EudraLex - Volume 1 - Pharmaceutical Legislation
Medicinal Products for Human Use
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Volume 1 of the publications "The rules governing medicinal products in the European Union" compiles the body of European Union legislation in the pharmaceutical sector for medicinal products for human use.
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On this page :
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Directives
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2001/83/EC |
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 (Consolided version : 21/07/2011). |
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| 2012/26/EU |
Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012
amending Directive 2001/83/EC as regards pharmacovigilance (Text with EEA relevance) (OJ L 299, 27.10.2012, p. 1–4) |
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| 2011/62/EC |
Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011
amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products. |
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| 2010/84/EC |
Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use. (Official Journal L 348, 31/12/2010, p.†74 - 99).
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| Corrigendum |
Corrigendum (Official Journal L 21, 25/1/2011 p. 8).
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| 2009/53/EC |
Directive 2009/53/EC of the European Parliament and of the Council of 18 June 2009 amending Directive 2001/82/EC and Directive 2001/83/EC, as regards variations to the terms of marketing authorisations for medicinal products. (Official Journal L 168, 30/6/2009, p. 33 - 34). |
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| Corrigendum |
Corrigendum to Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use ( OJ L 348, 31.12.2010) |
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2002/98/EC
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Amended by Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC (Official Journal L 33, 8/2/2003 p. 30 - 40).
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Corrigendum (Official Journal L 230, 24/8/2006 p. 12 PL).
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2003/63/EC
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Amended by 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 (Official Journal L 159, 27/6/2003 p. 46 - 94).
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Corrigendum (Official Journal L 302, 20/11/2003 p. 40 DE).
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2004/24/EC
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Amended by 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 (Official Journal L 136, 30/4/2004, p. 85 - 90).
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2004/27/EC
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Amended by 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 (Official Journal L 136, 30/4/2004 p. 34 - 57).
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2008/29/EC
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Amended by 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 (Official Journal L 81, 20/3/2008, p. 51 - 52 ).
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2009/120/EC
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Amended by Commission Directive 2009/120/EC of 14 September 2009 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use as regards advanced therapy medicinal products (Official Journal L 242 15/9/2009, p. 3 - 12).
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| 2001/20/EC |
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 (Official Journal L 121, 1/5/2001 p. 34 - 44). |
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Corrigendum (Official Journal L 300, 5/11/2002 p. 58 - 58 NL). |
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| 2003/94/EC |
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 (Official Journal L 262, 14/10/2003 p. 22 - 26). |
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| 2005/28/EC |
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 (Official Journal L 91, 9/4/2005 p. 13 - 19 ). |
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| 89/105/EEC |
Council Directive 89/105/EEC, of 21 December 1988, relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion within the scope of national health insurance systems (Official Journal L 40, 11/2/1989 p. 8 - 11; Finnish special edition: Chapter 15 Volume 9 p. 45; Swedish special edition: Chapter 15 Volume 9 p. 45). |
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Regulations
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EC/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 a European Medicines Agency (Consolided version : 20/04/2009, Lithuanian Consolidadted version 02/07/2012). |
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| 2012/1027/EU |
Regulation (EU) no 1027/2012 of the european parliament and of the council of 25 october 2012 amending regulation (EC) no 726/2004 as regards pharmacovigilance. (OJ L 316, 14.11.2012, p. 38-40)
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| 2010/1235/EU |
Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products Text with EEA relevance (OJ L 348, 31.12.2010, p. 1–16) |
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| Corrigendum |
Corrigendum to Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures forthe authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products ( OJ L 348, 31.12.2010) |
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| 2009/219/EC |
Amended by Regulation (EC) No 219/2009 of the European Parliament and of the Council of 11 March 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny Adaptation to the regulatory procedure with scrutiny - Part Two (Official Journal L 87, 231/3/2009, p. 109 - 154, especially p. 116 - 118, Annex 2.9, where Regulation (EC) No 726/2004 is adapted).
