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 authorization request (French version) (a new request, a request for a change to the authorization or a request to change the approved installations), plus appendix 2 if necessary « Field of application of the authorization » , must be submitted with all the required documents to the Federal Agency for Medicines and Health Products (FAMHP) by email to the mailbox email@example.com.
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 (more information regarding fees see Dutch-French).