Consultation: Future proposal for a harmonised regulatory framework for human tissue engineering

Brussels, 07 Apr 2004

Stakeholder consultation on the future regulatory framework for human tissue engineered products

Please note the deadline for comments: 30th April 2004

Purpose of this consultation

At present, there is no uniform and comprehensive regulatory framework in the Community covering human tissue engineered products. The European Commission therefore announced in its action plan for 2004 that it would propose legislation harmonising the rules on the authorisation of such products.

This public consultation invites stakeholders to present their views on key aspects of the future proposal. For this purpose, a consultation document was prepared by DG Enterprise. It makes suggestions as regards the key issues to be addressed in future legislation, as well as the structure and main requirements of the authorisation procedure.

Consultation Document

"Proposal for a harmonised regulatory framework on human tissue engineered products – DG Enterprise consultation paper"

Please note that this consultation does not prejudge the final form of any decision taken by the Commission. The consultation is subject to

data privacy rules

A privacy policy statement

specifies how your data will be used.

What you should know about this consultation

Whose opinions do we primarly want?

- Business associations at the European, national or regional level;

- Enterprises;

- Public administrations;

- Patient and health associations, other organisations active or interested in the field of tissue engineering;

- Hospitals, tissue banks, medical specialists, researchers, academics and other experts;

- Actors in the field of social and health insurance.

Comments and suggestions from any other parties interested in tissue engineering are also very welcome.

How do you respond?

By sending reactions that follow the structure of the consultation document. Comments should preferably be sent by e-mail to entr-human-tissue@cec.eu.int. You can also send a fax to: (+ 32) 2 296.64.67.

How long is the consultation open?

The consultation will be open until 30 April 2004.

What will happen after the consultation closes?

The Commission services will publish the comments received, a report about the results of the consultation and how the responses have been taken into account.

This information will be accessible via the consultation pages:

Your Voice in Europe

Consultations website of the Enterprise DG

For further information, please contact:

European Commission
Enterprise Directorate-General
Unit F3 - Biotechnology, Competitiveness in pharmaceuticals, cosmetics
B - 1049 Brussels

mailto: entr-human-tissue@cec.eu.int

Fax: +32 2 296.64.67

Enterprise DG
http://europa.eu.int/comm/enterprise/ind ex_en.htm
Item source: http://pharmacos.eudra.org/F3/human-tiss ue/Doc1.htm