Proper manufacturing practices are an important part of quality assurance when producing medicines for human and veterinary use. They ensure that manufacturers and importers of veterinary and human medicines always work in accordance with established quality standards. These practices are known as ‘Good Manufacturing Practice’ (GMP).
The GMP principles are set out by law and are described in the EU Directive 2003/94/EC. This directive was replaced on 16 July 2026 by the Implementing Regulation (EU) 2025/2091.
On behalf of the Ministry of Agriculture, Fisheries, Food Security and Nature (LVVN) and the Veterinary Medicinal Products Unit (Bureau Diergeneesmiddelen, BD) the Health and Youth Care Inspectorate (IGJ), carries out regular GMP inspections, generally every three years, at all manufacturers and importers of veterinary medicines in the Netherlands.
During this GMP inspection, the IGJ checks whether manufacturers or importers comply with the current GMP guidelines.
A manufacturer’s licence is required for the manufacture or import (from countries outside Europe/the EEA) of veterinary medicines. This licence must be applied for from BD.
Before BD can issue a manufacturer’s licence, the IGJ must generally carry out a GMP inspection. We request the IGJ to schedule a GMP inspection. Depending on the scope of the activities, a GMP inspection can take several days. BD can also, if required, take part in a GMP inspection (in an expert capacity).
Once a GMP inspection has been carried out, the IGJ draws up an inspection report. The outcome of the inspection may be ‘GMP compliant’ or ‘GMP non-compliant’. If the inspectorate’s assessment is satisfactory, BD will issue a GMP certificate.
You can find more information about the licence for the manufacture and/or import of veterinary medicines on the ‘Manufacturing’ page.