{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1991/schedule-5/paragraph-5",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1991/schedule-5/paragraph-5.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/5/paragraph/5",
  "kind": "paragraph",
  "number": "5",
  "heading": null,
  "text": "In relation to a product licence (parallel import), the fee payable in respect of each such application shall be waived—\n(a) where the licence 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, those marketing authorisations are indicated on the product licence (parallel import) as having been validly granted in those Member States and 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; or\n(b) the holder of the licence applies for a variation to the licence solely relating to a change in the number of a marketing authorisation referred to in sub- paragraph (a) above.",
  "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": [
    {
      "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"
    }
  ],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1991/1474/schedule/5/paragraph/5",
    "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."
}