GMP certificate
In the Netherlands, the Veterinary Medicinal Products Unit (VMPU), on behalf of the Minister of Agriculture, Fisheries, Food Security and Nature (LVVN) and on the advice of the Health Care and Youth Inspectorate (IGJ), issues GMP certificates to manufacturers and importers of veterinary medicinal products.
The IGJ is the supervisory authority and carries out inspections to investigate whether the manufacturer is observing the GMP regulations under Section 2d of the Animal Act (Designation of Supervisors) Decree.
The IGJ also inspects manufacturers based in countries outside the European Union. These inspections are 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 Veterinary Medicinal Products Unit can decide to have that manufacturer removed from the marketing authorisation dossier. This is done through the variation procedure. The 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 of a manufacturer/importer 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 three 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 three years.
The GMP certificate is issued by the Veterinary Medicinal Products Unit and published in the EudraGMP database. 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 you wish to receive a copy of a previously issued GMP certificate, please complete the application form for a (copy of the) GMP certificate.