{
  "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-3/paragraph-10",
  "json_url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-3/paragraph-10.json",
  "legislation": "uksi/1994/3144",
  "legislation_title": "The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994",
  "legislation_url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994",
  "path": "schedule/3/paragraph/10",
  "kind": "paragraph",
  "number": "10",
  "heading": "Offences",
  "text": "Any person who, while employed or engaged as an appropriately qualified person responsible for pharmacovigilance for the purposes of Chapter 3 of Title II of Council Regulation (EEC) No. 2309/93, or Chapter Va of Council Directive 75/319/EEC fails to—\n(a) establish or maintain a system for collecting and collating information about suspected adverse reactions;\n(b) prepare for the licensing authority a report on any such reactions; or\n(c) ensure that a request from the licensing authority for the provision of additional information necessary for the evaluation of the benefits and risks afforded by a relevant medicinal product is answered fully and promptly,\nas required by any provision of any such Chapter, shall be guilty of an offence.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [
    {
      "type": "added",
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      "affecting_title": "The Medicines (Provision of False or Misleading Information and Miscellaneous Amendments) Regulations 2005"
    },
    {
      "type": "added",
      "affecting": "uksi/2005/1710",
      "affecting_title": "The Medicines (Provision of False or Misleading Information and Miscellaneous Amendments) Regulations 2005"
    },
    {
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    {
      "type": "added",
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      "affecting_title": "The Medicines (Provision of False or Misleading Information and Miscellaneous Amendments) Regulations 2005"
    },
    {
      "type": "words substituted",
      "affecting": "uksi/2005/2759",
      "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005"
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    {
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      "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005"
    },
    {
      "type": "am",
      "affecting": "uksi/2006/1952",
      "affecting_title": "The Medicines for Human Use (National Rules for Homoeopathic Products) Regulations 2006"
    },
    {
      "type": "amended",
      "affecting": "uksi/1998/3105",
      "affecting_title": "The Medicines for Human Use (Marketing Authorisation Etc.) Amendment Regulations 1998"
    },
    {
      "type": "amended",
      "affecting": "uksi/1998/3105",
      "affecting_title": "The Medicines for Human Use (Marketing Authorisation Etc.) Amendment Regulations 1998"
    },
    {
      "type": "word substituted",
      "affecting": "uksi/2009/3222",
      "affecting_title": "The Medicines (Products for Human Use) (Amendments to Fees for Variations) Regulations 2009"
    },
    {
      "type": "applied (with modifications)",
      "affecting": "uksi/2010/1882",
      "affecting_title": "The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010"
    },
    {
      "type": "applied (with modifications)",
      "affecting": "uksi/2010/1882",
      "affecting_title": "The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010"
    },
    {
      "type": "applied (with modifications)",
      "affecting": "uksi/2010/1882",
      "affecting_title": "The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010"
    },
    {
      "type": "inserted",
      "affecting": "uksi/2010/1882",
      "affecting_title": "The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010"
    },
    {
      "type": "words inserted",
      "affecting": "uksi/2010/1882",
      "affecting_title": "The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010"
    },
    {
      "type": "words inserted",
      "affecting": "uksi/2010/1882",
      "affecting_title": "The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010"
    },
    {
      "type": "inserted",
      "affecting": "uksi/2010/1882",
      "affecting_title": "The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010"
    },
    {
      "type": "words substituted",
      "affecting": "uksi/2010/1882",
      "affecting_title": "The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010"
    },
    {
      "type": "added",
      "affecting": "uksi/2003/2321",
      "affecting_title": "The Medicines for Human Use (Fees and Miscellaneous Amendments) Regulations 2003"
    },
    {
      "type": "am",
      "affecting": "uksi/2003/2321",
      "affecting_title": "The Medicines for Human Use (Fees and Miscellaneous Amendments) Regulations 2003"
    },
    {
      "type": "inserted",
      "affecting": "uksi/2004/3224",
      "affecting_title": "The Medicines (Marketing Authorisations and Miscellaneous Amendments) Regulations 2004"
    },
    {
      "type": "inserted",
      "affecting": "uksi/2004/3224",
      "affecting_title": "The Medicines (Marketing Authorisations and Miscellaneous Amendments) Regulations 2004"
    },
    {
      "type": "Sch. 3 para. 1A renumbered as Sch. 3 para. 1A(1)",
      "affecting": "uksi/2005/2759",
      "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005"
    },
    {
      "type": "words inserted",
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      "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005"
    },
    {
      "type": "words inserted",
      "affecting": "uksi/2005/2759",
      "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005"
    },
    {
      "type": "inserted",
      "affecting": "uksi/2005/2759",
      "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005"
    },
    {
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      "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005"
    },
    {
      "type": "words inserted",
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      "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005"
    },
    {
      "type": "inserted",
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      "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005"
    },
    {
      "type": "words substituted",
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      "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005"
    },
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      "type": "words substituted",
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      "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005"
    },
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      "type": "words substituted",
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      "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005"
    },
    {
      "type": "words substituted",
      "affecting": "uksi/2005/2759",
      "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005"
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    {
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    },
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    {
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    {
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    },
    {
      "type": "inserted",
      "affecting": "uksi/2005/2759",
      "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005"
    },
    {
      "type": "words substituted",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002"
    },
    {
      "type": "words substituted",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002"
    },
    {
      "type": "words substituted",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002"
    },
    {
      "type": "words substituted",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002"
    },
    {
      "type": "words substituted",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002"
    },
    {
      "type": "words substituted",
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    },
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      "type": "words substituted",
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    },
    {
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      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002"
    },
    {
      "type": "substituted for words in Sch. 3 para. 10(c)",
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      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002"
    },
    {
      "type": "words substituted",
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      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002"
    }
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  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1994/3144/schedule/3/paragraph/10",
    "retrieved_at": "2026-10-29T13:21:07.489272+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."
}