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  • Guideline terminology: Canadian, US/North American, International
    Jennifer CarrollJ Jennifer Carroll

    Hey @HollyMed

    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.

    Claims & Support/References for Claims

  • Guideline terminology: Canadian, US/North American, International
    H 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?

    Claims & Support/References for Claims

  • Guideline terminology: Canadian, US/North American, International
    Jennifer CarrollJ Jennifer Carroll

    Hey @HollyMed

    Please see Q&A 593.

    Claims & Support/References for Claims

  • Expanded Manufacturer eFile Permissions
    D danthony

    Did you know?

    Manufacturer eFiles users have expanded permissions!

    In response to feedback received by manufacturers, we expanded permissions for manufacturer user and manufacturer admin user accounts in 2023.

    For all eFiles permissions, including client account permissions, please see PAAB : Resources : Do you know what your eFiles account can do for you?.

    If you regularly work within eFiles with a manufacturer user or manufacturer admin account, rest assured, nothing is changing in your day-to-day experience.

    If you currently do not have an eFiles account, we encourage you to register for greater transparency into the eFiles process.

    @Manufacturer

    Announcements

  • Guideline terminology: Canadian, US/North American, International
    H 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)?

    Claims & Support/References for Claims

  • Middle level fair balance linking to high-level fair balance
    Jennifer CarrollJ 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.

    Claims & Support/References for Claims

  • 577 - Hi - I understand that as per Section 6.6iv, an email informing HCPs about 'updated provincial formulary criteria for Drug X' would be considered PAAB exempt (if there were no linkage to therapeutic or promotional claims). Could you provide clarification on whether including a website link to the full formulary list of a province would still be considered exempt? Note that this formulary list contains criteria specific to Drug X.
    Jennifer CarrollJ 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.

    Linkage Issues

  • Middle level fair balance linking to high-level fair balance
    J 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?

    Claims & Support/References for Claims

  • 577 - Hi - I understand that as per Section 6.6iv, an email informing HCPs about 'updated provincial formulary criteria for Drug X' would be considered PAAB exempt (if there were no linkage to therapeutic or promotional claims). Could you provide clarification on whether including a website link to the full formulary list of a province would still be considered exempt? Note that this formulary list contains criteria specific to Drug X.
    A 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.

    Linkage Issues

  • Consensus Guidelines
    M megancouture

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

    PAAB Code

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