Licence types

Based on the Animals Act, a licence is required for the manufacture, importation, wholesale and/or retail trade in veterinary medicinal products.

The following types of licences are distinguished:

  • The manufacturing licence (F) is mandatory for those who prepare, modify, process, label or package veterinary medicinal products including filling and sealing the primary packaging for that veterinary medicinal product.
  • The import licence (I) is mandatory for those who import veterinary medicinal products from outside the European Economic Area (EEA; the EU Member States plus Norway, Iceland and Liechtenstein).
  • The wholesale licence (G) is mandatory for trade in non-prescription veterinary medicinal products, with the exception of distribution to keepers of animals.
  • The wholesale licence (GL) is mandatory for the trade in channelled veterinary medicinal products with a supply restriction (category URA/UDA/UDD), with the exception of distribution to keepers of animals.
  • The retail licence (D) is mandatory for those who supply non-prescription veterinary medicinal products (which are intended for use in food-producing animals) to keepers of animals. Pharmacists and veterinarians have a retail licence by operation of law.
  • The retail licence (DR) is mandatory for those who supply channelled veterinary medicines of the URA category, with a prescription from a veterinarian, to keepers of animals. Pharmacists and veterinarians have a retail licence by operation of law.

The applicant for a production 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 mentioned in a production and/or distribution licence only apply to the location provided in the licence.

The information on licences on this website relates to the provisions stated in European and national regulations. Where possible, reference is made to the article in the Animals Act, the Veterinary Medicinal Products Decree or the Veterinary Medicinal Products Regulations.

Below is the complete overview of the procedures with veterinary medicines that require a licence for manufacturing, importation and wholesale or retail trade.

Natural or legal persons who currently have a valid licence for the procedures listed below can be found in the register of licence holders.

There are also procedures with veterinary medicinal products that are exempt from the licensing requirement for manufacturing, importation and wholesale or retail trade. You will also find an overview of this.

Procedures involving veterinary medicinal products that require a licence for manufacturing, importation and wholesale or retail trade:

Manufacturing

  • The performance of one or more sub-operations necessary for the manufacture, including preparation, modification, processing, packaging (including filling and sealing the primary packaging), labelling or releasing a veterinary medicinal product for the market for which a marketing authorisation has been obtained, or that is exempt from this (according to Art. 2.19, section 1 of the Animals Act, Art. 1.1, section 5 and Art. 4.1 of the Veterinary Medicinal Products Decree, Art. 4.8 of the Veterinary Medicinal Products Regulations).

Importation

  • The importation of veterinary medicinal products to the Netherlands from countries other than EEA member states (Art. 4.21 of the Veterinary Medicinal Products Decree).

Wholesale trade

  • The possession of, trade in and supply of veterinary medicinal products, with the exception of supply to final users, including keepers of animals (Art. 2.19, section 1 of the Animals Act, Art. 1.1, section 1 and Art. 5.1 of the Veterinary Medicinal Products Decree)
    • The concept of "trade" includes the possession with the intent to sell, including the offer, any form of (free) transfer to third parties, as well as the sale and other forms of transfer itself (Art. 1.1, section 2 of the Animals Act)
  • The export as a wholesaler of veterinary medicines from the Netherlands (Art. 2.19, section 1 of the Animals Act, Art. 4.22 under a. of the Veterinary Medicinal Products Decree).

Retail trade

  • The possession of, trade in and supply of veterinary medicinal products, for own purposes or on behalf of another party, to keepers of animals (Art. 2.19, section 1 of the Animals Act, Art. 5.1 of the Veterinary Medicinal Products Decree)
  • The concept of "trade" includes the possession with the intent to sell, including the offer, any form of (free) transfer to third parties, as well as the sale and other forms of transfer itself (Art. 1.1, section 2 of the Animals Act)
  • The export as retail of veterinary medicinal products from the Netherlands (Art. 2.19, section 1 of the Animals Act, Art. 4.22 under a. of the Veterinary Medicinal Products Decree).

Procedures with veterinary medicinal products that are exempt from the obligation to obtain a licence for manufacturing, importation and wholesale or retail trade:

General

  • Manufacture, import, wholesale and retail of veterinary medicinal products that are intended for and exclusively used as diagnostic agent on non-living material of animal origin, in order to identify a disease or the immunological status of animals (up to 1.1.2020) is exempted from registration. See also Appendix 4, Part F of the Veterinary Medicines Regulations.

Manufacturing

  • The preparation, division or change of a veterinary medicinal product is only allowed for a veterinarian or by pharmacist prescription, if the veterinary medicinal product is divided in a smaller package or prepared or changed to another supply form that is consistent with the requirements for the intended treatment or therapy (Art. 4.11 of the Veterinary Medicinal Products Regulations);
  • Ex tempore (magisterial) preparation of a veterinary medicinal product by a veterinarian or a pharmacist on prescription by a veterinarian (Art. 4.12 of the Veterinary Medicinal Products Regulation);
  • The preparation of a veterinary medicinal product that is intended for trials as part of research and development (Art. 3, section 1 under e. of Directive 2001.82.EC)
  • Research institutes licensed under the Experiments on Animals Act for importing, transporting, receiving, holding, having in stock or applying veterinary medicines for animal testing (Art. 3.22, section 4 of the Veterinary Medicinal Products Decree)
  • The preparation of a veterinary medicinal product for an animal trial, for which the MEB Agency, VMPU has granted trial exemption on request (Art. 3.8 of the Veterinary Medicinal Products Regulation).

Importation

  • Importation to the Netherlands where the veterinary medicinal product is not marketed freely, but remains in a customs depot (in transit). This falls outside the scope of importation regulations according to the European Commission.

Wholesale trade

  • Supply of a veterinary medicinal product with a marketing authorisation in the Netherlands to an authorised Dutch wholesaler or retailer from a location in another member state, if the supplier is not located in the Netherlands and a wholesale licence has been obtained in another member state (Policy agreement).

Retail

  • Supply to keepers of animals of a non-prescription veterinary medicinal product that is not destined to be used for food-producing animals (Policy agreement)
  • A pharmacist in charge of a pharmacy and registered in the register of established pharmacists by the Public Health Supervisory Service legally has a retail licence (Art. 5.3 and 5.4 of the Veterinary Medicinal Products Decree)
  • A veterinarian legally has a retail licence to supply veterinary medicinal products to keepers of animals for animals for which the veterinarian provides medical care as part of the execution of his profession (Art. 5.3, section 1 and Art. 5.4, section 1 of the Veterinary Medicinal Products Decree).