Blood

Four European Directives have been put in place since 2004 to ensure that Member States have in place standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components. This legislation ensures that the blood supply throughout Europe meets the standards specified.

The Irish Medicines Board as competent authority has to ensure that blood establishments (which perform the collection, testing, processing, storage and distribution of blood and blood components) and hospital based blood banks (which store and crossmatch blood for patient use) comply with this legislation.

Blood requirements relating to quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components are regulated under Statutory Instrument No. 360 of 2005 (Quality and Safety of Human Blood and Blood Components) Regulations.

These regulations apply to blood establishments and to hospital blood banks which are defined as follows:

A ‘blood establishment’ is any structure or body involved in any aspect of the collection, testing, processing, storage and distribution of blood and blood components.

Blood establishments are required to be authorised by the Irish Medicines Board (IMB) for the activities which are carried out. In order to obtain authorisation, blood establishments must apply to the IMB for blood establishment authorisation and demonstrate compliance with the requirements of relevant Regulations. To ensure that compliance with these requirements are maintained, Blood and Tissue inspectors monitor compliance through regular on-site inspections.

A ‘hospital blood bank’ is a hospital unit which stores and distributes and may perform compatibility tests on blood and blood components exclusively for use within hospital facilities.

Hospital blood banks are required to comply with the requirements of relevant Regulations and are required to submit an annual report to the IMB describing the systems in place to ensure such compliance. Hospital Blood Banks must also operate to International Standard ISO 15189 (Medical laboratories – Particular requirements for quality and competence) not later than 8 November 2008.

If you wish to obtain more information about the licensing of these activities please dowload the relevant application forms and guidance from this website.

For more information contact:-

Blood & Tissues Section
Compliance Department
Irish Medicines Board
Kevin O'Malley House
Earlsfort Centre
Earlsfort Terrace
Dublin 2

Phone: +353-1-6764971
Fax: +353-1-6767836
email: compliance@imb.ie

The Irish Medicines Board - www.imb.ie

Blood