{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995/regulation-12",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995/regulation-12.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/12",
  "kind": "regulation",
  "number": "12",
  "heading": "Renewals in terms which are not identical to the existing authorization, licence or certificate",
  "text": "Where an applicant applies for renewal of a marketing authorization (other than a Community marketing authorization), a manufacturer’s licence, a wholesale dealer’s licence or a clinical trial certificate so as to contain provisions which are not identical to the provisions of that authorization, licence or certificate as in force at the date of that application, the fee payable under this Part of these Regulations shall be increased by an amount equal to the fee which would have been payable under Part III of these Regulations had he in addition made a separate application for variation of that authorization, licence or certificate in respect of each provision which is not identical.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [
    {
      "type": "words substituted",
      "affecting": "uksi/2004/1157",
      "affecting_title": "The Medicines for Human Use (Clinical Trials Fees Amendments) Regulations 2004"
    },
    {
      "type": "words substituted",
      "affecting": "uksi/2004/1157",
      "affecting_title": "The Medicines for Human Use (Clinical Trials Fees Amendments) Regulations 2004"
    },
    {
      "type": "am",
      "affecting": "uksi/2005/2979",
      "affecting_title": "The Medicines for Human Use (Fees Amendments)(No. 2) Regulations 2005"
    }
  ],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1995/1116/regulation/12",
    "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."
}