My HPRA: Register

Service Item Veterinary Medicines

The HPRA is actively striving to expand the range of authorised veterinary medicines various initiatives. One such initiative includes offering a reduced fee for veterinary medicines that serve vital but limited uses and for which no alternative authorised product is available in Ireland.

The “Service item” fee category allows applicants to apply for a marketing authorisation for a veterinary medicine at a fraction of the usual cost. This signifies our strong commitment to the providing veterinary medicines for minor uses to prevent animal suffering and uphold public health. As per national legislation, we must recover the costs of our activities, and thus the ‘Service Item’ category is used sparingly, in the best interests of animal welfare and public health. It assists applicants by lowering application fees, especially when the normal commercial returns are insufficient to cover the costs. Accordingly, marketing authorisation holders should be willing to disclose their expected turnover when discussing their application for service item status with us.

Applications under this category are considered on a case-by-case basis. The designation of a medicine as a service item must be agreed upon before submission. The following general rules apply to applications for service item veterinary medicines:

  1. No alternative veterinary medicine is currently authorised in Ireland.
  2. The product is needed for the treatment or prevention of animal diseases, maintenance of animal welfare, or public health.
  3. The revenue from the product’s sale is limited (less than € 25,000 turnover) and insufficient to cover the standard fee.
  4. All post-authorisation activities, such as variations and maintenance of the marketing authorisation, are charged at the regular rate.
  5. In cases where an applicant wishes to apply for mutual recognition of the Irish authorisation in the future or where market returns significantly exceed the expected revenues, the HPRA will recoup the difference between the service item fee and the applicable standard fee.

Please note that the HPRA reserves the right to amend any of the conditions at any time, based on the uptake of this fee category and the available agency resources each year.