Authorisation RD 14/12/2006

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. 

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).

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.


How to apply for an authorisation to manufacture medicines ? (see French - Dutch)

How to apply for an authorisation to distribute medicines ? (see French - Dutch)

How to apply for an authorisation to export medicines ? (see French - Dutch)

How to apply for an authorisation to hold medicines ? (see French - Dutch)

Last updated on 18/07/2023