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The Irish Medicines Board - www.imb.ie

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Availability of Veterinary Medicines

Various categories of veterinary medicines may be legally supplied in Ireland, including:

  • Veterinary medicines authorised nationally by the IMB
  • Veterinary medicines authorised by the EU Commision for pan-European use
  • Veterinary medicines authorised under exceptional circumstances by the Department of Agriculture, Food and the Marine (for animal or welfare reasons, or for clinical trials)
  • Products which are deemed to fall outside the scope of the veterinary medicines legislation

It should be noted that even when a product is authorised by the IMB, the product may not be marketed in Ireland. Marketing authorisation holders are not compelled to ensure the products are in continual supply.

In accordance with national and European legislation, certain preparations are exempted from the requirements for a marketing authorisation for a veterinary medicinal product. These include:

  • Feed additives
  • Biocides
  • Certain products that have, following application to the IMB, been exempted from the requirements for a marketing authorisation and which are intended solely for aquarium fish, cage birds, homing pigeons, terrarium animals, small rodents, and, ferrets and rabbits kept exclusively as pets. Further information is available in the Guide to the definition of an Animal Remedy and the Classification Process
  • Autogenous vaccines

Given the diversity of biological species in Ireland, the availability of an adequate range of veterinary medicines to treat every animal, bird, bee and fish type is a well recognised challenge. This is also the case throughout the EU. The IMB plays a leadership role at the EU level in trying to elaborate a shared understanding of the issue and in bringing forward solutions to it. At a national level the IMB works with the Irish Department of Agriculture, Food and the Marine to bring about a regulatory environment which meets the needs of animal health and welfare in this country. The focus of the IMB's response to the matter over recent years has been at a number of levels:

  1. Ensuring that the authorisation systems are cost effective, predictable and efficient.
  2. Subventing the registration costs for low volume veterinary medicines which are needed in Ireland.
  3. Communicating information on authorised veterinary medicines on the IMB website.
  4. Clarifying the IMS's role with regard to those of the other actors involved.
  5. Supporting the Department of Agriculture, Food and the Marine in framing a regulatory environment which supports availability.
  6. Championing the elaboration of applications for maximum residue limits for veterinary drugs of national importance which are not of commercial interest.
  7. Cooperating with agencies of other Member States to achieve common labelling of veterinary medicines where possible.
  8. Contributing ideas for the elaboration of a fit-for-purpose regulatory regime in the EU at various regulatory fora.

The IMB does not have a role in the licensing or importation of veterinary medicines for exceptional purposes. Neither does the IMB have a role in the pricing of veterinary medicines.

Advice on specific product categories is offered for the following:

  • National initiatives to improve availability of veterinary medicines
  • International initiatives to improve availability of veterinary medicines
  • Exceptional authorisations
  • Use of veterinary medicines outside the terms of their approved authorisation
  • The method of supply of veterinary medicines

Date Printed: 19 May 2013

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