The new Directive requires that all EU Member States adhere to the principles of the three Rs (replacement of the use of animals to the greatest extent possible with alternative testing methods, refinement of scientific procedures to improve animal welfare and reduction in numbers of animals used). These provisions are mandatory.
My Department is continuing work on the transposition which will be completed by November 2012. I would also like to advise the Deputy that I have decided that the Irish Medicines Board is to be designated as the Competent Authority for Directive 2010/63/EU. The transposing regulations will set out enforcement provisions, including penalties, that will apply where the provisions of the Directive, including requirements relating to the "Three Rs", are not complied with. These penalties will be effective, proportionate and dissuasive.