{
  "url": "https://openlegislation.uk/medicines-fees-relating-to-medicinal-products-for-human-use-regulations-1989/schedule-1/paragraph-4",
  "json_url": "https://openlegislation.uk/medicines-fees-relating-to-medicinal-products-for-human-use-regulations-1989/schedule-1/paragraph-4.json",
  "legislation": "uksi/1989/418",
  "legislation_title": "The Medicines (Fees Relating to Medicinal Products for Human Use) Regulations 1989",
  "legislation_url": "https://openlegislation.uk/medicines-fees-relating-to-medicinal-products-for-human-use-regulations-1989",
  "path": "schedule/1/paragraph/4",
  "kind": "paragraph",
  "number": "4",
  "heading": "Manufacturers' Licences",
  "text": "(1) The fee payable under regulation 3(a) of these Regulations in connection with an application for a manufacturer’s licence shall be —\n(a) in a case to which sub-paragraph (2) below applies, £50;\n(b) in any other case, £1,000; and\n(c) in either case, if appropriate, a fee calculated in accordance with Schedule 2 to these Regulations in respect of any inspection made in connection with that application.\n(2) This sub-paragraph applies to the case of an application for a manufacturer’s licence which is limited solely to the manufacture or assembly of medicinal products, the sale or supply of which do not require a product licence and to which Article 2(2)(i)(e) of the Medicines (Exemption from Licences) (Special and Transitional Cases) Order 1971 applies.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "S.I. 1971/1450; there are no relevant amending instruments."
    }
  ],
  "outstanding_effects": [
    {
      "type": "amended",
      "affecting": "uksi/1990/210",
      "affecting_title": "The Medicines (Fees Relating to Medicinal Products for Human Use) Amendment Regulations 1990"
    },
    {
      "type": "amended",
      "affecting": "uksi/1990/2326",
      "affecting_title": "The Medicines (Fees Relating to Medicinal Products for Human Use) Amendment (No. 2) Regulations 1990"
    }
  ],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1989/418/schedule/1/paragraph/4",
    "retrieved_at": "2026-10-29T15:47:51.296593+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."
}