Regulation (EU) N° 536/2014

In accordance with the Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use, an authorisation is required for manufacturing and importing investigational medicinal products. The distribution of experimental medicines requires the authorisation referred to in article 12 of the law of 25th March 1964 (french version) concerning medicines.

The authorisation request (French version) (a new request, a request  for a change to the authorisation or a request to change the approved installations), plus appendix 2 if necessary « Field of application of the authorisation » as well as the annex to application for modification of the authorisation (French version) must be submitted with all the required documents to the Federal Agency for Medicines and Health Products (FAMHP) by email to the mailbox

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 (more information regarding fees see Dutch-French).


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