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Food Safety

Safe and Effective Veterinary Medicinal Products

What are veterinary medicinal products

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.

The current requirements and procedures for granting a marketing authorisation for veterinary medicinal products are laid down primarily in Directive 2001/82/EC and in Regulation (EC) No 726/2004.

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.

The new Regulation (EU) 2019/6 on veterinary medicinal products, published on 7 January 2019, repeals Directive 2001/82/EC and brings the following main achievements:

  • 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.

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