Klíčové dokumenty

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)

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.

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.

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

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:

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:

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:

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:

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:

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.

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.

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

"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"

The hospital's and clinician's role in the optimal use of blood and blood products

The prevention of the possible transmission of variant Creutzfeldt-Jakob Disease (vCJD) by blood transfusion

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.

• Annex

Commission Staff Working Document

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

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

Action plan on Organ Donation and Transplantation (2009-2015): Strengthened Cooperation between Member States

Commission Decision establishing a model for agreements between the Commission and relevant organisations on the provision of product codes for use in the Single European Code.

• Annex: EN, FR, DE

Commission Directive (EU) 2015/565 amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells

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")

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

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 */

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 */

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)

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.

Commission Staff Working Document on the implementation of the principle of voluntary and unpaid donation for human tissues and cells.

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

(Year 2008)

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.

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.

Parliamentary questions - Written question E-1079/01