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 pre-defined legal criteria and, where relevant, agency policy.
Whenever the HPRA grants a marketing authorisation for a veterinary medicine, it is obliged to allocate an appropriate category of supply for the product. In deciding on the appropriate supply route at the time of the initial granting of the authorisation of a veterinary medicine, the agency must follow the designated criteria set out in the national legislation, as well as consider the benefit / risk balance of using the medicine concerned.
Where there is not a predetermined legal requirement already in force, the agency has adopted policies on:
to help clarify the drivers and considerations for how veterinary medicines are allocated a supply category in this country. In accordance with EU legislation, new medicines containing an active substance that has been authorised for fewer than five years must be restricted to prescription control.
The method allocated is subject to review and change 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 national legal framework underpinning the operation of the prescribing and dispensing regimes in Ireland is the responsibility of the Department of Agriculture, Food and the Marine.
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.