Challenges of the EU 'tissues and cells' directive

Reproductive BioMedicine Online

Volumn 11, Issue 4, 2005, Pages 404-407

  Hartshorne, Geraldine M ^a  

^a UNIVERSITY HOSPITAL COVENTRY   (United Kingdom)

Author keywords

Assisted conception; Cells; European union directive (204); Laboratory practice; Tissues

Indexed keywords

AIR QUALITY; CELL TRANSPLANTATION; CLINICAL LABORATORY; CLINICAL PRACTICE; CONCEPTION; EMBRYO TRANSFER; EUROPEAN UNION; FERTILIZATION IN VITRO; FUTUROLOGY; GOOD MANUFACTURING PRACTICE; HEALTH CARE QUALITY; HUMAN; INFERTILITY THERAPY; INTRAUTERINE INSEMINATION; MEDICAL RESEARCH; MEDICOLEGAL ASPECT; METHODOLOGY; NONHUMAN; NOTE; RISK ASSESSMENT; TISSUE TRANSPLANTATION; VALIDATION PROCESS;

EID: 28844473514     PISSN: 14726483     EISSN: None     Source Type: Journal    
DOI: 10.1016/S1472-6483(10)61129-7     Document Type: Note

References (10)

1. Boone WR, Johnson JE, Locke AJ et al. 1999 Control of air quality in an assisted reproductive technology laboratory. Fertility and Sterility 71, 150-154.
2. European Union. (In preparation 2) 'Technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells.' Draft 29/03/2005. See "Open Consultation document" (PDF file) in ttp://europa.eu.int/comm/health/ph_threats/human_substance/oc_tech_cell/ oc_tech_cell_en.htm [accessed 18 August 2005].
3. European Union. (In preparation 1) 'Technical requirements for the donation, procurement and testing of human tissues and cells.' Draft 3/08/2004 http://194.134.242.245/fileadmin/Regulatory/Technical_requirements.pdf [accessed 9 August 2005].
4. European Union 2004 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. Official Journal of the European Union L102/48. Also available at http://europa.eu.int/eur-lex/pri/en/oj/dat/2004/1_102/ 1_10220040407en00480058.pdf [accessed 18 August 2005].
5. European Union 2003 The European Union Guide to Good Manufacturing Practice. Revision to Annex 1. http://pharmacos.eudra.org/F2/eudralex/vol-4/pdfs-en/revan1vol4_3.pdf [accessed 17 August 2005].
6. European Union 2002 Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 on 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. Official Journal of the European Union L33/30.
7. Hartshorne GM, Baker H 2005 Fads and Foibles in ART-where is the evidence? Human Fertility (in press).
8. Mortimer D 2005 A critical assessment of the impact of the European Union Tissues and Cells Directive (2004) on laboratory practices in assisted conception. Reproductive BioMedicine Online 11, 162-176.
9. National Institute for Clinical Excellence (NICE) 2004 Clinical Guideline: Fertility: Assessment and Treatment for People with Fertility Problems. RCOG Press, London, UK.
10. Von Wyl S, Bersinger NA 2004 Air quality in the IVF laboratory: results and survey. Journal of Assisted Reproduction and Genetics 21, 283-284.