{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1991/schedule-1/part-II/paragraph-3",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1991/schedule-1/part-II/paragraph-3.json",
  "legislation": "uksi/1991/1474",
  "legislation_title": "The Medicines (Products for Human Use — Fees) Regulations 1991",
  "legislation_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1991",
  "path": "schedule/1/part/II/paragraph/3",
  "kind": "paragraph",
  "number": "3",
  "heading": "Product licences",
  "text": "Where a major application is made by a person who is already the holder of a clinical trial certificate in respect of a medicinal product containing the same active ingredient as the medicinal product in respect of which the product licence is applied for, the fee payable under regulation 4(a) in connection with that application shall be reduced by the amount of the fee paid in connection with the application for that certificate.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [
    {
      "type": "amended",
      "affecting": "uksi/1994/696",
      "affecting_title": "The Medicines (Products for Human Use—Fees) Amendment Regulations 1994"
    },
    {
      "type": "amended",
      "affecting": "uksi/1994/696",
      "affecting_title": "The Medicines (Products for Human Use—Fees) Amendment Regulations 1994"
    },
    {
      "type": "amended",
      "affecting": "uksi/1994/696",
      "affecting_title": "The Medicines (Products for Human Use—Fees) Amendment Regulations 1994"
    },
    {
      "type": "amended",
      "affecting": "uksi/1994/696",
      "affecting_title": "The Medicines (Products for Human Use—Fees) Amendment Regulations 1994"
    },
    {
      "type": "amended",
      "affecting": "uksi/1994/696",
      "affecting_title": "The Medicines (Products for Human Use—Fees) Amendment Regulations 1994"
    },
    {
      "type": "added",
      "affecting": "uksi/1994/696",
      "affecting_title": "The Medicines (Products for Human Use—Fees) Amendment Regulations 1994"
    },
    {
      "type": "amended",
      "affecting": "uksi/1994/696",
      "affecting_title": "The Medicines (Products for Human Use—Fees) Amendment Regulations 1994"
    },
    {
      "type": "substituted",
      "affecting": "uksi/1994/696",
      "affecting_title": "The Medicines (Products for Human Use—Fees) Amendment Regulations 1994"
    },
    {
      "type": "amended",
      "affecting": "uksi/1994/696",
      "affecting_title": "The Medicines (Products for Human Use—Fees) Amendment Regulations 1994"
    },
    {
      "type": "substituted",
      "affecting": "uksi/1992/756",
      "affecting_title": "The Medicines (Products for Human Use– Fees) Amendment Regulations 1992"
    },
    {
      "type": "substituted",
      "affecting": "uksi/1992/756",
      "affecting_title": "The Medicines (Products for Human Use– Fees) Amendment Regulations 1992"
    },
    {
      "type": "added",
      "affecting": "uksi/1992/756",
      "affecting_title": "The Medicines (Products for Human Use– Fees) Amendment Regulations 1992"
    }
  ],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1991/1474/schedule/1/part/II/paragraph/3",
    "retrieved_at": "2026-10-29T14:42:17.847283+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."
}