{
  "url": "https://openlegislation.uk/eu-regulation-2016-461/introduction",
  "json_url": "https://openlegislation.uk/eu-regulation-2016-461/introduction.json",
  "legislation": "eur/2016/461",
  "legislation_title": "Commission Regulation (EU) 2016/461 of 30 March 2016 amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate with effect from 1 April 2016 (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2016-461",
  "path": "introduction",
  "kind": "introduction",
  "number": null,
  "heading": "Introductory text",
  "text": "Commission Regulation (EU) 2016/461\nof 30 March 2016\namending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate with effect from 1 April 2016\n(Text with EEA relevance)\nTHE EUROPEAN COMMISSION,\nHaving regard to the Treaty on the Functioning of the European Union,\nHaving regard to Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products, and in particular the fifth paragraph of Article 12 thereof,\nWhereas:\n(1)\nIn accordance with Article 67(3) of Regulation (EC) No 726/2004 of the European Parliament and of the Council, the revenue of the European Medicines Agency consists of a contribution from the Union and fees paid to it by undertakings. Regulation (EC) No 297/95 lays down the categories and levels of such fees.\n(2)\nThose fees should be updated by reference to the inflation rate of 2015. The inflation rate in the Union, as published by the Statistical Office of the European Union, was 0,2 % in 2015.\n(3)\nFor the sake of simplicity, the adjusted levels of the fees should be rounded to the nearest EUR 100.\n(4)\nRegulation (EC) No 297/95 should therefore be amended accordingly.\n(5)\nFor reasons of legal certainty, this Regulation should not apply to valid applications which are pending on 1 April 2016.\n(6)\nIn accordance with Article 12 of Regulation (EC) No 297/95, the update is to be made with effect from 1 April 2016. It is therefore appropriate that this Regulation enters into force as a matter of urgency and applies from that date,\nHAS ADOPTED THIS REGULATION:",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "OJ L 35, 15.2.1995, p. 1."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "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 (OJ L 136, 30.4.2004, p. 1)."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2016/461/introduction",
    "retrieved_at": "2026-11-01T14:45:56.128777+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}