{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995/regulation-11",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995/regulation-11.json",
  "legislation": "uksi/1995/1116",
  "legislation_title": "The Medicines (Products for Human Use — Fees) Regulations 1995",
  "legislation_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995",
  "path": "regulation/11",
  "kind": "regulation",
  "number": "11",
  "heading": "Renewals of certain manufacturer’s licences",
  "text": "(1) Subject to regulation 23, the fee payable in connection with an application for renewal of a manufacturer’s licence which is limited solely to the manufacture or assembly of medicinal products the sale or supply of which does not require a marketing authorization or a product licence and to which article 2(2)(i)(e) (exemptions for certain special manufactured products) of the Medicines (Exemption from Licences) (Special and Transitional Cases) Order 1971 applies, shall be £85.\n(2) In respect of any inspection made in connection with an application referred to in paragraph (1), the fee payable shall be that prescribed in paragraph 2(d) of Schedule 2.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "S.I. 1971/1450; to which there are amendments not relevant to these Regulations."
    }
  ],
  "outstanding_effects": [
    {
      "type": "sum substituted",
      "affecting": "uksi/2000/592",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2000"
    },
    {
      "type": "am",
      "affecting": "uksi/2001/795",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2001"
    },
    {
      "type": "amended",
      "affecting": "uksi/1999/566",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 1999"
    },
    {
      "type": "am",
      "affecting": "uksi/2003/625",
      "affecting_title": "The Medicines for Human Use and Medical Devices(Fees Amendments) Regulations 2003"
    },
    {
      "type": "sum substituted",
      "affecting": "uksi/2004/666",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2004"
    },
    {
      "type": "am",
      "affecting": "uksi/2006/494",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2006"
    },
    {
      "type": "am",
      "affecting": "uksi/2002/542",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002"
    }
  ],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1995/1116/regulation/11",
    "retrieved_at": "2026-10-29T13:10:38.932521+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."
}