Contents of the drug manufacturing contract from October 1, 2023 in Vietnam

Contents of the drug manufacturing contract from October 1, 2023 in Vietnam (Internet image)

Regarding this issue, LawNet would like to answer as follows:

On August 15, 2023, the Minister of Health issued Circular 16/2023/TT-BYT on marketing authorization registration of contract manufactured medicine and medicine of technology transfer in Vietnam.

1. What is medicine contract manufacturing?

According to Clause 1, Article 2 of Circular 16/2023/TT-BYT, 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.

2. Contents of the drug manufacturing contract from October 1, 2023 in Vietnam

Drug manufacturing contracts in Vietnam from October 1, 2023 must contain the following contents:

- The contents specified in Article 39 of Decree 69/2018/ND-CP, specifically:

+ 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.

= Trademarks and geographical indications.

= The contract term.

- Other contain:

+ 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:

(i) 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;

(ii) 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.

Article 6. Registration for marketing authorization of contract manufactured medicine

.....

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.

+ Cases of cancellation of agreement and liability due to breach of agreement.

(Article 5 of Circular 16/2023/TT-BYT)

Circular 16/2023/TT-BYT takes effect from October 1, 2023 and replaces Circular 23/2013/TT-BYT dated August 13, 2013.

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