IMB establishes a Working Group on Classification of Method of Supply of Veterinary Anti-parasitic Agents for Companion Animals

17 July 2009

The policy of the Irish Medicines Board (IMB) for the allocation of an appropriate method of supply for veterinary anthelmintics (wormers) and antiparasitic agents (flea treatments etc.) for dogs and cats pre-dates the 2007 change in national legislation relating to the supply of prescription medicines. Many such products originally restricted as prescription-only medicines have maintained this classification since the date of their original authorisation many years ago and despite a long record of safe and effective use since. So too, certain worm treatments which were originally authorised for supply as ‘over the counter’ medicines and which converted to a ‘companion animal supply’ category over recent years have the same method of supply notwithstanding the effect of changes in the legislation.

Taking into consideration both the 2007 legislative changes relating to the supply of certain categories of veterinary medicines as well as international developments on access to veterinary medicines generally, the IMB believes that it is timely to review the suitability of the allocated methods of supply of the anthelmintic and antiparasitic group of veterinary medicines which are used for routine or prophylactic use for the control of parasites in companion animals (even if only to confirm the suitability of the existing methods of supply).

Accordingly, the Board of the IMB at their meeting on 25 June 2009 approved the formation of a working group of the Advisory Committee for Veterinary Medicines to:

• Review the current methods of supply of veterinary anthelmintics and antiparasitic agents intended for use in companion animals, and
• Prepare a guidance document for the IMB on the most appropriate criteria to allocate such products to the various national supply routes, taking into consideration the effect of the 2007 legislative changes to the distribution of veterinary medicines as well as the relevant risks and benefits associated with use of the products and any practical constraints.

The scope of the review excludes vaccines as well as medicines which have been authorised by the EU Commission.

The Chairperson of the working group is Dr. Iona Pratt, and the members are Dr. J.G. Beechinor, Dr. Ruaidhrí Breathnach, Mr. Diarmuid Dooge, Ms. Caroline Garvan and Professor Peter Weedle. The working group will convene in September 2009 and will invite submissions from interested parties before framing its report for consideration by the IMB during 2010. A separate notification advising of the submission request and deadline for same will be posted on the IMB website between 09 September and 15 October 2009. All such submissions must be submitted to the IMB; the members of the working group will appreciate to have the necessary independence to conduct their work without interference and should not be contacted in relation to their task.

The IMB estimates that there will be approximately 60 products concerned by this review.