging to ICH member countries or Australia.
2. In the case of a drug that is already included in Ministry of Health’s published list of brand name drug, for which a marketing registration number or a new import license is already issued and the manufacturing establishment of which is changed to that located in another country, such drug shall be announced in the list of brand name drugs if falling into one of the following categories:
a) Drugs involving a change in manufacturing establishments whereby the old and new establishments both belong to an ICH member country or Australia.
b) Drugs already included in the published list of brand name drugs, that are the subject of an arrangement for the transfer of associated technologies, techniques, specifications to a manufacturing establishment in Vietnam.
Article 6. List of patent-issuing intellectual property authorities accepted for the purpose of consideration for brand name drug announcement
Vietnam national office of Intellectual property office or Intellectual property authorities recognized by the World intellectual property organization (WIPO) as International searching and preliminary examining authorities, that do conduct substantive examination when issuing patents, covering:
1. Austrian Patent Office (country code: AT);
2. IP Australia (country code: AU);
3. National Institute of Industrial Property, Brazil (country code: BR);
4. Canadian Intellectual Property Office (country code: CA);
5. State Intellectual Property Office of the People’s Republic of China (country code: CN);
6. European Patent Office (IP office code: EP);
7. Spanish Patent and Trademark Office (country code: ES);
8. National Board of Patents and Registration of Finland (country code: FI);
9. Israel Patent Office (country code: IL);
10. Japan Patent Office (country code: JP);
11. Korean Intellectual Property Office (country code: KR);
12. Federal Service for Intellectual Property (country code: RU);
13. Swedish Patent and Registration Office (country code: SE);
14. United States Patent and Trademark Office (country code: US).
15. German Patent and Trade Mark Office (country code: DE);
16. United Kingdom Intellectual Property Office (country code: GB);
17. Institut National de la Propriété Industrielle (country code: FR);
18. Hungarian Intellectual Property Office (country code: HU).
Chapter III
IMPLEMENTATION
Article 7. Entry into force
1. This Circular shall take effect from … month…year 2017.
2. The following documents shall be repealed effective as of the date this Circular takes effect:
a) Decision no 2962/QĐ-BYT dated 22 August 8 2012 of Ministry of Health issuing the provisional
Regulations regarding document submission for the publication of the list of brand name drugs, drugs of therapeutic equivalence with a brand name drug, drugs supported by documents demonstrating bioequivalence;
b) Decision no. 1545/QĐ-BYT dated 08 May 2013 of Ministry of Health amending, supplementing Decision no. 2962/QĐ-BYT dated 22 August 2012 of Ministry of Health issuing the provisional Regulations regarding document submission for the publication of the list of brand name drugs, drugs of therapeutic equivalence with a brand name drug, drugs supported by documents demonstrating bioequivalence.
Article 8. Implementation
1. Drug Administration shall be responsible for updating, publishing the list of brand name drugs on Ministry of Health’s web portal.
2. Establishments that own drugs being marketed in Vietnam and meet the requirements in documentation, other provisions of this Circular shall send application dossiers to Ministry of Health (Drug Administration) for the latter’s consideration for inclusion into the list of brand name drugs.
In the course of implementation of this Circular, agencies, organizations, individuals involved please provide feedback about any issues encountered to Ministry of Health (Drug Administration) for the latter’s consideration, resolution../.
Recipients:
– Office of the Central Party; Office of the President;
– Offices of National Assembly; Ethnicity council and National assembly’s committees;
– Office of the Government (KGVX Directorate, Official gazette, Government’s web portal);
– Ministry of Justice (Legal normative document checking Division);
– Ministries, Ministerial level agencies, Gov affiliated agencies;
– People’s committee of provinces, centrally affiliated cities;
– State Audit office;
– Vietnam fatherland front;
– Central office of mass organizations;
– Finance Department, Health Department of provinces, centrally affiliated cities;
– Vietnam Chamber of Commerce and Industry;
– Ministry of Health’s agencies, affiliates;
– Vietnam Social insurance;
– Sector Health services (QP, CA, BCVT, GTVT);
– Vietnam Pharmaceutical association;
– Vietnam private hospital association;
– Vietnam Pharmaceutical general corporation;
– Ministry of Health’s web portal;
– Drug Administration’s web page;
– Administration of traditional medicine and pharmacognosy’ s web page;
– File: VT, KHTC(02), PC(02).
APPENDIX I
Template form for request for brand name drug announcement
(Enclosed with Circular no. /2017/TT-BYT dated dd mm 2017 of Minister of Health)
To: Ministry of Health (Drug Administration)
I. (The Company) requests that Ministry of Health (Drug Administration) to consider and announce the following drug products as brand name drugs:
1. Drug name:
2. Active ingredient:
3. Strength/concentration:
4. Dosage form, packaging form:
5. Registration no /Import license:
6. Name, address of manufacturing establishment:
7. Name, address of packaging establishment:
II. (The Company) hereby submits the following documents to prove that the above drug products are brand name drugs:
1. Patent:
– Number:
– Issuing authority:
– Issue date:
– Claims, Scope of protection:
– Information searchable at: (search address, search code if applicable).
– Name and address of patent’s owner:
2. Document certifying ownership transfer of patent rights.
3. Document certifying that the manufacturing establishment is delegated by the patent’s owner to manufacture the drug according to the claim defining the patent’s scope of protection.
4. Certificate of pharmaceutical product (CPP) or Free sale certificate (FSC) or Marketing authorization (MA) or Import license for the drug, issued to the owner by the competent authority.
5. Other supporting documents (if any).
(The Company) hereby confirm that it is the owner of the above drug products and takes responsibility before the laws of Vietnam for the accuracy of the above presented information, documents.
The Director:
(Signature, Seal)
Guidance for announcing brand drugs
