Φαρμακευτικά προϊόντα για ανθρώπινη χρήση
Legal framework governing medicinal products for veterinary use in the EU
The EU legal framework for veterinary medicinal products sets standards to ensure adequate health protection. It also promotes the functioning of the internal market, with measures to encourage innovation. It is based on the principle that the marketing of medicinal products is subject to the granting of a marketing authorisation by the competent authorities.
The requirements and procedures for granting marketing authorisation for veterinary medicinal products, as well as the rules for monitoring authorised products, are primarily laid down in Directive 2001/82/EC and in Regulation (EC) No 726/2004. These also include harmonised provisions for the manufacture, wholesale, or advertising of veterinary medicinal products.
EU wide rules have been laid down to ensure that you are protected against potentially harmful effects as a result of exposure to residues from veterinary medicinal products in food products. The rules on maximum residue limits are outlined in Regulation (EC) No 470/2009.
All Community legislation governing veterinary medicinal products is contained in EudraLex - Volume 5 of "The Rules Governing Medicinal Products in the European Union".
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:
- A detailed explanation of the marketing authorisation procedures in EudraLex - Volume 6 - Notice to applicants.
- Scientific guidance on the quality, safety and efficacy of medicinal products is provided in EudraLex - Volume 7.
- Specific guidance on the legal requirements concerning good manufacturing practices, maximum residue limits and pharmacovigilance is laid down in EudraLex - Volume 4, EudraLex - Volume 8 and EudraLex - Volume 9, respectively.
- Terms of reference for advice on the impact on public health and animal health of the use of antibiotics in animals.
- Volume 9B Version October 2011
- Table of the responses to the public consultation
To ensure that regulations are imposed only when necessary and that these are proportionate to their aim, the European Commission is committed to better regulation and reinforced efforts to deliver concrete benefits for businesses.
Issues with the implementation and interpretation of Community legislation by EU countries continue to create obstacles to the free movement of medicines. In order to optimise, simplify and rationalise regulatory processes, concrete measures aimed at reviewing and simplifying EU pharmaceutical legislation have been adopted.
Animal Health Strategy
The European Commission adopted a revision of the legislation in 2014 aimed at increasing the availability of veterinary medicinal products, reducing the administrative burden on enterprises, improving the functioning of the internal market, and assessing the potential for an improved response to antimicrobial resistance resulting from use of veterinary medicines.
The revision will contribute to realisation of certain actions in the Animal Health Strategy.
- Proposal for a Regulation of the European Parliament and of the Council on veterinary medicinal products
- Annexes to the Proposal for a Regulation of the European Parliament and of the Council on veterinary medicinal products
- Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
- Executive Summary of the Impact Assessment
- Impact Assessment
- Opinion of the Impact Assessment Board
- Press release and Q&A on veterinary medicines and medicated feed proposals
- Medicated feed
- Commission Work Programme