Legal status of supply is the way in which veterinary medicinal products reach the animal keeper and the animals. It determines the role of veterinarians, pharmacists, licence holders and animal owners in the supply and the administration of veterinary medicinal products. A veterinary medicinal product may only be supplied or used by specific, qualified persons under certain conditions. In the Netherlands, the legal status of supply is also referred to as ‘kanalisatie’.
European classification
The Veterinary Medicinal Products Regulation distinguishes between 2 categories of veterinary medicinal products:
- ‘Subject to veterinary prescription’. These veterinary medicinal products subject to veterinary prescription are internationally referred to as Prescription Only Medicine (POM: prescribed by a veterinarian).
- ‘Veterinary medicinal product not subject to veterinary prescription’. These freely available veterinary medicinal products are internationally referred to as Non-Prescription Only Medicine (Non-POM: available over-the-counter without a veterinary prescription (VRIJ)).
Across the EU, the legal classification of similar products will be harmonised based on Article 34 of the Regulation.
Legal status of supply of veterinary medicinal products in the Netherlands
In cases where POM (Prescription Only Medicine) classification has been established, further sub-categorisation of supply and use authorisations remains determined at national level. In the Netherlands, the POM category is divided into three sub-categories: UDD, UDA, URA.
The classification depends on the risks associated with the veterinary medicinal product with regard to public health, animals and the environment. In the Netherlands, veterinary medicinal products are classified into 4 categories:
- VRIJ: Freely available without a veterinary prescription. Veterinary medicinal products that can be traded freely.
- URA: Only available from a veterinarian or with a veterinary prescription from a veterinarian from a pharmacy or a licenced supplier.
- UDA*: Only available from a veterinarian or with a veterinary prescription from a veterinarian from a pharmacy. Veterinary medicinal products that may only be supplied to the animal keeper by the veterinarian or a pharmacist (with a veterinary prescription from a veterinarian).
- UDD: Only to be used by veterinarians. Veterinary medicinal products that may only be administered by veterinarians and therefore may not be supplied directly to the animal keeper.
An additional category will be introduced soon.
UDAV: Only to be supplied subject to additional requirements. This will be a new category for antibiotics and for certain vaccines for pigs that may be administered by animal keepers themselves, subject to additional conditions. Pursuant to Article 106(3), the current UDD category will become strictly UDD to which no exceptions are possible. That is why the exceptions that currently apply to UDD products, such as antibiotics and certain vaccines for pigs must be given a separate legal status of supply. The UDAV category will be introduced for this purpose. In practice, the applicable supply requirements for these products will remain in force.
*Please note: Veterinary medicinal products of the category UDA may only be supplied to the animal keeper by the veterinarian or a pharmacist (with a veterinary prescription from a veterinarian) by physical delivery. Veterinary medicines of the category UDA may not be supplied to animal keepers by a veterinarian or a pharmacist (on a veterinary prescription from a veterinarian) via internet trade in veterinary medicines. They may therefore not be offered online via a web shop.
Medicated feed
Animal keepers may only be supplied with medicated feed in cases:
- Where they are able to provide a veterinary prescription for medicated feed and;
- Of manufacture by feed processors on the farm and if they are in possession of such a prescription and;
- They meet the other requirements of Article 16 of the Medicated Feed Regulation.
A veterinary prescription for medicated feed is a document issued by a veterinarian for a type of medicated feed.
Regulations
The Veterinary Medicinal Products Regulation regulates:
- the classification of veterinary medicinal products in Article 34.
- the supply of prescription-only medicinal products in Article 105(9) (URA/UDA)
- exclusive administration by the veterinarian in Article 106(4)
The Articles of the Regulation have been fleshed out further in the Veterinary Medicinal Products Decree 2022. The Minister of Agriculture, Nature and Food Quality has the authority to take decisions regarding the legal status of supply of veterinary medicinal products under the Veterinary Medicinal Products Decree 2022 (Sections 5.1 and 5.3). The transitional law for the legal status of supply of veterinary medicinal products is set out in Section 10.1 of the Veterinary Medicinal Products Decree 2022.
Article 16 of the Medicated Feed Regulation sets out corresponding rules for medicated feed.
Please note that development of national legislation is currently still underway. We will update the information provided in the above as it becomes available.
Policy ruling on legal status of supply
The Policy ruling on legal status of supply sets out the criteria for legal status of supply. These criteria were drawn up by experts, including from the Veterinary Medicinal Products Authorisation Committee (Commissie toelating Diergeneesmiddelen, Ctd). The rules for the legal status of supply of veterinary medicinal products are based on the starting point that the risks to:
- public health,
- animal health,
- animal welfare and the
- environment
should determine the channeling/legal status of supply of an individual agent.
Please note that the current policy ruling will be amended at a later stage in order to comply with the Veterinary Medicinal Products Regulation.
Transitional measures
Under the European harmonisation of POM and Non-POM products, the established legal status of supply of a veterinary medicinal product may change. For this purpose, a European framework has been drawn up against which the individual veterinary medicinal products can be tested to determine the POM or Non-POM status. This concerns the Guideline on the application of Article 34 of Regulation (EU) 2019/6. This assessment must then show whether the national legal status of supply has to be changed.
The next step is that the changes in the legal status of supply will be processed in the product information of the relevant veterinary medicines.
Please note that we do not yet know which individual veterinary medicinal products will be subject to a change in terms legal status of supply. We will inform marketing authorisation holders once this information becomes available.
Additional information
If you would like to find out more about legal status of supply and the transitional measures, then please submit any enquiries to the Veterinary Medicinal Products Unit through our contact form.