Hi! We are interested in using a set of International Guidelines to provide messages about its recommendations and to make place-in-therapy claims about our product. While we note that international guidelines are generally not accepted and that PAAB favours Canadian and American guidelines, over 10 of the authors on these guidelines (including the lead author) are Canadian. Furthermore, because these guidelines are for a rare disease, there is no Canadian authoritative medical body that focuses on the disease, so getting "endorsement" from such a body may be difficult. Given these circumstances, would PAAB be a bit more flexible regarding the use of these guidelines?
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International Guidelines with a large Canadian presence in the committee -
Comparative therapeutic claims of schedule 2 products in DTC settingHey @Username
“Schedule 2” is a bit broad. There are many factors and combinations to consider. Could you provide the product or therapeutic class, or Federal drug schedule (see link) to help narrow down the response. Alternatively, if you’re not comfortable sharing in a public space, you can email review@paab. -
Comparative therapeutic claims of schedule 2 products in DTC settingIf there are two randomized controlled trials that support a comparative therapeutic claim for a schedule 2 product (not for a schedule A condition), can the therapeutic claim be mentioned in the DTC setting (e.g., Product A was superior to Product B)?
This seems to be the case according to the "Data Requirements to Support Comparative Claims Related to Therapeutic Aspects of Nonprescription Drugs Used in Consumer-Directed Advertising and Labelling" section of the "Therapeutic Comparative Advertising: Directive and Guidance Document" but it's also a very confusing document and 20 years old, so I maybe misinterpreting the text?
This document also stipulates that "Statements that compare the side effect and safety profiles, of drug products or ingredients, may be made in consumer-directed advertising provided the general provisions of the Directive, this Guidance document and this section are met," is this the case for schedule 2 products?
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Pre-NOC storyboard reviewHello @Jennifer-Thomson
It sounds like this would fall under a PILOT: Administrative Guideline for the Review of Pre-NOC Advertising Submissions. We’d get the file to “no further comments” pending review of the layout (video) post NOC. Please reach out to admin to discuss the specifics so that we can ensure we’re understanding the request and facilitating the best possible pathway to approval. -
Pre-NOC storyboard reviewOur client needs to submit its packaging to Health Canada as a part of its NDS. The packaging will have a QR code leading to an administration video. Health Canada would like the storyboard of the video approved by PAAB. Note that there is no PM yet. Can we have just the storyboard approved pre-NOC without a draft PM, and not have to include a video itself? Would this fall under a 10 day pre-NOC review?
