{
  "url": "https://openlegislation.uk/human-medicines-amendment-no-2-regulations-2014/regulation-16",
  "json_url": "https://openlegislation.uk/human-medicines-amendment-no-2-regulations-2014/regulation-16.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/16",
  "kind": "regulation",
  "number": "16",
  "heading": "Insertion of regulation 95A",
  "text": "After regulation 95 (offences in connection with marketing authorisation application) insert—\n“Offences in connection with parallel import licence application\n95A. A person is guilty of an offence if, in the course of an application for the grant, renewal or variation of a parallel import licence for a relevant medicinal product, the person—\n(a) fails to provide the licensing authority with any information that is relevant to the evaluation of the safety, quality or efficacy of the product; or\n(b) provides to the licensing authority any information that is relevant to the evaluation of the safety, quality or efficacy of the product but that is false or misleading in a material particular.”",
  "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/16",
    "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."
}