Declaration for export
A medicine which has not received marketing authorisation in Belgium or in another member state of the European Union can be exported as long as one obtains a declaration for export (Dutch or French) from the Minister or his representative (chief executive of AFMPS / FAMHP).
The request for a declaration for exporting a medicine for human use (Dutch or French) must contain the information and documents mentioned in § 1 of article 120 of the Royal Decree dated 14/12/2006 relating to medicines for human and animal use. It must be sent electronically to the FAMHP.
Each email can only contain one declaration request (1 email per declaration) and must clearly indicate the subject 'ED' and the name of the concerned medicinal product. The application must contain the different documents requested, separately (1 document = 1 file attached). Applications must be sent from the mailbox of the qualified person (QP), the responsible person or the legal representative of the company and must contain an extension specific to the company (hotmail addresses, gmail, skynet, ... will not be accepted). They must be sent to the generic address : D-EDfirstname.lastname@example.org .
The Minister or his representative communicates his decision to the applicant within 60 days from the date the request was submitted. He can demand additional information. In that case the 60-day timeframe is suspended until the requested information is supplied. The declaration for export is valid for 5 years.
The declarations for export are subject to a payment of 354,13 €.
An invitation to pay the amount will be sent to the applicant by the FAMHP via an invoice.
Federal Agency for Medicines and Health Products
DG Inspection - Division Authorizations
Cell Authorizations, Declarations and Certificates
Eurostation II, 6th floor
Place Victor Horta, 40 box 40
General telephone number: