Application

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 GMP and GDP certificates; MIAs and WDAs authorizations and API REG.
(documents uploaded in the EUDRAGMDP database)

EudraGMDP is the name of the Community database for manufacturer and importer authorizations (MIA), good manufacturing practice certificates (GMP), wholesale distributor authorizations(WDA), good distribution practice certificates(GDP) and registration of the manufacturers, importers and distributors of active ingredients for human use in the EER (API REG) (http://eudragmdp.eudra.org/). The eudragmdp documents provided by the FAMHP are official authorizations and certificates from the database.

Tip: How to find a document in the database ?

Annex to MIA and WDA

The manufacturing and import authorizations (MIA) and wholesale distributor authorizations (WDA) are issued by the European database EudraGMDP (http://eudragmdp.eudra.org ).These documents (MIA and WDA) are an integral part of the manufacturing and distribution authorizations issued by the FAMHP. These documents consist of Annex 1 or Annex 2 (MIA) or Annex 1 (WDA) which contains the licensed manufacturing activities (MIA) or distribution activities (WDA). These documents also include a series of optional annexes (MIA: Annexes 3 to 8 / WDA: Annexes 2 to 5). These optional annexes are not edited by the FAMHP.

Seen

These documents are created and signed by the applicant and are 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 ARIAL font.

For declared concurrent copies

It is possible to acquire copies declared concurrent by the FAMHP of previously issued documents, authorizations and certificates.

Certificate of Analysis (CA)

Using a certificate, the FAMHP confirms that the qualified person (QP) is authorized to sign analysis certificates.

General information for all certificates

As from June 2015 the left corner of the Certificates, issued by The Federal Agency for Medicines and Health Products (FAMHP Belgium), is no longer folded. This decision has been made because of the large amount of documents (example SPC) that is often to be attached to a certificate. Instead, the concerned document is stapled and every single page included in the document is stamped separately. This should ensure proper verification and further legalization remains possible.

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. The copy will be discontinued as of 1 June,  2015, so only one original will be submitted. 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 certificates@fagg-afmps.be. EUDRAGMDP in the title (subject line) only. MIA and GMP available in Dutch, French, English, German and Spanish. WDA, GDP and API REG are only available in English.

Contact

Federal Agency for Medicines and Health Products
DG Inspection - Division Authorizations/ Cell Authorizations, Declarations and Certificates

Eurostation II, 6th Floor
Victor Hortaplein 40 Box 40
1060 Brussels

e-mail: certificates@fagg-afmps.be

Central telephone number: +32 (0) 2 528 40 00

Last updated on 17/10/2017