Under the Veterinary Medicinal Products Regulation, a manufacturing or distribution licence is required for the manufacture, wholesale and/or retail trade in veterinary medicinal products.
A distinction is made between the following types of licences:
Manufacturers and importers who carry out the following activities must have a manufacturing license (F):
- manufacturing veterinary medicinal products, including those only for export purposes;
- processing, preparing, packaging and repackaging, labelling and relabelling, storage, sterilising, testing or release for the supply of a veterinary medicinal product that is part of the manufacturing process;
- importing veterinary medicinal products, also from countries outside the EEA.
The wholesale licence (G) is mandatory for wholesalers that:
- purchase, stock, supply and/or export veterinary medicinal products;
- trade in veterinary medicinal products that have marketing authorisation in one or more EEA Member States;
- trade in veterinary medicinal products that do not have marketing authorisation in the EEA and are intended for the EEA;
- trade in veterinary medicinal products that do not have marketing authorisation in the EEA and are intended for export outside the EEA.
- The retail licence (D) is mandatory for retailers who:
- supply non-prescription veterinary medicinal products of the VRIJ (FREE) category, which are to be used on food-producing animals, to keepers of animals.
- The retail licence (DR) is mandatory for retailers who:
- supply channelled veterinary medicinal products of the URA category (only with a prescription from a veterinarian) to keepers of animals.
Pharmacists and veterinarians hold a retail licence (DR) by operation of law.
The applicant for a manufacturing and/or distribution licence can be a natural or legal person. The name and address of the applicant must be the same as the information on the extract from the trade register of the Chamber of Commerce.
The activities described in a manufacturing and/or distribution licence only apply to the location provided in the licence.
The information on manufacturing and/or distribution licences on this website is based on European and national regulations. Where possible, reference is made to the relevant sections/articles of the Veterinary Medicinal Products Regulation, the Veterinary Medicinal Products Decree 2022 or the Veterinary Medicinal Products Regulations 2022.
Natural or legal persons who currently have a valid licence are listed in the register of licence holders.
Procedures with veterinary medicinal products exempt from the obligation to obtain a licence
- preparation, dividing up, changes in packaging or presentation of veterinary medicinal products, where those processes are carried out solely for retail directly to the public (Regulation (EU) 2019/6 – Article 88(2) and the Veterinary Medicinal Products Decree 2022 – Section 3.1(3));
- if a veterinary medicinal product is manufactured that is intended for clinical research for which an exemption for trial purposes has been granted (Regulation (EU) 2019/6 – Article 9);
- research institutions that have a licence for scientific research or quality control under the Experiments on Animals Act. Or if they supervise compliance with the rules for veterinary medicinal products for animal testing (Section 2.1(3) of the Veterinary Medicinal Products Decree 2022);
- veterinary medicinal products intended for animal testing for which an exemption for trial purposes has been issued by the Veterinary Medicinal Products Unit (Regulation (EU) 2019/6 – Article 9).
- A retail licence is not required for retail trade in non-prescription veterinary medicinal products intended for non-food-producing animals (Section 4.2(5) of the Veterinary Medicinal Products Decree 2022);
- Pharmacists who are registered in the register of established pharmacists (register van gevestigde apothekers) established by the Health and Youth Care Inspectorate, referred to in Section 61(5) of the Medicines Act , hold a retail licence by operation of law (Section 4.3(1) of the Veterinary Medicinal Products 2022);
- Veterinarians hold a retail licence by operation of law for the supply of veterinary medicinal products to keepers of animals for those animals for which the veterinarian has assumed medical care in the exercise of their profession (Section 4.3(2) of the Veterinary Medicinal Products Decree 2022).