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            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:

HAS ADOPTED THIS DIRECTIVE:

Article 1

Definitions

For the purposes of this Directive, the following definitions shall apply:

Article 2

Quality system standards and specifications

1.   Member States shall ensure that the quality system in place in all blood establishments complies with the Community standards and specifications set out in the Annex to this Directive.

2.   Good practice guidelines shall be developed by the Commission, in accordance with Article 28 of Directive 2002/98/EC, for the interpretation of the Community standards and specifications referred to in paragraph 1. When developing these guidelines, the Commission shall take fully into account the detailed principles and guidelines of good manufacturing practice, as referred to in Article 47 of Directive 2001/83/EC.

3.   Member States shall ensure that for blood and blood components imported from third countries and intended for use or distribution in the Community, there is a quality system for blood establishments in the stages preceding importation equivalent to the quality system provided for in Article 2.

Article 3

Transposition

1.   Without prejudice to Article 7 of Directive 2002/98/EC, Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 August 2006 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.

When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Article 4

Entry into force

This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

Article 5

Addressees

This Directive is addressed to the Member States.

Done at Brussels, 30 September 2005.

For the Commission

Markos KYPRIANOU            

Member of the Commission

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(1)OJ L 33, 8.2.2003, p. 30.

(2)OJ L 203, 21.7.1998, p. 14.

(3)OJ L 311, 28.11.2001, p. 67. Directive as last amended by Directive 2004/27/EC (OJ L 136, 30.4.2004, p. 34).

(4)OJ L 262, 14.10.2003, p. 22.

(5)OJ L 91, 30.3.2004, p. 25.

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ANNEX

Quality system standards and specifications

1.   INTRODUCTION AND GENERAL PRINCIPLES

1.1.   Quality system

1.2.   Quality assurance

2.   PERSONNEL AND ORGANISATION

3.   PREMISES

3.1.   General

Premises including mobile sites shall be adapted and maintained to suit the activities to be carried out. They shall enable the work to proceed in a logical sequence so as to minimise the risk of errors, and shall allow for effective cleaning and maintenance in order to minimise the risk of contamination.

3.2.   Blood donor area

There shall be an area for confidential personal interviews with and assessment of individuals to assess their eligibility to donate. This area shall be separated from all processing areas.

3.3.   Blood collection area

Blood collection shall be carried out in an area intended for the safe withdrawal of blood from donors, appropriately equipped for the initial treatment of donors experiencing adverse reactions or injuries from events associated with blood donation, and organised in such a way as to ensure the safety of both donors and personnel as well as to avoid errors in the collection procedure.

3.4.   Blood testing and processing areas

There shall be a dedicated laboratory area for testing that is separate from the blood donor and blood component processing area with access restricted to authorised personnel.

3.5.   Storage area

3.6.   Waste disposal area

An area shall be designated for the safe disposal of waste, disposable items used during the collection, testing, and processing and for rejected blood or blood components.

4.   EQUIPMENT AND MATERIALS

5.   DOCUMENTATION

6.   BLOOD COLLECTION, TESTING AND PROCESSING

6.1.   Donor eligibility

6.2.   Collection of blood and blood components

6.3.   Laboratory testing

6.4.   Processing and validation

6.5.   Labelling

6.6.   Release of blood and blood components

7.   STORAGE AND DISTRIBUTION

8.   CONTRACT MANAGEMENT

Tasks that are performed externally shall be defined in a specific written contract.

9.   NON-CONFORMANCE

9.1.   Deviations

Blood components deviating from required standards set out in Annex V to Directive 2004/33/EC shall be released for transfusion only in exceptional circumstances and with the recorded agreement of the prescribing physician and the blood establishment physician.

9.2.   Complaints

All complaints and other information, including serious adverse reactions and serious adverse events, which may suggest that defective blood components have been issued, shall be documented, carefully investigated for causative factors of the defect and, where necessary, followed by recall and the implementation of corrective actions to prevent recurrence. Procedures shall be in place to ensure that the competent authorities are notified as appropriate of serious adverse reactions or serious adverse events in accordance with regulatory requirements.

9.3.   Recall

9.4.   Corrective and preventive actions

10.   SELF-INSPECTION, AUDITS AND IMPROVEMENTS

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(1)OJ L 183, 29.6.1989, p. 1.

(2)OJ L 262, 17.10.2000, p. 21.

(3)OJ L 169, 12.7.1993, p. 1. Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).

(4)OJ L 331, 7.12.1998, p. 1. Directive as amended by Regulation (EC) No 1882/2003.

(5)  See page 32 of this Official Journal.

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