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The Irish Medicines Board -

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Blood, Tissues, Organs

The role of the IMB in respect of blood, tissues and cells, and organs intended for transplantation is outlined below. Please use the links to the left for further information.

Blood, Tissues and Cells
In 2005 the Irish Medicines Board (IMB) became the competent authority for blood legislation and in 2006 the IMB also became the competent authority for tissues and cells legislation.

As a result the IMB is obliged to:
  • Authorise all activities relating to the collection, testing, processing, storage and distribution of human blood and blood components  
  • Authorise all sites carrying out any prescribed activities that are involved in the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. Storage of tissues and cells at sites of human application are outside the scope of the legislation. 
  • Organise inspections and appropriate control measures to ensure that the requirements of the Directives are complied with 
  • Organise appropriate vigilance mechanisms for the collection and evaluation of serious adverse reactions (SARs) and relevant serious adverse events (SAEs) related to the collection and transfusion / application of blood and tissues & cells
Quality and Safety of Human Organs Intended for Transplantation
The Directive on standards of quality and safety of human organs intended for transplantation (Directive 2010/53/EC) was adopted by the European Parliament and the Council on 7 July 2010. This Directive was transposed into Irish legislation by Statutory Instrument (S.I. No. 325 of 2012) and was signed by the Minister for Health on 27 August 2012.

Under this legislation, the Irish Medicines Board (IMB) and the Health Service Executive (HSE) have been appointed as the responsible Competent Authorities for implementation of different aspects of this legislation. The IMB is responsible for the inspection and authorisation of organ procurement and transplant centres and for serious adverse event and reaction reporting.

Contact the IMB
Blood, Tissues, Organs Section
Telephone: +353-1-6764971   
Fax:          +353-1-6764061

Date Printed: 24 April 2014

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Address: Kevin O'Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2, Ireland.
Tel: 353-1-676 4971