Veterinary Medicines

 

This area of the website provides access to all information produced by the European Medicines Agency (EMEA) relating to veterinary medicines and their regulation.

The regulation of veterinary medicines is an important part of wider efforts in society to promote the health and wellbeing of animal populations. Veterinary medicines play a vital role, both in caring for animals and in protecting public health (for example when used to ensure that food products of animal origin are safe, or to prevent the spread of animal-borne diseases). It is therefore important to ensure the availability of high-quality, safe and effective medicines for veterinary use.

In simple terms, the regulation of medicines involves deciding whether or not new medicines developed by the pharmaceutical industry are suitable to be placed on the market, and whether they continue to be safe for use once they are on the market.

Regulation of veterinary medicines in the European Union

In the European Union (EU), a company that wishes to bring a veterinary medicine to the market may submit a single application to the EMEA for a 'marketing authorisation' (licence) that is valid simultaneously in all EU Member States, plus Iceland, Liechtenstein and Norway. This is called the 'centralised (or 'Community') authorisation procedure', and is mandatory for certain types of veterinary medicines and optional for others. (The precise scope is set out in Annex I of Regulation (EC) No 726/2004.)

Other procedures — 'national procedure', 'decentralised procedure' and 'mutual-recognition procedure' — exist for veterinary medicines that do not fall within the mandatory scope of the centralised procedure. An overview of these procedures is available here.

Role of the European Medicines Agency in the regulation of veterinary medicines

It is a fundamental requirement that decisions about the authorisation of medicines are based on an objective, scientific assessment of their quality, safety and efficacy.

Conducting these assessments is the primary role of the EMEA. In the case of veterinary medicines, the Agency does this through its Committee for Medicinal Products for Veterinary Use (CVMP). The CVMP assesses every veterinary medicine for which a marketing-authorisation application has been submitted to the EMEA (in accordance with the centralised procedure), and prepares a recommendation (called an 'opinion') that is then relayed to the European Commission, which has the ultimate responsibility for granting, refusing, revoking or suspending marketing authorisations.

Besides preparing scientific opinions on marketing-authorisation applications for veterinary medicines, the EMEA is also responsible for:

• communicating relevant information about veterinary medicines and their regulation to the public
• promoting the availability of veterinary medicines, including those for minor uses and minor species (MUMS)
• continuously monitoring and assessing the safety of veterinary medicines on the market (known as 'pharmacovigilance')
• recommending maximum residue limits (MRLs — the maximum acceptable concentration of medicinal residues in food produced from treated animals)
• drafting regulatory and scientific guidance to assist companies in all areas relating to the development and marketing of veterinary medicines
• providing scientific advice on the use of antibiotics in food-producing animals in order to minimise antimicrobial resistance
• providing scientific recommendations on matters referred to the Agency by EU Member States or the European Commission relating to veterinary medicines ('referral procedures').

Further reference

Use the menu on the left to access detailed information about the topics mentioned above.

For further information on EU legislation and procedures for the regulation of veterinary medicines, see also Volumes 4-9 of The Rules Governing Medicinal Products in the European Union.