I would like, at the outset, to clarify that the development and validation of alternative approaches to procedures using animals is a matter that must be addressed on a an EU wide basis. The Irish Medicines Board (IMB) is currently working with the European Commission regarding the identification and validation on alternative approaches that might be developed in the future. In this regard, one area that is being examined by Member States in co-operation with+ the EU Commission is the identification and nomination of suitable, specialist and qualified laboratories to carry out such validation studies. This work is on-going at present.