According to articles 12b and 12c of the law dated 25th March 1964 (french version) concerning medicines, the manufacture of medicines or intermediary products on Belgian territory requires authorisation. This authorisation is also required if the medicine is manufactured for export.
Authorisation is needed both for total or partial manufacture and for work such as dividing, packaging or presentation.
Authorisation is furthermore required for imports from third countries and for wholesale of medicines.
Before applying to the Federal Agency for Medicines and Health Products (FAMHP) for a new or updated manufacturing 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
The Royal Decree dated 14/12/2006 (french version) (part 1 - part 2) relating to medicines for human and veterinary use, defines the conditions for obtaining these authorisations (manufacture and imports : articles 74 to 83 – wholesale distribution : articles 90 to 99).
- MANUFACTURING & DISTRIBUTION: The application for authorization 14/12/2006 (French version) (a new application or an application to modify an authorization) for firms which manufacture medicines and/or distributes them with the Appendix 1 (area of application of the authorization) must be submitted with all the required documents by email to the Federal Agency for Medicines and Health Products via the mailbox email@example.com
- DISTRIBUTION: The application for an authorization 14/06/2006 (French version) (a new application or an application to modify an authorization) for firms which distributes medicines must be submitted with all the required documents 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 authorization 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 authorization.