Green light for new rules on veterinary medicines and medicated feed

27 Nov 2018 11:57 AM

The EU is introducing new and improved rules to step up the fight against antimicrobial resistance and improve the availability and safety of veterinary medicines and medicated feed. This will be of benefit to animal health and help boost the competitiveness of the EU veterinary pharmaceutical sector.

The Council yesterday adopted the animal medicines package including two new regulations on:

  1. veterinary medicinal products
  2. the manufacture, placing on the market and use of medicated feed

and changes to the existing rules laying down procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.

This package is a major milestone in the fight against antimicrobial resistance: on the one hand antimicrobials and antibiotics will have to be used much more prudently than is the case now, and on the other hand we encourage the development of better medicines and medicated feed. It is a win-win for public health and the competitiveness of the EU pharmaceutical industry.

Elisabeth Köstinger, Austrian Federal Minister for Sustainability and Tourism and President of the Council

The new rules on veterinary medicinal products:

The new rules on medicated feed:

In addition, regulation 726/2004 that establishes the European Medicines Agency and the centralised procedure for the authorisation and supervision of medicinal products is adapted in order to avoid any overlap with the procedures laid down in the new regulation on veterinary medicinal products.

EU responds to antimicrobial resistance

Next steps

The Council and the European Parliament now need to sign the adopted regulations. The signed texts will then be published in the EU Official Journal and will enter into force 20 days later. However, the new rules will only be fully operational as of end of 2021.


The animal medicines package is a package of three proposals for regulations updating the existing legislative framework for veterinary medicines and medicated feed by further tailoring it to the specificities of the animal health sector. While continuing to safeguard public and animal health, animal welfare, food safety and the environment, the package is aimed in particular at increasing the availability of veterinary medicines in the EU, improving the functioning of the EU market, reducing administrative burdens and fostering innovation.

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