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Reform of Veterinary Medicines Legislation Agreed

Earlier this month (5 June), the EU institutions reached a provisional agreement on a new regulation for veterinary medicinal products, following a lengthy 3 years of discussions.

The regulation (replacing Directive 2001/82/EC) harmonises the authorisation, distribution and pharmacovigilance systems for veterinary medicines in Member States and aims to reduce antibiotic use in food producing animals in order to address the public health risk of antimicrobial resistance.

Key points from the regulation:

  • Irish co-ops will continue to be able to supply key veterinary medicines, including anthelmintic medicines, through their roles as “Licensed Merchants”. Throughout the reform process ICOS defended this vitally important route of supply for farmers, without which would limit competition and availability and increase costs for farmers.
  • Co-op run Mastitis Control Programmes (operating under Schedule 8 of I. No 786 of 2007) are facilitated within the regulation, in that a veterinary prescription can be issued on the basis not only of a clinical exam, but “any other proper assessment of the health status of the animal or group of animals by a veterinarian.” A co-op vet within a Mastitis Control programme has access to all relevant laboratory data generated by the co-op, as well as reports and commentary from the co-op advisory staff and is therefore best placed to advise farmers on the mammary health of their herd. These programmes have significantly reduced the level of mastitis on Irish dairy farms and have had a significant impact on the dependence and use of antibiotics.
  • However, there is a restriction on the use of antimicrobial medicines for prophylaxtic and metaphylaxtiic treatments to only exceptional cases and for administration to an individual animal. This limitation may require a significant change in practice at farm level to move away from the use of the blanket dry cow therapy.

By Alison Graham

European Affairs Executive