As licences in respect of animal vaccines, which had been granted under the Therapeutic Substances Act 1932, no longer meet current scientific or EU legislative requirements, not least because a mandatory supply route was not specified, it was necessary to review all such licences on an individual basis. Under the review, which has been ongoing since 1999, the Irish Medicines Board has been progressively carrying out the detailed examination of application dossiers submitted by sponsoring companies. On this basis, the board makes a recommendation to my Department, as competent authority, for a final decision on the grant or otherwise of a licence and on the conditions, including route of supply, accompanying such licence.
In terms of designating routes of supply for individual vaccines, my Department does not have a general approach which would as a matter of policy necessarily exclude any of the outlets provided for under the Animal Remedies Regulations 1996. Rather, the decision is taken on the basis of the characteristics of each individual product taking account of the relevant recommendation of the Irish Medicines Board and the objective criteria laid down in Regulation 13 of the Animal Remedies Regulations 1996.
In this context, I should point out that my Department has concluded a review of the existing legislation governing regulation of the Irish market in veterinary vaccines and other veterinary medicines taking account of experience of their operation for almost a decade, of various developments over that period and likely developments in the future. Arising from this, my Department is preparing to brief stakeholders within the next few weeks on the direction of the proposed changes to the existing regime, following which consultations with the animal remedies consultative committee will take place.