302 - If the audience is not hc professionals and not consumers- somewhere in the middle (private drug plan managers)- how should this audience be treated?
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Pieces targeted to HCPs and groups which may be comprised of HCPs in addition to other specialized individuals responsible for making decisions about drug therapy which affect Canadians (e.g. drug plan managers and payers) potentially fall within the scope of the PAAB code. Content factors will therefore be pivotal in determining whether the content should be submitted for PAAB review. Here are some key considerations:
- Materials provided "reactively" upon specific request are exempt from PAAB review.
- Kits prepared for review by formulary committees are exempt from PAAB pre-clearance provided the content contained therein follows that committee's submission policy. Where such policy does not exist, the piece would still be exempt if the manufacturer ensures that the provided information is limited to that which would normally be required to support an application.
Where this information package is disseminated, in whole or part, to a wider audience simultaneously, or at a later date, it may be advertising to promote the sale of the drug concerned (in which case it should be submitted for PAAB review)
