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Marketing authorisations expiring on or after 28 January 2022
Safe and effective veterinary medicinal products
Veterinary medicines, also known as medicinal products for veterinary use, veterinary drugs or veterinary medicinal products (VMPs), are substances or combinations of substances to treat, prevent or diagnose disease in animals. The EU works to support the development and authorisation of safe, effective and quality veterinary medicinal products for food producing and companion animals, ensuring their availability and guaranteeing the highest level of public health, animal health and environmental protection.
The law governing veterinary medicinal products in the EU sets standards to ensure adequate health protection. Based on the principle of marketing authorisation by the EU or by the national competent authorities, it also promotes the functioning of the internal market, with measures to encourage innovation. These also include harmonised provisions for the manufacture, wholesale and advertising of veterinary medicinal products.
EU-wide authorisation procedures are in place since the mid-90s and the system is supported by the European Medicines Agency (EMA).
Medicated feed – Safe and controlled oral treatment
Medicated feed is a mixture of animal food and veterinary medicinal product produced under controlled conditions and has the purpose of treating or controlling disease in farmed animals, aquaculture species and pets. It requires a veterinary prescription and is one of the oral routes to administer veterinary medicines to animals. Depending on specific situation, this can be the most effective way to administer veterinary medicines to animals.
The EU regulates the manufacture, placing on the market and use of medicated feed, which is a specific type of feed.
Consumer protection through Maximum Residue Limits
Veterinary medicinal products may leave residues in the foodstuffs obtained from treated or diagnosed animals. These residues comprise pharmacologically active substances, excipients or degradation products, and their metabolites. Some of these substances could be harmful to humans.
To protect human health, the European Parliament and Council laid down uniform rules to ensure consumer protection against potentially harmful effects of residues in foodstuffs of animal origin. These rules provide for a science-based establishment of maximum residue limits for veterinary medicinal products. A maximum residue limit is the maximum concentration of a residue of a pharmacologically active substance which may be permitted in food of animal origin.
Implementation of Regulation (EU) 2019/6 on veterinary medicinal products and Regulation (EU) 2019/4 on medicated feed
The current legal framework for veterinary medicinal products and medicated feed Directive 2001/82/EC, Regulation (EC) No 726/2004 and Directive 90/167/EEC have been replaced by Regulation (EU) 2019/6 on veterinary medicinal products and Regulation (EU) 2019/4 on medicated feed; the new regulations will apply from 28 January 2022. As part of their implementation, the two Regulations require the European Commission to adopt delegated and implementing acts.
Delegated acts empower the Commission to supplement or amend the non‑essential elements of the basic act. Implementing acts may have individual or general application. They are often of an administrative or technical nature.
Unit E5 at DG Health and Food Safety: Animal nutrition, veterinary medicines
- Directive 2001/82/EC
- Regulation (EC) No 726/2004
- Regulation (EU) 2019/6
- Directive (90/167/EEC)
- Regulation (EU) 2019/4