Guidare la sanità pubblica nell'UE
Promuovere la buona salute
Substances of human origin
Valutazione del rischio
Endocrine disruptors
Biocides
Documenti principali
Blood - Legislation and guidelines
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11 Ottobre 2019
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26 Luglio 2016
Commission Directive (EU) 2016/1214 of 25 July 2016 amending Directive 2005/62/EC as regards quality system standards and specifications for blood establishments (Text with EEA relevance)
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17 Dicembre 2014
amending Directive 2004/33/EC as regards temporary deferral criteria for donors of allogeneic blood donations
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06 Giugno 2012
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12 Aprile 2011
of 11 April 2011 amending Annex V to Directive 2004/33/EC with regards to maximum pH values for platelets concentrates at the end of the shelf life
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03 Novembre 2009
allowing temporary derogations to certain eligibility criteria for whole blood and blood components donors laid down in Annex III to Directive 2004/33/EC in the context of a risk of shortage caused by the Influenza A(H1N1) pandemic.
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01 Ottobre 2005
Having regard to 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
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01 Ottobre 2005
of 30 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.
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30 Marzo 2004
of 22 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.
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08 Febbraio 2003
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
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23 Agosto 2002
pursuant to Article 251 (2), third subparagraph, point (c) of the EC Treaty, on the European Parliament's amendments to the Council's Common Position regarding the proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL setting standards of quality and safety for the collection, testing, processing, storage, and distribution of human blood and blood components and amending
Council Directive 2001/83/EC - (COM(2002) 479 final) -
14 Maggio 2002
Common Position (EC) No 28/2002 of 14 February 2002 adopted by the Council, acting in accordance with the procedure referred to in Article 251 of the Treaty establishing the European Community, with a view to adopting a Directive of the European Parliament and of the Council 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. Official Journal C 113 E , 14/05/2002 P. 0093 - 0108:
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26 Marzo 2002
Amended proposal for a directive of the European Parliament and of the Council setting standards of quality and safety for the collection, testing, processing, storage, and distribution of human blood and blood components and amending Council Directive 89/381/EEC
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21 Febbraio 2002
Opinion of the Economic and Social Committee on the "Proposal for a Directive of the European Parliament and the Council amending Council Directive 93/42/EEC, as amended by Directive 2000/70/EC, as regards medical devices incorporating stable derivatives of human blood or human plasma". Official Journal C 048 , 21/02/2002 P. 0069 - 0069:
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28 Novembre 2001
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. Official Journal L 311, 28/11/2001 P. 0067 - 0128
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30 Ottobre 2001
Proposal for a Directive of the European Parliament and of the Council amending Council Directive 93/42/EEC, as amended by Directive 2000/70/EC, as regards medical devices incorporating stable derivates of human blood or human plasma/* COM/2001/0480 final - COD 2001/0186 */. Official Journal C 304 E, 30/10/2001 P. 0334 - 0334:
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06 Settembre 2001
European Parliament legislative resolution on the proposal for a European Parliament and Council directive setting standards of quality and safety for the collection, testing, processing, storage, and distribution of human blood and blood components and amending Council Directive 89/381/EEC (COM(2000) 816 - C5-0034/2001 - 2000/0323(COD))
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07 Agosto 2001
Opinion of the Economic and Social Committee on the "Proposal for a Directive of the European Parliament and of the Council setting standards of quality and safety for the collection, testing, processing, storage, and distribution of human blood and blood components and amending Council Directive 89/381/EEC". Official Journal C 221 , 07/08/2001 P. 0106 - 0109:
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13 Dicembre 2000
Proposal for a Directive of the European Parliament and of the Council setting standards of quality and safety for the collection, testing, processing, storage, and distribution of human blood and blood components and amending Council Directive 89/381/EEC
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13 Dicembre 2000
Directive 2000/70/EC of the European Parliament and of the Council of 16 November 2000 amending Council Directive 93/42/EEC as regards medical devices incorporating stable derivates of human blood or human plasma. Official Journal L 313 , 13/12/2000 P. 0022 - 0024:
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21 Luglio 1998
Council recommandation on the suitability of blood and plasma donors and the screening of donated blood in the European Community (98/463/EC). Official Journal L 203 , 21/07/1998 P. 0014 - 0026:
Blood - Reports on implementation
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05 Gennaio 2021
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05 Gennaio 2021
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10 Gennaio 2020
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08 Marzo 2019
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21 Febbraio 2019
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22 Maggio 2018
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12 Dicembre 2017
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11 Aprile 2017
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13 Ottobre 2016
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31 Maggio 2016
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26 Aprile 2016
Report from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on the implementation of the Directives 2002/98/EC, 2004/33/EC, 2005/61/EC and 2005/62/EC setting standards of quality and safety for human blood and blood components.
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26 Aprile 2016
Commission Staff Working Document on the implementation of the principle of voluntary and unpaid donation for human blood and blood components as foreseen in Directive 2002/98/EC on 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.
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26 Aprile 2016
Commission Staff Working Document on the application of Directive 2002/98/EC on 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 Accompanying the document.
