{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-217CA",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-217CA.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "regulation/217CA",
  "kind": "regulation",
  "number": "217CA",
  "heading": "Original pack dispensing: medicinal products containing a relevant substance: Northern Ireland",
  "text": "(1) Subject to paragraph (2) and for the purposes of this Part, the sale or supply of a prescription only medicine containing a relevant substance is not in accordance with a prescription unless—\n(a) it is sold or supplied in its manufacturer’s original outer packaging; and\n(b) if the sale or supply is of a quantity that is different to the quantity which has been ordered on the prescription, it is sold or supplied in a quantity which is as close as possible to the quantity in which it has been ordered on the prescription.\n(2) Paragraph (1) does not apply where—\n(a) the sale or supply is by or under the supervision of or pursuant to an authorisation (under regulation 220B) given by a pharmacist; and\n(b) the pharmacist is satisfied that—\n(i) a risk assessment is in place that refers to the need for the patient to be sold or supplied the medicine containing a relevant substance in different packaging from its manufacturer’s original outer packaging (for example in a monitored dosage system); and\n(ii) unless the medicine containing a relevant substance is unauthorised (other than by reason of it being an authorised product that has ceased to be so as a result of a process of assembly), processes are in place to ensure the supply to or for the patient of the package leaflet.\n(3) In this regulation, “relevant substance” means any of the following—\n(a) sodium valproate;\n(b) valproic acid;\n(c) valproate semisodium.",
  "extent": "NI",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Reg. 217CA inserted (N.I.) (4.6.2024) by The Human Medicines (Amendment Relating to Original Pack Dispensing) Regulations (Northern Ireland) 2024 (S.R. 2024/125), regs. 1(2), 2(3)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in reg. 217CA(2)(a) inserted (7.1.2026) by The Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 (S.I. 2025/1249), arts. 1(2)(5)(c), 12(10)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/regulation/217CA",
    "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."
}