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| EC/297/95 |
Council Regulation (EC) No 297/95, of 10 February 1995, on fees payable to the European Agency for the Evaluation of Medicinal Products (Official Journal L 35, 15/2/1995 p. 1 - 5).
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Corrigendum (Official Journal L 75, 4/4/1995 p. 29.
ES DA DE EL EN FR IT NL PT FI SV). |
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EC/2743/98
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Council Regulation (EC) No 2743/98 of 14 December 1998 amending Regulation (EC) No 297/95 on fees payable to the European Agency for the Evaluation of Medicinal Products (Official Journal L 345, 19/12/1998 p 3 - 8).
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EC/494/2003
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Commission Regulation (EC) No 494/2003 of 18 March 2003 amending Council Regulation (EC) No 297/95 on the fees payable to the European Agency for the Evaluation of Medicinal Products (Official Journal L 73, 19/3/2003 p. 6 - 7)
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EC/1905/2005
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Council Regulation (EC) No 1905/2005, of 14 November 2005, amending Regulation (EC) No 297/95 on fees payable to the European Medicines Agency (Official Journal L 340, 13/11/2005 p. 1 - 9)
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EC/312/2008
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Commission Regulation (EC) No 312/2008 of 3 April 2008 amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate
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EC/249/2009
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Commission Regulation (EC) No 249/2009 of 23 March 2009 amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate (Official Journal L 79, 25/3/2009 p. 34 - 36)
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| EU/261/2010 |
Commission Regulation (EU) No 261/2010 of 25 March 2010 amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate
(OJ L 80, 26.3.2010, p. 36–39) |
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| EU/301/2011 |
Commission Regulation (EU) No 301/2011 of 28 March 2011 amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation.
Text with EEA relevance
(OJ L 81, 29.3.2011, p. 5–7)
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| EU/273/2012 |
Commission Regulation (EU) No 273/2012 of 27 March 2012 amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate Text with EEA relevance (OJ L 90, 28.3.2012, p. 11–13) |
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| EC/540/95 |
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 authorized in accordance with the provisions of Council Regulation (EEC) No 2309/93 (Official Journal L 55, 11/3/1995 p. 5 - 6).
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| EC/1662/95 |
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 authorizations for products for human or veterinary use (Official Journal L 158, 8/7/1995 p. 4 - 5).
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Corrigendum (Official Journal L 249, 17/10/1995 p. 47 PT). |
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| EC/2141/96 |
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 (EEC) No 2309/93 (Official Journal L 286, 8/11/1996 p. 6 - 8). |
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EC/141/2000
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Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (Official Journal L 18, 22/1/2000 p. 1 - 5).
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| EC/847/2000 |
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’ (Official Journal L 103, 28/4/2000 p. 5 - 8). |
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| EC/2049/2005 |
Commission Regulation (EC) No 2049/2005, of 15 December 2005, laying down, pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council, rules regarding the payment of fees to, and the receipt of administrative assistance from, the European Medicines Agency by micro, small and medium-sized enterprises (Official Journal L 329, 16/12/2005 p. 4 - 7). |
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| EC/507/2006 |
Commission Regulation (EC) No 507/2006 of 29 March 2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council (Official Journal L 92, 30/3/2006 p. 6 - 9). |
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| EC/1901/2006 |
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 |
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| EC/1902/2006 |
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 |
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| EC/658/2007 |
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 (Official Journal L 155, 15/6/2007 p. 10 - 19). |
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| EU/488/2012 |
Commission Regulation (EU) No 488/2012 of 8 June 2012 amending Regulation (EC) No 658/2007 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 (Official Journal L 150, 9/6/2012, p. 68–70) |
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| Corrigendum |
Corrigendum to Commission Regulation (EU) No 488/2012 (Official Journal L 338, 12/12/2012, p. 44) |
