{
  "url": "https://openlegislation.uk/medicines-for-human-use-and-medical-devices-fees-amendments-regulations-2007/regulation-3",
  "json_url": "https://openlegislation.uk/medicines-for-human-use-and-medical-devices-fees-amendments-regulations-2007/regulation-3.json",
  "legislation": "uksi/2007/610",
  "legislation_title": "The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2007",
  "legislation_url": "https://openlegislation.uk/medicines-for-human-use-and-medical-devices-fees-amendments-regulations-2007",
  "path": "regulation/3",
  "kind": "regulation",
  "number": "3",
  "heading": "Amendment of Part I of the Medicines Fees Regulations",
  "text": "In Part I of the Medicines Fees Regulation (general), in regulation 2 (interpretation)—\n(a) for the definition of “the 2001 Directive” substitute the following definition—\n““the 2001 Directive” means Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use, as amended by—\n(a) Directive 2002/98/EC of the European Parliament and of the Council setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components,\n(b) Commission Directive 2003/63/EC amending Directive 2001/83/EC,\n(c) Directive 2004/24/EC of the European Parliament and of the Council amending, as regards traditional herbal medicinal products, Directive 2001/83/EC,\n(d) Directive 2004/27/EC of the European Parliament and of the Council also amending Directive 2001/83/EC, and\n(e) Regulation (EC) No. 1901/2006 of the European Parliament and of the Council 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;”;\n(b) after the definition of “EEA State” insert the following definition—\n““exempt imported product” means a medicinal product, as defined in Article 1(2) of the 2001 Directive, to which paragraph 1 of Schedule 1 to the 1994 Regulations applies, which was not manufactured in the United Kingdom and in relation to which no marketing authorization has been granted;”; and\n(c) after the definition of “relevant fee period” substitute the following definition—\n““special import notice” means a written notice given to the licensing authority in accordance with paragraph 7(2) of Schedule 2 to, or paragraph 3(2) of Schedule 4 to, the Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005;”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "OJ No. L311, 28.11.2001, p.67."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "OJ No. L33, 8.2.2003, p.30."
    },
    {
      "type": "footnote",
      "label": "f3",
      "text": "OJ No. L159, 27.6.2003, p.46."
    },
    {
      "type": "footnote",
      "label": "f4",
      "text": "OJ No. L136, 30.4.2004, p.85."
    },
    {
      "type": "footnote",
      "label": "f5",
      "text": "OJ No. L136, 30.4.2004, p.34."
    },
    {
      "type": "footnote",
      "label": "f6",
      "text": "OJ No. L378, 27.12.2006, p.1."
    },
    {
      "type": "footnote",
      "label": "f7",
      "text": "See regulation 2(1) of the Medicines Fees Regulations for the definition of “the 1994 Regulations”."
    },
    {
      "type": "footnote",
      "label": "f8",
      "text": "S.I. 2005/2789."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2007/610/regulation/3",
    "retrieved_at": "2026-10-29T03:59:51.648137+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."
}