Service Item Animals Remedies
The HPRA continues to work to improve the range of authorised veterinary medicines through a number of initiatives, including the provision of a reduced fee for veterinary medicines with severely limited but important uses for which no alternative authorised product exists.
The service item fee category allows applicants to apply for a marketing authorisation for a veterinary medicine at a fraction of the cost of the agency in providing that service. It therefore represents a significant commitment by the HPRA to the provision of veterinary medicines for minor use indications in order to avoid animal suffering and safeguard public health. As the national legislation requires us to recover the costs of our activities, the ‘Service Item’ category is to be used exceptionally, in the interests of animal welfare and public health, to assist applicants in bringing applications to Ireland where the normal commercial returns from the market would not be expected to cover the applicable new product application fees. Accordingly, the marketing authorisation holder should be prepared to divulge their expected turnover when discussing their application for service item status with the agency.
Applications for consideration under this category will be judged on a case-by-case basis. The designation of a medicine as a service item must be agreed with the agency in advance of a submission. The following general rules apply to applications for service item veterinary medicines:
- There is no alternative veterinary medicine currently authorised in Ireland.
- There is a need for the product for the treatment or prevention of disease in animals or for the maintenance of animal welfare or public health.
- The revenue from the sale of the product is limited (less than € 20,000 turnover) and would not be expected to cover the applicable standard fee.
- All post-authorisation activities such as variations, maintenance of the marketing authorisation etc are charged at the normal rate.
- The HPRA will recoup the difference between the service item fee and the applicable standard fee in those cases where an applicant wishes to apply for mutual recognition of the Irish authorisation at a future date or in those cases where the returns from the market significantly exceed the expected revenues.
In the light of uptake of this fee category and the available agency resource in any particular year, the HPRA reserves the right to alter any of the conditions at any time.