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.