List of the different certificates
- EUDRA GMP
This is a European certificate issued by the FAMHP. The EUDRA GMP certificate is issued in the language of the company after a positive inspection and is free. Additional certificates can be obtained by paying € 57.05 per certificate. These certificates are available in French, Dutch, English or German.
- GMP Good Manufacturing Practice
General GMP model (veterinary use)
GMP (DOC, 206 Kb): Good Manufacturing Practice certificate
BPF (DOC, 205.5 Kb): Certificat de Bonnes Pratiques de Fabrication
BPM (DOC, 209 Kb): Certificado de Buenas Practicas de Manufactura
Particular GMP model
GMP certificate - Registered products (DOC, 207 Kb)
GMP certificate - Batch release (DOC, 207 Kb)
GMP certificate - Batch release for an registered product (DOC, 207.5 Kb)
GMP certificate - Homeopathic products (DOC, 206 Kb)
GMP certificate - Medicinal gases (DOC, 206 Kb)
GMP certificate - Declared products (DOC, 207.5 Kb)
GMP certificate - Secondary packaging and labeling (DOC, 206 Kb)
GMP certificate - Mutual Recognition Procedure (DOC, 206.5 Kb)
GMP certificate - Last inspection (DOC, 206.5 Kb)
GMP certificate - Clinical investigation (DOC, 205 Kb)
GMP certificate - Clinical investigation for an pharmaceutical product (DOC, 205.5 Kb)
GMP certificate - Active Pharmaceutical Ingredients (API) (DOC, 203.5 Kb)
- CPP Certificate of a Pharmaceutical Product
+ General instructions in English (DOC, 26 Kb) , French (DOC, 25.5 Kb) and Spanish (DOC, 30.5 Kb)
Export Declaration
Certificate of Pharmaceutical Product - ED (DOC, 212.5 Kb)
Certificat de Produit Pharmaceutique - ED (DOC, 209.5 Kb)
Certificado de Producto Farmaceutico - ED (DOC, 212.5 Kb)
Declarations
Certificate of Pharmaceutical Product - D (DOC, 213 Kb)
Product registered in Belgium and manufactured abroad
Certificate of Pharmaceutical Product - IS (DOC, 214 Kb)
Certificat de Produit Pharmaceutique - IS (DOC, 210.5 Kb)
Certificado de Producto Farmaceutico - IS (DOC, 211.5 Kb)
Product registered and manufactured in Belgium
Certificate of Pharmaceutical Product - S (DOC, 214.5 Kb)
Certificat de Produit Pharmaceutique - S (DOC, 211.5 Kb)
Certificado de Producto Farmaceutico - S (DOC, 212.5 Kb)
- CC Copie Conforme
- CA Certificate of Analysis
Product manufactured abroad: Certificate of Analysis - OUT (DOC, 205.5 Kb)
Product for human use manufactured in Belgium: Certificate of Analysis - HUM (DOC, 205.5 Kb)
Product for veterinary use manufactured in Belgium: Certificate of Analysis – VET (DOC, 205.5 Kb)
Contact
Sandra BOON (NL) – Sabrina DUFAYS (FR) – An SOUFFRIAU (NL)
Federal Agency for Medicines and Health Products
DG Inspection - Division Industry
Eurostation II, 6th floor Office 6E370
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