EU Directives and Regulations

• UK Blood Safety and Quality Regulations (BSQR)
  www.legislation.gov.uk/uksi/2005/50/contents/made#top

• BSQR amendments
  www.legislation.gov.uk/uksi/2005/1098/contents/made
  www.legislation.gov.uk/uksi/2005/2898/contents/made
  www.legislation.gov.uk/uksi/2006/2013/contents/made

• EU Directives

  • Directive 2002/98/EC of the European Parliament and of the Council
    27 January 2003 (pdf - 242KB)
    Standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components.

  • Directive 2004/33/EC of the European Parliament and of the Council
    22 March 2004 (pdf - 201KB)
    Certain technical requirements for blood and blood components.

  • Directive 2005/61/EC of the European Parliament and of the Council
    30 September 2005 (pdf - 63KB)
    Traceability requirements and notification of serious adverse reactions and events.

  • Directive 2005/62/EC of the European Parliament and of the Council
    30 September 2005 (pdf - 61KB)
    Community standards and specifications relating to a quality system for blood establishments.

  • Commission Directive 2009/135/EC
    3 November 2009 (pdf - 712KB)
    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.

• EU web page
  http://ec.europa.eu/health/blood_tissues_organs/policy/index_en.htm

Human Tissues and cells

• The Human Tissue (Quality and Safety for Human Application) Regulations 2007
  www.legislation.gov.uk/uksi/2007/1523/pdfs/uksi_20071523_en.pdf

• EU Directives

  • Directive 2004/23/EC of the European Parliament and of the Council
    31 March 2004 (pdf - 243KB)
    Setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells

  • Directive 2006/17/EC of the European Parliament and of the Council
    08 February 2006 (pdf - 84KB)
    Technical requirements for the donation, procurement and testing of human tissues and cells

  • Directive 2006/86/EC of the European Parliament and of the Council
    24 October 2006 (pdf - 162KB)
    Traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells

• EU web page
  http://ec.europa.eu/health/blood_tissues_organs/policy/index_en.htm

Human Organs

• EU web page
  http://ec.europa.eu/health/blood_tissues_organs/policy/index_en.htm