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  2. PAAB Q&A
  3. FYI post-approval change/preclearance exemption/what requires review/PAAB scope
  4. 201 - Does a letter announcing provincial listing for a drug need to be PAAB'd? The letter will be a direct mailing from the pharmaceutical company to HCPs in the province announcing the listing, reimbursement criteria and indication of the product.
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201 - Does a letter announcing provincial listing for a drug need to be PAAB'd? The letter will be a direct mailing from the pharmaceutical company to HCPs in the province announcing the listing, reimbursement criteria and indication of the product.

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

    A letter announcing provincial listing for a drug is required to undergo preclearance if includes reimbursement criteria/indication. Note that the preclearance exemption under PAAB code section only applies to a formulary listing announcement which is not linked to a therapeutic claim in any way (e.g. an ad containing only the product name and "Now on formulary").

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