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 € 53.53 per certificate. These certificates are available in French, Dutch, English or German.
- GMP Good Manufacturing Practice
General GMP model
GMP (DOC, 27.5 Kb): Good Manufacturing Practice certificate
BPF (DOC, 23 Kb): Certificat de Bonnes Pratiques de Fabrication
BPM (DOC, 26 Kb): Certificado de Buenas Practicas de Manufactura
Particular GMP model
GMP certificate - Registered products (DOC, 25.5 Kb)
GMP certificate - Batch release (DOC, 25 Kb)
GMP certificate - Batch release for an registered product (DOC, 25.5 Kb)
GMP certificate - Homeopathic products (DOC, 24 Kb)
GMP certificate - Medicinal gases (DOC, 24 Kb)
GMP certificate - Declared products (DOC, 25.5 Kb)
GMP certificate - Secondary packaging and labeling (DOC, 25 Kb)
GMP certificate - Mutual Recognition Procedure (DOC, 24.5 Kb)
GMP certificate - Last inspection (DOC, 25 Kb)
GMP certificate - Clinical investigation (DOC, 22.5 Kb)
GMP certificate - Clinical investigation for an pharmaceutical product (DOC, 23.5 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, 44.5 Kb)
Certificat de Produit Pharmaceutique - ED (DOC, 31.5 Kb)
Certificado de Producto Farmaceutico - ED (DOC, 34.5 Kb)
Declarations
Certificate of Pharmaceutical Product - D (DOC, 34 Kb)
Product registered in Belgium and manufactured abroad
Certificate of Pharmaceutical Product - IS (DOC, 33 Kb)
Certificat de Produit Pharmaceutique - IS (DOC, 31.5 Kb)
Certificado de Producto Farmaceutico - IS (DOC, 31.5 Kb)
Product registered and manufactured in Belgium
Certificate of Pharmaceutical Product - S (DOC, 38 Kb)
Certificat de Produit Pharmaceutique - S (DOC, 33 Kb)
Certificado de Producto Farmaceutico - S (DOC, 32.5 Kb)
- CMD Certificate of a Medical Device
Certificate of a Medical Device (DOC, 30 Kb)
Certificado de Dispositivo Medico (DOC, 30.5 Kb)
- CC Copie Conforme
- CA Certificate of Analysis
Product manufactured abroad: Certificate of Analysis - OUT (DOC, 27 Kb)
Product for human use manufactured in Belgium: Certificate of Analysis - HUM (DOC, 27 Kb)
Product for veterinary use manufactured in Belgium: Certificate of Analysis – VET (DOC, 27 Kb)
- LS Licensing Status Certificate
Licensing Status Certificate (DOC, 32 Kb)
Contact
Sandra BOON (NL) – Sabrina DUFAYS (FR) – An SOUFFRIAU (NL)
Federal Agency for Medicines and Health Products
“Production and Distribution” Department
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