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Special FeaturesLast update June 4, 2019

Ask PAAB

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We have enhanced the Ask PAAB section to make it more user-friendly due to the growing number of questions. You can now select a category of interest from the drop down menu above to view existing question and answers or you can also do a search for questions that have been submitted to Ask PAAB since the beginning.

Most Recent Questions and Answers
726

Hi Patrick, I often find it easier to apply PAAB code when I understand the rationale behind it. But I have struggled to understand the blanket application of section 3.1. In many instances, the PAAB requirement that claims remain "within the limitations of the TMA" makes sense - specifically when "beyond the limitations" is also off label. However, I am curious to know why efficacy and safety data from longer-term, follow-up of the pivotal trial population is not allowed - especially when we hear from physicians that this is the information they are most interested in. As long as there is no limitation on length of therapy, why not allow longer-term clinical information to be shared with physicians? What is the rationale for blocking it? 

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725

Question 497 - Patient video for product use on company website , has Health Canada provided a response? 

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724

We have an HCP piece approved by PAAB to be used as a print Leave-Behind. We would like to use a part of the content (unchanged) for a digital advertisement. Does is require to be submitted to PAAB as a new file?

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723

We are in the early stages of planning a website for use by healthcare professionals and patients (gated appropriate for each) to access disease and product information for multiple therapeutic areas. For convenience, we wish to create on the ungated home page a link to a portal (also gated) housing accredited CHE for healthcare professional sponsored by the company, The user would be notified that they were leaving the main site and as mentioned they would have to pass through the gate of the CHE portal. Some of the accredited CHE may contain content not consistent with product TMAs. How do we avoid any linkage issues while offering convenience to healthcare professionals of going to one location?

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722

Understanding that Help-Seeking messages can not include the sponsor, what if a message was broad enough not to allude to a single product? eg. “Ask your doctor about CV medications from Company-X”.

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721

Can a patient survey be used to support claims of ease of use? Would it make a difference if the prescription product were administered through a Class-II medical device?

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720

What are the rules regarding using similar graphic symbols for branded PAAB approved promotional pieces addressed to HCPs and branded DTC materials for the same OTC product. Is it acceptable that they have the same graphic elements such as icons to illustrate the approved claims/indications?

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719

With regards to question #645, the question asked about repurposing a piece approved for DTC use with "potential patients". Is a potential patient not viewed as a consumer? I thought the definition of patient was restricted to those who had already been prescribed a drug. I had previously been advised by a PAAB reviewer that pieces for "potential patients" would be reviewed as DTC. Could you please clarify the differences in these audiences? Thank you.

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718

If a efile was previously exempted and no changes were made, does the file need to go through PAAB assessment again (re-exemption)?

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717

How can I access archival copies of the PAAB Code? I am looking for the version relevant to 1996. Many thanks. 

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Deputy Commissioner  

Jennifer Carroll
Senior Reviewer Communications

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Code of Advertising Acceptance
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Have a great summer and see you in September.