@jennifer-carroll Thanks! So, just to be clear, would the message "The formulary status for Drug XYZ has been updated" (not linked to product/therapeutic area messages) by exempt from PAAB review under s.1.5?
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Formulary message - exemption confirmation -
Formulary message - exemption confirmation@jennifer-carroll It is a fact that provincial formularies will often expand the funding criteria for listed products during a product's lifecycle. Can you suggest language that can be used to communicate this fact in a way that does not, in your words, amount to an "unclear claim of product merit and an embellishment". Note that AskPAAB Question 71 indicates that companies may inform of a changes in formulary status.
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Formulary ClaimsAccording to the answer to Question 519 and other guidance PAAB has published, when an advertisement includes details relating to coverage (such as formulary codes or eligibility criteria), the presentation must be complete (e.g. inclusion criteria, exclusion criteria, definitions, notes, etc.) so as not be misleading. Can you advise how a company can meet this requirement for completeness when the coverage details for a drug may be viewed as broader than the terms of market authorization for that same drug?