GMP certificate | Medicines Evaluation Board

In the Netherlands, the Veterinary Medicines Agency (BD) issues GMP certificates to manufacturers and importers of veterinary medicines. We do so on behalf of the Minister of Agriculture, Fisheries, Food Security and Nature and on the basis of the advice from the Health and Youth Care Inspectorate (IGJ).

The IGJ is the supervisory authority for GMP relating to medicinal products for human and veterinary use and carries out inspections to verify that manufacturers and importers comply with the GMP requirements as set out in the European Directive and in the Implementing Regulation. The IGJ’s role as the supervisory authority for GMP is set out in Article 2d of the Animal Act (Designation of Supervisors) Decree.

The IGJ also inspects manufacturers in countries outside the European Union. These inspections are carried out on behalf of the European Medicines Agency (EMA) and the Veterinary Medicinal Products Unit.

If a manufacturer does not comply with the GMP quality requirements, we may remove this manufacturer from the marketing authorisation registration dossier. This is always done in consultation with the IGJ, other European authorities, the EMA and the Coordination Group for Mutual Recognition and Decentralised Procedures for Veterinary Medicinal Products (CMDv).

What does a GMP certificate include?

A GMP certificate shows that a manufacturer or importer complies with the requirements for good manufacturing practice. The certificate specifies the location at which a manufacturer or importer is authorised to carry out certain activities. These activities include the manufacture, packaging, importing, analysing and releasing of products for human and veterinary use onto the market in accordance with the applicable GMP requirements.

A manufacturer or importer of veterinary medicines will be issued with a GMP certificate within 90 days of a positive inspection result. Generally speaking, a GMP certificate is valid for 3 years.

The GMP certificate is then also entered into the European database for manufacturers, importers and distributors of veterinary medicines. This is known as the EudraGMDP database. This database contains information on GMP certificates held by all manufacturers and importers of medicinal products for human and veterinary use within the European Economic Area (EEA), as well as other manufacturers outside the EEA that have been inspected by European authorities.

If you require a copy of a previously issued GMP certificate, please complete an application form for a (copy) of a GMP certificate.