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    • S

      Scope of Terms of Market Authorization - strictly limited to Product License?
      Terms of Market Authorization • • spi555

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      Jennifer Carroll

      Good Morning @spierf

      The general principle to keep in mind is that therapeutic claims must be consistent with the product’s Health Canada approved “Terms of Market Authorization” (TMA). In the Natural Health Product (NHP) realm, monographs such as the Multi-Vitamin/Mineral Supplements Monograph are intended to serve as a guide to industry for the preparation of Product Licence Applications. Once the NNHPD completes its review of the PLA form, the approved components of the form are reflected on the Product Licence. As such, for NHPs, all claims in advertising should be consistent with the Health Canada approved Product Licence corresponding to the particular product in question (as this is the TMA for said product).

    • N

      Guidelines for Online Activities
      Electronic Media • • NIvanov

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      Jennifer Carroll

      Hello @nivanov
      The section in question (6.6) has been revised and rolled into section 1.5 Materials not Subject to Preclearance of the PAAB Code

      Thank you for identifying the old number. We will update the document accordingly.

    • T

      pre-NOC and post NOC disease state APS
      Non-product branded APS, pre-NOC teasers • • turnapage

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      @jennifer-carroll Thank you for your help

    • K

      edirect campaign to HCP
      Electronic Media • • Kalli

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      Jennifer Carroll

      Hello @kalli,

      If the intent of the message is to promote a company sponsored service/offering linked to a brand, and is created and controlled by the sponsor, it is likely subject to advertising regulations regardless of branding elements within the edirect specifically. Remember that when we link advertising and non-advertising, everything becomes advertising. Similarly, when we link branded and unbranded, everything becomes branded.

    • A

      Guiding Principles for Digital Conferences
      Guidance on Code Application • • admin

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    • H

      Meta data for product website for patients
      Electronic Media • • HollyMed

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      Jennifer Carroll

      Hello @hollymed

      The PAAB does not require that meta-descriptors for webpages be used. We merely require to review them when they are used. On a side note, there may be reasons to use them (or some other meta data) post gate. For example, some implementations of intra-site(post-gate) search would employ these. But as you’ve pointed out, you’d need to make sure that no content beyond name/price/qty appears in external (e.g. Google) search results. That would be a matter of setting the appropriate robot text. Hope that helps.

    • G

      Brand colours in the PM
      Visuals/Layout • • gbrl88

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      Jennifer Carroll

      Good morning @gbrl88

      The treatment does not extend beyond the cover. The reason for this, is that it can be easy to unintentionally emphasize a heading, chart, graphic etc, through the addition of colour.

    • A

      Guidance Documents for Claims Based on Kaplan-Meier Analysis
      Guidance on Code Application • • admin

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    • G

      Using RWE as support for a comparison claim
      Claims & Support/References for Claims • • gbrl88

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      Jennifer Carroll

      Good Morning @gbrl88

      Apologies for not seeing this sooner. Thank you for bringing this document to our attention. This informational piece was put out while we were discussing proposed changes to the use of RWE. However, the proposed change did not go forward. Although these were intended as the beginning of an incremental process of change, following consultation it became clear that the industry felt that the guidance did not go far enough. We are therefore awaiting preliminary output from the ongoing Health Canada and CADTH collaboration on decision-grade RWE. An expert stakeholder committee will work through that output to determine which elements are applicable to drug advertising. As such, we will be taking the document referenced above, down.

      As a courtesy, the document Guidance on Observational Studies continues to inform on acceptable uses of observational studies in drug advertising.

    • D

      Real-world evidence
      PAAB Code • • Donna

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      Jennifer Carroll

      Good Morning @donna
      The proposed change did not go forward. Although these were intended as the beginning of an incremental process of change, following consultation it became clear that the industry felt that the guidance did not go far enough. We are therefore awaiting preliminary output from the ongoing Health Canada and CADTH collaboration on decision-grade RWE. An expert stakeholder committee will work through that output to determine which elements are applicable to drug advertising.

      As a courtesy, the document Guidance on Observational Studies continues to inform on acceptable uses of observational studies in drug advertising.

    • T

      Video embedded in an IVA APS
      Claims & Support/References for Claims • • tmcd

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      Jennifer Carroll

      Hello @tmcd
      If the video is to always be part of the IVA and never shown outside of the IVA, it is fair to assume that the fair balance and logos do not have to be incorporated into the video itself, if it is sufficiently captured in the IVA (i.e. minimum middle level fair balance). When submitting, the IVA should be included in the submission, with clear instructions on the incorporation into the IVA (i.e. placement, access, any additional functionality accorded to the video or IVA to access the video).

    • T

      Pre NOC Communications
      Non-product branded APS, pre-NOC teasers • • turnapage

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      @jennifer-carroll Thank you very much for the advice.

    • Jennifer Carroll

      PAAB 2020-2021 training sessions! Don't miss out.
      Announcements • education training • • Jennifer Carroll

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    • D

      New PAAB logo on APS we plan to retire
      Miscellaneous • • Donna

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      Jennifer Carroll

      Yes @Donna, that would be fine.

    • Jennifer Carroll

      AODA compliance accessibility disclaimers
      Newsletters/Blogs • • Jennifer Carroll

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    • L

      COVID-19 information on patient website
      Claims & Support/References for Claims • • llmktg

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      Jennifer Carroll

      Hey @llmktg

      As a general guidance, advertising material must be consistent with the TMA and be supported by quality references. No copy, content or linkages should suggest that the product somehow helps to manage/prevent/detect COVID-19 infection that extends beyond the TMA.

      With that in mind, any specifics about the disease (COVID) should be directed to the homepage of groups considered to be authoritative sources, such as the WHO and Public Health Agencies for disease information. As the product is not indicated for COVID and it is not likely that there is COVID specific messaging in the TMA, it may be misleading to present this information on the branded website. It could house links to acceptable resources, and house material on practical information, e.g. virtual appts, mask wearing etc. clearly separate from any branding messages or content. The sponsor should ensure separation is done in a distinct manner so as not to suggest that the sponsors brand addresses the condition.

      When we start to get into how comorbidities interact with the condition and it’s treatment or the treatment the patient is on, the evidence requirements are subject to statistically significant data from high quality studies per our usual review.

    • T

      Payer audience
      Miscellaneous • • tmcd

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      Jennifer Carroll

      @tmcd Please see response to PAAB Q&A 302.

    • T

      Patient support program leave behind
      Patient Info • • tmcd

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      Jennifer Carroll

      Good Morning @tmcd

      The PSP is a service offered by the sponsor and for the sponsors brand, it is therefore subject to the PAAB code and would not be deemed exempt.

    • A

      Tips for App Store Review Removals
      Guidance on DTCA / DTCI Regulations • • admin

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    • Jennifer Carroll

      Clarification on Logo Sizing
      PAAB Logo • • Jennifer Carroll

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      Jennifer Carroll

      Great question @rebeccaallen

      For simplicity, we have constructed the chart below: