Allocating the method of supply
The allocation of the route of supply of an animal remedies nationally is carried out by the HPRA in accordance with pre-defined legal criteria and, where relevant, agency policy.
When the HPRA grants a marketing authorisation for an animal remedy it is obliged to allocate an appropriate category of supply in accordance with Schedule 1 of SI No. 786 of 2007. In deciding on the appropriate route at the time of the initial granting of the authorisation of an animal remedy, the agency must follow the designated criteria set out in the national legislation, as well as 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 (or veterinary practitioner use only).
The method allocated is subject to review and change based on the experience of the product in the market and on any change in the benefit/risk profile since the previous decision.
The operation of the prescribing and dispensing regimes in Ireland is defined by national legislation (S.I. No. 786 of 2007). The reader is advised to contact the Department of Agriculture, Food and the Marine in relation to any questions relating to prescribing and dispensing practices. 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.