{
  "url": "https://openlegislation.uk/medicines-manufacturers-undertakings-for-imported-products-amendment-regulations-1992/note",
  "json_url": "https://openlegislation.uk/medicines-manufacturers-undertakings-for-imported-products-amendment-regulations-1992/note.json",
  "legislation": "uksi/1992/2845",
  "legislation_title": "The Medicines (Manufacturer’s Undertakings for Imported Products) Amendment Regulations 1992",
  "legislation_url": "https://openlegislation.uk/medicines-manufacturers-undertakings-for-imported-products-amendment-regulations-1992",
  "path": "note",
  "kind": "note",
  "number": null,
  "heading": "Explanatory note",
  "text": "(This note is not part of the Regulations)\nThese Regulations amend the Medicines (Manufacturer’s Undertakings for Imported Products) Regulations 1977 (“the 1977 Regulations”) so implementing in part Commission Directive 91/356/EEC (OJ No. L193, 17.7.91, p.30) (“the Directive”) so as to prescribe additional conditions to the undertakings given by or on behalf of manufacturers of imported medicinal products in connection with an application for the grant of a product licence.\nIn particular, these Regulations require manufacturers to undertake—\nto provide and maintain an independent quality control department (regulation 6(2), article 11(1) of the Directive);\nto maintain an effective pharmaceutical quality assurance system (regulation 6(3), article 6 of the Directive);\nto require the keeping of records for five years or until one year after the expiry date of the product (regulation 6(4), article 9 of the Directive);\nto retain samples of starting materials and finished products for the periods prescribed and to keep appropriate records (regulation 6(5), article 11(4) of the Directive); and\nto maintain an effective system whereby complaints are reviewed (regulation 6(5), article 13 of the Directive).\nThese Regulations also exclude from the scope of the 1977 Regulations applications relating to products imported from another member State of the European Economic Community (regulations 4 and 5).",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1992/2845/note",
    "retrieved_at": "2026-10-29T14:11:54.169742+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."
}