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| EC/1394/2007 |
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 (Note: shall apply from 30 December 2008)(Official Journal L 324, 10/12/2007 p. 121 - 137). |
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| EC/1234/2008 |
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 (Official Journal L 334, 12/12/2008 p. 7 - 24). |
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Consolidated version : 2.11.2012 |
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| EC/712/2012 |
Commission Regulation (EU) No 712/2012 of 3 August 2012 amending Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (Official Journal L 209, 4/8/2012, p. 4 - 14). |
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| EC/688/2009 |
Commission Regulation (EC) No 668/2009 of 24 July 2009 implementing Regulation (EC) No 1394/2007 of the European Parliament and of the Council with regard to the evaluation and certification of quality and non-clinical data relating to advanced therapy medicinal products developed by micro, small and medium-sized enterprises (Official Journal L 194, 25/7/2009 p. 7 - 10). |
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Miscellaneous
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75/320/EEC |
Council Decision 75/320/EEC, of 20 May 1975, setting up a Pharmaceutical Committee (Official Journal L 147, 9/6/1975 p. 23; Spanish special edition: Chapter 13 Volume 4 p. 102; Portuguese special edition: Chapter 13 Volume 4 p. 102; Finnish special edition: Chapter 13 Volume 4 p. 108 Swedish special edition: Chapter 13 Volume 4 p. 108). |
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Corrigendum (Official journal L 229, 15/8/1986 p. 63 DA; Official journal L 220, 20/8/1975 p. 22 DE). |
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| 2009/35/EC |
Directive 2009/35/EC of the European Parliament and of the Council of 23 April 2009 on the colouring matters which may be added to medicinal products (recast) (Official Journal L 109, 30/4/2009 p. 10-13). |
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| 2009/41/EC |
Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms (Recast) (Text with EEA relevance) (OJ L 125, 21.5.2009, p. 75–97) |
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EU/469/2009
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Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (Codified version) (Text with EEA relevance ) (OJ L 152, 16.6.2009, p. 1–10)
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| 6/5/1982 |
Commission Communication on parallel imports of proprietary medicinal products for which marketing authorizations have already been granted (Official Journal C 115, 6/5/1982, p. 5). |
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| COM/2003/839 |
Commission Communication on parallel imports of proprietary medicinal products for which marketing authorisations have already been granted. [Update of the 1982 Commission Communication](COM/2003/839 final). |
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| 94/C 82/04 |
Commission Communication 94/C 82/04 on the implementation of the new marketing authorization procedures for medicinal products for human and veterinary use in accordance with Council Regulation (EEC) No 2309/93 of 22 July 1993 and Council Directives 93/39/EEC, 93/40/EEC and 93/41/EEC, adopted on 14 June 1993. (Official Journal C 82, 19/3/1994 p. 4). |
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| 98/C 229/03 |
Commission communication on the Community marketing authorisation procedures for medicinal products (Official Journal C 229, 22/7/1998 p. 4 - 17). |
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| 2004/C 24/06 |
Note for guidance on minimising the risk of transmitting animal spongiform encephalopathyagents via human and veterinary medicinal products (EMEA/410/01 Rev. 2 - October 2003) adopted by the Committee for Proprietary Medicinal Products (CPMP) and by the Committee for Veterinary Medicinal products (CVMP)
(Official Journal C 24, 2006 p. 6 - 18) |
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| 2006/C 133/05 |
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 (Official Journal C 133, 8/6/2006 p. 5 - 7) |
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| 2008/C 243/09 |
Guideline on the format and content of applications for agreement or modif ication of a paediatric investigation plan and requests for waivers or deferrals and concerning the operation of the compliance check and on criteria for assessing significant studies
(Official Journal C 243/1, 2008) |
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| 2013/51/EU |
Commission Implementing Decision of 23 January 2013 on the assessment of a third country’s regulatory framework applicable to active substances of medicinal products for human use and of the respective control and enforcement activities pursuant to Article 111b of Directive 2001/83/EC of the European Parliament and of the Council |
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Last update : 20/02/2013
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