The National Health Regulation Authority (ANRS) has published Resolution 004/2024 which outlines the Requirements and Procedures for the approval of Manufacturing Contracts, Maquila or Third-Party Contracts or Quality Agreements (Medical Devices) and third-party contracts or letters of food and beverage manufacturers:
- Each registration will entail a payment and completion of a form.
- Contracts and quality agreements must meet certain minimum requirements listed on pages 17-19.
- The authority will have a period of no more than 10 days to issue its comments. If the document does not comply, the procedure will be canceled and must be restarted with the relevant payment.
- This resolution takes immediate effect for pharmaceutical products. For devices and food, it will take effect on May 5, 2024.
