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Summary of the main regulatory developments in xenotransplantation by country:
Australia
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Proposal for a Directive of the European Parliament and of the Council on the protection of animals used for scientific purposes {SEC(2008) 2410} {SEC(2008) 2411}/* COM/2008/0543 final - COD 2008/0211 */

Directive 86/609/CEE of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes

Council Directive 90/219/EEC of 23 April 1990 on the contained use of genetically modified micro-organisms

Resolution on the interpretation of certain provisions and terms of the Convention (adopted by Multilateral Consultation on 27 November 1992)

Resolution on education and training of persons working with laboratory animals (adopted by the Multilateral Consultation on 3 December 1993)

Resolution on the accommodation and care of laboratory animals (adopted by the Multilateral Consultation on 30 May 1997)

Resolution on the acquisition and transport of laboratory animals (adopted by the Multilateral Consultation on 30 May 1997)

Recommendation No (97) 15, on xenotransplantation, of 30 September 1997

Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions

Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions

Council Directive 98/81/EC of 26 October 1998 amending Directive 90/219/EEC on the contained use of genetically modified micro-organisms

Recommendation 1399 (1999) on xenotransplantation, of 29 January 1999

Directive 2000/54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work (seventh individual directive within the meaning of Article 16(1) of Directive 89/391/EEC)

Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC

Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use

Recommendation Rec (2003)10 of the Committee of Ministers to Member States on xenotransplantation of 19 June 2003

Regulation (EC) No 1946/2003 of the European Parliament and of the Council of 15 July 2003 on transboundary movements of genetically modified organisms

Directive 2003/65/EC of the European Parliament and of the Council of 22 July 2003 amending Council Directive 86/609/EEC on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes

Commission Directive 2003/94/EC, of 8 October 2003, laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use Replacement of Commission Directive 91/356/EC of 13 June 1991 to cover good manufacturing practice of investigational medicinal products.

Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells

Opinion of the European Economic and Social Committee on the Communication from the Commission on the European Parliament and the Council on a Community Action Plan on the Protection and Welfare Animals (2006/C 234/08)

Communication from the Commission to the European Parliament and the Council on a Community Action Plan on the Protection and Welfare of Animals 2006-2010 (COM/2006/0013)

European Parliament resolution on a Community Action Plan on the Protection and Welfare of Animals 2006-2010 (2006/2046(INI))

Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (Text with EEA relevance)

Public call for expressions of interest as Commission appointees to the European Medicines Agency Committee for Advanced Therapies, Brussels, 9/1/2008, ENTR NR D (2007)