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11 Novembre 2015
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11 Giugno 2015
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15 Luglio 2014
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13 Agosto 2013
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13 Agosto 2013
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23 Marzo 2011
Second Report from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on Voluntary and Unpaid Donation of Blood and Blood Components
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19 Gennaio 2010
Communication from the Commission to the Council, the European Parliament, the European Economic and Social Committee and the Committee of the Regions on the application of Directive 2002/98/EC 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
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15 Gennaio 2010
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12 Febbraio 2008
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16 Novembre 2006
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19 Giugno 2006
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17 Maggio 2006
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08 Dicembre 2005
Directive 2002/98/EC on the quality and safety of blood and blood components requires Member States to designate the competent authority or authorities responsible for implementing its requirements
Blood - Other key documents
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08 Ottobre 2019
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13 Dicembre 2017
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20 Aprile 2016
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08 Aprile 2015
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08 Aprile 2015
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01 Ottobre 2004
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01 Ottobre 2004
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16 Ottobre 2003
"The impact of arthropod borne diseases (including WNV) on the safety of blood used for transfusion as well as organs used for transplantation in the European Community"
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19 Giugno 2003
The introduction of pathogen inactivation procedures for blood components
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10 Ottobre 2002
The hospital's and clinician's role in the optimal use of blood and blood products
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21 Febbraio 2002
Parliamentary questions - Written question P-0590/02
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07 Marzo 2001
The prevention of the possible transmission of variant Creutzfeldt-Jakob Disease (vCJD) by blood transfusion
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29 Gennaio 2001
Parliamentary questions - Written question E-0096/01
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18 Settembre 1998
Organs - Legislation and guidelines
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21 Marzo 2016
Toolbox on Living Kidney Donation developed by the EU Working group on Living Donation under the EU Action Plan on Organ Donation and Transplantation, for National Authorities.
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10 Luglio 2015
Commission Decision on the adoption of a financing decision for 2015 for the pilot project "Platform for increasing organ donation in the European Union and neighbouring countries: EUDONORG 2015-2016.
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10 Luglio 2015
Commission Decision on the adoption of a financing decision for 2015 on the pilot project "The Effect of Differing Kidney Disease Treatment Modalities and Organ Donation and Transplantation Practices on Health Expenditure and Patient Outcomes.
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25 Aprile 2014
Commission Staff Working Document
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21 Dicembre 2012
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09 Ottobre 2012
Commission Implementing Directive 2012/25/EU of 9 October 2012 laying down information procedures for the exchange, between Member States, of human organs intended for transplantation
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06 Agosto 2010
Corrigendum to Directive 2010/45/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation (OJ L 207, 6.8.2010)
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07 Luglio 2010
Directive 2010/45/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation
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08 Dicembre 2008
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08 Dicembre 2008
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08 Dicembre 2008
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08 Dicembre 2008
Action plan on Organ Donation and Transplantation (2009-2015): Strengthened Cooperation between Member States
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01 Aprile 2008
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01 Novembre 2007
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01 Maggio 2007
Organ donation and transplantation: Policy actions at EU level
Organs - Reports on implementation
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04 Gennaio 2017
Report from the Commission to the European Parliament, the Council, The European Economic and Social Committee and the Committee of the Regions on the implementation of Directive 2010/53/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation.
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04 Gennaio 2017
Commission Staff Working Document on the implementation of Directive 2010/53/EU.
Accompanying the document "Report from the Commission to the European the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on the implementation of Directive 2010/53/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation
Organs - Other key documents
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23 Maggio 2018
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13 Dicembre 2017
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01 Novembre 2017
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30 Giugno 2013
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19 Novembre 2009
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01 Gennaio 2009
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27 Giugno 2006
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19 Maggio 2004
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01 Gennaio 2003
Tissues and cells - Legislation and guidelines
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11 Ottobre 2019
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07 Luglio 2015
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08 Aprile 2015
Commission Directive (EU) 2015/565 amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells
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08 Aprile 2015
Commission Directive (EU) 2015/566 implementing Directive 2004/23/EC as regards the procedures for verifying the equivalent standards of quality and safety of imported tissues and cells
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26 Novembre 2012
Commission Directive 2012/39/EU of 26 November 2012 amending Directive 2006/17/EC as regards certain technical requirements for the testing of human tissues and cells
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03 Agosto 2010
Commission Decision of 3 August 2010 establishing guidelines concerning the conditions of inspections and control measures, and on the training and qualification of officials, in the field of human tissues and cells provided for in Directive 2004/23/EC of the European Parliament and of the Council
Operational Manual for Competent Authorities on inspection of tissue and cell procurement and tissue establishments (translations available under "Tissues and cells - Other key documents") -
24 Ottobre 2006
implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells
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08 Febbraio 2006
implementing 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
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31 Marzo 2004
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
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05 Febbraio 2004
pursuant to Article 251 (2), third subparagraph, point (c) of the EC Treaty, on the European Parliament's amendments to the Council's common position regarding the proposal for a Directive of the European Parliament and of the Council on setting standards of quality and safety for the donation, procurement, testing, processing, storage, and distribution of human tissues and cells amending the proposal of the Commission pursuant to Article 250 (2) of the EC Treaty
/* COM/2004/0080 final - COD 2002/0128 */ -
16 Dicembre 2003
on the Council common position adopting a European Parliament and Council directive on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (10133/3/2003 - C5-0416/2003 - 2002/0128(COD))
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18 Agosto 2003
Communication from the Commission to the European Parliament pursuant to the second subparagraph of Article 251 (2) of the EC Treaty concerning the common position of the Council on the adoption of a Directive of the European Parliament and of the Council on setting standards of quality and safety for the donation, procurement, testing, processing, storage, and distribution of human tissues and cells /* SEC/2003/0906 final - COD 2002/0128 */
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22 Luglio 2003
adopted by the Council, acting in accordance with the procedure referred to in Article 251 of the Treaty establishing the European Community, with a view to adopting a directive of the European Parliament and of the Council on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells.
