Disclosure requirements: PI & Safety Information | Federal schedule | study parameters | reference lists


When constructing Fair Balance, under “Other relevant warnings & precautions,” are we required to include caution in use within certain patient populations where no/limited safety or efficacy data are available? In this situation, patients with certain medical conditions were excluded from the clinical trials, as is standard with other brands in the category. When it […]


Has the PAAB ever considered a “priority review” stream, whereby Clients could receive a shorter initial review (3-5 days vs 10) for a higher fee ($1000, $2000, etc)? There are occasions where guaranteed expedited timing is vital, and this option would serve the industry while generating additional revenue for the PAAB. To restrict use, Submission […]


I’m curious as to why the STI Innovicares program is allowed to advertise specific brand name drugs on a website without PAAB review; especially given two main pharmaceutical companies are behind a large promotion of their brands (AZ/Sanofi)? Isn’t this considered DTC advertising linked to brand name drugs? The website is at www.innovicares.ca and also […]


Would a natural OTC Supplement (no DIN number) require PAAB approval for promotional materials targeted to HCPs? Would consumer advertising require PAAB and/or ASC? Per PAAB code section 11.3(a), APS promoting supplements purely for the maintenance of normal health do not require PAAB review. Note that APS directed to healthcare professionals (or patients through healthcare […]


When PAAB approves a submitted piece, it provides an approval identification number. Can you advise me as to the configuration of that number? How many characters is it? Is it an alpha-numeric configuration? We are formatting a cloud-based internal review system and would like to capture our PAAB approvals accordingly. Thank you. Currently, our PAAB […]


It seems to be standard industry practice to post the Product Monographs for pharmaceutical drug products on the corporate websites. There are no ancillary messages provided with these, just the links to the full texts of the product monographs. In addition, these PMs are available through Health Canada’s Drug Product Database to anyone who searches, […]

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