Subcategories

• CEI Survey and Tagging System

  Questions and comments around the Accelerated Review Options (set to launch in July 2022)

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  The new CEI Dashboard is now available in eFiles. This dashboard allows you to access all active survey invitations that are awaiting completion within your eFiles account.

  Once you have logged in to your eFiles account, you will see a new tab in the top navigation bar labelled “My surveys”. Within this tab is a list of your active survey invitations for any eFile where you have been identified as the CEI Contact.

  To complete the survey from this list, simply click the “Launch the survey” button associated with the eFile you wish to complete the survey for, and the survey will open within eFiles for completion. After completion, the survey will disappear from your list. If you abandon the survey before completing it, the survey will remain in your list until expiry so that you are able to complete it at a later time.

  Please note: Surveys will disappear from your list upon expiry. Survey invitations expire 2 weeks after initial invitation. If you would like to complete a survey for an eFile for which the link has expired, please contact review@paab.ca for assistance.

• HCP Gating

  Questions and comments around the Accelerated Review Options (set to launch in July 2022)

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  Hello @Manufacturer and @Agency

  We are pleased to announce that guidance on gating mechanisms for HCP digital assets has now been posted.

  In the recent years, it has come to the attention of PAAB and Health Canada, that there has been variance in the application of "sufficient barrier" when it comes to limiting healthcare professional advertising from being accessible by consumers. Considering this, PAAB has worked with Health Canada to generate guidance on the creation and implementation of gating mechanisms which would qualify as presenting a sufficient barrier between the general public and healthcare professional advertising.

  The gating requirements have not changed. This guidance clarifies the existing Health Canada requirements and provides insight into how those requirements can be met. In fact, a new option is outlined to further assist advertisers in meeting gating requirements. The new option is modeled after the gating methodology that is currently predominantly used across this industry. However, as the option addresses areas in which current gates fail to meet requirements, some gates will need to be fortified. It is understood that this will take time. Until January 2024, insufficiently robust gating mechanism noted through our monitoring activities will simply trigger a courtesy email informing the manufacturer of the gating deficiencies and providing potential solutions where applicable.

  Where relevant during preclearance reviews, the PAAB will continue to remind advertisers that an effective gating mechanism will be required.

  PAAB will not provide "approvals" for gates, however we can assess if the approach and guardrails proposed by the company would appear to be sufficient in the context of a formal opinion submission.

  We hope that you find this guidance helpful. If you have any questions, please post them below or in this category: HCP Gating.

• Guidance on Code Application
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  Hey @kshulist

  The guidance does apply in this scenario. In addition to the considerations identified in your question, section 4.2 of the guidance relating to emphasis is also applicable. There should be no emphasis on burdens upon which the product has not demonstrated an effect and it should be part of a balanced presentation that includes burdens upon which the product has demonstrated an effect. Clear and prominent disclosure as per section 5.2 of the guidance will be required and this may include clarification of the indication even if it has already been included elsewhere.

  As a reminder, PAAB will be starting to review under the new guidance starting February 19th.

• Guidance on Submission Procedures
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  @palanski

  We're so glad to hear your team is excited to use the new dashboard! We hope it makes tracking and resubmission more streamlined for everyone.

• Guidance on DTCA / DTCI Regulations
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  @jennifer-carroll Thank you for the clarification!

• Myths vs. Facts

  Digital Conferences
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  Check out some of the top Digital Conference Myths we've seen to date.

• PAAB Icons
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  Enter your Comments here.

• Activities
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  What is this?

  PAAB has been asked to it make it easier to access stage 2 complaint rulings. This has been accomplished by maintaining a registry of all stage 2 rulings on a single webpage in a dynamic table. This complaints page can be accessed any of the following ways:

  By entering "complaints" in the website search field By clicking on the menu item "Complaints" found in the RESOURCE page. The RESOURCE page is accessible through the main navigation menu By clicking HERE

  We've subsequently been asked to consider adding any APS which are subject to future complaints to the registry. Prior to doing so, we would engage in formal consultation with several key stakeholders, including Health Canada and we'd report the consultation findings to our Board. However, before deciding whether to begin this consultation work, we'd like to get a rough idea of the size of the appetite for inclusion of APS within the complaint registry. Please let us know your thoughts by participating in this informal poll. Only users who are registered on the PAAB Forum can vote or to leave comments. Once registered, simply click on the bubble corresponding to your choice then click "Vote" to record your vote. If you see the results screen rather than the options, click “To Voting” to reveal the options.

  Reminder on how to register for an account

  Registration is easy, just complete this REGISTRATION FORM. Note that when setting the password, the system will look for at least 12 characters, at least one uppercase and one number.

  Will I need to register each time I want to participate in the PAAB forum?

  No. The account created by registering just once enables you to provide feedback AND ask questions in comment boxes throughout the website. It also enables you to receive email notifications when there is a reply to your post. Please note that some areas of the website are still under construction.

• External Resources
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  Enter your comments here.

• PAAB Logo
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  In order to create consistency across advertising pieces, and to reflect the rationale behind the “Reviewed by PAAB” logo design, the following ALT text copy should be used when descriptive copy is added for accessibility.

  Reviewed by PAAB

  The PAAB Logo Guidelines have been updated accordingly.

• Accelerated Review Options (AROs)

  Questions and comments around the Accelerated Review Options (set to launch in July 2022)

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  @danthony Thank you for the clarification!