Chapter II
GENERAL PROVISIONS ON MARKETING AUTHORIZATION REGISTRATION OF CONTRACT MANUFACTURED MEDICINE
Article 3. Rights and responsibilities of owners and facilities registering for marketing authorization (hereinafter referred to as “applicants”) of contract manufactured medicine
In addition to rights and obligations under Article 181 of the Law on Commerce and Clause 1 Article 42 of Decree No. 69/2018/ND-CP dated May 15, 2018 of the Government elaborating the Law on Foreign Trade Management (hereinafter referred to as “Decree No. 69/2018/ND-CP”), owners have rights, obligations, and responsibilities below:
1. Owners have the right to:
a) authorize eligible facilities to register for marketing authorization of medicine as per the law;
b) register for marketing authorization of medicine when:
- They possess certificate of eligibility for pharmaceutical business which permits them to: manufacture, trade, export, or import medicine, medicinal ingredients in regard to Vietnamese owners;
- They possess legitimate documents issued by foreign competent authority and granting them permission to: manufacture, trade, export, or import medicine, medicinal ingredients and license to establish representative office in Vietnam in regard to foreign owners.
2. Owners have the responsibility to:
a) comply with Article 3 of Circular No. 08/2022/TT-BYT dated September 5, 2022 of the Minister of Health on marketing authorization registration of medicine and medicinal ingredients (hereinafter referred to as “Circular No. 08/2022/TT-BYT”);
b) provide contract facilities with:
- Partial or total ingredients, materials, and technical specifications including production procedures, quality standards, testing methods for starting ingredients, semi-finished products, finished products, and excipients for the purpose of contract manufacturing;
- Other documents relating to market authorization registration of contract manufactured medicine and contract manufacturing of medicine.
c) be responsible for legitimacy and authenticity of intellectual property of contract manufactured medicine, ingredients, materials, production procedures, and technical specifications transferred to contract facility;
d) cooperate with applicants in staying up-to-date with quality standards of medicine and medicinal ingredients in accordance with Circular No. 11/2018/TT-BYT dated May 4, 2018 of the Minister of Health on quality of medicine and medicinal ingredients, Circular No. 03/2020/TT-BYT dated t h1 22, 2020 of the Minister of Health on amendment to Circular No. 11/2018/TT-BYT dated May 4, 2018;
d) examine and supervise contract facility regarding production of contract manufactured medicine with the right transferred ingredients, materials, specifications, documents, and approved medicine marketing authorization in order to properly adhere to manufacturing contract and comply with GMP;
e) assume responsibility for quality, safety, and efficacy of contract manufactured medicine;
g) file report or cooperate with applicants of contract manufactured medicine (if the owner does not register for marketing authorization) in filing report on monitoring and assessment of safety and efficacy of contract manufactured medicine in accordance with Clause 2 Article 5 of Circular No. 08/2022/TT-BYT.
h) inform contract facilities and applicants about:
- Issues relating to medicine to be contract manufactured in terms of safety or efficacy;
- Change or addition to technical specifications of medicine to be contract manufactured during circulation;
- Decision on revocation of market authorization of medicine to be contract manufactured issued in any country.
3. Applicants are responsible for cooperating with owners and contract facilities in informing Drug Administration of Vietnam in writing within 30 days from the date on which decision on revocation of marketing authorization of medicine to be contract manufactured is issued in any country (if current marketing authorization is still effective) and exercising other responsibilities under Article 3 of Circular No. 08/2022/TT-BYT.
4. Exercise other rights, obligations, and responsibilities as per relevant law provisions.
Article 4. Rights and responsibilities of contract facilities
In addition to rights and obligations under Article 181 of the Law on Commerce and Clause 2 Article 42 of Decree No. 69/2018/ND-CP, contract facilities have rights, obligations, and responsibilities below:
1. Contract facilities have the right to:
a) manufacture medicine under contract in a manner that is appropriate to the scope of certificate of eligibility for pharmacy business with respect to contract facilities that are manufacturing facilities in Vietnam issued with certificate of eligibility for pharmacy business;
b) manufacture medicine under contract in a manner that is appropriate to the scope of GMP certificate with respect to contract facilities that conduct pharmacy business for non-commercial purposes under Point a Clause 1 Article 35 of the Law on Pharmacy;
c) register contract manufactured medicine under their name if they are authorized by owners.
