Authorisations

In our role as the competent authority, we aim to ensure that procedures involving the use of scientific animals follow the provisions of the relevant legislation in the EU (Directive 2010/63/EU) and in Ireland (S.I. No. 543 of 2012).

The authorisation process for breeders, suppliers and users of scientific animals is based on a three strand system of control as follows:

  1. Breeder/supplier/user authorisations: if you are intending to breed, supply and/or use animals for scientific or educational purposes, you must first be vetted by us and hold a breeder/supplier/user authorisation. Guides and forms for breeder/ supplier/user authorisations can be found here.

     

  2. Project authorisations: to perform scientific procedures involving the use of animals, a project application detailing the planned study and project details must first be provided to us in order to obtain a project authorisation. Guides and forms for project authorisations can be found here.

     

  3. Individual authorisations: if you are involved in carrying out scientific procedures on animals; acting as a project manager for a project authorisation as well as individuals performing euthanasia of animals, must be adequately educated and trained in order to obtain an individual authorisation from us. Guides and forms for individual authorisations can be found here.

 

In addition, to the above, we also assess and approve amendments and renewal of the above authorisations types.

Approval of Applications for Authorisation

We apply timelines to all of the application procedures, details can be found in the relevant guidance documents. Where we deem necessary; an inspection may be required prior to granting an approval. In addition, once an authorisation has been granted, authorisation holders are subject to inspections at their breeder/supplier/user establishment to verify compliance with the terms of the authorisation. A proportion of these inspections will be unannounced inspections.

We ourselves may also be inspected by the EU Commission for compliance with the tasks laid down by the Directive.

Transitional Arrangements

Please note that the Department of Health was the competent authority for the regulation of animals used for scientific purposes authorised before 31 December 2012. Transitional arrangements apply to all licences issued by the Department before 31 December 2012, in accordance with the Directive.