Veterinary medicines, also known as medicinal products for veterinary use, veterinary drugs or veterinary medicinal products (VMPs), have to be authorised before being placed on the internal market. The Union Register of medicinal products provides information on centrally authorised medicinal products and procedures. To receive a marketing authorisation, all veterinary medicinal products must undergo a scientific evaluation of their quality, safety and efficacy.
Divergent transposition of the provisions of Directive 2001/82/EC in the Member States has led to different levels of public and animal health protection and created obstacles to the functioning of the internal market. To improve the situation of the veterinary sector, the European Commission proposed a harmonised and proportionate regulatory framework on veterinary medicinal products. It aims to create a legal environment, which is modern, innovative and fit for purpose.
- harmonises the internal market for veterinary medicinal products
- reduces the administrative burden
- enhances the internal market
- stimulates innovation
- provides for incentives to increase the availability of veterinary medicinal products
- strengthens the EU action to fight antimicrobial resistance.
As part of its implementation, the Regulation requires the European Commission to adopt delegated and implementing acts.
Current legislation on Veterinary medicinal products
To facilitate the interpretation of the legislation and its uniform application across the EU, numerous guidelines of a regulatory and scientific nature have been adopted. These documents are compiled in the various volumes of “The Rules Governing Medicinal Products in the European Union”, also known as EudraLex.
- The current legislation governing veterinary medicinal products is contained in EudraLex – Volume 5.
- The marketing authorisation procedures are detailed in EudraLex – Volume 6 – Notice to applicants
- Scientific guidance on the quality, safety and efficacy of medicinal products is given in EudraLex – Volume 7
- Terms of reference for advice on the impact on public health and animal health of the use of antibiotics in animals
- Volume 9B of the EU rules governing medicinal products – version October 2011
- Directive 2001/82/EC
- Regulation (EU) 2019/6
- Factsheet for NEW regulation
- Questions and Answers
- Union Register of medicinal products
- Proposal for a Regulation on veterinary medicinal products
- Annexes to the Proposal for a Regulation on veterinary medicinal products
- Proposal for a Regulation amending Regulation (EC) No 726/2004
- Executive Summary of the Impact Assessment
- Impact Assessment
- Opinion of the Impact Assessment Board