{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-10",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-10.json",
  "legislation": "nisr/2012/134",
  "legislation_title": "The Medicines (Products for Human Use) (Fees) Regulations 2012",
  "legislation_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012",
  "path": "regulation/10",
  "kind": "regulation",
  "number": "10",
  "heading": "Fee for advice for other purposes",
  "text": "(1) Unless paragraph (4) applies, the fee payable by a person specified in paragraph (2) with whom the licensing authority holds a meeting for a purpose specified in paragraph (3) is £4,810.\n(2) A person who—\n(a) is, or is to be, a sponsor of a clinical trial;\n(b) manufactures medicinal products;\n(c) is, or is to be, responsible for placing medicinal products on the market; or\n(d) acts on behalf of, or provides advice or assistance to, a person referred to in sub-paragraphs (a) to (c),\nis a specified person for the purpose of paragraph (1).\n(3) A meeting referred to in paragraph (1) is for a specified purpose if it is held to provide advice in relation to—\n(a) scientific or regulatory issues relating to the development of a medicinal product or a type of medicinal product;\n(b) the design of pharmaceutical or pre-clinical tests, or clinical trials, for a medicinal product or a type of medicinal product;\n(c) the management of risk in relation to a medicinal product or a type of medicinal product which is under development, or is being marketed in the European Union; or\n(d) other scientific or regulatory issues relating to a medicinal product or a type of medicinal product after an EU marketing authorization has been granted for that product or a product of that type.\n(4) Paragraph (1) does not apply in the case of a meeting where the purpose of such a meeting is to provide only advice specified in regulations 4 to 9.\n(5) In this regulation—\n“Directive 93/42/EEC” means Council Directive 93/42/EEC concerning medical devices;\n“medical device” has the same meaning as in Article 1(2)(a) of Directive 93/42/EEC;\n“medicinal product” includes a substance incorporated in a medical device which, if used separately, may be considered to be a medicinal product as defined in Article 1(2) of the 2001 Directive;\n“regulatory issues” means issues relating to the application of any EU instrument relating to EU marketing authorizations or to medical devices, or any enactment which implements such an instrument;\n“risks” means any risk relating to the quality, safety or efficacy of a medicinal product as regards patients’ health or public health, or any risk of undesirable effects on the environment;\n“sponsor” shall be interpreted in accordance with regulation 3 (sponsor of a clinical trial) of the Clinical Trials Regulations;\nand a reference to the development of a medicinal product or a type of medicinal product is a reference to development for the purposes of—\n(a) obtaining an EU marketing authorization, or making a variation to an EU marketing authorization, for that product or a product of that type; or\n(b) obtaining a design-examination certificate of the type mentioned in paragraph 4.3 of Annex II to Directive 93/42/EEC or a type-examination certificate of the type mentioned in paragraph 5 of Annex III to that Directive, for a medical device incorporating that product or a product of that type.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "OJ No. L 169, 12.7.1993, p.1. This Directive has been amended by Directive 98/79/EC of the European Parliament and of the Council (OJ No. L 331, 7.12.1998, p.1), Directive 2000/70/EC of the European Parliament and of the Council (OJ No. L 313, 13.12.2000, p.22), Directive 2001/104/EC of the European Parliament and of the Council (OJ No. L 6, 10.1.2002, p.50), Regulation (EC) No. 1882/2003 of the European Parliament and of the Council (OJ No. L 284, 31.10.2003, p.1) and Directive 2007/47/EC of the European Parliament and of the Council (OJ No. L 247, 21.9.2007, p.21)."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "Regulation 3 has been amended by S.I. 2006/1928."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/nisr/2012/134/regulation/10",
    "retrieved_at": "2026-10-29T01:16:38.443269+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."
}