Veterinary Medicines and Medicated Feed
Veterinary Medicines and Medicated Feed
Veterinary medicines help prevent and treat diseases of animals. The EU works to develop optimal and safe medicines for animals, while ensuring their availability for all animal species.
The law governing medicinal products for veterinary use in the EU sets standards to ensure adequate health protection. Based on the principle of marketing authorisation by the EU or by the competent authorities, it also promotes the functioning of the internal market, with measures to encourage innovation.
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 and advertising of veterinary medicinal products.
Divergent transposition of the provisions of the Directive 2001/82/EC in the EU countries has led to different levels of public and animal health protection and created obstacles to the functioning of the internal market. In order to draw up a harmonised and proportionate regulatory framework on veterinary medicines which would create an improved, modern legal environment, thus improving the veterinary sector in general, the European Commission launched its revision and adopted on 10 September 2014 a proposal for a regulation on veterinary medicinal products.
After four years of negotiations, the European Parliament and Council approved the new Regulations on veterinary medicines and medicated feed (see box below) on 25 October and 26 November 2018.
Vytenis Andriukaitis, European Commissioner for Health and Food Safety: the "endorsement by EU ministers of a new legislation on veterinary medicinal products and medicated feed marks a major step forward in the fight against antimicrobial resistance. It has been a priority since the beginning of my mandate given that, in the EU, the majority of antimicrobials are consumed in animals. I am convinced that the legislation will have a major impact in Europe, but also on a global stage since the EU proves itself as a leader in the battle against antimicrobial resistance." (26/11/2018)
The new Regulation on veterinary medicinal products repeals the Directive 2001/82/EC and brings the following main achievements:
- provides for a modern, innovative and fit for purpose legal framework
- gives incentives to stimulate innovation
- gives incentives to increase the availability of veterinary medicines
- strengthens the EU action to fight antimicrobial resistance
Medicated feed is a mixture of animal food and veterinary medicine produced under controlled conditions, and requires a veterinary prescription. It is one of the oral routes to administer veterinary medicines to animals. Depending on specific situation, this can be the most effective way for a farmers to treat their livestock.
The EU regulated the manufacture, placing on the market and use of medicated feed Directive 90/167/EEC. Due to the diverging national implementations, production standards of medicated feed varies between the EU countries. In some EU countries, there is a need to address increased risk for the development of antimicrobial resistance (AMR), due to the tolerance levels of antimicrobials in feed and the irresponsible use of antimicrobials via medicated feed.
See report on medicated feed in the EU.
Therefore, the European Commission launched the revision of the Directive and adopted proposals on veterinary medicinal products and medicated feed on 10 September 2014.
The new Regulation on medicated feed will repeal the outdated Directive (90/167/EEC) and bring the following main achievements:
EU legislation on Veterinary Medicines
All EU 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 in EudraLex - Volume 7
- Specific guidance on the legal requirements concerning good manufacturing practices, maximum residue limits and pharmacovigilance 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 of the EU rules governing medicinal products - version October 2011
- Comments received on Volume 9B Revision - October 2009
Maximum residue limits
EU wide rules have been laid down to ensure protection 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.
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 EU legislation by EU countries continue to create obstacles to the free movement of medicines. In order to optimise and rationalise regulatory processes, concrete measures aimed at reviewing and simplifying EU pharmaceutical legislation have been adopted.
Unit E5 at DG Health and Food Safety: Animal nutrition, veterinary medicines