{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995/regulation-4",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995/regulation-4.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/4",
  "kind": "regulation",
  "number": "4",
  "heading": "Applications for authorizations, licences or certificates",
  "text": "Subject to regulations 5, 19 and 23, in connection with an application for a marketing authorization (other than a Community marketing authorization), a manufacturer’s licence, a wholesale dealer’s licence or a clinical trial certificate, there shall be payable by the applicant—\n(a) the fee prescribed in Part II of Schedule 1 in connection with that application; and\n(b) in respect of any inspection defined in paragraph 1 of Schedule 2 made in connection with that application the fee payable in accordance with paragraphs 2 to 6 of that Schedule.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [
    {
      "type": "am",
      "affecting": "uksi/2005/2979",
      "affecting_title": "The Medicines for Human Use (Fees Amendments)(No. 2) Regulations 2005"
    },
    {
      "type": "words substituted",
      "affecting": "uksi/2004/1157",
      "affecting_title": "The Medicines for Human Use (Clinical Trials Fees Amendments) Regulations 2004"
    },
    {
      "type": "words inserted",
      "affecting": "uksi/2004/666",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2004"
    }
  ],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1995/1116/regulation/4",
    "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."
}