Since 2002, and particularly in the three-year period 2005-2007, more laws regulating transfusion and associated activities, have been introduced than ever before.
The regulatory scenario that has emerged is therefore very complex in terms of the relationship between European and national regulations, in particular because of the need to harmonise the acts transposing European directives into existing national law.
Directive 2002/98/EC of the European Parliament and of the Council of 27th January 2003
European Directive
Directive 2002/98/EC of the European Parliament and of the Council of 27th 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”.
National Transposition Law
“Harmonised” National Laws
European Commission Directive 2004/33/EC of 22nd March 2004
European Directive
European Commission Directive 2004/33/EC of 22nd March 2004 “implementing Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components”.
National Transposition Law
“Harmonised” National Laws
Law no. 219 of 21st October 2005 “New regulations on blood transfusion activities and national production of blood derivatives”
European Commission Directive 2005/61/EC of 30th September 2005
European Directive
European Commission Directive 2005/61/EC of 30th September 2005 “implementing Directive 2002/98/EC of the European Parliament and of the Council as regards traceability requirements and notification of serious adverse effects and events”.
National Transposition Law
Legislative Decree Nov. 9, 2007, no. 207 “Implementation of Directive 2005/61/EC implementing Directive 2002/98/EC as regards requirements for traceability of blood and blood components intended for transfusion and notification of serious adverse effects and incidents”.
“Harmonised” National Laws
Legislative Decree Dec. 20, 2007, no. 261 “Revision of Legislative Decree No. 191 of 19 August 2005, implementing Directive 2002/98/EC setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components”.
European Commission Directive 2005/62/EC of 30th September 2005
European Directive
European Commission Directive 2005/62/EC of 30th September 2005 “implementing Directive 2002/98/EC of the European Parliament and of the Council as regards Community standards and specifications relating to a quality system for blood establishments”.
National Transposition Law
Legislative Decree No 208 of 9th November 2007 “implementing Directive 2002/98/EC of the European Parliament and of the Council as regards Community standards and specifications relating to a quality system for blood establishments”.
“Harmonised” National Laws
Directive 2004/23/EC of the European Parliament and of the Council of 31st March 2004
European Directive
Directive 2004/23/EC of the European Parliament and of the Council of 31st March 2004 “on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells”.
National Transposition Law
Agreement of 10th July 2003. Agreement between the Minister of Health, the Regions and the Autonomous Provinces of Trento and Bolzano on the document entitled: “Guidelines on the collection, handling and clinical use of haematopoietic stem cells (HSCs)”.
“Harmonised” National Laws
Legislative Decree No. 191 of 6th November 2007 191 “Implementation of 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”.