In accordance with article 24 §1 of the law of 7th May 2004 (french version) concerning experiments on humans, an authorisation is required for manufacturing and importing experimental medicines. Such an authorization is also required if the experimental medicine is intended for exportation. The distribution of experimental medicines requires the authorisation referred to in article 12 part 3 of the law of 25th March 1964 (french version) concerning medicines.
The Royal Decree dated 30th June 2004 (french version), which defines the measures for implementing the law of 7th May 2004 (french version) about experiments on humans for clinical trials of medicines for human use, states the details of the cases where authorization is required, the conditions and details that must be met to obtain it, and the requirements that an authorisation holder must meet. Article 16 refers to manufacture of medicines intended for clinical trials, to importation for manufacture or importation of medicines for clinical trials that are received packaged from a country outside the EU / EES (European Economic Space)
The Royal Decree of 14th December 2006 (French version) (part 1 - part 2) about medicines for human and veterinary use applies to the importation of medicines packaged in an EU / EES country, to stocking and distributing medicines for clinical trials, and also for exportation of packaged medicines.
The authorization request – Royal Decree 30/06/2004 (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).