Veterinary medicines > Marketing authorisation

The Veterinary Medicinal Products Unit coordinates the applications for marketing authorisations for veterinary medicinal products and has assessments done by internal experts and expert institutes based on the accompanying dossier. The quality, safety and efficacy of the veterinary medicinal product are central to the assessment of veterinary medicinal products.

It is prohibited in the Netherlands to prepare, hold or stock veterinary medicinal products, deliver them or apply them to or in an animal if a marketing authorisation has not been granted. This applies to everything that falls under the definition of a veterinary medicinal product.

The Veterinary Medicinal Products Regulation describes all criteria that a veterinary medicinal product must meet. In appendix II to the Veterinary Medicinal Products Regulation describe the dossier requirements for the dossier that must be submitted together with the application for a marketing authorisation. The Guidance to Applicants - Veterinary Medicinal Products contains veterinary guidelines for the application for a marketing authorisation.

Please note: You must therefore first compile a dossier (or have it compiled) before you can submit an application for a marketing authorisation for a veterinary medicinal product.

The Animals Act, the Veterinary Medicinal Products Decree 2022 and the Dutch Veterinary Medicinal Products Regulation 2022 describe all the national criteria which veterinary medicinal products have to meet.