{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1991/schedule-1/part-III/paragraph-2",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1991/schedule-1/part-III/paragraph-2.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/III/paragraph/2",
  "kind": "paragraph",
  "number": "2",
  "heading": "Product licences",
  "text": "Where a product licence has been granted in accordance with an application to which paragraph 5 of Chapter III of Part 3 of the Annex to Council Directive 75/318/EEC applies, the fee in connection with the first application for variation of that product licence made within 5 years of the date of the grant of that product licence, so as to authorise use of the medicinal product in a new therapeutic area, shall, in addition to the fee payable under regulation 7(a), be the difference between the fee paid in connection with the application for the grant of that licence and the fee which would have been payable had that application been a major application and the provisions of that paragraph had not applied.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [
    {
      "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": "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/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"
    },
    {
      "type": "amended",
      "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/III/paragraph/2",
    "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."
}