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Information Notice VMS 2/2018 - Availability of Equine Rotavirus Vaccine

To: Equine Veterinary Practitioners

Subject: Availability of Equine Rotavirus Vaccine

The Department of Agriculture, Food and the Marine (DAFM) was made aware in March 2018  of the non- availability of equine rotavirus vaccine (VPA 10438/050/001) on the Irish market for the remainder of  2018  season and  also for  the 2019 season.

In an effort to ensure the availability of a vaccine, the Department has issued on a very exceptional basis, a licence to import 12,000 doses of ‘Equine Rotavirus vaccine’ from the USA. The vaccine can now be obtained through one of the following wholesalers in accordance with the terms of the licence:

  • Uniphar PLC,  4045 Kingswood Road, Citywest Business Campus, Dublin 24 - (WS/DN/062)
  • C+M Vetlink PLC, Unit 11 Annacotty Business Park,Annacotty, Co. Limerick - (WS/LK/007
  • Agrihealth Ltd, Clones Road,  Monaghan,Co. Monaghan - (WS/MN/001)
  • Chanelle Provet,  I.D.A. Industrial Estate, Dublin Road,Loughrea, Co. Galway - (WS/GY/010)

Veterinary practitioners and horse owners should note that this vaccine does not currently have a marketing authorisation valid in the EU and thus the normal safeguards provided in European legislation by Council Directive 2001/82 relating to safety, quality and efficacy do not apply.   Products without a marketing authorisation valid in the EU are used at the individual’s own risk and in such situations the Department of Agriculture, Food and the Marine cannot be held responsible for any negative consequences that may occur. That said it should be noted that in this case both the product and the premises of manufacture in the US are authorised by the USDA; the company have advised that each batch is manufactured in accordance with the an Outline of Production approved by the USDA and tests in relation to purity, safety, potency and product moisture testing are submitted to the USDA for review and batch release before the product can be placed on the market in the US.                                                                                               

Veterinary Medicines
01 August 2018