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 (Text with EEA relevance)
Modified by
  • Regulation (EC) No 1901/2006 of the European Parliament and of the Councilof 12 December 2006on 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(Text with EEA relevance), 32006R1901, December 27, 2006
  • Regulation (EC) No 1394/2007 of the European Parliament and of the Councilof 13 November 2007on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004(Text with EEA relevance), 32007R1394, December 10, 2007
  • Regulation (EC) No 219/2009 of the European Parliament and of the Councilof 11 March 2009adapting 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 scrutinyAdaptation to the regulatory procedure with scrutiny — Part Two, 32009R0219, March 31, 2009
  • Regulation (EC) No 470/2009 of the European Parliament and of the Councilof 6 May 2009laying 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(Text with EEA relevance), 32009R0470, June 16, 2009
  • Regulation (EU) No 1235/2010 of the European Parliament and of the Councilof 15 December 2010amending, 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)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 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(Official Journal of the European Union L 348 of 31 December 2010), 32010R123532010R1235R(01), December 31, 2010
  • Regulation (EU) No 1027/2012 of the European Parliament and of the Councilof 25 October 2012amending Regulation (EC) No 726/2004 as regards pharmacovigilance(Text with EEA relevance), 32012R1027, November 14, 2012
  • Regulation (EU) 2018/1718 of the European Parliament and of the Councilof 14 November 2018amending Regulation (EC) No 726/2004 as regards the location of the seat of the European Medicines Agency(Text with EEA relevance), 32018R1718, November 16, 2018
  • Regulation (EU) 2019/5 of the European Parliament and of the Councilof 11 December 2018amending 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, Regulation (EC) No 1901/2006 on medicinal products for paediatric use and Directive 2001/83/EC on the Community code relating to medicinal products for human use(Text with EEA relevance), 32019R0005, January 7, 2019
Corrected by
  • 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 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, 32010R1235R(01), July 27, 2012
Regulation (EC) No 726/2004 of the European Parliament and of the Councilof 31 March 2004laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing a European Medicines Agency(Text with EEA relevance) TITLE IDEFINITIONS AND SCOPE
Article 1The purpose of this Regulation is to lay down Union procedures for the authorisation, supervision and pharmacovigilance of medicinal products for human use and to establish a European Medicines Agency ("the Agency") which shall carry out the tasks relating to medicinal products for human use and veterinary medicinal products that are laid down in this Regulation and other relevant Union legislation.The provisions of this Regulation shall not affect the powers of Member States' authorities as regards setting the prices of medicinal products or their inclusion in the scope of the national health system or social security schemes on the basis of health, economic and social conditions. In particular, Member States shall be free to choose from the particulars shown in the marketing authorisation those therapeutic indications and pack sizes which will be covered by their social security bodies.
Article 2The definitions laid down in Article 1 of Directive 2001/83/EC shall apply for the purposes of this Regulation.As a consequence, in this Regulation, the terms, "medicinal product" and "medicinal product for human use" mean a medicinal product as defined in point (2) of Article 1 of Directive 2001/83/EC.In addition, the following definitions shall apply for the purposes of this Regulation:(1)"veterinary medicinal product" means a medicinal product as defined in point (1) of Article 4 of Regulation (EU) 2019/6 of the European Parliament and of the CouncilRegulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (OJ L 4, 7.1.2019, p. 43). ;(2)"antimicrobial" means an antimicrobial as defined in point (12) of Article 4 of Regulation (EU) 2019/6.The holder of a marketing authorisation for medicinal products covered by this Regulation must be established in the Union. The holder shall be responsible for the placing on the market of those medicinal products, whether he does it himself or via one or more persons designated to that effect.
Article 31.No medicinal product appearing in the Annex may be placed on the market within the Union unless a marketing authorisation has been granted by the Union in accordance with the provisions of this Regulation.2.Any medicinal product not appearing in Annex I may be granted a marketing authorisation by the Union in accordance with this Regulation, if:(a)the medicinal product contains an active substance which, on 20 May 2004, was not authorised in the Union; or(b)the applicant shows that the medicinal product constitutes a significant therapeutic, scientific or technical innovation or that the granting of authorisation in accordance with this Regulation is in the interest of patients' health at Union level.3.A generic medicinal product of a reference medicinal product authorised by the Union may be authorised by the competent authorities of the Member States in accordance with Directive 2001/83/EC under the following conditions:(a)the application for authorisation is submitted in accordance with Article 10 of Directive 2001/83/EC;(b)the summary of the product characteristics is in all relevant respects consistent with that of the medicinal product authorised by the Union except for those parts of the summary of product characteristics referring to indications or dosage forms which were still covered by patent law at the time when the generic medicine was marketed; and(c)the generic medicinal product is authorised under the same name in all the Member States where the application has been made. For the purposes of this provision, all the linguistic versions of the INN (international non-proprietary name) shall be considered to be the same name.4.After the competent committee of the Agency has been consulted, the Commission may adapt the Annex to technical and scientific progress and may adopt any necessary amendments without extending the scope of the centralised procedure.Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 87(2a).
Article 41.Applications for the marketing authorisations referred to in Article 3 shall be submitted to the Agency.2.The Union shall grant and supervise marketing authorisations for medicinal products for human use in accordance with Title II.3.The Union shall grant and supervise marketing authorisations for veterinary medicinal products in accordance with Title III.
Loading ...