{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-222A",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-222A.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "regulation/222A",
  "kind": "regulation",
  "number": "222A",
  "heading": "Assembly or part-assembly as part of “hub and spoke” dispensing arrangements between different businesses",
  "text": "(1) Paragraph (2) applies where—\n(a) an order for the sale or supply of a medicinal product to or for the use of a particular patient (P) is submitted to a person acting in the course of a retail pharmacy business or an NHS dispensing practice;\n(b) the person carrying on the retail pharmacy business or the NHS dispensing practice (B1) has entered into written arrangements (whether or not legally binding) with a person carrying on a retail pharmacy business (B2) which—\n(i) are for the purpose of B2 supporting B1 with regard to the fulfilment of orders submitted as mentioned in sub-paragraph (a) (but must not allow B2 to fulfil the order directly), and\n(ii) include (but are not limited to) a comprehensive statement of the responsibilities of B1 and B2 in relation to those orders;\n(c) B1 has conspicuously displayed a notice—\n(i) at B1’s registered pharmacy or premises of B1’s NHS dispensing practice, if B1 supplies medicinal products to patients who are present at that pharmacy or those premises, and\n(ii) in B1’s dispensing content for patients, if B1 sells or supplies medicinal products by means of an internet service,\ncontaining the names and addresses of any parties with whom they have entered into arrangements of the type mentioned in sub-paragraph (b) and a brief statement of the general effect of the arrangements;\n(d) the medicinal product is—\n(i) assembled or part-assembled in the course of B2’s business, and\n(ii) sold or supplied by B2 to B1,\nas part of the written arrangements of the type mentioned in sub-paragraph (b); and\n(e) the activities carried out as mentioned in sub-paragraph (d) are carried out with a view to any of the following taking place at or from premises of B1 (following further assembly in the case of part-assembled products)—\n(i) the retail sale of the product by B1 to or for the use of P, or\n(ii) the supply of the product in circumstances corresponding to retail sale by B1 to or for the use of P.\n(2) For the purposes of these Regulations and the Medicines Act 1968, each sale or supply mentioned in paragraph (1)(d)(ii) by B2—\n(a) is treated as or as part of a retail sale; and\n(b) is treated as being in accordance with a prescription if—\n(i) it is for the purpose of fulfilling an order that is a prescription, and\n(ii) the final sale or supply is in accordance with the prescription,\nnotwithstanding that B2 does not have the prescription.\n(3) The definitions of “sell” and “supply” in regulation 213(1) do not apply for the purposes of this regulation.\n(4) Where both B1 and B2 are retail pharmacy businesses and a pharmacist may, pursuant to regulation 217B, 217BA or 226A, change an order for the sale or supply of a medicinal product, the final decision as regards whether or not that change is to be made for the sale or supply to or for the use of P is for a pharmacist acting on behalf of B1, even if—\n(a) an initial decision, in accordance with which a retail sale was made by B2 to B1, was made by a pharmacist acting on behalf of B2; and\n(b) the final decision by the pharmacist acting on behalf of B1 is by way of a confirmation of what the pharmacist acting on behalf of B2 initially decided.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Regs. 222A, 222B inserted (1.10.2025) by The Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025 (S.I. 2025/758), regs. 1(2), 9"
    }
  ],
  "outstanding_effects": [
    {
      "type": "words inserted",
      "affecting": "uksi/2025/1249",
      "affecting_title": "The Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025"
    }
  ],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/regulation/222A",
    "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."
}