What are the contents of medicine contract manufacturing in Vietnam? What are the rights and responsibilities of owners of contract manufactured medicine?
What is medicine contract manufacturing?
Pursuant to the provisions in Clause 1, Article 2 of Circular 16/2023/TT-BYT regulating medicine contract manufacturing as follows
Medicine contract manufacturing means to legally produce medicine under contract manufacturing contract where manufacturing facility performs one, several, or all stages in medicine production process at request of ordering facility for a payment.
What are the contents of medicine contract manufacturing in Vietnam?
Pursuant to the provisions of Article 5 of Circular 16/2023/TT-BYT stipulating the contents that must be included in a medicine contract manufacturing include:
The processing must be made in writing or another equivalent form and contain at least:
- Name and address of the contracting parties and processor.
- Name and quantity of processed products.
- Price.
- Payment period and methods of payment.
- A list of materials to be imported and locally produced materials (if any) for processing, quantity and value thereof; amount of required material for each finished unit, quota for consumables and material wastage rate in processing.
- A list of machinery and equipment to be leased, borrowed or given for processing (if any) and value thereof.
- Actions against scrap, wreckage and rules for actions against leased or borrowed machinery and equipment, and oversupplied materials after the processing contract finishes.
- Delivery place and time.
At the same time, the medicine contract manufacturing must have the following content:
- 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.
- Owners, contract facilities, and applicants (if any) have rights and responsibilities pertaining to:
+ 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;
+ storage of recordings pertaining to production, quality inspection, distribution, circulation, storage of drug samples, settlement of issues relating to quality, complaints, product recall.
- Responsibilities of owners, contract facilities, and applicants (if any) regarding intellectual property issues relating to contract manufactured medicine.
- Procedures for inspecting, supervising contract facilities.
- 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 of Circular 16/2023/TT-BYT.
- Situations that lead to termination of the agreement and responsibilities of infringing party.
- Trademarks and geographical indications.
- The contract term.
What are the contents of medicine contract manufacturing in Vietnam? What are the rights and responsibilities of owners of contract manufactured medicine?
What are the rights and responsibilities of owners of contract manufactured medicine in Vietnam?
Pursuant to the provisions of Article 3 of Circular 16/2023/TT-BYT regulating the rights and responsibilities of owners of contract manufactured medicine as follows:
Owners have the right to:
- authorize eligible facilities to register for marketing authorization of medicine as per the law;
- 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.
Owners have the responsibility to:
- 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;
- 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.
- be responsible for legitimacy and authenticity of intellectual property of contract manufactured medicine, ingredients, materials, production procedures, and technical specifications transferred to contract facility;
- 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;
- 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;
- assume responsibility for quality, safety, and efficacy of contract manufactured medicine;
- 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.
- 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.
Circular 16/2023/TT-BYT will take effect from October 1, 2023
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