Directive 2005/62 - Implementation of Directive 2002/98/EC as regards Community standards and specifications relating to a quality system for blood establishments - Main contents
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official title
Commission Directive 2005/62/EC 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| Legal instrument | Directive |
|---|---|
| Number legal act | Directive 2005/62 |
| CELEX number i | 32005L0062 |
| Document | 30-09-2005 |
|---|---|
| Publication in Official Journal | 18-10-2006; OJ L 256, 1.10.2005,OJ L 287M , 18.10.2006,Special edition in Bulgarian: Chapter 15 Volume 015,Special edition in Romanian: Chapter 15 Volume 015,Special edition in Croatian: Chapter 15 Volume 014 |
| Effect | 21-10-2005; Entry into force Date pub. + 20 See Art 4 |
| End of validity | 31-12-9999 |
| Transposition | 31-08-2006; At the latest See Art 3 |
1.10.2005 |
EN |
Official Journal of the European Union |
L 256/41 |
COMMISSION DIRECTIVE 2005/62/EC
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
(Text with EEA relevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
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 (1), and in particular point (h) of the second paragraph of Article 29 thereof,
Whereas:
(1) |
Directive 2002/98/EC lays down standards of quality and safety for the collection and testing of human blood and blood components, whatever their intended purpose, and for their processing, storage and distribution when intended for transfusion so as to ensure a high level of human health protection. |
(2) |
In order to prevent the transmission of diseases by blood and blood components and to ensure an equivalent level of quality and safety, Directive 2002/98/EC calls for the establishment of specific technical requirements including Community standards and specifications with regard to a quality system for blood establishments. |
(3) |
A quality system for blood establishments should embrace the principles of quality management, quality assurance, and continuous quality improvement, and should include personnel, premises and equipment, documentation, collection, testing and processing, storage and distribution, contract management, non-conformance and self-inspection, quality control, blood component recall, and external and internal auditing. |
(4) |
This Directive lays down those technical requirements, which take account of Council Recommendation 98/463/EC of 29 June 1998 on the suitability of blood and plasma donors and the screening of donated blood in the European Community (2), 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 (3), Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use (4), Commission Directive 2004/33/EC 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 (5), certain recommendations of the Council of Europe, the monographs of the European Pharmacopoeia, particularly in respect of blood or blood components as a starting material for the manufacture of proprietary medicinal products, recommendations of the World Health Organisation, as well as international experience in this field. |
(5) |
In order to ensure the highest quality and safety for blood and blood components, guidance on good practice should be developed to support the quality system requirements for blood establishments taking fully into account the detailed guidelines referred to in Article 47 of Directive 2001/83/EC so as to ensure that the standards required for medicinal products are maintained. |
(6) |
Blood and blood components imported from third countries, including those used as starting material or raw material for the manufacture of medicinal products derived from human blood and human plasma intended for distribution in the Community, should meet equivalent Community standards and specifications relating to a quality system for blood establishments as set out in this... |
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