Hi @supraja When a Risk Management Measure/Tool (RMM/T) is intended to be distributed with any other PAAB reviewed pieces, the entire package is considered in context and should be submitted as a separate PAAB review/opinion. We are unable to comment on the compliance of the proposed APS without assessing the content of the APS and suggest submitting for review or an opinion. During the review, we would be able to provide advice on the acceptability of the APS content and its linkages. Any folder intended to be combined with an RMM/T is also subject to PAAB review. Please see our guidance document on RMM/RMTs for context of use and other information.

Hi @supraja In general, actual patient images may be used in HCP materials. Please see the following PAAB Forum post Q&A for additional details. For patient materials, actual images may also be used with a disclaimer when consistent with part 3 of the product monograph but with a caveat. Patient materials may not contain promotional claims as per code section 6. Patient images will not be accepted if they are determined to be promotional.

@llmktg Graphs and tables that are informational in nature are generally not considered creative imagery. Creative imagery usually refers to visuals such as photos or images that are often intended to accompany a claim of benefit or to infer a claim of benefit.

@sean-cai Hi Sean.cai. The development of the Renewal Management Dashboard was done in collaboration with both an agency committee and a manufacturer committee. On page four of the attached Renewals Management Dashboard Guide, found on the Renewals Management Dashboard page of the PAAB website, the process for batching and notification settings is identified to address your concerns about email volume.

Hello @gmc Please see Appendix A for turn around times. Turn around post approval is impacted by the final approved PM and if it is different from the PM in the previous round of review. Whether ARO is available for additional pieces would depend on the ARO requirements (i.e. length, new content, etc.).

@charlton The proposed plan does not necessarily contravene the PAAB Code provided the messaging in those advertising materials are within the limitations of the product’s label. However, there is more than the PAAB Code to consider here. While the materials may be designed in a manner that meets the applicable standards of the PAAB Code, use of those materials in the proposed context may trigger activities/discussions that fall within the scope of federal regulations despite falling outside of the PAAB Code’s scope. Consequently, it may be prudent to pause and consider whether this proposed approach fits the company’s risk profile from the perspective of broader federal regulations. For example, it may be challenging to manage risks related to the conference context. As is always the case, sales reps operating the booth must not discuss off-label uses (even in response to requests for such information as this reactive discussion would be taking place in a promotional context that is subject to federal advertising regulations). The more challenging nuance, relating to this case specifically, may be that it would be difficult to direct attendees to the medical booth without appearing to have intended to trigger that off-label discussion all along. This would likely disqualify the off-label discussion from the federal advertising regulation exemption relating to “unsolicited” requests. Additionally, please be reminded that in-person branded booths should not include or be linked in some manner, to unbranded editorial material, exempt material, press releases, learning sessions, etc. The same principles apply for digital conferences with digital linkages, targeting, etc. as well. Please see our Digital conferences document for other considerations.

@username Hello. As the example does not specify the product, we are unable to answer the question directly. The product, therapeutic area and Health Canada product schedule will determine which regulations apply in the DTC space. We direct you to the Food and Drugs regulations and the document Guidance Document: Schedule A and Section 3 to the Food and Drugs Act. It will provide clarification on advertising restrictions to the general public. Please note section 3 and 2.3 of the document regarding Schedule A diseases in advertising. Linking a DTC website even to an unedited PM may be a violation of the regulations depending on the therapeutic area. We suggest contacting PAAB for a general question call should you need further clarification. Please also note that the DTC site is considered promotional advertising so the Distinction document does not apply in this scenario.

