Steering Committee on Tissues and Cells Directive

Directive 2004/23/EC of 31st March 2004 and Directive 2006/17/EC of 8th February 2006 were transposed into Irish Law on 7th April 2006 under the European Communities (Quality and Safety of Human Tissues and Cells) Regulations. This is Statutory Instrument No. 158 of 2006. 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 and of manufactured products derived from human tissues and cells intended for human applications.

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

Membership

Mary Jackson, Chairperson DOHC
Ann McGrane DOHC
Colette Bonner DOHC
Patrick Costello Irish Medicines Board (IMB)
Maura O' Donovan IMB
John Lynch IMB
Sinead Masterson IMB
Donna Harkin IMB
Anne Hayes IMB
Ruth Ryan Health Service Executive (HSE)
Louise McMahon HSE
Jeff Connell National Virus Reference Laboratory
Tony Finch Irish Blood Transfusion Service
Conor O' Keane Cappagh Bone Bank
Fiona Clarke Cappagh Bone Bank
Joe Goulding University College Hospital Galway
Paul Browne St. James's
Aonghus Nolan Irish Clinical Embryologists
Mary Wingfield Institute of Obstetricians and Gynaecologists
John Waterstone Irish Fertility Society
Tim Dineen Irish Clinical Embryologists
Frances Norton, Secretary to the Group DOHC

Terms of Reference

Terms of Reference of the committee are as follows:

  1. To identify the number and types of tissue bank facilities in Ireland
  2. To advise the Department of Health and Children, the Health Service Executive and private hospitals and clinics on the steps necessary to prepare for implementation of the Directive by 7 April, 2006.
  3. To assist the Department of Health and Children and the Health Service Executive in ensuring that persons responsible for management of tissue banks are aware of the implications of the Directive and are supported in taking the necessary actions to comply fully with the requirements of the Directive by 7 April, 2006.
  4. To advise the Irish Medicines Board in carrying out its role as competent authority for the Directive.
  5. To assist in agreeing the final text for transposing the Directive on or before 7 April, 2006.
  6. To monitor progress of implementation of the Directive during 2006.

Minutes of Meetings of the Steering Committe

All documents are in PDF format.

Workshops on the implementation of Directive 2004/23/EC on Quality and Safety of Tissues and Cells

Programme and presentations from workshop in National College of Ireland on 29th November, 2005

Programme and presentations from workshop in National College of Ireland on 6th and 7th March, 2007

Workshop on Cleanroom/Facilities

A workshop was held on Cleanroom/Facilities to comply with EU Directive 2004/23/EC on Quality and Safety of Tissues and Cells in the National College of Ireland on Tuesday, 6th December, 2005. The day's programme and presentations are available below:

Links