{
  "url": "https://openlegislation.uk/human-medicines-amendment-no-2-regulations-2014/regulation-17",
  "json_url": "https://openlegislation.uk/human-medicines-amendment-no-2-regulations-2014/regulation-17.json",
  "legislation": "uksi/2014/1878",
  "legislation_title": "The Human Medicines (Amendment) (No. 2) Regulations 2014",
  "legislation_url": "https://openlegislation.uk/human-medicines-amendment-no-2-regulations-2014",
  "path": "regulation/17",
  "kind": "regulation",
  "number": "17",
  "heading": "Substitution of regulation 97",
  "text": "For regulation 97 (breach of pharmacovigilance condition) substitute—\n“Breach of pharmacovigilance condition\n97. (1) The holder of a marketing authorisation or a parallel import licence is guilty of an offence if the holder fails to comply with a condition to which the marketing authorisation or parallel import licence is subject by virtue of regulation 59 (conditions of a UK marketing authorisation or parallel import licence: general).\n(2) The holder of a marketing authorisation is guilty of an offence if the holder fails to comply with a condition to which the marketing authorisation is subject by virtue of regulation 60 (conditions of a UK marketing authorisation: exceptional circumstances) or 61 (conditions of a UK marketing authorisation: new obligations post-authorisation).”",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2014/1878/regulation/17",
    "retrieved_at": "2026-10-29T00:09:33.447150+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."
}