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  2. PAAB Q&A
  3. FYI post-approval change/preclearance exemption/what requires review/PAAB scope
  4. 71 - As per 6.6d and the exemption of "now on provincial formulary", does this apply to a change in formulary status? As an example "Product Y has a new formulary status". This is of course would not be linked to a therapeutic message but is intended to inform the audience of a change in formulary status. Would such a mention be PAAB exempt?
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71 - As per 6.6d and the exemption of "now on provincial formulary", does this apply to a change in formulary status? As an example "Product Y has a new formulary status". This is of course would not be linked to a therapeutic message but is intended to inform the audience of a change in formulary status. Would such a mention be PAAB exempt?

Scheduled Pinned Locked Moved FYI post-approval change/preclearance exemption/what requires review/PAAB scope
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  • Jennifer CarrollJ Offline
    Jennifer CarrollJ Offline
    Jennifer Carroll
    wrote on last edited by
    #1

    The exemption would still apply given that it remains a "formulary announcement" not linked to any therapeutic message. However, the example that is cited would be unclear as a stand alone because the 'new status' is not well defined in the message and may cause confusion.

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