Medicines for export

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 (DOC, 224 Kb) from the Minister or his representative (chief executive of AFMPS / FAMHP).

The request for a declaration for exporting a medicine for human use  (DOC, 221.5 Kb) must contain the information and documents mentioned in § 1 of article 120 of the Royal Decree dated 14/12/2006 (PDF, 2.02 MB) relating to medicines for human and animal use. It must be sent to 

Federal Agency for Medicines and Health Products (FAMHP)
for the attention of Ms Séverine Brasseur,
Production and Distribution,
Eurostation 8D30,
place Victor Horta, 40 box 40
1060 Brussels.

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, unless it is referring - in the case of medicines for human use – to Article 276 of the Royal Decree of 14/12/2006, in which case the declaration remains valid until 31st December 2011.

The declarations for export are subject to a payment of 134 euros (payable to the account 679-0021942-20 - IBAN: BE 28 6790 0219 4220 - BIC: PCHQBEBB / mention code: 700100).

Contact
Séverine Brasseur
tel: 02/524.82.56
fax: 02/524.80.01
e-mail: severine.brasseur@afmps.be