{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-3A",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-3A.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "regulation/3A",
  "kind": "regulation",
  "number": "3A",
  "heading": "Preparation and assembly of medicinal products used for vaccination against an infectious disease or in the reformulation of such products",
  "text": "(1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .\n(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .\n(3) Regulation 17(1) does not apply in circumstances where a medicinal product used under relevant arrangements for vaccination against an infectious disease is labelled by a holder of a wholesale dealer’s licence to take account of a change to the shelf life of the product because of the thawing of the product.\n(4) Chapter 1 of Part 13 (requirements for packaging and package leaflets relating to medicinal products)—\n(a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .\n(b) is to be construed as permitting labelling in accordance with paragraph (3), in the case of a product which is otherwise labelled in accordance with that Part.\n(5) For the purposes of this regulation—\n...\n“relevant arrangements” has the meaning given in regulation 19(4C) (exemptions from requirement for wholesale dealer’s licence).\n(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Reg. 3A inserted (19.12.2020) by The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.I. 2020/1594), regs. 1(2), 4 and The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.R. 2020/350), regs. 1(2), 4"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Reg. 3A(1) omitted (31.3.2026) by virtue of The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 4(3)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Reg. 3A(2) omitted (31.3.2026) by virtue of The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 4(3)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Words in reg. 3A(3) substituted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 4(4)"
    },
    {
      "type": "F",
      "label": "F5",
      "text": "Reg. 3A(4)(a) omitted (31.3.2026) by virtue of The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 4(5)"
    },
    {
      "type": "F",
      "label": "F6",
      "text": "Words in reg. 3A(5) omitted (31.3.2026) by virtue of The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 4(6)"
    },
    {
      "type": "F",
      "label": "F7",
      "text": "Reg. 3A(6) omitted (31.3.2026) by virtue of The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 4(7)"
    },
    {
      "type": "F",
      "label": "F8",
      "text": "Words in reg. 3A heading substituted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 4(2)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/regulation/3A",
    "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."
}