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EU: rules for veterinary medicinal products and medicated feed published

The Council and the European Parliament have signed the adopted regulations. The signed texts have been published in the EU Official Journal.

Thursday 10 January 2019 (2 months 9 days ago)
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The new rules on veterinary medicinal products:

  • clarify and simplify the procedures through which a marketing authorisation can be granted to new medicines, thereby reducing the administrative burden for companies, especially small ones
  • better frame the use of antimicrobials in animals by further limiting their use for animals that are not yet sick but may run the risk of falling ill, both in the case of prophylaxis and metaphylaxis
  • provide for certain critical antimicrobials to be set aside for the treatment of certain infections in humans in order to preserve their effectiveness
  • improve the protection of the European consumers against the risk of the spreading of AMR through imports of animals and products of animal origin
  • strengthen pharmacovigilance and controls

The new rules on medicated feed:

  • set out criteria for the approval of feed business operators and their obligations when manufacturing medicated feed
  • lay down harmonised requirements in order to avoid cross contamination of a non target feed with active substances
  • clarify the prescription and use of medicated feed containing antimicrobials in food-producing animals
  • prohibit the use of medicated feed for prophylaxis

pdfREGULATION (EU) 2019/4 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 December 2018 on the manufacture, placing on the market and use of medicated feed, amending Regulation (EC) No 183/2005 of the European Parliament and of the Council and repealing Council Directive 90/167/EEC

pdfREGULATION (EU) 2019/6 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC

Monday January 7, 2019/ OJEU/ European Union.
https://eur-lex.europa.eu

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