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.