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Identification
Reference COD/2000/0323  
Title Public health and human blood: quality and safety of transfusion chain (amend. direct. 89/381/EEC)
Legal Basis EC 152-p4  
Dossier of the committee CODE/5/16690
Subject(s) 4.20.04.02 safety of blood and transfusion
Stage reached Procedure ended
Stages
Stages Documents: references Dates
Source reference Equivalent references Votes and amendments Joint resolution of document of publication in Official Journal
Commission/Council: initial legislative document Summaries EC COM(2000)0816 C5-0034/2001         13/12/2000 C 154 29.05.2001, p. 0141 E
EP: draft report by the committee responsible   EP PE304.662           29/05/2001  
Economic and Social Committee: opinion, report   ESC CES0717/2001           30/05/2001 C 221 07.08.2001, p. 0106
EP: decision of the committee responsible, 1st reading/single reading Summaries               11/07/2001  
EP: tabled legislative report, 1st reading or single reading   EP A5-0272/2001           11/07/2001  
EP: position, 1st reading or single reading Summaries EP T5-0443/2001           06/09/2001 C 072 21.03.2002, p. 0235-0289 E
Committee of the Regions: opinion   CofR CDR0066/2001           20/09/2001 C 019 22.01.2002, p. 0006
Commission: modified legislative proposal Summaries EC COM(2001)0692 C5-0686/2001         15/11/2001 C 075 26.03.2002, p. 0104 E
Council: common position Summaries CSL 14402/1/2001 C5-0069/2002         14/02/2002 C 113 14.05.2002, p. 0093 E
Commission: communication on the common position Summaries EC SEC(2002)0233           26/02/2002  
EP: decision of the committee responsible, 2nd reading Summaries               23/04/2002  
EP: tabled legislative report, 2nd reading   EP A5-0141/2002           23/04/2002  
EP: position, 2nd reading Summaries EP T5-0300/2002           12/06/2002 C 261 30.10.2003, p. 0150-0290 E
Commission: opinion on the EP position at second reading Summaries EC COM(2002)0479 C5-0391/2002         23/08/2002  
EP: tabled legislative report, 3rd reading   EP A5-0442/2002           26/09/2002  
EP/Council: Conciliation committee, results Summaries               02/10/2002  
EP/Council: joint text   CSL/EP 3652/2002 C5-0469/2002         04/11/2002  
EP: draft report by the delegation to the Conciliation Committee   EP PE287.615           06/12/2002  
EP: legislative resolution, 3rd reading Summaries EP T5-0618/2002           18/12/2002 C 031 05.02.2004, p. 0160-0176 E
Final legislative act Summaries EU 32002L0098           27/01/2003 L 033 08.02.2003, p. 0030-0040
  Follow-up documents
Agents
European Parliament
Committee
Rapporteur / Co-rapporteurs   Previous
Political group Appointed
EP Delegation to Conciliation Committee (responsible)
Nisticò Giuseppe
PPE-DE
26/08/2002
European Commission and Council of the Union
European Commission DG Health and Consumer Protection Transmission date: 16/01/2001
Council of the Union
  Previous Councils
  Agriculture and Fisheries meeting: 2476 of: 16/12/2002
Links to other sources
National parliaments IPEX
European Commission PreLex
 
27/01/2003 - Final legislative act
PURPOSE : to establish high standards of quality and safety for human blood and blood components.
COMMUNITY MEASURE : Directive 2002/98/EC 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.
CONTENTS : the safety requirements of proprietary industrially prepared medicinal products derived from human blood or plasma were ensured through Directive 2001/83/EC. The specific exclusion of whole blood, plasma and blood cells of human origin from that directive, however, has led to a situation whereby their quality and safety, in so far as they are intended for transfusion and not processed as such, are not subject to any binding Community legislation. This Directive, therefore, contains provisions to ensure that blood and its components are of comparable quality and safety throughout the blood transfusion chain in all Member States. It applies to the collection and testing of human blood and blood components, whatever their intended purpose, and to their processing, storage, and distribution when intended for transfusion. The main provisions of the Directive are as follows:
- Member States must designate the competent authority responsible for implementing the provisions of the Directive. Member States may introduce more stringent protective measures, including requirements for voluntary and unpaid donations;
- activities relating to collection and testing, preparation, storage and distribution must be undertaken only by the blood establishments which have been authorised by the competent authority;
- the competent authority must organise inspection and control measures at least every two years. Officials from the competent authority must be empowered to take samples and examine documents;
- blood establishments must designate a responsible person to ensure that every unit of blood or blood components has been collected, tested, processed, stored and distributed in compliance with the law. The responsible person must fulfil prescribed minimum conditions of qualification;
- each blood establishment must establish a quality system based on the principles of good practice. They must also maintain documentation on operational procedures, guidelines, training and reference manuals and reporting forms. Records of information must be kept for a minimum of 15 years;
- there are provisions to ensure that blood can be traced from donor to recipient and vice versa. Data needed for full traceability must be kept for at least 30 years;
- adverse events must be notified to the competent authority and blood associated with the event must be withdrawn;
- there must be evaluation procedures for all donors;
- a qualified health professional is responsible for examining donors and assessing eligibility;
- Member States must encourage voluntary and unpaid donations and report on the measures taken to do so two years after the Directive enters into force;
- donations must be tested in conformity with the Directive.
DATE OF TRANSPOSITION : 08/02/05.
ENTRY INTO FORCE : 08/02/03.
 
List of summaries
Summaries 19/06/2006 Commission/Council: follow-up document
Summaries 17/05/2006 Commission/Council: follow-up document
Summaries 30/09/2005 Implementing legislative act
Summaries 30/09/2005 Implementing legislative act
Summaries 22/03/2004 Implementing legislative act
Summaries 27/01/2003 Final legislative act
Summaries 18/12/2002 EP: legislative resolution, 3rd reading
Summaries 02/10/2002 EP/Council: Conciliation committee, results
Summaries 23/08/2002 Commission: opinion on the EP position at second reading
Summaries 12/06/2002 EP: position, 2nd reading
Summaries 23/04/2002 EP: decision of the committee responsible, 2nd reading
Summaries 26/02/2002 Commission: communication on the common position
Summaries 14/02/2002 Council: common position
Summaries 15/11/2001 Commission: modified legislative proposal
Summaries 06/09/2001 EP: position, 1st reading or single reading
Summaries 11/07/2001 EP: decision of the committee responsible, 1st reading/single reading
Summaries 13/12/2000 Commission/Council: initial legislative document
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