{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/schedule-7/paragraph-12A",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/schedule-7/paragraph-12A.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "schedule/7/paragraph/12A",
  "kind": "paragraph",
  "number": "12A",
  "heading": null,
  "text": "(1) In Northern Ireland, the qualified person is responsible for securing—\n(a) that each batch of medicinal products manufactured in Northern Ireland has been manufactured and checked in accordance with these Regulations and the requirements of the marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration relating to those products; and\n(b) in the case of medicinal products imported from a country other than an EEA State, irrespective of whether the products have been manufactured in Northern Ireland or an EEA State, that each batch has undergone—\n(i) a full qualitative analysis,\n(ii) a quantitative analysis of all the active substances, and\n(iii) all other tests or checks necessary to ensure the quality of medicinal products in accordance with the requirements of the marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration relating to those products.\n(c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .\n(2) This paragraph does not apply in relation to listed NIMAR products in Northern Ireland.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Sch. 7 para. 12A inserted (31.12.2020) by S.I. 2019/775, regs. 1, 32(3)(aa) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 22(d)); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Sch. 7 para. 12A(1)(b): full stop substituted for word (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 135(a)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Sch. 7 para. 12A(1)(c) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 135(b)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Sch. 7 para. 12A(2) inserted (1.1.2022) by The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 26"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/schedule/7/paragraph/12A",
    "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."
}