For the most part, the rules and regulations on veterinary medicinal products are established at European level. These are set out in the Veterinary Medicinal Products Regulation. The Veterinary Medicinal Products Regulation is binding for all Member States. There is limited scope for interpretation of veterinary medicinal products legislation at national level.
Definition of veterinary medicinal product
The Veterinary Medicinal Products Regulation pertains to veterinary medicinal products. But what exactly does this term mean? Article 4 of the Veterinary Medicinal Products Regulation states that a veterinary medicinal product is any substance or combination of substances that satisfies at least one of the following conditions:
- It is sold as having therapeutic or prophylactic properties with regard to animal diseases.
- It is intended for use in or administration to animals to restore, improve or modify physiological functions by bringing about a pharmacological, immunological or metabolic effect.
- It is intended for use in making diagnoses in animals.
- It is intended for use in animal euthanasia.
Substances are key to the definition of a veterinary medicinal product. A substance is a material of:
- human origin
- animal origin
- plant origin; or
- chemical origin.
A substance’s purpose is a key component of the definition too. This purpose could be specified on the label. A seller of a product might also adopt a different form of advertising. Substances that manifestly exhibit a particular pharmacological effect are also designated as veterinary medicinal products. This is further elaborated in the Guidance to Applicants - Veterinary Medicinal Products.
Mandatory registration does not apply to some categories of veterinary medicinal product, the so-called exemptions.
Objectives of the Veterinary Medicinal Products Regulation
The most important objectives of the Veterinary Medicinal Products Regulation are:
- to simplify legislation and to reduce the administrative burden for pharmaceutical companies engaged in the development of veterinary medicinal products
- to encourage the development of innovative veterinary medicinal products including, for example, products for minor markets
- to improve the operation of the internal market for veterinary medicinal products
- to strengthen EU initiatives to combat antimicrobial resistance through measures to ensure the proper use of antimicrobial substances in animals.
Delegated and implementing regulations
The Veterinary Medicinal Products Regulation is further detailed in delegated and implementing regulations. The European Commission draws these up. The other regulations will be established at a later point in time.
Additional national legislation
There is limited scope for interpretation of veterinary medicinal products legislation at national level, except where this is stated in the Regulation or if the Regulation does not govern a particular issue.
The Dutch Animals act determines rules for kept animals and related subjects. This also includes the subject of veterinary medicinal products. The new version of the Animals Act includes the brackets that are necessary for subjects that will be completed nationally. The Ministry of Agriculture, Fisheries, Food Security and Nature is responsible for policy in this regard.
Various decrees and regulations have been subsumed under the Dutch Animals Act. These are:
- Veterinary Medicinal Products Regulation and Decree
- Animal Feed Regulation and Decree
- Animal Products Regulation and Decree
- Enforcement and Other Matters (Animals Act) Regulation and Decree
- Animal Keepers Regulation and Decree
- Veterinarians Regulation and Decree.
In particular, the Veterinary Medicinal Products Regulation 2022 and the Veterinary Medicinal Products Decree 2022 are important when it comes to veterinary medicinal products. These have been revised in 2022 with a view to implementing the regulations at national level.
Further information
You can also find more information about the new veterinary medicinal products legislation on the page of RVO under Veterinary Medicines. If you have any questions on legislation on veterinary medicinal products, please feel free to contact the Veterinary Medicinal Products Unit.
