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  3. Terms of Market Authorization
  4. 396 - Does PAAB let us place information in detail aids that is in a reference found in a PM but not in the PM text itself?
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396 - Does PAAB let us place information in detail aids that is in a reference found in a PM but not in the PM text itself?

Scheduled Pinned Locked Moved Terms of Market Authorization
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  • Jennifer CarrollJ Offline
    Jennifer CarrollJ Offline
    Jennifer Carroll
    wrote on last edited by
    #1

    Mention of a study in the PM bibliography has no influence on the PAAB review. PAAB code section 3.1.2 states that citation in the bibliography section of the Product Monograph does not indicate proof of acceptance by Health Canada. For consideration in advertising, a reference must meet the PAAB code requirements relating to the desired claim regardless of whether that reference appears in the PM bibliography or not.

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