{
  "node_id": "uk-human-medicines-regulations-2012",
  "title": "UK Human Medicines Regulations 2012",
  "domain": "Pharmaceuticals & Life Sciences",
  "version": "1.0.0",
  "last_updated": "2023-01-01",
  "bluf": "The Human Medicines Regulations 2012 (SI 2012/1916) is the primary UK pharmaceutical legislation governing the authorisation, manufacture, importation, distribution, and advertising of human medicines, with…",
  "paywall": {
    "status": "LOCKED",
    "unlock_cost_usd": "0.01",
    "skyfire_id": "41779894-ece2-4163-9761-b3b1b76e19b0"
  },
  "crosswalks": {
    "_available_keys": [
      "eu-medicinal-products-human-directive-2001-83",
      "uk-data-protection-act-2018",
      "eu-in-vitro-diagnostics-regulation-2017-746"
    ],
    "_note": "Full crosswalk values included in vault response"
  },
  "dependencies": [
    "eu-medicinal-products-human-directive-2001-83",
    "uk-data-protection-act-2018",
    "eu-in-vitro-diagnostics-regulation-2017-746"
  ],
  "primary_citations_count": 6,
  "workflow_steps_count": 8,
  "schema_fields_count": 12,
  "citation_preview": [
    {
      "title": "Human Medicines Regulations 2012 (SI 2012/1916)",
      "url": "https://www.legislation.gov.uk/uksi/2012/1916/contents",
      "section": "Regulations 2, 17, 18, 43-45, 182, 289, 295, Schedules 7, 10, 13",
      "relevance": "Primary UK pharmaceutical legislation post-Brexit; establishes UK marketing authorisation requirement, MHRA as competent authority, GMP manufacturing licence obligations, qualified person batch certification, pharmacovigilance framework, wholesale dealer licensing, and advertising restrictions for human medicines on the Great Britain market"
    },
    {
      "title": "Medicines and Medical Devices Act 2021 (c. 3)",
      "url": "https://www.legislation.gov.uk/ukpga/2021/3/contents",
      "section": "Sections 1-9, 14-18 (human medicines, medical devices, Northern Ireland, international recognition procedure)",
      "relevance": "Primary post-Brexit Act amending the Human Medicines Regulations 2012 to enable the International Recognition Procedure, conferring power to update medicines and devices regulation by statutory instrument, and providing the legal basis for the UK-specific medicines licensing framework diverging from EU law over time"
    }
  ]
}