Tánaiste signs Regulations to transpose Directive 2004/23/EC on quality and safety of tissues and cells

18 April 2006

The Tánaiste and Minister for Health and Children , Mary Harney TD signed the European Communities (Quality and Safety of Human Tissues and Cells) Regulations (Statutory Instrument No.156 of 2006) into law on 7th April.

The Regulations lay down standards of quality and safety for human tissues and cells intended for human applications, in order to ensure a high level of protection of human health. The Regulations apply to the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells intended for human applications and of manufactured products derived from human tissues and cells intended for human applications.

All tissue establishments must be inspected and authorised to carry out their activities by the Irish Medicines Board, which is the competent authority under the Regulations.

The Regulations set out the information which must be given to donors before they consent to donation. They deal with requirements for procurement, traceability, donor selection, evaluation and testing criteria, storage and packaging and import and export of tissues and cells.