Ochrana verejného zdravia v EÚ
Starostlivosť o zdravie
Substances of human origin
Hodnotenie rizika
Endocrine disruptors
Biocides
Kľúčové dokumenty
Blood - Legislation and guidelines
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11 Október 2019
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26 Júl 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 December 2014
amending Directive 2004/33/EC as regards temporary deferral criteria for donors of allogeneic blood donations
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06 Jún 2012
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12 Apríl 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 November 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 Október 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 Október 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 Marec 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 Február 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 August 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 Máj 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 Marec 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 Február 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 November 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 Október 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 September 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 August 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 December 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 December 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 Júl 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 Január 2021
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05 Január 2021
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10 Január 2020
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08 Marec 2019
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21 Február 2019
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22 Máj 2018
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12 December 2017
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11 Apríl 2017
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13 Október 2016
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31 Máj 2016
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26 Apríl 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 Apríl 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 Apríl 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 November 2015
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11 Jún 2015
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15 Júl 2014
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13 August 2013
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13 August 2013
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23 Marec 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 Január 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 Január 2010
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12 Február 2008
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16 November 2006
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19 Jún 2006
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17 Máj 2006
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08 December 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 Október 2019
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13 December 2017
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20 Apríl 2016
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08 Apríl 2015
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08 Apríl 2015
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01 Október 2004
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01 Október 2004
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16 Október 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 Jún 2003
The introduction of pathogen inactivation procedures for blood components
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10 Október 2002
The hospital's and clinician's role in the optimal use of blood and blood products
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21 Február 2002
Parliamentary questions - Written question P-0590/02
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07 Marec 2001
The prevention of the possible transmission of variant Creutzfeldt-Jakob Disease (vCJD) by blood transfusion
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29 Január 2001
Parliamentary questions - Written question E-0096/01
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18 September 1998
Organs - Legislation and guidelines
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21 Marec 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 Júl 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 Júl 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 Apríl 2014
Commission Staff Working Document
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21 December 2012
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09 Október 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 August 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 Júl 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 December 2008
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08 December 2008
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08 December 2008
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08 December 2008
Action plan on Organ Donation and Transplantation (2009-2015): Strengthened Cooperation between Member States
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01 Apríl 2008
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01 November 2007
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01 Máj 2007
Organ donation and transplantation: Policy actions at EU level
Organs - Reports on implementation
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04 Január 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 Január 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 Máj 2018
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13 December 2017
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01 November 2017
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30 Jún 2013
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19 November 2009
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01 Január 2009
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27 Jún 2006
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19 Máj 2004
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01 Január 2003
Tissues and cells - Legislation and guidelines
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11 Október 2019
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07 Júl 2015
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08 Apríl 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 Apríl 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 November 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 August 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 Október 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 Február 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 Marec 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 Február 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 December 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 August 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 Júl 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 Máj 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 Apríl 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 Jún 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 Január 2021
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05 Január 2021
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10 Január 2020
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08 Marec 2019
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21 Február 2019
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22 Máj 2018
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12 December 2017
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11 Apríl 2017
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12 Október 2016
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31 Máj 2016
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26 Apríl 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 Apríl 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 Apríl 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 Apríl 2016
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11 November 2015
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22 Jún 2015
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19 August 2014
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18 August 2014
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10 September 2013
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17 Jún 2013
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17 Jún 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 Január 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 December 2009
(Year 2008)
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04 November 2008
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06 Február 2007
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16 Október 2006
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16 Október 2006
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01 Február 2006
Tissues and cells - Other key documents
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13 December 2017
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18 Júl 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 Júl 2016
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01 Október 2015
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18 Máj 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 Marec 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 December 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 Marec 2006
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16 Marec 2004
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06 Apríl 2001
Parliamentary questions - Written question E-1079/01
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21 Júl 1998
elektronický spravodajca
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Publikované10 Marec 2021
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Publikované21 Január 2021