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EudraLex - Volume 1 - Pharmaceutical legislation for medicinal products for human use

2015 marks the 50th anniversary of pharmaceutical legislation in the EU, which began with the adoption of Directive 65/65 in 1965.

Today the EU legal framework for medicinal products for human use guarantees high standards of quality and safety of medicinal products, while promoting the good functioning of the internal market with measures that encourage innovation and competiveness.

Directives

Legal framework
2001/83/EC
(Consolidated)		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 : 26/07/2019).
 

Version History

  • 2019/1234 (EU)
    Regulation (EU) 2019/1243 of the European Parliament and of the Council of 20 June 2019 (OJ L 198, p. 241).
  • 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 (OJ L 299, 27.10.2012, p. 1–4).
  • 2011/62/EU
    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 (OJ L 174, 1.7.2011, p. 74-87).
  • 2010/84/EU
    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, p. 74-99).
    • Corrigendum (OJ L 21, 25.1.2011, p. 8).
    • 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 276, 21.10.2011, p. 63).
  • 2009/120/EC
    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 (OJ L 242, 15.9.2009, p. 3-12).
  • 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 (OJ L 168, 30.6.2009, p. 33-34).
  • 2008/29/EC
    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 (OJ L 81, 20.3.2008, p. 51-52).
  • 2004/27/EC
    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 (OJ L 136, 30.4.2004, p. 34-57).
  • 2004/24/EC
    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 (OJ L 136, 30.4.2004, p. 85-90).
  • 2003/63/EC
    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 (OJ L 159, 27.6.2003, p. 46-94).
  • 2002/98/EC
    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 (OJ L 33, 8.2.2003, p. 30-40).
2001/20/EC
(Consolidated)		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 (Consolidated version : 07/08/2009).
89/105/EECCouncil 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 (OJ 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).
2009/35/ECDirective 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) (OJ L 109, 30.4.2009, p. 10-13).
2009/41/ECDirective 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) (OJ L 125, 21.5.2009, p. 75–97)

Regulations

Legal framework
726/2004
(Consolidated)		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 (Consolidated version : 28/01/2019).
 

Version History

  • 2019/5
    Regulation (EU) No 2019/5 of the European Parliament and of the Council of 11 December 2018 amending Regulation (EC) No 726/2004 (OJ L 4, 7.1.2019, p. 24-42)
  • 1027/2012
    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).
  • 1235/2010
    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).
  • 470/2009
    Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council. (OJ L 152, 16.6.2009, p. 11-22).
  • 219/2009
    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 (OJ L 87, 11/3/2009, p. 109-154, especially p. 116-118, Annex 2.9, where Regulation (EC) No 726/2004 is adapted).
141/2000
(Consolidated)		Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (Consolidated version : : 25/07/2019).
 

Version History

  • 2019/1234 (EU)
    Regulation (EU) 2019/1243 of the European Parliament and of the Council of 20 June 2019 (OJ L 198, p. 241).
  • 596/2009
    Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18 June 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 Four (OJ L 188, 18.7.2009, p. 14-92).
1901/2006
(Consolidated)		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 (consolidated version : 26/01/2007).
 

Version History

  • 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 (OJ L 378, 27.12.2006, p. 20-21).
1394/2007
(Consolidated)		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 (Consolidated version : 25/07/2019).
 

Version History

  • 2019/1234 (EU)
    Regulation (EU) 2019/1243 of the European Parliament and of the Council of 20 June 2019 (OJ L 198, p. 241).
  • 1235/2010
    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).
469/2009Regulation (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) (OJ L 152, 16.6.2009, p. 1–10).
536/2014Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.05.2014, p. 1-76).
297/95
(Consolidated)		Council Regulation (EC) No 297/95, of 10 February 1995, on fees payable to the European Agency for the Evaluation of Medicinal Products (Consolidated version : 01/04/2018).
 

Version History

  • 1905/2005
    Council Regulation (EC) No 1905/2005 of 14 November 2005 amending Regulation (EC) No 297/95 on fees payable to the European Medicines Agency (OJ L 304, 23.11.2005, p. 1–9).
  • 2743/98
    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 (OJ L 345, 19.12.1998, p. 3–8).
658/2014Regulation (EU) No 658/2014 of the European Parliament and of the Council on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use (OJ L 189, 27.6.2014, p.112).

Non-legislative acts

Legal framework
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 (OJ L 158, 8.7.1995, p. 4-5).

EC/2141/96Commission 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 (OJ L 286, 8.11.1996, p. 6-8).
EC/847/2000Commission 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" (OJ L 103, 28.4.2000, p. 5-8).
EC/2049/2005Commission 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 (OJ L 329, 16.12.2005, p. 4-7).
EC/507/2006Commission 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 (OJ L 92, 30.3.2006, p. 6-9).
EC/2003/94Commission 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 (OJ L 262, 14.10.2003, p. 22-26).
EC/658/2007
(Consolidated)		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 (Consolidated version : 02/07/2012).
 

Version History

  • EC/658/2007 (non-consolidated)
    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 (OJ L 155, 15.6.2007, p. 10-19).
  • 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 (OJ L 150, 9.6.2012, p. 68–70).
EC/1234/2008Commission 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 (Consolidated version: 13/05/2021).
 

