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-EDemail@example.com .Who must submit the request for a declaration for export ?
t is the exporter who must submit the request. In the particular case of a drug manufactured in Belgium on behalf of a European exporter, by concluding a contract with a Belgian subcontractor, the European contract giver also undertakes to comply with article 120 of the royal decree of 14/12/2006 relating to medicinal products for human or veterinary use. But the Belgian manufacturer can take care of submitting the export declaration request. It will then be verified that the contract giver who is exporting has a WDA mentioning the export.
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. All fees are indexed annually. An overview is available on our website:
• in French in the document ‘Autorisation - enregistrements - déclarations - certificats – inspection’.
• in Dutch in the document ‘Vergunningen - registraties - declaraties - certificaten – inspectie’.
The fees will be invoiced by the FAMHP and do not need to be paid in advance.
Federal Agency for Medicines and Health Products
DG Inspection - Division Authorisations - Cell Authorisations, Declarations and Certificates
General telephone number: