|
|
|
|
|
|
|
|
|
|
| - Directives and Regulations | |||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
- Legend |
|
|
|
|
- word document |
|
|
|
|
- attachment |
|
|
|
|
- modified or completed document |
|
|
|
|
- repealed document |
|
|
|
- Directives |
download |
|
|
- Directive 2008/29/EC of the European Parliament and of the Council of 11 March 2008 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the implementing powers conferred on the Commission |
|
|
|
- Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (Consolidated version : 30/12/2008). |
|
|
|
- Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use |
|
|
|
- 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 |
|
|
|
- Commission Directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use |
|
|
|
- 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 |
|
|
|
- Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use |
|
|
|
- Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use |
|
|
|
- Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products |
|
|
|
- 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 |
|
|
|
- Regulations |
download |
|
|
- Commission Regulation (EC) No. 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products |
|
|
|
- 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 |
|
|
|
- Commission Regulation (EC) No. 658/2007 of 14 June 2007 concerning financial penalties for infringement of certain obligations in connection with marketing authorisations granted under Regulation (EC) No. 726/2004 of the European Parliament and of the Council |
|
|
|
- Regulation (EC) No. 1902/2006 of the European Parliament and of the Council of 20 December 2006 amending Regulation 1901/2006 on medicinal products for paediatric use |
|
|
|
- Regulation (EC) No. 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No. 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No. 726/2004 |
|
|
|
- Regulation (EC) No. 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing an European Medicines Agency |
|
|
|
- Commission Regulation (EC) No. 1085/2003 of 3 June 2003 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products falling within the scope of Council Regulation (EEC) No. 2309/93 |
|
|
|
- Commission Regulation (EC) No. 1084/2003 of 3 June 2003 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products granted by a competent authority of a Member State |
|
|
|
- Commission Regulation (EC) No. 847/2000 of 27 April 2000 laying down the provisions for implementation of the criteria for designation of a medicinal product as an orphan medicinal product and definitions of the concepts ‘similar medicinal product’ and‘clinical superiority’ |
|
|
|
- Regulation (EC) No. 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products |
|
|
|
- Commission Regulation (EC) No. 2141/96 of 7 November 1996 concerning the examination of an application for the transfer of a marketing authorisation for a medicinal product falling within the scope of Council Regulation (EC) No. 2309/93 |
|
|
|
- Commission Regulation (EC) No. 1662/95 of 7 July 1995 laying down certain detailed arrangements for implementing the Community decision-making procedures in respect of marketing authorisations for products for human or veterinary use |
|
|
|
- Commission Regulation (EC) No. 540/95 of 10 March 1995 laying down the arrangements for reporting suspected unexpected adverse reactions which are Not serious, whether arising in the Community or in a third country, to medicinal products for human or veterinary use authorised in accordance with the provisions of Council Regulation (EEC) No. 2309/93 |
|
|
|
- Miscellaneous |
download |
|
|
- Guideline on the definition of a potential serious risk to public health in the context of Article 29(1) and (2) of Directive 2001/83/EC - March 2006 |
|
|
|
- Commission Communication on parallel imports of proprietary medicinal products for which marketing authorisations have already been granted - Dec 2003 |
|
|
|
- Commission Communication on parallel imports of proprietary medicinal products for which marketing authorisations have already been granted - 1982 |
|
