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
(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 points (b) to (g) 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.
(3) 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), certain recommendations of the Council of Europe, the opinion of the Scientific Committee for Medicinal Products and Medical Devices, 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 and recommendations of the World Health Organisation (WHO), as well as international experience in this field.
(4) Blood and blood components imported from third countries, including those used as starting material/raw material for the manufacture of medicinal products derived from human blood and human plasma, should meet the quality and safety requirements set out in this Directive.
(5) With regard to blood and blood components collected for the sole purpose of, and exclusive use in, autologous transfusion (autologous donation), specific technical requirements should be laid down, as required by Article 2(2) of Directive 2002/98/EC. Such donations should be clearly identified and kept separate from other donations to ensure that they are not used for transfusion to other patients.
(6) It is necessary to determine common definitions for technical terminology in order to ensure the consistent implementation of Directive 2002/98/EC.
(7) The measures provided for in this Directive are in accordance with the opinion of the Committee set up by Directive 2002/98/EC,
Definitions
For the purposes of this Directive, the definitions set out in Annex I shall apply.
Provision of information to prospective donors
Member States shall ensure that blood establishments provide prospective donors of blood or blood components with the information set out in Part A of Annex II.
Information required from donors
Member States shall ensure that upon agreement of willingness to commence the donation of blood or blood components, donors provide the information set out in Part B of Annex II to the blood establishment.
Eligibility of donors
Blood establishments shall ensure that donors of whole blood and blood components comply with the eligibility criteria set out in Annex III.
Storage, transport and distribution conditions for blood and blood components
Blood establishments shall ensure that the storage, transport and distribution conditions for blood and blood components comply with the requirements set out in Annex IV.
Quality and safety requirements for blood and blood components
Blood establishments shall ensure that the quality and safety requirements for blood and blood components comply with the requirements set out in Annex V.
Autologous donations
1. Blood establishments shall ensure that autologous donations comply with the requirements set out in Directive 2002/98/EC and the specific requirements set out in this Directive.
2. Autologous donations shall be clearly identified as such and shall be kept separate from allogeneic donations.
Validation
Member States shall ensure that all testing and processes referred to in Annexes II to V are validated.
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 8 February 2005 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.
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Entry into force
This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.
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Addressees
This Directive is addressed to the Member States.