2. Contract facilities have the responsibility to:
a) exercise responsibilities of medicine manufacturing facilities under Article 4 of Circular No. 08/2022/TT-BYT;
b) manufacture medicine under contract in a manner that is appropriate to the scope under certificate of eligibility for pharmacy business or GMP certificate with respect to facilities that conduct pharmacy business for non-commercial purposes under Point a Clause 1 Article 35 of the Law on Pharmacy;
c) manufacture medicine under contract with the right ingredients, materials, production procedures, and technical specifications transferred by owners, ensure medicine quality according to marketing authorization, and comply with GMP requirements and request of the owners under manufacturing contracts. Store documents, files, medicine samples relating to medicine contract manufacturing process and provide the documents for competent authority upon requested;
d) make changes relating to formula; production procedure; ingredient quality standards; finished product quality standards; trade name in case of contract manufactured medicine satisfying Point a Clause 1 Article 6 hereof if corresponding changes of contract manufactured medicine have been approved by competent authority are made. Changes to contract manufactured medicine shall only be implemented if owners require and if the Drug Administration of Vietnam approves these changes;
dd) exercise regulations pertaining to production, transportation, import, export, circulation, use, disposal, delivery, reporting, documentation, and storage of documents relating to contract manufactured medicine and ingredients thereof that are controlled drugs according to Decree No. 54/2017/ND-CP dated May 8, 2017 of the Government elaborating the Law on Pharmacy (hereinafter referred to as “Decree No. 54/2017/ND-CP”), Decree No. 155/2018/ND-CP dated November 12, 2018 of the Government on amendment to business and investment conditions under state management of the Ministry of Health (hereinafter referred to as “Decree No. 155/2018/ND-CP”), Circular No. 20/2017/TT-BYT dated May 10, 2017 of the Minister of Health elaborating the Law on Pharmacy and Decree No. 54/2017/ND-CP dated May 8, 2017 of the Government on controlled medicine and medicinal ingredients (hereinafter referred to as “Circular No. 54/2017/ND-CP”) and other relevant law provisions on controlled drugs;
e) apply for contract manufacturing permit in order to manufacture medicine under contract with owners that are foreign traders in accordance with Clause 4 Article 38 of Decree No. 69/2018/ND-CP.
3. Exercise other rights, obligations, and responsibilities as per relevant law provisions.
Article 5. Manufacturing contract
In addition to satisfying provisions under Article 39 of Decree No. 69/2018/ND-CP, drug manufacturing contracts must contain:
1. Agreement on supply of ingredients and materials. Technical specifications provided for contract facilities by owners include: production procedures, quality standard, test methods for starting ingredients, semi-finished products, finished products, excipients, and other documents relating to contract manufacturing of medicine.
2. Owners, contract facilities, and applicants (if any) have rights and responsibilities pertaining to:
a) production procedures, quality inspection, preservation and transportation of starting ingredients, semi-finished products, finished products, excipients, packaging procedures, printing or application of label of contract manufactured medicine and detailing of responsibilities of facilities signing batch certificate of analysis and factory release certificate of contract manufactured medicine;
b) storage of recordings pertaining to production, quality inspection, distribution, circulation, storage of drug samples, settlement of issues relating to quality, complaints, product recall.
3. Responsibilities of owners, contract facilities, and applicants (if any) regarding intellectual property issues relating to contract manufactured medicine.
4. Procedures for inspecting, supervising contract facilities.
5. Contract manufacturing roadmap for production stages of contract manufactured medicine in Vietnam and responsibilities of relevant parties in regard to contract manufactured medicine under Clause 2 Article 6 hereof.
6. Situations that lead to termination of the agreement and responsibilities of infringing party.
Article 6. Registration for marketing authorization of contract manufactured medicine
1. For the purpose of registration for marketing authorization, contract manufactured medicine shall be classified as follows:
a) Contract manufactured medicine share the followings with medicine to be contract manufactured: formula; production procedures; ingredient quality standards; finished product quality standards; trade name;
If changes to at least one criterion under this Point (not including trade name) or to quality have been made to contract manufactured medicine relative to medicine to be contract manufactured which has had original proprietary drug and reference product declared by the Ministry of Health, either these changes must be approved by pharmacy authority of manufacturing country or authority under Clause 9 Article 2 of Circular No. 08/2022/TT-BYT which previously granted marketing authorization for the medicine or applicants must provide proof that the contract manufactured medicine has quality equivalent to that of medicine to be contract manufactured.
b) Other contract manufactured medicine that does not fall under cases of Point a of this Clause.
2. In regard to contract manufactured medicine whose contract production stages in Vietnam follow a roadmap, applicants or contract facilities implement contract manufacturing of medicine under Point a Clause 1 of this Article must file report on contract manufacturing progress of production stages of finished products in Vietnam to the Ministry of Health (via the Drug Administration of Vietnam) using Form No. 04/TT under Appendix 1 attached hereto on an annual basis from the date on which marketing authorization is issued.
3. Effective period of marketing authorization of contract manufactured medicine shall conform to Clause 1 and Clause 2 Article 8 of Circular No. 08/2022/TT-BYT.
4. Deadline for applying for marketing authorization of contract manufactured medicine shall conform to Clause 4 Article 8 of Circular No. 08/2022/TT-BYT.
Tìm kiếm
Thông tư 16/2023/TT-BYT (Bản Word)
Thông tư 16/2023/TT-BYT (Bản Pdf)