National initiatives to improve availability of veterinary medicines
Even if it is the case that availability of veterinary medicines is an international and long-standing challenge, HPRA has taken a number of national initiatives to help address the position in Ireland.
The relatively small size of the market for veterinary medicinal products in Ireland compared to a number of other European countries poses a particular challenge to the animal health industry. This is the reason why we have developed a range of measures to help address the position:
Cross Authority Cooperation
The HPRA’s Veterinary Sciences Department and the Veterinary Medicines Directorate in the UK have a number of initiatives in place to encourage pharmaceutical companies to maintain product marketing authorisations in both markets and thus increase availability of medicines. Due to economies of scale, it is not always viable to have special packaging uniquely for the smaller Irish market. Our initiatives are therefore focused on enabling companies to have common packaging for authorised medicines which are identical in terms of formulation, packaging and manufacture. Details of the particular procedures involved are available elsewhere on this site.
Applications for veterinary medicines with severely limited but important uses for which no alternative authorised product exists may be designated by HPRA as a service item.
The service item fee category allows applicants to apply for a marketing authorisation for a veterinary medicine at a fraction of the cost of that incurred by us in providing that service. It therefore represents a significant commitment by us to the provision of veterinary medicines for minor use indications in order to avoid animal suffering and safeguard public health. As the 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.
Applications for consideration under this category will be judged on a case-by-case basis. The designation of a medicinal product as a service item must be agreed with us 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 €20k turnover) and would not be expected to cover the applicable standard fee.
- All post-authorisation activities such as variations, maintenance of the VPA etc are charged at the normal rate.
- We 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 HPRA resource, we reserve the right to alter any of the conditions at any time.