Temporary electronic submission of dossiers
Following the work adaptations prescribed to federal public servants due to the Covid-19 outbreak, you can send your requests for Certificates of Pharmaceutical Products, Licensing Status Certificates or Compliant Copy by email to the mailbox firstname.lastname@example.org. We ask that you send only one request by email. For the time being, documents are delivered mainly in PDF-format with an electronic signature. You can ask to check the validity of an electronic signature with the FAMHP via the mailbox email@example.com
Certificate of Pharmaceutical Product (CPP) & Licensing Status Certificate (LS)
Regarding export, registration and tenders, the Minister or their delegate may certify upon request that a pharmaceutical product was manufactured pursuant to the standards of good manufacturing practice. These certificates are issued pursuant to the applicable administrative guidelines of the World Health Organization (WHO).
Upon request, for a well-defined pharmaceutical product, the Minister or their delegate (the Chief Executive Officer of the FAMHP) may certify that a manufacturer is following the standards of good manufacturing practice. These certificates are issued pursuant to the applicable administrative guidelines of the World Health Organization (WHO).
EUDRAGMDP - Additional originals of certificates (GMP and GDP) and authorizations (MIA's and WDA's)
(documents uploaded in the EUDRAGMDP database)
EudraGMDP is the name of the Community database for manufacturer and importer authorisations (MIA), good manufacturing practice certificates (GMP), wholesale distributor authorisations(WDA) and good distribution practice certificates(GDP) (http://eudragmdp.eudra.org/). The eudragmdp documents provided by the FAMHP are official authorisations and certificates from the database.
These documents are created and signed by the applicant. Then legalized by the FAMHP. They are printed on paper with the company's letterhead. The SEEN FAMHP section must be placed on the first page of the document to be legalized (even if it consists of multiple pages). The “SEEN FAMHP field” is for the stamp and signature of the FAMHP, with a choice of CEO signature (for translations, for example) or CEO and a veterinarian (DVM) (for TSE statements for example, or at the request of foreign authorities). Please copy this box in its current form (do not reduce or enlarge), and retain the Verdana font.
It is possible to acquire certified copies of previously issued documents by the FAMHP (for example: authorisations and certificates).
Certificate of Analysis (CA)
Using a certificate, the FAMHP confirms that the qualified person (QP) is authorised to sign analysis certificates.
General information for all certificates
As from 17th October 2019 the round ink stamp has been replaced by a dry stamp (relief stamp) with the logo of the FAMHP. This stamp will be used on the relevant documents (CPP, LS, SEEN, CC, extra original EudraGMDP documents). This means that the usual round stamp is only placed in the provided frame with the signature. The authenticity of a certificate or document can always be verified on request via the e-mailbox firstname.lastname@example.org.
How to make a request?
The request occurs by post or by e-mail, depending on the type of document:
- By post (CPP, LS, SEEN, CC, CA,…): All requests are submitted using the request form for certificates (1 form per envelope). Any corrections are requested by mail. If a certificate consists of more than 1 page, please attach with a paper clip and do not staple. The documents must be created using the official templates.
- By Email (additional originals from the EudraGMDP database): All requests must be submitted by sending the eudra request form to email@example.com. EUDRAGMDP in the title (subject line) only. MIA and GMP available in Dutch, French, English, German and Spanish. WDA and GDP are only available in English.
Federal Agency for Medicines and Health Products
DG Inspection - Division authorisations/ Cell authorisations, Declarations and Certificates
Eurostation II, 6th Floor
Victor Hortaplein 40 Box 40
Central telephone number: +32 (0) 2 528 40 00