{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-167C",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-167C.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "regulation/167C",
  "kind": "regulation",
  "number": "167C",
  "heading": "Early Access to Medicines Scheme: establishment and licensing authority functions",
  "text": "(1) The licensing authority must establish and operate a scheme, to be known as the Early Access to Medicines Scheme—\n(a) the purpose of which is to give patients with life threatening or seriously debilitating conditions access to medicinal products that may be used for preventing, diagnosing or treating those conditions but which are either not authorised or not authorised for that use; and\n(b) which is to include arrangements to support the collection of data about EAMS medicinal products.\n(2) The licensing authority has the following functions with regard to the Early Access to Medicines Scheme—\n(a) issuing, where appropriate, a designation (“Promising Innovative Medicines designation”) in respect of a product under consideration for inclusion in the Scheme to the person who is or may in due course be responsible for placing the product on the market, after concluding based on early clinical and non-clinical data that the medicinal product may be eligible for inclusion in the Scheme because—\n(i) there is a life threatening or seriously debilitating condition and a high unmet need,\n(ii) the medicinal product is likely to offer a major advantage over methods of preventing, diagnosing or treating the condition already in use in the United Kingdom, and\n(iii) the potential adverse effects of the medicinal product are likely to be outweighed by the potential benefits, allowing for a reasonable expectation of a positive risk-benefit balance;\n(b) issuing, where appropriate, an opinion (“EAMS scientific opinion”) to a holder of a Promising Innovative Medicines designation to the effect that the holder is able—\n(i) to demonstrate that there is a life threatening or seriously debilitating condition and a high unmet need,\n(ii) to demonstrate that the medicinal product offers a major advantage over methods of preventing, diagnosing or treating the condition already in use in the United Kingdom,\n(iii) to demonstrate that the potential adverse effects of the medicinal product are outweighed by the potential benefits, allowing for a reasonable expectation of a positive risk-benefit balance,\n(iv) to supply the product to or within the United Kingdom (or a part thereof) for use as part of the Scheme, and\n(v) to manufacture, or secure the manufacturing of, the product to a consistent quality standard and in compliance with good manufacturing practice,\nas a consequence of which the product is included in and may be supplied as part of the Scheme;\n(c) where it issues an opinion under sub-paragraph (b), attaching where appropriate conditions, which may be varied from time to time, to the access to the Scheme that the opinion gives (which may include conditions that are equivalent to requirements of Part 13);\n(d) revoking, pursuant to paragraph (3), opinions issued in accordance with sub-paragraph (b); and\n(e) renewing opinions issued in accordance with sub-paragraph (b) that would otherwise cease to have effect in accordance with regulation 167D(1).\n(3) The licensing authority may, if it is reasonable to do so, revoke an EAMS scientific opinion at any time (as a consequence of which, subject to regulation 167D(2), the product can no longer be supplied as part of the Scheme) if—\n(a) there is a breach of the conditions referred to in paragraph (2)(c);\n(b) there is a breach of regulation 167E to 167G; or\n(c) sufficient grounds no longer exist for inclusion of the product within the Scheme.\n(4) For the purposes of this regulation and regulations 167E and 167G, “authorised” has the meaning given in regulation 3(15), and (including the purposes of regulation 43(6)(aa)) “unauthorised” is to be construed accordingly.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Regs. 167C-167H inserted (15.4.2022) by The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 8 (with reg. 19)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/regulation/167C",
    "retrieved_at": "2026-10-29T01:24:34.993203+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."
}