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

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  PAAB Exemption
  • akar  

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  Hey @akar The Distinction Between Advertising and Other Activities, the Health Canada document which outlines what constitutes advertising, asks a series of questions to determine the nature of the activity. The author and distributor being a medical director in and of itself, does not, in and of itself, necessarily render a piece exempt from Federal advertising regulations, the PAAB Code, or PAAB preclearance. Please see PAAB Q&A 403. While this question asks about “slides”, the same would apply to letters, emails, etc. PAAB Q&A 750 also walks through a similar set of questions to ask about the activity. A letter stating only that the sponsor’s product is available would be exempt from preclearance regardless of the source within the company. But it should be noted that certain industry association Codes do not permit such promotional materials to be signed by Medical/Scientific personnel. Similarly, a letter only indicating that the sponsor’s product is not available would also be exempt. However, in my experience, when such a letter is signed-off by medical/scientific personnel, it’s because the letter goes beyond that simple message (e.g., why the shortage exists, when the shortage is expected to be resolved, what is being done to mitigate the shortage, what prescribers can consider in the meantime, or so on). Anything on this matter beyond the fact that the product is available or unavailable would require preclearance. If you are unsure if the activity would be considered advertising, and if that advertising requires review, please submit a request for a written opinion (see fee schedule on the PAAB website).
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  Linking out to RAMQ website
  • gbrl88  

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  @Jennifer-Carroll said in Linking out to RAMQ website: A link to the formulary site for any province would render the piece subject to review. While a message of “now on formulary” may be considered exempt and the formulary alone is not within the scope of the PAAB code, the linking of the two pieces renders the content subject to the advertising provisions as it creates a link between the brand and a therapeutic message. As per PAAB Q&A 565, the link to RAMQ coverage would be considered a therapeutic link. Hope that helps. Thank you for clarifying Jennifer!
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  767 - It is not uncommon for employees in a sales or marketing function to have the name of the product they support in their email signatures. If such an employee sends an email to a HCP and attaches materials that are not specific to a product (i.e. unbranded disease related) does that attachment now become an APS and therefore subject to PAAB review due to its association to the product name in the email signature?
  • Jennifer Carroll  

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  763 - When and why was the following removed from the PAAB code? Disease information materials which make no mention of treatment by name, class, or category AND are not linked to healthcare product advertising in any way, are exempt from PAAB preclearance. Does it not still apply?
  • Jennifer Carroll  

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  What constitutes a 2 month extension approval?
  • rcolbear  

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  Good Morning @rcolbear As per “Chapter 4. Post Approval” in the document “Guidance on Submission Process”, a request for extension can be submitted for assessment. An annotated copy of the product monograph with all changes since the previous TMA should be uploaded. The PAAB will make an assessment to see if the changes to the product monograph impact the piece. It is possible for changes deemed to be “minimal” by the sponsor, to still have a meaningful impact on the piece. Upon PAAB assessment, if the piece is still deemed to meet the requirements of the Code, a maximum 2 month extension can be granted. Note that it is the responsibility of the manufacturer to ensure that they are not using a piece which is inconsistent with PM updates occurring during approval and/or extension periods. Thank you for the question.
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  750 - We are creating a gated patient website that will show clinics near the patient's location. After initial PAAB approval, is it possible to continue to update the list of available nearby clinics as they open/close/move? Or are those updates subject to PAAB approval again, even if it is within the approved year?
  • Jennifer Carroll  

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  752: My question is specifically regarding a sales rep emailing a (known, consented) HCP one on one with: A) A one line message that a product has now received Health Canada approval with approved indication. No claims, data etc B) A request to HCP to discuss Patient Support Program which may include info on the PAAB approved patient enrolment form Is this communication different if a Medical Affairs staff member sends the email? thanks very much.
  • Jennifer Carroll  

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  750: I’ve reviewed your forum and website but my colleagues and I still have varying views. If a product receives Health Canada NOC, may an employee in a sales role email an HCP with this information with no efficacy claims? Would an employee in a medical affairs position be able to send same email? Is there a difference in who may send communication? Thank you.
  • Jennifer Carroll  

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  749: We are looking to develop a corporate email that would be sent by the reps to outline the opportunity to communicate virtually with them. The layout would be corporate branded with no mention of any brands. The content simply outlines the benefits of a virtual call and how to connect/steps to make a video call. Would this type of information be exempt from PAAB review?
  • Jennifer Carroll  

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  741 - Do OTC product materials require PAAB review? Does this change if they are rep delivered materials vs online (or other multi-channel mediums not driven by sales resp)?
  • Jennifer Carroll  

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  740 - Dear PAAB, The Product Monograph of one of our products has been updated with a new indication. We want to send a message to physicians informing them that the PM for AAA product has been updated with the results of BB study. Since there is no claim/indication in this message, our understanding is that this message is PAAB-exempt. Can you please confirm? Thank you.
  • Jennifer Carroll  

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  739 - For messaging on formulary coverage, in accordance with the PAAB Advisory March 2019, while it is PAAB exempt to state "Drug X: Now on ODB Formulary", can a manufacturer also provide the HCP (along with the PAAB exempt message that the Drug X is on ODB Formulary), a link to the listing criteria on the "ODB Formulary" associated with that particular Drug X?
  • Jennifer Carroll  

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  737 - Hello, We would like to know if PAAB would accept the following tool: A desk-calendar for HCPs to use as a counselling tool for when they are scheduling the next dose of a vaccine. It would also feature facts about the disease and best practice tips. Thank you.
  • Jennifer Carroll  

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  733 - Is it voluntary to get promotional materials approved and simply acts as a benefit to the product or is it this process mandatory?
  • Jennifer Carroll  

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  729 - Can you please confirm that use of a drug name along with its pharmacologic classification (eg. 'diuretic') is exempt from PAAB review? The therapeutic classification (eg. 'antihypertensive') would not be included, as this alludes to therapeutic use.
  • Jennifer Carroll  

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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?
  • Jennifer Carroll  

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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)?
  • Jennifer Carroll  

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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?
  • Jennifer Carroll  

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  706 - Can sales representatives provide information on a drug's reimbursement criteria in response to a question from a HCP if the reimbursement criteria are not aligned with the TMA. For example, the approved Health Canada indication is for use as 2nd line therapy but the drug is only reimbursed for use in 3rd line. Could the sales representative respond to the question and provide information on reimbursement if not aligned with the TMA. Thank you.
  • Jennifer Carroll  

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  702 - Hello, If we are temporarily suspending a website while we update the contact (as the website's current content is set to expire), do we need to PAAB this temporary page? Or since there is not claims and no other pages can be accessed this step is unnecessary? Thanks
  • Jennifer Carroll  

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