{
  "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-3/paragraph-7",
  "json_url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-3/paragraph-7.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/7",
  "kind": "paragraph",
  "number": "7",
  "heading": "Offences",
  "text": "Any person responsible for placing on the market a relevant medicinal product authorized by the Community or by the licensing authority who, at any time, does not have at his disopsal an appropriately qualified person responsible for pharmacovigilance as required by Chapter 3 of Title II of Council Regulation (EEC) No. 2309/93 or Chapter Va of Council Directive 75/319/EEC shall be guilty of an offence.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [
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      "affecting_title": "The Medicines (Provision of False or Misleading Information and Miscellaneous Amendments) Regulations 2005"
    },
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      "affecting_title": "The Medicines (Provision of False or Misleading Information and Miscellaneous Amendments) Regulations 2005"
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      "affecting_title": "The Medicines (Provision of False or Misleading Information and Miscellaneous Amendments) Regulations 2005"
    },
    {
      "type": "words substituted",
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      "type": "am",
      "affecting": "uksi/2006/1952",
      "affecting_title": "The Medicines for Human Use (National Rules for Homoeopathic Products) Regulations 2006"
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    {
      "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",
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      "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",
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      "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",
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      "affecting_title": "The Medicines for Human Use (Fees and Miscellaneous Amendments) Regulations 2003"
    },
    {
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    },
    {
      "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)",
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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": "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"
    },
    {
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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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    },
    {
      "type": "words substituted",
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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",
      "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",
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    {
      "type": "words substituted",
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    {
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      "affecting": "uksi/2002/236",
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    },
    {
      "type": "substituted for words in Sch. 3 para. 10(c)",
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      "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/7",
    "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."
}