The general issue of product testing on animals is covered at EU level by Council Directive 86/609 which lays down rules regarding the protection of animals used for experimental and other scientific purposes. Responsibility for implementation of this regime in Ireland rests with my colleague, the Minister for Health and Children under the cruelty to animals legislation.
My Department implements a specific licensing regime under EU pharmaceutical legislation in relation to clinical trials conducted in the context of applications for marketing authorisations for veterinary medicines. The purposes of this regime are protection of public health and ensuring that the data generated by such trials meet the standard required to substantiate the application for a marketing authorisation in terms of safety and efficacy.