1. Cross Authority Cooperation
The Veterinary Medicines Department of the Irish Medicines Board and the Veterinary Medicines Directorate in the UK have a number of initiatives in place to encourage pharmaceutical companies to maintain product authorisations in both markets and thus increase availability of medicines. Due to economies of scale, it is not always viable to have special packaging for the Irish market. These initiatives are therefore focused on enabling companies to have common packaging for authorised products which are identical in terms of formulation, packaging and manufacture. The difference between the two procedures outlined below relates to whether the product is authorised nationally or through a mutual recognition or decentralised procedure.
1.1 Harmonisation procedure
The harmonisation procedure is relevant for nationally authorised products and involves harmonisation of the SPC and product literature in Ireland and the UK. The harmonisation process is dealt with as a variation in both countries and assessment of the variations is co-ordinated between them. No technical assessment is carried out as part of the procedure. A clarification paper is available in the veterinary publications section of this site.
1.2 Joint labelling procedure
The joint labelling procedure is relevant for products authorised via a European procedure (mutual-recognition or decentralised) in which Ireland and the UK were both involved. The joint labelling procedure is dealt with during the national phase of the European procedure and involves co-ordination of approval of final colour mock-ups with no additional fees. No technical assessment is carried out as part of the procedure as the SPC and label text will have been agreed during the European procedure. A clarification paper outlining the procedure is available in the veterinary publications section of this site.
2. Service Item
Applications for veterinary medicinal products with severely limited but important uses for which no alternative authorised product exists may be designated as a service item.
The service item fee category allows applicants to apply for a marketing authorisation for a veterinary medicinal product at a fraction of the cost of the IMB in providing that service. It therefore represents a significant commitment by us to the provision of veterinary medicinal products for minor use indications in order to avoid animal suffering and safeguard public health. As the Irish Medicines Board Act 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 the IMB 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.
- The IMB 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 IMB resource, the IMB reserves the right to alter any of the conditions at any time.