{
  "url": "https://openlegislation.uk/human-medicines-amendment-regulations-2019/regulation-8",
  "json_url": "https://openlegislation.uk/human-medicines-amendment-regulations-2019/regulation-8.json",
  "legislation": "uksi/2019/62",
  "legislation_title": "The Human Medicines (Amendment) Regulations 2019",
  "legislation_url": "https://openlegislation.uk/human-medicines-amendment-regulations-2019",
  "path": "regulation/8",
  "kind": "regulation",
  "number": "8",
  "heading": "Insertion of regulation 94A (offences relating to Commission Regulation 2016/161)",
  "text": "After regulation 94 (failure to submit report to EMA), insert—\n“Offences relating to the safety features appearing on the packaging of medicinal products\nOffences relating to Commission Regulation 2016/161\n94A. (1) The holder of a marketing authorisation or parallel import licence, or a parallel distributor, is guilty of an offence if the holder fails to comply with a requirement or obligation contained in a provision of Commission Regulation 2016/161 listed in paragraph (2).\n(2) The provisions mentioned in paragraph (1) are—\n(a) Article 33 (uploading of information in the repositories system);\n(b) Article 40 (products recalled, withdrawn or stolen);\n(c) Article 41 (products to be supplied as free samples); and\n(d) Article 42 (removal of unique identifiers from the repositories system).\n(3) In this regulation “parallel distributor” means a person who imports from another EEA state a product which has been granted a marketing authorisation under Regulation (EC) No 726/2004 and in relation to which that person is not the holder of marketing authorisation, Article 126a authorisation, certificate of registration or a traditional herbal registration.”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2019/62/regulation/8",
    "retrieved_at": "2026-10-28T22:49:09.308987+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."
}