Production and distribution license

The Veterinary Medicinal Products Unit issues licences for the production and distribution of veterinary medicinal products.

Procedures with veterinary medicinal products that require a license

Manufacture

  • The complete or partial preparation, packaging or labelling of a veterinary medicinal product (registered or exempt from registration), for own purposes or on behalf of another party. (Art. 44 of Directive 2001/82/EC, art. 2.19, section 1 Animals Act, art. 4.1 Decree on veterinary medicinal products)
  • Giving a preparation order to a contract manufacturer and then releasing a veterinary medicinal product on the market. (Art. 55, section 3 of Directive 2001/82/EC, art. 4.8. of the Regulation on veterinary medicinal products)
  • Changing the packaging or supply form for own purposes or on behalf of another party. (Art. 44, section 2 of Directive 2001/82/EC, art. 1.1. section 5 Decree on veterinary medicinal products)

Importation

  • The importation of veterinary medicinal products to the Netherlands from countries other than EEA member states. (Art. 44, section 3 of Directive 2001/82/EC, art. 4.21 Decree on veterinary medicinal products)

Wholesale

  • The possession of, trade in and supply of veterinary medicinal products – for own purposes or on behalf of another party – except the supply to final users, including holders of animals (see retail). (Art. 65 of Directive 2001/82/EC, art. 2.19, section 1 Animals Act, art. 5.1 Decree on veterinary medicinal products)
    • 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 of veterinary medicinal products from the Netherlands. (Art. 2, under section 17 of Directive 2001/82/EC, art. 2.19, section 1 Animals Act, art. 4.22 under a. of the Decree on veterinary medicinal products)
  • Trade in veterinary medicinal products where (physical) storage and delivery is outsourced to third parties. The storage and/or distribution location must be authorised inside or outside the Netherlands.
  • Trade in veterinary medicinal products by a veterinarian or pharmacist to a person other than an animal holder. (Art. 4.11 of the Regulation on veterinary medicinal product

Retail

  • The possession of, trade* in and supply of veterinary medicinal products – for own purposes or on behalf of another party – to final users, including holders of animals. (Art. 65 of Directive 2001/82/EC, art. 2.19, section 1 Animals Act, art. 5.1 Decree on veterinary medicinal products)
    • 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 of veterinary medicinal products from the Netherlands. (Art. 2, under section 17 of Directive 2001/82/EC, art. 2.19, section 1 Animals Act, art. 4.22 under a. of the Decree on veterinary medicinal products)
  • Trade in veterinary medicinal products where (physical) storage and delivery is outsourced to third parties. The storage and/or distribution location must be authorised inside or outside the Netherlands.

Procedures with veterinary medicinal products that are exempt from the obligation to obtain a license

Manufacture

  • 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 Regulation on veterinary medicinal products)
  • 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 Regulation on veterinary medicinal products)
  • The preparation of a veterinary medicine product that is intended for trials as part of research and development. (Art. 3, section 1 under e. of Directive 2001/82/EC)
  • 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 Regulation on veterinary medicinal products)

Importation

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

Wholesale

  • 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 license has been obtained in another member state. (Policy agreement)

Retail

  • Supply to an animal holder 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 for State supervision of public health of established pharmacists, legally has a licence for retail. (Art. 5.3. and 5.4 of the Decree on veterinary medicinal products)
  • By law, a veterinarian has a licence for retail to dispense veterinary medicinal products to holders of animals for those 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 Decree on veterinary medicinal products)