{
  "url": "https://openlegislation.uk/draft-human-medicines-authorisation-by-pharmacists-and-supervision-by-pharmacy-technicians-order-2025/article-4",
  "json_url": "https://openlegislation.uk/draft-human-medicines-authorisation-by-pharmacists-and-supervision-by-pharmacy-technicians-order-2025/article-4.json",
  "legislation": "ukdsi/2025/9780348274202",
  "legislation_title": "The Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025",
  "legislation_url": "https://openlegislation.uk/draft-human-medicines-authorisation-by-pharmacists-and-supervision-by-pharmacy-technicians-order-2025",
  "path": "article/4",
  "kind": "article",
  "number": "4",
  "heading": "Exemption from requirement for manufacturer’s licence or marketing authorisation: authorisation of a pharmacist",
  "text": "(1) The Medicines Act 1968 is amended as follows.\n(2) In section 10 (exemptions for pharmacists)—\n(a) in subsection (1)—\n(i) in the words before paragraph (a), after “pharmacist” insert “or in accordance with subsection (1A)”, and\n(ii) in the words after paragraph (b), for “done by or under the supervision of a pharmacist” substitute “which is done by or under the supervision of a pharmacist or in accordance with subsection (1A) and”;\n(b) after subsection (1) insert—\n“(1A) Something is done in accordance with this subsection if—\n(a) it is done in Great Britain in a registered pharmacy, a hospital, a care home service or a health centre,\n(b) it is done—\n(i) by a registered pharmacy technician who has the authorisation of a pharmacist to do it, or\n(ii) under the supervision of a registered pharmacy technician who has the authorisation of a pharmacist to supervise the doing of it, and\n(c) it is done with due regard to patient safety.\n(1B) See section 10A for provision about authorisations given for the purposes of subsection (1A)(b)(i) and (ii).”;\n(c) in subsection (3), for “Those restrictions” substitute “The restrictions imposed by regulations 17(1) (manufacturing of medicinal products) and 46 (requirement for authorisation) of the 2012 Regulations”;\n(d) in subsection (4), in the words after paragraph (b)—\n(i) after “health centre” insert “and is done there”, and\n(ii) after “pharmacist” insert “or in accordance with subsection (1A)”;\n(e) in subsection (7A), after “pharmacist” insert “or registered pharmacy technician”; and\n(f) in subsection (7B), after “pharmacist” insert “or registered pharmacy technician”.\n(3) After section 10 insert—\n“Authorisation for the purposes of section 10(1A)(b)(i) or (ii)\n10A (1) An authorisation given to a registered pharmacy technician for the purposes of section 10(1A)(b)(i) or (ii)—\n(a) may be general or specific,\n(b) may be given orally or in writing,\n(c) may be given subject to conditions or restrictions, and\n(d) may be varied or withdrawn by the pharmacist by whom it is given.\n(2) An authorisation given for the purposes of section 10(1A)(b)(i) must state, in relation to anything it authorises a registered pharmacy technician to do, that it authorises the registered pharmacy technician to do it only in a registered pharmacy, hospital, care home service or health centre specified in the authorisation.\n(3) An authorisation given for the purposes of section 10(1A)(b)(ii) must state, in relation to anything it authorises the registered pharmacy technician to supervise, that it authorises the registered pharmacy technician to supervise it only if it is done in a registered pharmacy, hospital, care home service or health centre specified in the authorisation.\n(4) An authorisation given for the purposes of section 10(1A)(b)(i) may (among other things) authorise a registered pharmacy technician—\n(a) to prepare or dispense medicinal products in accordance with prescriptions given after the authorisation is given, or\n(b) to procure the preparation or dispensing of medicinal products in accordance with prescriptions given after the authorisation is given.\n(5) An authorisation given for the purposes of section 10(1A)(b)(ii) may (among other things) authorise a registered pharmacy technician to supervise—\n(a) the preparation or dispensing of medicinal products in accordance with prescriptions given after the authorisation is given, or\n(b) the procurement of the preparation or dispensing of medicinal products in accordance with prescriptions given after the authorisation is given.\n(6) In giving an authorisation for the purposes of section 10(1A)(b)(i) or (ii), a pharmacist must have due regard to patient safety.\n(7) A failure to comply with subsection (6)—\n(a) does not affect the validity of the authorisation, but\n(b) may constitute misconduct for the purposes of section 80 of this Act (power for relevant disciplinary committee to disqualify and direct removal from register) or article 51(1)(a) of the Pharmacy Order 2010 (impairment of fitness to practise) and the relevant disciplinary committee may deal with any such failure accordingly.”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "1968 c. 67."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "Amendments have been made to subsections (1), (3) and (4) by S.S.I 2002/162, S.I 2006/2407, 2012/1916, 1971/1445 and 2022/849."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/ukdsi/2025/9780348274202/article/4",
    "retrieved_at": "2026-10-30T14:38:47.073227+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."
}