Allocating the method of supply
The allocation of the route of supply of a veterinary medicine nationally is carried out by the HPRA in accordance with legal criteria and, where relevant, HPRA policy.
Whenever the HPRA grants a marketing authorisation for a veterinary medicine, it must allocate an appropriate category of supply for the product, based on:
- the criteria set out in EU and national legislation,
- the benefit / risk balance of using the medicine concerned.
Where there is not a predetermined legal requirement already in force, the HPRA has policies on:
to help clarify how veterinary medicines are allocated a supply category in this country. In accordance with EU legislation, new medicines containing an active substance that have been authorised for fewer than five years must be restricted to prescription control.
The originally allocated supply category may be reviewed and changed over time, based on the real-life experience of the product in the market, as well as any change in the benefit/risk profile since the previous decision.
The Department of Agriculture, Food and the Marine is responsible for controls relating to the operation of the prescribing and dispensing regimes in Ireland.
The Veterinary Council of Ireland has published a code of professional conduct, known as ‘Ethical Veterinary Practice’ in relation to prescribing of veterinary medicines by veterinary practitioners in Ireland.