GMP certificate
In the Netherlands, the Veterinary Medicinal Products Unit, on behalf of the Minister of Agriculture, Nature and Food Quality (LNV) and on the advice of the Health Care and Youth Inspectorate (IGJ), issues a 'Certificate of GMP compliance of a manufacturer' (hereafter: GMP certificate) to the manufacturer of veterinary medicinal products if it complies with GMP guidelines. IGJ is the supervisory authority and carries out inspections to investigate whether the manufacturer is observing GMP regulations.
This part of our website is not up-to-date. The Veterinary Medicines Regulation has been in effect since 28 January 2022. The final national veterinary medicinal products legislation is not published yet. As soon as the final national veterinary medicinal products legislation is published, the Dutch web texts will be updated. Once these are ready, they will be translated into English. This will take some time. Therefore, check our website regularly for any updates.
IGJ also inspects manufacturers in countries outside the European Union. This is commissioned by the European Medicines Agency (EMA) and the Veterinary Medicinal Products Unit. If a manufacturer does not work in accordance with GMP quality requirements, the MEB Agency, Veterinary Medicinal Products Unit can decide to have that manufacturer removed from the marketing authorisation dossier. This is done through the variation procedure. The MEB Agency, Veterinary Medicinal Products Unit does this in consultation with the IGJ and other European inspection authorities and the European bodies CMDv (Coordination Group for Mutual Recognition and Decentralised Procedures – Veterinary) and EMA (European Medicines Agency).
A GMP certificate aims to indicate:
- Which production location, activities and forms of administration from a manufacturer comply with the Guidelines for Good Manufacturing Practice (GMP) for Veterinary Medicinal Products after a GMP inspection, pursuant to Directive 91/412/EG;
- Who the Qualified Person (QP) is;
- The list of veterinary medicinal products that may be produced or imported;
- When the last GMP inspection took place. European regulations require that a subsequent GMP inspection be carried out within 3 years after the last inspection.
A GMP certificate is issued to a manufacturer or importer of veterinary medicinal products within 90 days after a GMP inspection has been successfully completed. A GMP certificate is generally valid for 3 years.
The GMP certificate is issued by the Veterinary Medicinal Products Unit and also published on Eudra-GMP. This database contains information on GMP certificates from all manufacturers and importers of medicinal products for humans and animals in the EEA and other manufacturers outside the EEA that have been inspected by European authorities.
If a copy of a previously issued GMP certificate is desired, you must complete the application form for a (copy of the) GMP certificate.