{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/schedule-4/paragraph-5",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/schedule-4/paragraph-5.json",
  "legislation": "nisr/2012/134",
  "legislation_title": "The Medicines (Products for Human Use) (Fees) Regulations 2012",
  "legislation_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012",
  "path": "schedule/4/paragraph/5",
  "kind": "paragraph",
  "number": "5",
  "heading": "Marketing authorizations",
  "text": "Unless paragraphs 6 to 10 apply, the fee payable under regulation 33(3) in connection with the holding of a marketing authorization relating to a medicinal product of a kind described in column 1 of the following table is the applicable fee specified in the corresponding entry in column 2 of that table.\nPeriodic fees for holding marketing authorization\nColumn 1\nType of Medicinal Product\nColumn 2\nFee payable\n1. New Active Substance\n£23,025\n2. Parallel Import\n£300\n3. Others\n(a)\nAny product (not being a derivative of a new active substance) in respect of which a marketing authorization has been granted in consequence of a complex application submitted on or after 1st April 1989\n£9,481\n(b)\nPrescription Only Medicine\n(i)\nStandard Fee\n£2,371\n(ii)\nReduced Rate Fee\n£1,183\n(iii)\nLower Fee\n£300\n(c)\nPharmacy\n£300\n(d)\nGeneral Sale List\n£300\n(e)\nHerbal remedy\n£75\n(f)\nTraditional herbal registrations\n£75\n(g)\nNational homoeopathic product\n£75\n(h)\nHomoeopathic or anthroposophic product which is the subject of a licence of right\n£75",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/nisr/2012/134/schedule/4/paragraph/5",
    "retrieved_at": "2026-10-29T01:16:38.443269+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."
}