{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/schedule-16/part-2",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/schedule-16/part-2.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "schedule/16/part/2",
  "kind": "part",
  "number": "2",
  "heading": "Persons on whose behalf a patient group Direction must be signed",
  "text": "Column 1: Class of person by whom product is supplied\nColumn 2: Person on whose behalf direction must be signed\nCommon Services Agency\nThe Agency\nHealth authority\nThe health authority\nSpecial health authority\nThe special health authority\nNHS trust or NHS foundation trust\nThe trust\nLocal authority\nThe Chief Executive or Director of Public Health of the local authority\nthe United Kingdom Health Security Agency\nThe Chief Executive of the United Kingdom Health Security Agency\nPublic Health Agency\nThe Public Health Agency\n...\n...\nA person who supplies medicinal products pursuant to an arrangement made with—\n(a) the Common Services Agency;\n(b) a health authority;\n(c) a special health authority;\n(d) an NHS trust;\n(da) an integrated care board;\n(db) NHS England;\n(dc) a local authority; ...\n(dd) the United Kingdom Health Security Agency;\n(de) Public Health Agency; or\n(e) an NHS foundation trust; ...\n(f) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .\nThe Common Services Agency (where the arrangement has been made with the Agency); otherwise the—\n(a) health authority,\n(b) special health authority,\n(c) NHS trust,\n(ca) an integrated care board,\n(cb) NHS England,\n(cc) a local authority, ...\n(cd) Chief Executive of the United Kingdom Health Security Agency,\n(ce) Public Health Agency, or\n(d) NHS foundation trust, ...\n(e) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .\nwith which the arrangement has been made.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in Sch. 16 Pt. 2 inserted (1.4.2013) by The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 176(7)(a) (with Sch. 3 para. 28)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in Sch. 16 Pt. 2 added (E.W.S.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 7(2)(a) and words in Sch. 16 Pt. 2 added (N.I.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 7(2)(a)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Words in Sch. 16 Pt. 2 Table substituted (2.12.2024) by The Human Medicines (Amendments Relating to Naloxone and Transfers of Functions) Regulations 2024 (S.I. 2024/1125), regs. 1(2), 10(a)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Words in Sch. 16 Pt. 2 Table substituted (2.12.2024) by The Human Medicines (Amendments Relating to Naloxone and Transfers of Functions) Regulations 2024 (S.I. 2024/1125), regs. 1(2), 10(b)"
    },
    {
      "type": "F",
      "label": "F5",
      "text": "Words in Sch. 16 Pt. 2 omitted (1.4.2013) by virtue of The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 176(7)(b) (with Sch. 3 para. 28)"
    },
    {
      "type": "F",
      "label": "F6",
      "text": "Words in Sch. 16 Pt. 2 inserted (1.4.2013) by The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 176(7)(c)(i) (with Sch. 3 para. 28)"
    },
    {
      "type": "F",
      "label": "F7",
      "text": "Words in Regulations substituted (1.7.2022) by The Health and Care Act 2022 (Consequential and Related Amendments and Transitional Provisions) Regulations 2022 (S.I. 2022/634), reg. 1(2), Sch. para. 1(1)(3) (with Sch. para. 1(2))"
    },
    {
      "type": "F",
      "label": "F8",
      "text": "Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1"
    },
    {
      "type": "F",
      "label": "F9",
      "text": "Word in Sch. 16 Pt. 2 omitted (E.W.S.) (1.4.2015) by virtue of The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 7(2)(b)(i) and word in Sch. 16 Pt. 2 omitted (N.I.) (1.4.2015) by virtue of The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 7(2)(b)(i)"
    },
    {
      "type": "F",
      "label": "F10",
      "text": "Words in Sch. 16 Pt. 2 inserted (E.W.S.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 7(2)(b)(ii) and words in Sch. 16 Pt. 2 inserted (N.I.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 7(2)(b)(ii)"
    },
    {
      "type": "F",
      "label": "F11",
      "text": "Words in Sch. 16 Pt. 2 omitted (1.4.2013) by virtue of The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 176(7)(c)(ii) (with Sch. 3 para. 28)"
    },
    {
      "type": "F",
      "label": "F12",
      "text": "Words in Sch. 16 Pt. 2 inserted (1.4.2013) by The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 176(7)(d)(i) (with Sch. 3 para. 28)"
    },
    {
      "type": "F",
      "label": "F13",
      "text": "Word in Sch. 16 Pt. 2 omitted (E.W.S.) (1.4.2015) by virtue of The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 7(2)(c)(i) and word in Sch. 16 Pt. 2 omitted (N.I.) (1.4.2015) by virtue of The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 7(2)(c)(i)"
    },
    {
      "type": "F",
      "label": "F14",
      "text": "Words in Sch. 16 Pt. 2 inserted (E.W.S.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 7(2)(c)(ii) and words in Sch. 16 Pt. 2 inserted (N.I.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 7(2)(c)(ii)"
    },
    {
      "type": "F",
      "label": "F15",
      "text": "Words in Sch. 16 Pt. 2 omitted (1.4.2013) by virtue of The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 176(7)(d)(ii) (with Sch. 3 para. 28)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/schedule/16/part/2",
    "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."
}