GMP inspection
Good Manufacturing Practice is a component of quality assurance when preparing (veterinary) medicinal products. It ensures that manufacturers of (veterinary) medicinal products always prepare and monitor according to the quality standards for the intended use. This is also known as GMP. The principles of GMP are laid down in legislation and described in EU Directive 2003/94/EC.
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.
At the request of the Ministry of Agriculture, Fisheries, Food Security and Nature (LVVN) and the Veterinary Medicinal Products Unit, the Health Care and Youth Inspectorate (IGJ) conducts periodic GMP inspections at all manufacturers of veterinary medicinal products in the Netherlands. During this GMP inspection, the IGJ, in consultation with the BD, assesses whether these manufacturers comply with the GMP guidelines.
The application for a manufacturer's licence, i.e. a licence for the manufacture and/or import of veterinary medicinal products, is submitted to the Veterinary Medicinal Products Unit (BD). See also information mentioned under Manufacturing (F) (GMP) and Requirements for importation (I).
Before such a licence can be issued, a GMP inspection must be carried out by the IGJ (where possible in the presence of the BD). The BD submits the request for scheduling a GMP inspection to the IGJ. Depending on the scope of the activities, the GMP inspection can take several days.
After assessing the inspected location, the IGJ, in consultation with the BD, draws up an inspection report. The BD will issue a GMP certificate depending on the outcome of the inspection (GMP level is sufficient or insufficient). See also GMP certificate.