{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-324",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-324.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "regulation/324",
  "kind": "regulation",
  "number": "324",
  "heading": "Enforcement in Northern Ireland",
  "text": "(1) The Minister for Health, Social Services and Public Safety (in this regulation referred to as “the Minister”) must enforce or secure the enforcement of these Regulations and the relevant EU provisions in Northern Ireland.\n(2) The Minister may make arrangements for a district council to enforce the provisions of these Regulations listed in paragraph (3) in its district to the extent specified in the arrangements.\n(3) Those provisions are—\n(a) regulations 221 (sale or supply of medicinal products subject to general sale), 222 (sale of medicinal products from automatic machines) and 255(6) (certain offences relating to dealings with medicinal products);\n(b) regulations 251 (compliance with standards specified in certain publications) and 255(1)(e) (certain offences relating to dealings with medicinal products);\n(c) Part 13 (packaging and leaflets); and\n(d) Part 14 Chapter 2 (requirements relating to advertising).\n(4) Functions conferred by virtue of paragraph (2) are to be exercised concurrently with the Minister.\n(5) Regulation 323(9) has effect in relation to functions conferred by this regulation as it has effect in relation to functions conferred by regulation 323.\n(6) In this regulation, “district council” means a council established under the Local Government Act (Northern Ireland) 1972 .",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "M",
      "label": "M1",
      "text": "1972 c.9 (N.I.)."
    },
    {
      "type": "C",
      "label": "C1",
      "text": "Reg. 324(1) applied (with modifications) by The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg 47(1), Sch. 9 (as substituted (14.8.2012) by S.I. 2012/1916, reg. 1(2), Sch. 34 paras. 57(b), 64 (with Sch. 32))"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/regulation/324",
    "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."
}