Regulations

2018 REGIONAL STATE AGREEMENT: Minimum Requirements for Tissue Institutes

Minimum organisational, structural and technological requirements

2016 GUIDELINES FOR THE PROCUREMENT, PROCESSING AND DISTRIBUTION OF TISSUES FOR TRANSPLANTATION PURPOSES

‘Guidelines for the procurement, processing and distribution of tissues for transplantation purposes’, approved at the NTC meeting on 14 September 2016.

2016_Decree No. 256_Enactment of EU Directive 565 - Fabric Coding

Implementation of Directive 2015/565/EU amending Directive 2006/86/EC as regards certain coding requirements for textiles

2016_Decree 15 November Imported textiles safety

Implementation of Directive 2015/566/EU

2015_DECREE LAW 29 July

Amendments and additions to the Decree of 10 October 2012, laying down modalities for the export or import of human tissues, cells and reproductive cells intended for human applications.

2015_EU Directive 566 Commission 8 April

Implementation of Directive 2004/23/EC with regard to quality and safety standards for imported textiles

2015_EU Commission Directive 565 of 8 April

Amendment Directive 2006/86/EC technical prescriptions fabric coding

2014_GUIDELINES FOR THE CRYOBIOLOGY ROOM OF A TISSUE INSTITUTE

Approved by the National Transplant Centre, November 2014

2012_DECREE 10 October

Arrangements for the export and import of human tissue

2012 LEGISLATIVE DECREE No. 85 OF 30 May

Amendments and additions to Legislative Decree No 16 20/1/2010 as regards requirements for tissue donation, procurement and testing

2010 LEGISLATIVE DECREE OF 25 JANUARY

Implementation of EC Directives 2006/17/EC and 2006/86/EC implementing Directive 2004/23/EC

2007 LEGISLATIVE DECREE No. 191 of 6 November

Implementation of Directive 2004/23/EC on setting standards of quality and safety of human tissues

2006 COMMISSION DIRECTIVE 17/EC of 8 February 2006

Implementation of 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

2004 DIRECTIVE 23/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 March 2004

on setting quality and safety standards for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells

Law No. 91 of 1 April 1999 (G.U. No. 87, 15.4.99)

Provisions on organ and tissue removal and transplantation