Application
For export purposes the Ministry or its representative (the chief executive of FAMHP ) can also certify, when so requested, that a medicine destined for export has been produced in line with the GMP rules. These certificates are delivered according to the administrative rules of WHO.
When requested for a particular medicine the Ministry or its representative (the chief executive of FAMHP) can certify that a manufacturer follows the GMP rules.
These certificates are delivered according to the administrative rules of WHO.
Two copies of a certificate must always be requested (1 original and 1 copy for the authorities).
- If it is for a certificate for a particular product (Certificate of a Pharmaceutical Product (CPP), Good Manufacturing Certificate (GMP), Licensing Status Certificate (LS) or other for an authorized medicine, the request must always be accompanied by a copy of the most recent marketing authorization and, if it is applicable, the automatic mails for the authorized variations and the document proving that the request for the renewal has been submitted.
- If it is a certificate for a particular product (CPP, GMP, LS or other) for a declared medicine the request must always be accompanied by a copy of the most recent export declaration or declaration.
- If it is a general GMP certificate the request can be accompanied by a copy of the first page of the general authorization.
Contact
Sandra BOON (NL) – Sabrina DUFAYS (FR) – An SOUFFRIAU (NL)
Federal Agency for Medicines and Health Products
Department “Production and Distribution”
Eurostation II, 8th floor Office 8D268
Place Victor Horta, 40 box 40
1060 Brussels
Tel.: +32 (0)2 524 82 97 / +32 (0)2 524 82 98 / +32 (0)2 524 80 61
Fax: +32 (0)2 524 83 01
E-mail:
sandra.boon@fagg.be
sabrina.dufays@afmps.be
an.souffriau@fagg.be