{
  "url": "https://openlegislation.uk/eu-regulation-2007-658/article-11",
  "json_url": "https://openlegislation.uk/eu-regulation-2007-658/article-11.json",
  "legislation": "eur/2007/658",
  "legislation_title": "Commission Regulation (EC) No 658/2007 of 14 June 2007 concerning financial penalties for infringement of certain obligations in connection with marketing authorisations granted under Regulation (EC) No 726/2004 of the European Parliament and of the Council",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2007-658",
  "path": "article/11",
  "kind": "article",
  "number": "11",
  "heading": "Statement of objections",
  "text": "1. Where, following a request from the Agency pursuant to Article 10(2), the Commission decides to continue with the infringement procedure, it shall notify in writing to the marketing authorisation holder a statement of objections containing the following:\n(a) the allegations against the marketing authorisation holder, including a precise indication of which provision has allegedly been infringed, and the evidence on which those allegations are founded;\n(b) notice that fines or periodic penalty payments may be imposed.\n2. Where, within 18 months of receiving the request from the Agency, the Commission has not notified a statement of objections, it shall provide the marketing authorisation holder with an explanatory statement.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2007/658/article/11",
    "retrieved_at": "2026-11-01T14:52:54.256207+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."
}