Regulations

Guidelines for Harvesting, processing and distributing tissue for transplantation 9/2016

1. DIRECTIVE 2004/23/EC of the European Parliament and of the Council of 31 March 2004.
   It defines quality of standards and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissue and cells
2. DIRECTIVE 2006/17/EC of the Council of 08 February 2006 that implements the Directive 2004/23/CE of the European Parliament and of the Council.
   It is related to specific technical requirements for the donation, procurement and control of tissue and cells.
3. DIRECTIVE 2000/86/EC of the Council of 24 October 2006 that implements the directive 2004/23/CE of the European Parliament and the Council.
   It defines the requirements of traceability, the notification of adverse events and specific technical requirements for coding, processing, storage and distribution of human tissues and cells.
4. DIRECTIVE 2012/39/EU of the Council of 26 November 2012 that modify the directive 2006/17/EU.
   It is related to specific technical requirements for analysis performed on human tissues and cells.
5. Legislative Decree 6/11/07 n. 191.
   Implementation of the Directive 2004/23/EC on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells.
6. Legislative Decree 25/01/10 n. 16.
   Implementation of the Directives 2006/17/EC and 2006/86/EC implementing Directive 2004/23/EC in relation to technical requirements for donation, procurement and control of human tissues and cells, as well as to requirements of traceability, notification of serious reactions and adverse events and specific technical requirements for the coding, processing, preservation, storage and distribution of tissues and human cells.
7. Legislative Decree 30/05/12 n. 85.
   Changes and additions to the legislative Decree of 25/01/2010 n.16, implementing the Directive 2006/17/EC and 2006/86/EC that, in turn, implements the Directive 2004/23/EC in relation to the technical requirements for the donation, procurement and control of tissue and cells as well as to the requirements of traceability, notification of serious reaction and adverse events and to specific technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells.
8. Law 01/04/99 n.91.
   Provisions related to procurement and trasplant of organs and tissues.