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  • [Amended Proposal for a Directive [...] on setting standards of quality and safety for the donation, procurement, testing, processing, storage, and distribution of human tissues and cells. COM(2003) 340 final]


This proposal attempts to close the existing gap in Community legislation related to ensuring a high level of quality and safety of human tissues and cells and takes fully into account existing provisions in these areas. It seeks to ensure a comparable level of quality and safety of human tissues and cells in all Member States, bearing in mind the freedom of movement of citizens within Community territory.

The Commission has made a number of amendments to its original proposal, which was published as (COM{2002} 319). Reflecting the key concerns of the European Parliament, the main amendments to the original proposal cover areas such as: ethical provisions, the scope of the directive, accreditation, import and export, anonymity and traceability, and establishment of technical standards.

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Record Number: 4967 / Last updated on: 2003-06-12
Category: comDocument