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PMCPA Case

AUTH/3073/9/18: Director v Novartis — Clinical trial disclosure (outwith scope; no breach)

📅 2018 | 🖉 Dr Anzal Qurbain
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Key facts

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Case numberAUTH/3073/9/18
PartiesDirector v Novartis
TopicClinical trial disclosure
Complaint received12 September 2018
Completed03 July 2019
Applicable Code year2016
OutcomeNo breach (outwith the scope of the Code)
Clause(s)Outwith the scope of the Code
AppealNo appeal
Additional sanctionsNot stated
PMCPA published summary/reportNo summary and no case report (outwith scope)

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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What happened

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  • A complaint was brought by the PMCPA Director against Novartis.
  • The subject matter related to clinical trial disclosure.
  • The case was assessed under the ABPI Code year 2016.
  • The PMCPA determined the matter was outwith the scope of the Code.
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Outcome

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  • No breach (outwith the scope of the Code).
  • No case summary published (stated as outwith scope).
  • No full case report published (stated as outwith scope).
  • No appeal hearing.
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