European Laws and regulations
| Title | Link |
|---|---|
| Commission Regulation (EC) No 240/96 of 31 January 1996 on the application of Article 85 (3) of the Treaty to certain categories of technology transfer agreements | http://europa.eu.int/eur-lex/en/lif/dat/1996/en_396R0240.html |
| EU - Directive 2001/20/EC relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use | http://www.efgcp.org/webdocs/guidelines_for_retention.pdf |
| Council Directive 93/42/EEC of 14 June 1993 concerning medical devices | http://europa.eu.int/eur-lex/en/lif/dat/1993/en_393L0042.html |
| Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices | http://europa.eu.int/eur-lex/en/lif/dat/1990/en_390L0385.html |
| Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use | http://www.eortc.be/Services/Doc/clinical-EU-directive-04-April-01.pdf |
| Council Directive - of 24 November 1986 - 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 | http://europa.eu.int/comm/food/fs/aw/aw_legislation/scientific/86-609-eec_en.pdf |
| Council Directive of 7June 1988 on the inspection and verification of Good Laboratory Practice (GLP) (88/320/EEC) | http://europa.eu.int/eur-lex/en/consleg/pdf/1988/en_1988L0320_do_001.pdf |
| List of directives and regulations of the European Union regarding proprietary medicinal products | http://europa.eu.int/eur-lex/en/lif/reg/en_register_1530.html |
| Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products | http://europa.eu.int/eur-lex/en/lif/dat/1965/en_3 |
| Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products | http://europa.eu.int/eur-lex/en/lif/dat/1975/en_3 |
| Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products | http://europa.eu.int/eur-lex/en/lif/dat/1975/en_3 |
| Council Directive 78/25/EEC of 12 December 1977 on the approximation of the laws of the Member States relating to the colouring matters which may be added to medicinal products | http://europa.eu.int/eur-lex/en/lif/dat/1978/en_3 |
| Council Directive 89/342/EEC of 3 May 1989 extending the scope of Directives 65/65/EEC and 75/319/EEC and laying down additional provisions for immunological medicinal products consisting of vaccines, toxins or serums and allergens | http://europa.eu.int/eur-lex/en/lif/dat/1989/en_3 |
| Directive 2001/20/EC 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 | http://europa.eu.int/eur-lex/en/lif/dat/2001/en_3 |
| Commission Regulation (EC) No 2141/96 of 7 November 1996 concerning the examination of an application for the transfer of a marketing authorization for a medicinal product falling within the scope of Council Regulation (EC) No 2309/93 | http://europa.eu.int/eur-lex/en/lif/dat/1996/en_3 |
| The rules governing medicinal products in the European Union - Pharmaceutical legislation- Medicinal products for human use- Volume I -1998 - (294 pages) | http://pharmacos.eudra.org/F2/eudralex/download/volpdf/vol1/vol1en.pdf |
| Notice to Applicants Volume 2A - Procedures for marketing autorisation | http://pharmacos.eudra.org/F2/eudralex/download/volpdf/vol2/vol2aen.pdf |
| Notice to Applicants - Volume 2B - Medicinal products for human use - Presentation and content of the dossier - 1998 - (206 pages) | http://pharmacos.eudra.org/F2/eudralex/download/volpdf/vol2/vol2ben.pdf |
| Guidelines - Volume 3A - Medicinal products for human use - Quality and biotechnology - 1998 - (417 pages) | http://pharmacos.eudra.org/F2/eudralex/download/volpdf/vol3/vol3aen.pdf |
| Guidelines - Volume 3B - Medicinal products for human use - Safety, environment and information - 1998 - (240 pages) | http://pharmacos.eudra.org/F2/eudralex/download/volpdf/vol3/Vol3ben.pdf |
| Guidelines - Volume 3C - Medicinal products for human use - Efficacy - 1998 - (402 pages) | http://pharmacos.eudra.org/F2/eudralex/download/volpdf/vol3/Vol3cen.pdf |
| Volume 4 - Good manufacturing practices - Medicinal products for human and veterinary use - (153 pages) | http://pharmacos.eudra.org/F2/eudralex/download/volpdf/vol4/vol4en.pdf |
| European Commission - Revision of Annex 14 to the EU Guide to Good Manufacturing Practice - Manufacture of medicinal products1 derived from human blood or human plasma - (7 pages) | http://pharmacos.eudra.org/F2/eudralex/vol-4/pdfs-en/gmpan14_en.pdf |
| EEC Council: Regulation No 17: First Regulation implementing Articles 85 and 86 of the Treaty | http://europa.eu.int/eur-lex/en/lif/dat/1962/en_362R0017.html |
| Regulation No 19/65/EEC of 2 March of the Council on application of Article 85 (3) of the Treaty to certain categories of agreements and concerted practices | http://europa.eu.int/eur-lex/en/lif/dat/1965/en_365R0019.html |
| Regulation (EEC) No 2821/71 of the Council of 20 December 1971 on application of Article 85 (3) of the Treaty to categories of agreements, decisions and concerted practices | http://europa.eu.int/eur-lex/en/lif/dat/1971/en_371R2821.html |
| Commission Regulation (EC) No 2790/1999 of 22 December 1999 on the application of Article 81(3) of the Treaty to categories of vertical agreements and concerted practices | http://europa.eu.int/eur-lex/en/lif/dat/1999/en_399R2790.html |
| Commission Regulation (EC) No 2659/2000 of 29 November 2000 on the application of Article 81(3) of the Treaty to categories of research and development agreements (Text with EEA relevance) | http://europa.eu.int/eur-lex/en/lif/dat/2000/en_300R2659.html |
| Community legislation in force on Foodstuffs | http://europa.eu.int/eur-lex/en/lif/reg/en_register_133014.html |
| Community legislation in force on cosmetics | http://europa.eu.int/eur-lex/en/lif/reg/en_register_133016.html |
| Community legislation in force on health protection | http://europa.eu.int/eur-lex/en/lif/reg/en_register_1530.html |
| Proposal for a Directive of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to the advertising and sponsorship of tobacco products - May 30, 2001 | http://europa.eu.int/comm/health/ph/programmes/tobacco/comm283_en.pdf |
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Last updated: July 7, 2002