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28 Maggio 2003
Amended Proposal for a Directive of the European Parliament and of the Council on setting standards of quality and safety for the donation, procurement, testing, processing, storage, and distribution of human tissues and cells (presented by the Commission pursuant to Article 250 (2) of the EC Treaty)
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08 Aprile 2003
Opinion of the European Economic and Social Committee on the "Proposal for a Directive of the European Parliament and of the Council setting standards of quality and safety for the donation, procurement, testing, processing, storage, and distribution of human tissues and cells" (COM(2002) 319 final - 2002/0128 (COD)). Official Journal C 085 , 08/04/2003 P. 0044 - 0051
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19 Giugno 2002
Proposal for a Directive of the European Parliament and of the Council on setting standards of quality and safety for the donation, procurement, testing, processing, storage, and distribution of human tissues and cells /* COM/2002/0319 final - COD 2002/0128 */
Tissues and cells - Reports on implementation
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05 Gennaio 2021
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05 Gennaio 2021
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10 Gennaio 2020
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08 Marzo 2019
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21 Febbraio 2019
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22 Maggio 2018
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12 Dicembre 2017
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11 Aprile 2017
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12 Ottobre 2016
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31 Maggio 2016
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26 Aprile 2016
Report from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on the implementation of Directives 2004/23/EC, 2006/17/EC and 2006/86/EC setting standards of quality and safety for human tissues and cells.
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26 Aprile 2016
Commission Staff Working Document on the implementation of Directives 2004/23/EC, 2006/17/EC and 2006/86/EC on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells.
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26 Aprile 2016
Commission Staff Working Document on the implementation of the principle of voluntary and unpaid donation for human tissues and cells.
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15 Aprile 2016
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11 Novembre 2015
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22 Giugno 2015
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19 Agosto 2014
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18 Agosto 2014
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10 Settembre 2013
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17 Giugno 2013
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17 Giugno 2011
Second Report from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on Voluntary and Unpaid Donation of Tissues and Cells
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06 Gennaio 2010
Communication from the Commission to the Council, the European Parliament, the European Economic and Social Committee and the Committee of the Regions on the application 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
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01 Dicembre 2009
(Year 2008)
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04 Novembre 2008
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06 Febbraio 2007
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16 Ottobre 2006
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16 Ottobre 2006
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01 Febbraio 2006
Tissues and cells - Other key documents
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13 Dicembre 2017
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18 Luglio 2016
While tissues and cells are usually donated by citizens without any payment, they still require further processing before they can be applied as a therapy. This involves costs and different options to recover (part of) these costs. This study was therefore financed under the Health Programme to help increase understanding of these economic factors. Such understanding helps Member States to organize this essential and often public healthcare service at best.
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06 Luglio 2016
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01 Ottobre 2015
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18 Maggio 2015
The Operational Manual complements Commission Decision 2010/453/EU and aims to support EU Member States in implementing a series of regulatory tasks under Directives 2004/23/EC, 2006/17/EC, 2006/86/EC and 2015/566 with respect to inspection of tissue and cell procurement and tissue establishments.
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04 Marzo 2011
The Operational Manual complements Commission Decision 2010/453/EU and aims to support EU Member States in implementing a series of regulatory tasks under Directives 2004/23/EC, 2006/17/EC and 2006/86/EC with respect to inspection of tissue and cell procurement and tissue establishments.
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10 Dicembre 2010
The study, conducted by the ESHRE, maps the existing practice of assisted reproductive technologies (ART). It provides an overview of existing legislation and reimbursement policies as well as established practices and cross-border aspects of ART.
The study was funded by the Commission. However, the findings of the study reflect the work undertaken by ESHRE, and do not necessarily represent the Commission's official position.
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07 Marzo 2006
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16 Marzo 2004
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06 Aprile 2001
Parliamentary questions - Written question E-1079/01
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21 Luglio 1998
e-newsletter
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Pubblicazione21 Gennaio 2021
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Pubblicazione13 Gennaio 2021
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Pubblicazione14 Dicembre 2020