JPAC Joint United Kingdom (UK) Blood Transfusion and Tissue Transplantation Services Professional Advisory Committee

19.4: References

  1. Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. OJ, L 102, 07.04.2004, p48.
  2. Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells. OJ, L 038, 09.02.2006, p40.
  3. Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards 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. OJ, L 294, 25.10.2006, p32.
  4. Statutory Instrument 2007 No. 1523 The Human Tissue (Quality and Safety for Human Application) Regulations 2007. Available at www.legislation.gov.uk/uksi/2007/1523/made.
  5. Human Tissue Act 2004 (except Scotland). Available at www.legislation.gov.uk.
  6. Human Tissue (Scotland) Act 2006. Available at www.show.scot.nhs.uk.
  7. Human Tissue Authority: Directions given under the Human Tissue Act 2004 to establishments licensed under the Quality and Safety Regulations, available at www.hta.gov.uk/legislationpoliciesandcodesofpractice/htalegaldirections.cfm:
    • 003/2010 implementing the ‘Guide to Quality and Safety Assurance for Human Tissues and Cells for Patient Treatment’
       
  8. Human Tissue Authority: Codes of Practice, available at www.hta.gov.uk:
    •  Code 1. Consent
    •  Code 2. Donation of solid organs for transplantation
    •  Code 5. Disposal of human tissue
    •  Code 8. Import and export of human bodies, body parts and tissue
    •  Code 9. Research
       
  9. Joint UKBTS/NIBSC Professional Advisory Committee’s (JPAC) Donor Selection Guidelines. Available at www.transfusionguidelines.org.uk:
    • Tissue donor selection guidelines: living donors (TDSG-LD)
    • Tissue donor selection guidelines: deceased donors (TDSG-DD).
       
  10. SaBTO (2011). Guidance on the Microbiological Safety of Organs, Tissues and Cells used in Transplantation. Available at www.dh.gov.uk/en/Publicationsandstatistics/Publications   /PublicationsPolicyAndGuidance/DH_121497.
  11. Council of Europe (2010) Guide to Safety and Quality Assurance for the Transplantation of Organs, Tissues and Cells, fourth edition. Council of Europe Publishing.
  12. Royal College of Ophthalmologists (2008). Standards for retrieval of human ocular tissue used in transplantation, research and training. Available at www.rcophth.ac.uk
  13. Medicines and Healthcare products Regulatory Agency (2007). Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2007. London: Pharmaceutical Press.
  14. EC Guidelines to Good Manufacturing Practice Volume 4, Annex 1 (2008 revision): Manufacture of Sterile Medicinal Products. Available at http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm.
  15. Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices. OJ, L 331, 07.12.98, p1.
  16. The Royal College of Pathologists and the Institute of Biomedical Science (2009). The Retention and Storage of Pathological Records and Specimens, fourth edition.
  17. Data Protection Act 1998. Available at www.legislation.gov.uk.