Applications for certificates, SEEN statements and certified copies

Electronic submission of dossiers
As of 2021, the following applications can only be submitted by email to certificates@fagg-afmps.be.

  • Certificate of Pharmaceutical Product (CPP)
  • Licensing Status Certificate (LS)
  • Certified copies (CC)
  • SEEN statement
  • Certificate of Analysis (CA)

Please send only one email per application. This email should contain the following documents:

  • the completed application form in Excel format;
  • the certificate in Word format;
  • related documents in PDF format.

Use the official templates.
Please specify in the subject line of your email: the type of certificate (CPP-LS-CC-SEEN) – firm reference – name of applicant's firm – country – product name.

Certificates and documents issued, are signed and transmitted electronically. Should you nevertheless need a hand-signed certificate, you can exceptionally request one. The time limit for delivering « paper » documents with a wet signature is considerably longer then the time limit for delivering electronically signed documents.

More information on certificate applications (in Dutch or French).

General information
Paper certificates contain a dry stamp (embossed stamp) with the FAMHP logo. The stamp will be used on the following documents: CPP, LS, SEEN, CC, CA and extra original EudraGMDP documents. The usual round stamp will only be used on documents with a box for the stamp and signature. The authenticity of a certificate or document can always be verified at your request via certificates@fagg-afmps.be.
 

Certificates


Certificate of Pharmaceutical Product (CPP) and Licensing Status Certificate (LS)
For the purpose of export, registration and tenders, the minister or his representative (the CEO of the FAMHP) may certify, upon request, that a medicinal product was manufactured according to the Good Manufacturing Practices. These certificates are issued in accordance with the administrative regulations of the World Health Organization (WHO).

Certificate of Analysis (CA)
The FAMHP confirms by means of a certificate that the qualified person (QP) and possibly other qualified persons are allowed to sign certificates of analysis.

SEEN statement
These documents are drawn up on paper with the firm's header and the applicant's signature. The documents are then legalised by the FAMHP. The box "SEEN FAMHP" must be placed on the first page of the document to be legalised (even if the document is several pages long). The box "SEEN FAMHP" is reserved for the stamp and signature of the FAMHP, either that of the CEO (e.g. for translations), or those of the CEO and a veterinarian (DMV) (e.g. for TSE declarations or at the request of foreign authorities). Please copy this box in its current form (without reducing or extending it) and keep the Verdana font.

Certified copies (CC)
It is possible to obtain a certified copy of certain documents previously issued by the FAMHP.

EudraGMDP


Additional original certificates (GMP and GDP), authorisations (MIA and WDA) and registrations of active pharmaceutical ingredients (API REG)
EudraGMDP is the name of the Community database for manufacturing and importation authorisations (MIA), good manufacturing practices certificates (GMP), wholesale distribution authorisations (WDA), good distribution practices certificates (GDP) and registration of manufacturers, importers and distributors of active pharmaceutical ingredients for human use in the EEA (API REG). The EudraGMDP documents provided by the FAMHP are official authorisations, registrations and certificates from this database.

Requests for additional original EudraGMDP documents:

  • must always be submitted by email to eudragmdp@fagg-afmps.be;
  • please only mention EUDRAGMDP E-SIGN or EUDRAGMDP PAPER and the name of the applicant's firm in the subject line;
  • please also select the type of document you need (digital or paper) from the Excel menu.

MIA and GMP are available in English, Dutch, French, German and Spanish. WDA, GDP and API REG are only available in English.

Tip: how to find a document in the EudraGMDP database?

Annexes to MIA and WDA
The manufacturing and import authorisations (MIA) as well as the wholesale distribution authorisations (WDA) are issued via the European database EudraGMDP. These documents form an integral part of the manufacturing and distribution authorisations provided by the FAMHP. The documents consist of annex 1 or annex 2 (MIA) or annex 1 (WDA) which lists manufacturing activities (MIA) or distribution activities (WDA). These documents also include a series of optional annexes (MIA: annexes 3-8 / WDA: annexes 2-5). These optional annexes are not published by the FAMHP.
 

Legalisation of documents (legalisation/e-apostille)

 

Documents signed by authorised officials on behalf of the FAMHP can be submitted for further legalisation to the Legalisation service of the FPS Foreign Affairs, Foreign Trade and Development Cooperation. This service possesses the names of the persons authorised to sign the documents and can verify the authenticity of documents.

Electronically signed documents must be uploaded by the FAMHP via the eLegalisation website. Hand-drawn documents can either be uploaded by the FAMHP via the eLegalisation website or the applicant of the paper document can request a legalisation or e-apostille at the desk of the Legalisation Service of the FPS Foreign Affairs.

 

Fees
 

You will receive an invitation from the FAMHP to pay by invoice.

Overview of the application fees for authorisations and certificates (Dutch & French).
More information on all FAMHP fees.

Contact

 

Federal Agency for Medicines and Health Products
DG Inspection - Authorisations Division - Authorisations, Declarations and Certificates Entity

General phone number: +32 2 528 40 00

For certificates
email: certificates@fagg-afmps.be

For extra EudraGMDP documents
email: eudragmdp@fagg-afmps.be

Last updated on 23/06/2021