Enhancing availability of veterinary medicines in Ireland
The availability of veterinary medicines has been a long-standing international challenge. In Ireland, the market size for veterinary medicines is small compared to other European countries. This presents a challenge to the animal health industry. To address this issue and within the limits of our role as State Regulator, the HPRA has undertaken several national initiatives to help address the position. The Department of Agriculture, Food and the Marine has established a complementary licensing system for exceptional importation of needed veterinary medicines for which there is not a commercial market. This article outlines the measures we have taken to improve availability nationally.
Cross Authority Cooperation
The HPRA collaborates with other EU Member States to jointly evaluate applications for new veterinary medicines. The goal is to achieve a common outcome so that the marketing authorisation is the same across all markets. By doing so, a single batch of a veterinary medicine can be manufactured with a common, multi-lingual label and package leaflet, benefiting all concerned markets.
Traditionally, many veterinary medicines on the market in Ireland were also marketed in the UK using a common label, with the medicine free to move between both countries. Despite the challenges posed by Brexit, the HPRA and the UK’s Veterinary Medicines Directorate have taken steps to maintain product marketing authorisations in both markets, ensuring availability of medicines. The focus is on enabling companies to use common packaging for authorised medicines with identical formulations, packaging, and manufacturing processes.
More information about the labelling procedures is available.
Service Item category
In cases where veterinary medicines have very limited but important uses and no alternative authorised product exists, the HPRA designates them as “service items.”
This fee category allows applicants to seek marketing authorisation at a fraction of the normal fee, representing our commitment to providing veterinary medicines for minor use indications to prevent animal suffering and protect public health. As we are required to be self-funding, we can only use the “Service Item” category exceptionally, to assist applicants in bringing applications to Ireland where normal commercial returns from the market would not cover the new product application fees.
Applications for “Service item” veterinary medicines are considered on a case-by-case basis, and certain conditions apply:
- There is currently no alternative veterinary medicine authorised in Ireland.
- The product is needed for treating or preventing disease or for maintaining animal welfare or public health.
- The product’s revenue is limited (less than € 50,000 annual turnover) and not expected to cover the applicable standard fee.
- Post-authorisation regulatory activities, such as variations and maintenance fees, are charged at the normal rate.
- In cases where an applicant seeks mutual recognition of the Irish authorisation in the future, or market returns significantly exceed expectations, the difference between the service item fee and the standard fee will be recouped.
- The HPRA reserves the right to modify any conditions depending on the uptake of this fee category and our available resources.
Through cross-authority cooperation and the establishment of a service item category, the HPRA is making significant efforts to enhance availability of veterinary medicines in Ireland. By streamlining the authorisation process and supporting applicants, these initiatives contribute to animal welfare and public health, despite the challenges posed by the country’s small market size.