Hello @username 1.4D states: “The Code applies to all Advertising/Promotion Systems and corporate messages directed to licensed members of the professions of medicine, dentistry, naturopathy, homeopathy, nursing, pharmacy and related health disciplines, to institutions, and to patient information that will be distributed by or recommended by a healthcare professional.” Please also see Code section 7.4 for direction of corporate advertising. The Code also states that a corporate message may be considered exempt if it meets 1.5E “Corporate Messages that do not Contain Product Information or Product Lists”. The Distinction Between Advertising and Other Activities states: *Corporate messages - A corporate message is a communication (such as a website, brochure, published article, prospectus or annual report) that gives information about a health product manufacturer or organization. This information could be on the philosophy, activities, product range (by name), financial details and/or area of future development or research. Corporate messages, or information disseminated through corporate messages, may be considered promotional if: they seem to provide information about the health products being marketed, developed or researched rather than the manufacturer or organization there is far more information about the health product being marketed, developed or researched than simply its name and the therapeutic area in the case of unauthorized drugs or an unauthorized indication, there is no mention that the product's safety and efficacy is still under investigation and that Health Canada has not yet granted market authorization* Given that we do not know the specifics of the content, it is hard to say if this would qualify as an exempt or non-promotional message. It seems probable that a discussion around manufacturing practices and processes may have implications for brands (e.g., manufacturing process of monoclonal antibodies could easily have implications for the safety and efficacy of the brands mentioned and linked on the parent company website) rather than the manufacturer’s philosophy, activities, or areas of future research and development. We would recommend submitting for an opinion. As a courtesy, if it requires review and you know you will proceed with that review should that be the case, we suggest including something similar to “If this does not meet exemption criteria we would like to proceed with a full review” in the cover letter so as to not incur a new file new fee upon submission for review (see PAAB Policy and Procedure for Exemption Requests). You may also find Q&A 440 helpful.

@jennifer-carroll Thank you very much for your response. We will submit the formal request.

@supraja yep.

Hey @arat101 It is hard to answer this question without the context of the headline copy. As both pieces are branded, we would assume that the claim has been accepted in the context of the brand. A consideration is that content written for consumers (who you cannot promote its therapeutic use for Schedule F drugs) can sometimes be inappropriate for HCP advertising since HCPs would link the message with the therapeutic use, which could change the meaning of the statement. This could impact acceptability of use in HCP pieces.

Good Morning @marta Brand-specific "fair balance" as a term outlined by PAAB, is in reference to promotion of a healthcare product. Unbranded material should not place emphasis on information specifically about the sponsor’s product(s) as this would render the piece branded. Fair balance is inherently branded as it is specific to the brand and would make mention of the brand. There is no way to put brand-specific “fair balance” on an unbranded piece. This should not be confused with the requirement for the piece to be balanced and complete. An unbranded piece should still be balanced.

@jennifer-carroll Hi Jennifer, thank you for your detailed response. I was simply wondering if there was an example of a paid social submission provided in any of the online guidance resources. From your response, I don't believe there are any. thank you

Hello @tayyeba The PAAB Code applies to advertising directed to HCPs and information provided to patients through an HCP. Direct to consumer advertising of healthcare products and is reviewed against the Food and Drug Act and Food and Drug Regulations. Both PAAB and Ad Standards can provide this review. When the primary audience is patients, it should be reviewed by PAAB. If it will also be visible to consumers, this should be disclosed to PAAB at the time of review. PAAB can concurrently provide a DTC review (i.e. the piece would be subject to the applicable sections of the Food and Drugs Act and Regulations, policy and guidance documents pertaining to advertising, and the PAAB Code). Regardless of who reviews the content, it should be sent to Health Canada by the respective agency per Health Canada’s request to see all DTC advertising.

@jennifer-carroll Thanks very much for your feedback.

@jennifer-carroll thank you for your input!

Hey @nimisha We are assuming that you mean “a resource in Veeva which is a PAAB approved HCP email”. If so, yes, it is possible to use patient feedback. Claims should be limited to the program features. If it’s a branded PSP, copy may have implications for the brand. Additional nuances may arise during the review process.

Hello @nimisha In the scenario described above, the HCP is the secondary audience. Why do we say that? We say that because a brochure intended to be shared with a patient should be written in patient friendly language (content is based off part III of the TMA). A HCP should not be detailed to off a patient brochure. They are the secondary audience as they will see the brochure before handing it to the patient, but they’ll be viewing it with the understanding that it is patient information. Depending on where the holder is intended to be placed, you may also need to consider the consumer regulations. For example, if the holder is intended to be placed in a context that is visible to anyone who enters the examination room, then any openly visible element on the holder (and any exposed section of the brochure) must not exceed the consumer regulations (see Q&A 240 for additional guidance).

Happy Friday @username The status of NOC/c does not impact which DTC regulations are applicable.