{
  "url": "https://openlegislation.uk/medicines-fees-relating-to-medicinal-products-for-human-use-amendment-regulations-1990/regulation-22",
  "json_url": "https://openlegislation.uk/medicines-fees-relating-to-medicinal-products-for-human-use-amendment-regulations-1990/regulation-22.json",
  "legislation": "uksi/1990/210",
  "legislation_title": "The Medicines (Fees Relating to Medicinal Products for Human Use) Amendment Regulations 1990",
  "legislation_url": "https://openlegislation.uk/medicines-fees-relating-to-medicinal-products-for-human-use-amendment-regulations-1990",
  "path": "regulation/22",
  "kind": "regulation",
  "number": "22",
  "heading": "Amendment of Schedule 3 to the principal Regulations",
  "text": "In Schedule 3 to the principal Regulations (waiver, reduction or refund of fees)—\n(a) in paragraphs 2(1) and 2(2)—\n(i) after “clinical trial certificate” there shall be inserted in each case “or for a variation to or for a renewal of a product licence”; and\n(ii) for “3(a) or 4” there shall be substituted in each case “3(a), 4, 6 or 10”;\n(b) after paragraph 4 there shall be inserted the following paragraph—\n“5 The fee payable in respect of each such application shall be waived where—\n(a) a product licence (parallel import) relates to a medicinal product in respect of which a separate marketing authorisation has been granted pursuant to the provisions of Council Directive 65/65/EEC in more than one Member State of the European Economic Community; and\n(b) those marketing authorisations are indicated on the product licence (parallel import) as having been validly granted in those Member States; and\n(c) the holder of that licence applies for the grant of a separate product licence (parallel import) in respect of each marketing authorisation which has been granted and so indicated.”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "O.J. No. 22, 9.2. 1965, p.369/65, as amended by Council Directives 75/319/EEC O.J. No. L147, 9.6. 1975, p.13, 83/570/EEC O.J. No. L332, 28.11. 1983, p.1, 87/21/EEC O.J. No. L15, 17.1. 1987, p.36 and 89/341/EEC O.J. No. L142, 25.5. 1989 p.11."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1990/210/regulation/22",
    "retrieved_at": "2026-10-29T15:28:25.454171+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."
}