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Jennifer Carroll

Yes, per the copy "In the scenario described above where guidelines lower in the aforementioned hierarchy are being used over the available US guidelines, evidence must be provided to support that these guidelines are a true reflection of Canadian practice". Note that there may be instances where we ask for more information about US guidelines. This is extremely rare and the rationale is disclosed during the review process. If you find yourself in this rare instance, please reach out to the reviewer for clarification.

HollyMed

Thank you, Jennifer. Is it saying it that in the absence of Canadian guidelines, US guidelines can be used without a letter of endorsement from a Canadian healthcare body?

Jennifer Carroll

Hey @HollyMed

Please see Q&A 593.

danthony

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HollyMed

Hello! Could you please clarify whether US guidelines are considered to be international guidelines in the following statement:

"In the absence of Canadian guidelines we can consider US or North American guidelines. In the absence of those, we can consider international guidelines. When an international guideline is being submitted, we require authoritative support that the International guidelines are endorsed by a recognized Canadian health
professional organization representing this therapeutic area."

This statement sounds like US guidelines do not need Canadian endorsement, whereas international guidelines do. Wondering if you are separating out US/North American guidelines from international guidelines. Could you please specify when specifically the Canadian endorsement is needed for guidelines (assuming there are no Canadian guidelines available)?

Jennifer Carroll

@Jennifer_CM
Example 3 appears to be about the product monograph web link destination. The original question above is about linking middle level fair balance to highest level fair balance. Linking middle level fair balance to highest requires that it’s within the same tool or directly attached. A print journal ad is not the same medium as a URL link (web based) and therefore would not be acceptable.

Jennifer Carroll

Hey @ALee
“Indirect link to a general formulary/Provincial homepage” is the same as “full formulary list of a province”. As per the response above, this would not be considered exempt.

Jennifer_CM

As a follow up, if you have middle balance in a printed journal ad with a URL to the PM on manufacturer’s website (no gating required), would that be permissible per example 3 in the July 2013 guidance document?

ALee

As a follow-up to Q&A 577, we understand inclusion of the written statement “See Formulary listing for more information” would still be exempt for a simple “Now on Formulary” Email. Can you please advise if an indirect link to a general Formulary/Provincial homepage would maintain this exemption? The Sponsor has done their diligence in not directly linking to the therapeutic use, and the onus would be on the HCP to seek out the product information (if desired) through the Formulary.

megancouture

Hi @Jennifer-Carroll , thank you so much for confirming!

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