Hi, I understand that NOC/c product materials have to have the text "PRODUCT has been issued conditional marketing authorization pending the results of studies to verify its clinical benefit. Patients should be advised of this conditional marketing authorization."
My question is- does this text always have to be accompanied by the indication or can there be PAAB exempt pieces where only this text is there and no indication? Thanks!
G
gbrl88
@gbrl88
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Posts
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NOC/c box without indication -
Brand colours in the PMHi PAAB! According to the promotional monograph guidance doc (http://www.paab.ca/resources/pdfs/code-revision/Guidance_on_Promotional_Monographs.pdf) “a product monograph wrapped in a simple cover (e.g. brand colours) does not require PAAB review”. We were wondering if this treatment may extend to the pages of the PM such that that brand colours are also added to the subheadings/tables/etc, without changing any text or creating any undue emphasis on specific sections? Thanks
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Information about controlled substance advertising regulationsHi PAAB, what are some good resources to learn more about discussing controlled substances with HCPs including promo, rep activities, sampling, etc?
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Using RWE as support for a comparison claimHi PAAB, I saw your guidance on the use of RWE here (https://www.paabtraining.com/rwe.html) and I am wondering if this extends to 'high quality' studies in which the efficacy of two or more products is compared? For example - an observational study including data from patients using several products? Thank you for your time!
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Linking out to RAMQ website@Jennifer-Carroll said in Linking out to RAMQ website:
A link to the formulary site for any province would render the piece subject to review. While a message of “now on formulary” may be considered exempt and the formulary alone is not within the scope of the PAAB code, the linking of the two pieces renders the content subject to the advertising provisions as it creates a link between the brand and a therapeutic message. As per PAAB Q&A 565, the link to RAMQ coverage would be considered a therapeutic link. Hope that helps.
Thank you for clarifying Jennifer!
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Linking out to RAMQ websiteCould you please clarify if a piece that links out to the RAMQ website can still be PAAB-exempt given the formulary requirements specific to Quebec? Thank you!
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Linking from a branded HCP site to a non-promotional website with HCP resources.Dear PAAB, we are interested in linking from a branded HCP site to a non-promotional website with HCP resources (which may include off-label information). Is it possible to do so? For example - if we link from a post-gate page of the branded HCP site and the user lands on a simple 'landing page' where they must log in to view resources. Thank you for your time.
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If making a branded website for patients such as 'Product.ca' that has information about what the product treats - is it necessary to gate that website because consumers can see it?patient, dtc, gating