On August 15, 2023, the Minister of Health issued Circular 16/2023/TT-BYT. Circular on registration of circulation of processed drugs and technology-transferred drugs in Vietnam.
Overview
A drug processing contract is an agreement between the parties. Accordingly, the processing Party creates products at the request of the ordering Party. The ordering party accepts the product and pays the processing fee.
Content
Specifically, the content and form of the contract are detailed in Article 5 of Circular 23/2013/TT-BYT as follows:
First: About the form of contract.
The contract must be in writing. The contract must comply with the provisions of Vietnamese law on economic contracts.
Second: Compulsory contents of the contract.
Response to the contents specified in Article 39 of Decree 69/2018/ND-CP.
In addition, a drug processing contract must contain the following contents:
– Agreement on the supply of raw materials and materials. The provision of technical dossiers by an ordering Party includes the following requirements:
+ Production process;
+ Quality standards;
+ Methods of testing starting materials
+ Semi-finished products, finished products, accessories
+ Other documents related to the production.
– Rights and responsibilities of drug processing Party, drug ordering Party and drug registration Party (if any):
+ In each stage of the production process, about the production process, quality control, storage and transportation of starting materials, quality assurance measures should be taken. Finished products after being processed need to be checked for quality before packing. Regulations on the responsibility of the establishment signing the test report for each batch of finished products and the drug ex-factory note.
+ The keeping of records on production, quality control, distribution and circulation of drugs. Sample storage, resolution of quality-related issues, complaints, product recalls.
– Responsibilities of processing Party, processing Party and drug registration Party for intellectual property issues related to processed drugs.
– Process and procedures for inspection and supervision of production facilities.
– The roadmap for processing the stages of the drug manufacturing process in Vietnam. And the responsibilities of related parties are specified in Clause 2, Article 6 of Circular 16/2023/TT-BYT .
– Cases of cancellation of agreement and liability due to breach of agreement.
Conclusion:
Having an accurate and satisfactory drug processing contract from October 1, 2023. Will help create a healthy cooperation environment, bringing long-term benefits to both parties.
Harley Miller Law Firm “HMLF”
Head office: 14th floor, HM Town building, 412 Nguyen Thi Minh Khai, Ward 05, District 3, Ho Chi Minh City.
Phone number: +84 937215585
Website: hmlf.vn Email: miller@hmlf.vn
