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247 - Could we use global data to support a worldwide market share claim which would include Canada? or is this something that can be confirmed by the sponsor's Med/Reg Department e.g. Drug X: Over 1.5 million patients worldwide.
Claims & Support/References for Claims
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Non-comparative experience claims relating to # of patients (or patient years) can be supported by either providing worldwide/Canadian data or by providing a letter from the sponsor's med/reg department confirming the claim. However, market share claims (such as #1 dispensed...) require independent data (e.g. from IQVIA, Rogers etc.) which meet the market share guidelines which can be found on the PAAB website.
