Commission Opinion on the Amendments to the Common Position for the Directive on setting standards of quality and safety for the donation, procurement, testing, processing, storage, and distribution o

February 11, 2004

Brussels, 10 Feb 2004

OPINION OF THE COMMISSION
pursuant to Article 251 (2), third subparagraph, point (c) of the EC Treaty, on the European Parliament's amendments to the Council's common position regarding the proposal for a
DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
on setting standards of quality and safety for the donation, procurement, testing, processing, storage, and distribution of human tissues and cells
AMENDING THE PROPOSAL OF THE COMMISSION
Full Text

INTRODUCTION

Article 251(2), third subparagraph, point (c) of the EC Treaty provides that the Commission is to deliver an opinion on the amendments proposed by the European Parliament at second reading. The Commission sets out its opinion below on the amendments proposed by Parliament.

2. BACKGROUND

Date of transmission of the proposal1 to the European Parliament and the Council (2002/0128(COD)) 20.06.2002

Date of the opinion of the European Economic and Social Committee2 11.12.2002 Date of the opinion of the European Parliament3, first reading: 10.04.2003

Date of transmission of the amended proposal (10122/03 SAN 130 CODEC 779). 30.05.2003

Date of adoption of the common position4: 22.07.2003

Adoption by Parliament of the Resolution, second reading: 16.12.2003

3. PURPOSE OF THE PROPOSAL

The aims of this proposal are to establish European Community legislation setting standards for the quality and safety of tissues and cells of human origin used for application in the human body, in particular to strengthen suitability and screening of donors, and establish requirements for establishments and their accreditation.

The text also provides a mechanism for lay down provisions for a register of accredited establishments, quality system, training, traceability and regulation of imports and exports.

4. OPINION OF THE COMMISSION ON THE AMENDMENTS BY THE EUROPEAN

Brussels, 5.2.2004 COM(2004) 80 final 2002/0128 (COD)

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