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• Live 3.0 PAAB Training

  Have more questions about training? Let us know.

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• About

  Want to know more about the organization, strategic plan, services, and fee schedule? Ask here.

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  For web security reasons, please register with your professional email.

  You are not required to disclose your email on your profile (this can be managed in settings). While we do encourage using your real name for your account, to promote building a community, it is not required, and you are free to use a user name of your choosing (within the limitations of the Community Forum Guidelines).

  Thank you

• Announcements

  Announcements regarding our community

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  Hello @Manufacturer and @Agency

  With the implementation of Law 25 in Quebec on September 22, 2023, PAAB is aware that there will be updates that need to occur to approved websites which are accessed in the province of Quebec. If the sponsor plans to apply a standard pop-up across all sites with the same copy and functionality regardless of website content, PAAB can provide a one-time courtesy review as an FYI. Moving forward, sites which apply the regulations outlined in Law 25 will not require separation into separate files when restricted to the content required to meet the spirit of the law, however the copy should be included within the copy deck (and example images within the layout) so that the reviewer may ensure that no aspects contravene the PAAB Code (e.g., unsubstantiated claims). Where the exact copy is not available to the sponsor (third-party site with no influence) we will request an attestation confirming that the cookies pop-up contains no service or product branding elements (e.g., colours, logos, font), or claims such as corporate claims, therapeutic mention, or links to therapeutic use of a health product. It should also confirm that the copy is restricted to the information required to meet the spirit of Law 25.

  Please feel free to post questions below.
  Thank you

• Tours

  A place for patient and healthcare professional feedback.

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  Enter your comments here.

• PAAB Forum Tutorials

  Have questions about how to use the forum, set up your account, functionality etc.? Ask them here and we'll help you out.

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  Lets start with a quick registration video.

• Newsletters/Blogs

  Blog posts from individual members

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  @costeap Absolutely we can add guidance on why tags were deemed invalid. Great suggestion. We’ll add it in to Q3. Thank you for the feedback.

• PAAB Code

  Do you have questions about particular sections of the PAAB code? Do you have insights on how sections of the code be improved? Do you want to share insights about how related standards are addressed in other jurisdictions? Post here.

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  Hey @mbos

  There are a few regulatory issues that must be considered. For example, the approval process must not be discussed in advertising per C.01.007 of the F&DR. Another issue is that one cannot convey a message that implies a Health Canada endorsement/recommendation.
  We could consider a message which is factual such as “the indication of Product X has changed from NOC/c to NOC”. This message should be presented in a manner that is separate and distinct from other messages (e.g., pivotal trial data that may or may not be the basis for the change).

• Events & Training

  Have more questions about training? Let us know.

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  Hello @erinmacisaac

  We’re in the process of building out the 3.0 training which is be similar in format to last year (case based) and directed at a “3.0 level”.

  If there are topics that you think would be beneficial for a “3.0 level”, please post them below or email them to info@paab.ca and we’ll try to work them into the learning. More details to come.

• Resources

  CEI Survey and Tagging System

  HCP Gating

  Guidance on Code Application

  Guidance on Submission Procedures

  Guidance on DTCA / DTCI Regulations

  Myths vs. Facts

  PAAB Icons

  Activities

  External Resources

  PAAB Logo

  Accelerated Review Options (AROs)
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  @jennifer-carroll Hi there! Thank you for the clarification. I'd like to note that your initial reply has been the basis of many successful renewal submissions, whereby only EN layout has been provided by our agency and others for renewal of originally EN+FR efiles. It was very clear that this was the correct approach:
  Q: "Does this mean that for renewals, we only need to send in the English layout without English and French copy decks?"
  A: "You are correct for straight renewals if the previous file contained a copy correct layout."

  This latest reply is a change to this previously clear policy; it may be simpler to delete the original post to prevent confusion if this is the way things will be moving forward.

• PAAB Q&A

  Claims & Support/References for Claims

  Non-product branded APS, pre-NOC teasers

  NHP, OTC

  CME, educational material, Reprints, reports, textbooks, independently created content

  DTCA/I, consumer secondary audience

  Electronic Media

  FYI post-approval change/preclearance exemption/what requires review/PAAB scope

  Miscellaneous

  Disclosure requirements: PI & Safety Information, Federal schedule, study parameters, reference lists

  Giveaways, Incentives & GIfts, contests, coupons (maybe activities)
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  @jennifer-carroll Thank you for your help!