Details
- Status
- Closed
- Opening date
- Deadline
- Department
- Directorate-General for Health and Food Safety
Target audience
Public health community
Why we are consulting
Open Consultation on Draft Technical Requirements for Tissues and cells
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 was adopted in March 2004. This text entered into force on 7 April 2004, the date of its publication in the Official Journal of the European Communities.
The Directive empowers the Commission to establish and update technical requirements in relation to quality and safety of human Tissues and cells. In anticipation of its responsibilities under this Directive, the Commission conducted in June 2005 an open consultation on draft technical requirements related to the coding, processing, preservation, storage and distribution of human tissues and cells.
This Open Consultation was the second phase in the process towards a Commission Directive on the technical requirements in the aforementioned areas. This document reflected the technical annexes adopted by the Commission in the original proposal for the Directive (COM(2002) 0319 final) which Council and Parliament decided during the legislative process to be developed by comitology. In addition the document incorporated the extensive comments and contributions received from a Commission working group of experts representing the tissues and cells community, including the Council of Europe. That contribution and the comments received on it were amalgamated, edited and reorganised into the Open Consultation document on coding, processing, preservation, storage and distribution of human tissues and cells.
The European Commission thanks all the national and regional authorities, NGOs, individual citizens, companies and associations who participated in this consultation which will feed into the preparation of the future technical requirements.
List of all the contributions received
Directive 2004/23/EC establishing the above requirements
Respond to the consultation
Europeans Associations/organisations
National Associations/organisations
Establishments
Individuals
Others
Europeans Associations/Organisations
| Sender | |||
| R-001 | I. M. FRANKLIN | European Blood Alliance | EU |
| R-002 | G. JONES | European Eye Bank Association | EU |
| R-003 | I. SLAPER-CORTENBACH | JACIE and ISCT | EU |
| R-004a R-004b |
P. COPPO | World Marrow Donor Association | EU |
| R-005 | D. PIROVANO | Eucomed | EU |
| R-006 | A. McNAB | European Assisted Conception Consortium (EACC) | EU |
National associations/organisations
| Sender | |||
| R-007 | A. WOLTHUIS | Dutch Workgroup Semen | NL |
| R-008 | A. PACEY | British Fertility Society (BFS) | UK |
| R-009 | T. TANBO | Norwegian Association of Assisted Reproduction (NOFAB) | N |
| R-010 | D. MORROLL | UK Association of Clinical Embryologists | UK |
| R-011 | S. MÄKINEN | Finnish Laboratory Society | FI |
| R-012 | C. BASAK | Royal College of Nursing | UK |
| R-013 | J. CLOHERTY | Association of Irish Clinical Embryologists (ICE) | IR |
| R-014 | S. ZIEBE H. MEINERTZ |
Danish Fertility Society
Danish Society of Obstetrics and Gynaecology |
DA |
| R-015 | C. HUNT | National Institute for Biological Standards and Control | UK |
| R-016 | G.J. HUISMAN | Ministry of Health, Welfare and Sport | NL |
| R-017 | L. MUYLLE | FPS Directorate-general for Medicinal Products | B |
| R-018 | K. SMITH | National Blood Service UK | UK |
| R-019 | G. GALEA | SAC Tissues UK Blood Transfusion Services | UK |
| R-020 | P. KASTROP | Dutch Society of Clinical Embryologists | NL |
| R-021 | I. RENOLEN | Ministry of Health and Care Services | N |
| WANNINGER | Bavarian. Administrative office for health and food security | DE | |
| R-022 | B. LOTY T. LE LUONG |
Agence de la biomedecine | F |
| R-041 | R. HöCHSTETTER | German hospital society registered association (German hospital Association) | DE |
| R-023 | J. HREINSSON H.GÄBEL |
KG Nygren, Gabriel Fried, Matts Wikland, Julius Hreinsson for the clinical and laboratory IVF profession in Sweden | SE |
| R-024a R-024b |
F. GEISTHÖVEL | Bundesverband Reproduktionsmedizinischer Zentren (BRZ) | DE |
| R-025 | C. LISTER | Human Fertilisation and Embryology Authority (HFEA) | UK |
| R-026 | R. HÜBNER | Belgian Superior Health Council | B |
| R-027 | J. VAN BAARE | Netherlands Association of Tissue Banks | NL |
| R-028 | R. VILLALBA | Spanish Association of Tissue Banks | ES |
| R-029 | E. VAN DER SCHOOT | Sanquin (Dutch Foundation for Blood Transfusion) | NL |
| R-030 | A. M. VANGSTED | Danish Medicines Agency | DA |
| R-031 | H. ZECH | Austrian Society of Human Reproduction and Endocrinology | A |
Establishments
| Sender | |||
| R-040 | M. BENGTSSON O. ÅKERBLOM |
Clinical immunology and transfusion medicine University Hospital, UPPSALA, Sweden | SE |
| R-032 | R. CUTTING | The Jessop Wing Sheffield Teaching Hospitals NHS Foundation Trust | UK |
| R-033 | O. SCHOU | Cryos International Sperm Bank | DA |
| A. WILSON | Smith & Nephew Wound Management | UK | |
| R-034 | L. BARNOUIN | TBF Banque de Tissus | F |
| R-038 | M. JARRAYA | Banque de Tissus Humains Saint louis | F |
| M. KURFüRST | Nordmark Arzneimittel GmbH & Co. KG | DE | |
| R-039 | M. CLAESSON | Department of Ophthalmology, Sahlgrens University Hospital | SE |
| M. L. KAVANAGH | Jacobs Engineering U.K. Limited | UK | |
| R-035 | V. WETZEL | Karlsruher IVF-Programm AG für Fortpflanzungsmedizin | DE |
| D. R. BRISON | Department of Reproductive Medicine, St Mary's Hospital, Manchester | DE |
Individuals
| Sender | |||
| A. GORGY | Director The Fertility & Gynaecology Academy | UK | |
| R-036 | J. ARMITAGE | Professor W J Armitage; CTS Bristol Eye Bank, Bristol Eye Hospital, Bristol | UK |
| D. MORTIMER
|
Dr Davis Mortimer | Canada |
Others
| Sender | |||
| R-037 | D. L. CONFER | National Marrow Donor Program US | US |