Regulation (EU) 2019/6 on veterinary medicinal products

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Publication Date 07/01/2019
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In September 2014 the European Commission presented a proposal for a Regulation aiming to make more medicines available in the European Union (EU) to treat and prevent diseases in animals.

The European Parliament's plenary session adopted a set of amendments to the original proposal in March 2016 and later a vote by the relevant committee on the draft resolution was postponed so that interinstitutional negotiations could start. The Council of the European Union adopted a general approach on 20 December 2017.

An informal agreement was reached on 5 June 2018. The Council's committee of permanent representatives endorsed it on 13 June, followed by the Parliament's environment committee on 20 June. The Regulation was adopted on 11 December.

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Work on a European legal framework for veterinary medicinal products started in 1965 with the adoption of Directive 65/65/EEC, which required that marketing authorisations be issued before such products could be placed on the market. The existing legal framework for the marketing authorisation, distribution and use of veterinary medicines was set out in Directive 2001/82/EC and Regulation 726/2004.

Over time operators underlined the limitations of these rules especially in relation to availability of medicines for limited markets 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 became more evident and the efforts to combat it were stepped up.

The proposed Regulation seeks to put in place an updated body of legislation, tailored to the specificities of the veterinary sector; to simplify procedures for obtaining a marketing authorisation, and to review incentives for breakthrough medicines. The draft law also tackles the issue of antimicrobial resistance. It introduces the possibility of restricting the use in animals of certain antimicrobials, to be reserved to treat human infections.

The proposal was put forward as part of a legislative package on improving animal and human health.

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Related Links
EurActiv, 18/02/2016: MEPs want to restrict farmers’ use of antibiotics in healthy animals
EurActiv, 11/03/2016: Parliament endorses plan to curb unnecessary antibiotic use

EUR-Lex: COM(2014)558: Proposal for a Regulation on veterinary medicinal products
EUR-Lex: SWD(2014)273: Impact assessment accompanying COM(2014)558
EUR-Lex: SWD(2014)274: Executive summary of the impact assessment accompanying COM(2014)558
European Parliament: Legislative Train: Veterinary Medicinal Products
European Parliament: Legislative Observatory: Procedure File on veterinary medicinal products
European Parliament: Press Release, 10/03/2016: Superbugs: MEPs want to curb use of antibiotics in farming
Council of the European Union: Press Release, 13/06/2018: Veterinary medicines: new EU rules to enhance availability and fight against antimicrobial resistance

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