Legal status of supply of veterinary medicinal products

The legal status of supply determines how veterinary medicinal products reach animal owners and their animals. It determines the role of veterinarians, license holders, pharmacists and animal owners in the supply and administration of veterinary medicinal products to animals. A veterinary medicinal product may only be supplied under certain conditions and administered by persons specifically qualified to do so.

European legislation identifies two categories of legal status of supply of veterinary medicinal products:

  • Prescription Only Medicine (POM: prescribed by a veterinarian
  • NON-Prescription Only Medicine (NON-POM: available-over-the-counter (OTC))

In the Netherlands, the POM category is divided into three subcategories: UDD, UDA and URA.

In the Netherlands, depending on the risks to animal and public health associated with medicinal products, veterinary medicinal products are divided into a total of four categories:

  • OTC: freely available without a prescription - veterinary medicinal products which can be traded freely. 
  • URA: Exclusively available from a veterinarian or on prescription from a veterinarian from a pharmacy or a license holder.
  • UDA: Exclusively available from a veterinarian or on prescription from a veterinarian from a pharmacy. Veterinary medicinal products that can only be supplied by a veterinarian or a pharmacist - on prescription from a veterinarian – to the animal owner.
  • UDD: Only to be used by veterinarians - veterinary medicinal products that may only be administered by the veterinarian and may therefore not be supplied directly to the animal owner.

Legislation

Articles 17, 65, 67 and 68 of the European code relating to veterinary medicinal products (Directive 2001/82/EG) specify rules on the legal status of supply of veterinary medicinal products. Article 8 of the European directive relating to animal nutrition (Directive 90/167/EG) specifies similar regulations for animal feed with a medicinal action.

In Dutch national legislation, the course of the legal status of supply is laid down in Article 2.21 of the Animals Act and in Articles 5.7 to 5.10 (inclusive) of the Veterinary Medicines Decree and in Articles 2.13 to 2.18 (inclusive) of the Veterinary Medicines Regulations.

Policy ruling on legal status of supply

The Policy ruling on legal status of supply came into force on 1 July 2016. The underlying principle of the rules for the legal status of supply of veterinary medicinal products, is that the risks to public health, animal health, animal welfare and the environment should determine the legal status of supply of an individual medicinal product. Experts, including the Dutch Veterinary Medicines Board (CRD), have compiled criteria. If individual veterinary medicinal products fulfil these criteria, the animal owner may administer them instead of the veterinarian.

Up to 1 July 2016, specific groups of veterinary medicinal products were statutorily accorded a legal status of supply. This is now based on the risks carried by individual veterinary medicinal products instead of by group. For this reason, certain veterinary medicinal products now fall under other legal status of supply regulations. As a result of this the legal status of supply of a number of veterinary medicinal products changed at the end of 2016:

  • From OTC to UDA: as it is necessary to administer these either subcutaneously or intramuscularly to animals, including companion animals, instruction from a veterinarian is necessary in order to ensure correct administration. The CRD is of the opinion that a diagnosis from a veterinarian is necessary in order to ensure the correct administration of these veterinary medicinal products.
  • From OTC to URA: due to the limited potential dangers to human health (waiting periods) and/or the environment (environmental mitigation measures).