Open Consultation on Draft Technical Requirements for Blood and Blood Components

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 Council Directive 2001/83/EC, was adopted in December 2002. This text entered into force on 8 February 2003, the date of its publication in the Official Journal of the European Communities. The Directive empowers the Commission to establish and update technical requirements in relation to quality and safety of blood.

In anticipation of its responsibilities under this Directive, the Commission conducted an open consultation on the draft technical requirements that were drawn up with the assistance of the Council of Europe.

Comments on these requirements were to be submitted in electronic form by 21 March 2003.

The responses are presented in three different files: File 1 presents the list of respondents and general comments; File 2 presents comments on the proposed technical Annexes for inclusion in the draft Commission Directive; and File 3 presents responses to the labelling and testing requirements that may replace the existing Annexes III and IV of Directive 2002/98/EC should it be considered necessary.

Technical requirements

The technical requirements were presented in two different files.
File 1 presented the proposed technical Annexes for inclusion in the draft Commission Directive.
File 2 presented labelling and testing requirements that may replace the existing Annexes III and IV of Directive 2002/98/EC should it be considered necessary.

In addition, a text of the Draft Commission Directive establishing the above requirements was also provided.

Documents on the Response

List of respondents and general comments

• List of respondents
• General comments

Responses to Annexex I-IV

• Responses on annex I
• Responses on annex II
• Responses on annex III
• Responses on annex IV

Responses to Annexes A and B

• Responses on annex A
• Responses on annex B

Note: The contents of these files do not necessarily represent the Commission's views and is in no way an indication of the Commission's future position in this area.

Neither the Commission nor any person acting on its behalf can be held responsible for any use that may be made of the information compiled in these Responses to the Open Consultation.

Permission to include these comments has been given by those concerned.