According to articles 88 and 99 of the regulation (EU) 2019/6 concerning medicines for veterinary use, the manufacture of medicines or intermediary products on Belgian territory requires authorisation. This authorisation is also required if the medicine is manufactured for export.
A manufacturing authorisation is required for
- the manufacture of veterinary medicinal products, even if intended exclusively for export;
- any of the steps in the manufacturing process of a veterinary medicinal product or for bringing a veterinary medicinal product to its final state: manufacture of the pharmaceutical form, primary packaging, secondary packaging, analysis, batch certification;
- importation of veterinary medicinal products
From 28 January 2022, before applying to the Federal Agency for Medicines and Health Products (FAMHP) for a new or updated manufacturing or wholesale authorisation, you must check that your organisation is correctly registered in OMS. We would like to refer you to the European Medicines Agency (EMA) for more information.
- Organisation Management Service (OMS)
- SPOR Data Management Service portal
- Video tutorial: Overview of OMS
- Webinar for Industry: Introduction to OMS services and activities
Application for an authorisation
- MANUFACTURING & DISTRIBUTION: The application for authorisation (French version) (a new application or an application to modify an authorisation) for firms which manufacture medicines and/or distributes them with the Appendix 1 (area of application of the authorisation), the declaration of the applicant (French version) and all required documents must be submitted by email to the Federal Agency for Medicines and Health Products via the mailbox email@example.com
- DISTRIBUTION: The application for an authorisation (French version) (a new application or an application to modify an authorisation) for firms which distributes medicines must be submitted with all the required documents (example the declaration of the applicant (French version) by email to the Federal Agency for Medicines and Health Products via the mailbox firstname.lastname@example.org
The amount of the fee related to the making of the authorisation is included in the annual fee or in the cost of a complementary inspection, not included in the amount of this annual fee. Therefore no proof of payment has to be provided when submitting an application for an authorisation.