Legislation for blood and blood components

Below is a list of the national and European legislation for regulating blood and blood components.

European legislation

  • Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC.
  • Commission Directive 2004/33/EC of 22 March 2004 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components.
  • Commission Directive 2005/61/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards traceability requirements and notification of serious adverse reactions and event.
  • Commission Directive 2005/62/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards Community standards and specifications relating to a quality system for blood establishment.
  • Commission Directive 2009/135/EC of 3 November 2009 allowing temporary derogations to certain eligibility criteria for whole blood and blood components donors laid down in Annex III to Directive 2004/33/EC in the context of a risk of shortage caused by the Influenza A(H1N1) pandemic.
  • Commission Implementing Directive 2011/38/EU of 11 April 2011 amending Annex V to Directive 2004/33/EC with regards to maximum pH values for platelets concentrates at the end of the shelf life. 
  • Commission Directive 2014/110/EU of 17 December 2014 amending Directive 2004/33/EC as regards temporary deferral criteria for donors of allogeneic blood donations.
  • Commission Directive (EU) 2016/1214 of 25 July 2016 amending Directive 2005/62/EC as regards quality system standards and specifications for blood establishments.
  • Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC.

National Legislation

  • S.I. No. 360 of 2005- European Communities (Quality and Safety of Human Blood and Blood Components) Regulations 2005.
  • S.I. No. 547/2006- European Communities (Human Blood and Blood Components Traceability Requirements and Notification of Serious Adverse Reactions and Events) Regulations 2006.
  • S.I. No. 552/2006- European Communities (Quality System for Blood Establishments) Regulations 2006.
  • S.I. No. 562/2006- European Communities (Quality System for Blood Establishments) Regulations 2006.
  • S.I. No. 179/2008- European Communities (Quality and Safety of Human Blood and Blood Components) (Amendment) Regulations 2008.
  • S.I. No. 507/2009- European Communities (Quality and Safety of Human Blood and Blood Components) (Amendment) Regulations 2009.