Regulations

National and Community regulations and protocols

In practical PDF format, Italian and Community legislation, guidelines and protocols on public and private cryogenic storage and the therapeutic use of haematopoietic stem cells.

1.  AGREEMENT CSR 62 of 29/04/2010 – “Permanent Conference for relations between the State, Regions and Autonomous Provinces of Trento and Bolzano”
2. Ministerial Decree of 18.11.2009 in GU 31.12.2009
3.  Ministerial Ordinance of 26.02.2009  - Provisions regards the preservation of umbilical cord blood stem cells.
4. Ministerial Ordinance of 04.05.2007 – Urgent measures regarding umbilical cord stem cells.
5. Ministerial Ordinance of 13.4.2006 – Urgent measures regarding umbilical cord stem cells
6. Law n. 219 of 21.10.2005 –  New discipline of transfusion activities and of the national production of blood products
7. Ministerial Ordinance of 7.4.2005 – Urgent measures regarding umbilical cord stem cells
8. Ministerial Decree of 3.3.2005 – Protocols for ascertaining blood donor suitability and blood components
9. Ministerial Ordinance of 25.2.2004 – Urgent measures regarding umbilical cord stem cells.
10. 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
11. AGREEMENT CSR n.1770 of 10 July 2003 – Guidelines for the collection, manipulation and clinical use of haematopoietic stem cells. (CSE)..
12. Ministerial Ordinance of 30.12.2002 – Urgent measures regarding umbilical cord stem cells.
13. Ministerial Ordinance of 11.1.2002 – Urgent measures regarding umbilical cord stem cells.
14. 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
15. Ministerial Decree of 7-09-2000 – Provisions on the import and export of human blood and its products, for therapeutic, prophylactic and diagnostic use
16. Legislative Decree 502 of 30.12.1992  – Reorganization of  healthcare regulations, in compliance with article 1 of Law 421 of 23 October 1992
17. Law 107 of 4.5.1990  – Discipline for transfusions of human blood and its components and for the production of plasma derivatives
18. Law 833 of 23.12.1978  – Establishment of the Italian National Health Service