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.