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  • 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. COM(2002) 319 final

Abstract

This proposal for a Directive reflects the recommendations made by the European Group on Ethics in Science and New Technologies (EGE) to the European Commission in its report of 1998. The proposal for a Directive on human tissues and cells aims to cover all human cells and tissues, which are used for application to the human body, during the first phases of the process - donation, procurement and testing - in order to ensure their quality and safety. The proposal, however, excludes blood and blood products (other than blood precursors), human organs, as well as organs, tissues, or cells of animal origin.

This Directive does not intend to cover research using human tissues and cells, such as when used for purposes other than application to the human body, i.e. in vitro research or in animal models. Only those cells and tissues that in clinical trials are applied to the human body should comply with the quality and safety standards laid down in this Directive.

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Record Number: 1827 / Last updated on: 2002-06-19
Category: COM DOCUMENT