Version History

  • (EU) 2024/1701 
    Commission Delegated Regulation (EU) 2024/1701 of 11 March 2024 amending Regulation (EC) No 1234/2008 as regards the examination of variations to the terms of marketing authorisations for medicinal products for human use.
  • (EU) 2021/756
    Commission Delegated Regulation (EU) 2021/756 of 24 March 2021 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.
  • 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 (OJ L 209, 4.8.2012, p. 4-14).
EC/668/2009Commission 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 (OJ L 194, 25.7.2009, p. 7-10).
EU/520/2012Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council (OJ L 159, 20.6.2012, p. 5-25).
2012/715/EUCommission implementing decision of 22 November 2012 establishing a list of third countries with a regulatory framework applicable to active substances for medicinal products for human use and the respective control and enforcement activities ensuring a level of protection of public health equivalent to that in the Union, in accordance with Directive 2001/83/EC of the European Parliament and of the Council (OJ L 325, 23.11.2012, p. 15-16).
 

Version History

  • 2013/196/EU
    Commission Implementing Decision of 24 April 2013 amending Implementing Decision 2012/715/EU establishing a list of third countries with a regulatory framework applicable to active substances for medicinal products for human use and the respective control and enforcement activities ensuring a level of protection of public health equivalent to that in the Union (OJ L 113, 25.4.2013, p. 22-23).
  • 2013/262/EU
    Commission Implementing Decision of 4 June 2013 amending Implementing Decision 2012/715/EU establishing a list of third countries with a regulatory framework applicable to active substances for medicinal products for human use and the respective control and enforcement activities ensuring a level of protection of public health equivalent to that in the Union (OJ L 152, 5.6.2013, p. 52-53).
  • 2013/301/EU
    Commission Implementing Decision of 11 June 2013 amending Implementing Decision 2012/715/EU establishing a list of third countries with a regulatory framework applicable to active substances for medicinal products for human use and the respective control and enforcement activities ensuring a level of protection of public health equivalent to that in the Union (OJ L 169, 21.6.2013, p. 71-72).
  • 2015/1057/EU
    Commission Implementing Decision of 1 July 2015 amending Implementing Decision 2012/715/EU establishing a list of third countries with a regulatory framework applicable to active substances for medicinal products for human use and the respective control and enforcement activities ensuring a level of protection of public health equivalent to that in the Union (OJ L 171, 2.7.2015, p. 23-24).
EU/51/2013Commission 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 (OJ L 21, 24.1.2013, p. 36).
EU/198/2013Commission Implementing regulation (EU) No 198/2013 of 7 March 2013 on the selection of a symbol for the purpose of identifying medicinal products for human use that are subject to additional monitoring (OJ L 65, 8.3.2017, p. 17-18).
EU/357/2014Commission Delegated Regulation (EU) No 357/2014 of 3 February 2014 supplementing Directive 2001/83/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council as regards situations in which post-authorisation efficacy studies may be required (OJ L 107, 10.4.2014, p. 1-4).
EU/699/2014Commission Implementing Regulation (EU) No 699/2014 of 24 June 2014 on the design of the common logo to identify persons offering medicinal products for sale at a distance to the public and the technical, electronic and cryptographic requirements for verification of its authenticity (OJ L ).
2014/1252/EUCommission delegated Regulation (EU) No 1252/2014 of 28 May 2014 supplementing Directive 2001/83/EC of the European Parliament and of the Council with regard to principles and guidelines of good manufacturing practice for active substances for medicinal products for human use (OJ L ).
2016/161/EUCommission Delegated Regulation (EU) No 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use (OJ L 32, 9.2.2016, p. 1-27).

Miscellaneous

Legal framework
75/320/EEC

Council Decision 75/320/EEC, of 20 May 1975, setting up a Pharmaceutical Committee (OJ 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).

  • Corrigendum (OJ L 229, 15.8.1986, p. 63, DA; OJ L 220, 20.8.1975, p. 22, DE).
82/C 115/05Commission Communication on parallel imports of proprietary medicinal products for which marketing authorizations have already been granted (OJ C 115, 6.5.1982, p. 5).
COM/2003/839Commission Communication on parallel imports of proprietary medicinal products for which marketing authorisations have already been granted (Update of the 1982 Commission Communication).
94/C 82/04Commission 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 (OJ C 82, 19.3.1994, p. 4).
98/C 229/03Commission Communication on the Community marketing authorisation procedures for medicinal products (OJ C 229, 22.7.1998, p. 4-17).
2004/C 24/06Note 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) (OJ C 24, 28.1.2004, p. 6-19).
2006/C 133/05Guideline 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 (OJ C 133, 8.6.2006, p. 5-7).
2013/C 223/01

Guidelines on the details of the various categories of variations, on the operation of the procedures laid down in Chapters II, IIa, III and IV of 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 and on the documentation to be submitted pursuant to those procedures (OJ C 223, 2.8.2013, p. 1-79).

  • Addendum: Communication from the Commission Addendum to the Guidelines on the details of the various categories of variations, on the operation of the procedures laid down in Chapters II, IIa, III and IV of 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 and on the documentation to be submitted pursuant to those procedures 2021/C 215 I/01 (OJ C 215I , 7.6.2021, p. 1–2)
2013/C 343/01Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (OJ C 343, 23.11.2013, p. 1-14).
 

Version History

  • 2013/C 68/01
    Guidelines of 7 March 2013 on Good Distribution Practice of Medicinal Products for Human Use (OJ C 68, 8.3.2013, p. 1-14).
2014/C 338/01Guideline 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 (OJ C 338, 27.9.2014, p. 1-17).
 

Version History

  • 2008/C 243/09
    Guideline on the format and content of applications for agreement or modification 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 (OJ C 243, 24.9.2008, p.1-12).