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Special FeaturesLast update August 29, 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
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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716

Hello, I'm looking for where to find guidance regarding regulations for executing a 'help seeking' DTC campaign for vaccines at the same time as a branded DTC vaccine campaign. Given the DTC nature, pre-clearance would likely be through ASC. I've reviewed the guidance from Health Canada at length and am well aware of the criteria for help seeking. My understanding is that the help seeking and branded campaigns must be different (ie: in colour, tag lines etc) and not linked in any way, but I'm unable to find specific direction. I'd like to be more clear on how the campaigns must be different, assuming they are not linked in anyway (visually or otherwise), and if/how they may be executed concurrently. ie: can a vaccine help seeking TV ad be on during the same time a vaccines DTC branded banner ad or social media campaign is running (again, assuming not linked in any way). Thank you in advance for your assistance.

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715

Hi, I'm from the Arthritis Society. I have a company that is currently developing a product; in phase 2. They want to support/sponsor one of our tool in a field that is relevant to their upcoming indication. Content and material will be elaborate by the Society without any interference by the pharma company. Would that interfere with any regulation in Canada. If so, which one? Thanks Ken Gagnon kgagnon@arthritis.ca

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714

If a representative during a social meal mentions to an HCP a reference to a slide that was viewed at another meeting to HCP's with regards to utilization rates of a genericized molecule, is this considered a violation?

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713

Can ongoing studies for a group of products (same therapeutic category) be discussed in a Corporate APS, or must this be done in individual branded APS? For example, a company has a portfolio of diabetes drugs that with ongoing research into weight loss indications, and would like to produce a single piece discussing all trials.

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Deputy Commissioner  

Jennifer Carroll
Senior Reviewer Communications

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