Veterinary medicines: new EU rules to enhance availability and fight against antimicrobial resistance

13.06.2018

On 13 June 2018 EU ambassadors meeting in the Committee of Permanent Representatives (Coreperconfirmed an agreementreached on 5 June between the Bulgarian Presidency of the Council and European Parliament representatives on a regulation on veterinary medicines.

The agreement paves the way for a new system of rules that will improve the availability of these medicines, enhance competitiveness and innovation in the veterinary pharmaceutical sector and contribute to the fight against antimicrobial resistance (AMR) - the ability of bacteria to render the antibiotics used to treat infections ineffective.

"Today is a good day for both animal and public health. New smart EU rules will give us robust tools to prevent the abuse of antibiotics and limit the risk of the development of antimicrobial resistance. At the same time it will stimulate innovation and will lead to increased availability and easier access to veterinary medicines for veterinarians, farmers and pet owners that really need medicines to treat and prevent animal diseases."

Rumen Porodzanov, minister of agriculture, food and forestry of the Republic of Bulgaria and president of the Council

The current legal framework for the marketing authorisation, distribution and use of veterinary medicines is set out in directive 2001/82/EC and regulation 726/2004. 
Over time operators have underlined the limitations of these rules especially in relation to availability of medicines for limited markets (e.g. for bees) and the lack of innovation connected to the heavy administrative burden linked to the authorisation procedure. At the same time awareness of the risks associated with antimicrobial resistance has grown and the efforts to combat it have been stepped up.

Read the full press release on the website of the Council of the European Union.

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