{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995/regulation-5",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995/regulation-5.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/5",
  "kind": "regulation",
  "number": "5",
  "heading": "Inspections in connection with multiple applications for authorizations or licences",
  "text": "Where an inspection mentioned in regulation 4(b) is made at a site which has been named as a possible site for manufacture or assembly of a medicinal product, or for the preparation of a substance which is to be used in the manufacture of an immunological product or a blood product, by more than one applicant for—\n(a) a marketing authorization and that site is located outside the United Kingdom; or\n(b) a manufacturer’s licence and that site is located in the United Kingdom,\nthe fee in respect of that inspection shall be payable in equal proportions by each of those applicants.",
  "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 inserted",
      "affecting": "uksi/2004/1157",
      "affecting_title": "The Medicines for Human Use (Clinical Trials Fees Amendments) Regulations 2004"
    },
    {
      "type": "words inserted",
      "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/5",
    "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."
}