Market Compliance and Surveillance

The HPRA investigates, on the basis of risk to public and animal health, reports of suspected quality defects in veterinary medicines and in their related active substances. We also co-ordinate any subsequent recall actions on the Irish market.

Our risk based sampling and analysis programme is focused on monitoring the quality and safety of veterinary medicinal products both on the Irish market and manufactured for export.

In relation to veterinary medicines, the Department of Agriculture, Food and the Marine is the responsible authority for the licensing of wholesalers and retailers of veterinary medicines, as well as advertisements for veterinary medicines marketed in Ireland and monitoring any reports of illegal products being used. The legislation governing the sale and possession of veterinary medicines is necessarily strict in order to protect animal and consumer health. In this regard, it should be noted that all product presentations marketed in Ireland must be authorised. It is also a requirement of national legislation that veterinary medicines must not be advertised in contravention of their marketing authorisation and that products which have been designated as subject to prescription [i.e. restricted to supply only to veterinary practitioners directly or under veterinary prescription] must not be advertised to the general public or farmers.

The HPRA monitors the annual consumption of antibiotic veterinary medicines under a programme known as ESVAC.

Finally, the HPRA monitors reports of suspected adverse reactions to veterinary medicines (a process known as pharmacovigilance). An adverse reaction is a harmful or unintentional side effect experienced by an animal following the use of a medicine. The HPRA also monitors harmful or unintended effects in humans exposed to veterinary medicines.