{
  "url": "https://openlegislation.uk/medicines-exemption-from-licences-clinical-trials-order-1995/schedule-1/paragraph-12",
  "json_url": "https://openlegislation.uk/medicines-exemption-from-licences-clinical-trials-order-1995/schedule-1/paragraph-12.json",
  "legislation": "uksi/1995/2808",
  "legislation_title": "The Medicines (Exemption from Licences) (Clinical Trials) Order 1995",
  "legislation_url": "https://openlegislation.uk/medicines-exemption-from-licences-clinical-trials-order-1995",
  "path": "schedule/1/paragraph/12",
  "kind": "paragraph",
  "number": "12",
  "heading": null,
  "text": "(a) Where a specification has been established for a constituent—\n(i) a summary of pharmaceutical data in respect of the specification of each such constituent (whether active or not) or, where a constituent is the subject of a monograph, the monograph name, if preferred,\n(ii) in the case of each constituent (whether active or not), a summary of pharmaceutical data in respect of the quality control procedures and methods to be applied to ensure compliance with the specification of that constituent;\n(b) where a specification has not been established for a constituent, a batch characterisation for each batch of that constituent to be used in the clinical trial.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1995/2808/schedule/1/paragraph/12",
    "retrieved_at": "2026-10-29T12:59:11.142361+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."
}