Hello @Jennifer-Carroll, would this mean that safety data from a comparative clinical trial would be permitted in a promotional piece (knowing that there is typically no p-value for safety endpoint), or would comparative trials still be subjected to the "Guidance on secondary endpoints" as other trials outside the PM? And, would it change if the study was NOT the basis for the approval, but was carried out subsequently? Thank you!

@jennifer-carroll Thank you this helps!

Hello @abhi-patel While consumer advertising for Schedule D health products (e.g., vaccine), and ethical schedule health products fall within the scope of PAAB services, consumer advertising for OTC and NHP products does not. Please note that Health Professional directed advertising of these products falls within the scope of the PAAB Code.

Hi @tk2022 Reprint holders are a common term we see in advertising for the “folder” which houses the reprint. This can be as simple as the brand name, study title, and fair balance, or house complex claim copy. The content that appears is at the discretion of the sponsor as long as it meets the advertising requirements. All requirements from Section 2 of the PAAB RWE Guidance would apply. Yes, it is applicable to virtual distributions. An unaccompanied (by any form of verbal or written information designed by or on behalf of the manufacturer for the purpose of promoting a health product) study reprint pdf in its original form (i.e. unaltered) is exempt from PAAB preclearance but not advertising regulations, however if additional verbal/written messages or context is added through the distribution channel, it may not be exempt as noted in our previous response. We suggest submitting for an opinion if you are unsure.

Hey @maryssa The relevant standards of the PAAB Code of Advertising Acceptance are applicable to APS directed at HCPs and APS directed at patients when there is HCP involvement. This remains true regardless of how else the APS may be used. In questions 1 and 2, leaving physical copies of APS in an HCP's practice constitutes distribution involving the HCP. The HCP maintains full control over which materials are allowed to remain in their practice. It would be prudent, as a best practice, to seek permission from the HCP before leaving such materials in their practice. In question 3, the messaging is directed specifically to the HCP. The fact that the messaging is about a consumer campaign does not exempt it from the applicable provisions of the PAAB Code for the message itself. If inclusion of the DTC website/material is for awareness only, it would not subject to PAAB review. However, should there be copy that suggests the material is intended for consumption by the HCP or disseminated to patients through the HCP, e.g. “Tools and resources…”, “Learn more at…”, then the website/material would be subject to PAAB review. Conversely, in question 4, the HCP is receiving the message as a member of the general public. Therefore, the PAAB Code does not apply. While the question may be framed humorously (I would hope), the general public includes individuals from all walks of life, even HCPs. Don't forget the Advisory - APS in Patient Interaction Areas as well.

Hello @mimi77 During the review, you’d want to make the reviewer aware of the intended link. They will advise if it can be linked based on the content in the PAAB-exempt piece and the unbranded disease-state piece undergoing review.

Apologies for the delay @SMurcar. We were in the process of upgrading the forum over the last two days. As the piece would be moving from two sided to one sided this would change the flow. The content in the top section may set context for the bottom section depending on the formatting and flow. We would suggest submitting for a minor update (if the resizing is intended to replace the small postcard altogether) so that we can assess the revised visual flow to ensure all aspects of the Code remain met. The addition of the QR code as described above could be considered as a minor update. Please see the Submission Guidelines for more information

Good Morning @HollyMed Pooled data is not acceptable even if part of a pre-planned long-term extension study.

Hey @dmauri Section 7.3 of the PAAB Code states “Advertising with Product Claim Link to Terms of Market Authorization: One of the following must appear prominently within the main advertising message of the APS: Electronic link(s) to the current TMA (and Health Canada endorsed risk communications issued since approval of the TMA, if relevant) URL(s) for a webpage containing the current TMA (and Health Canada endorsed risk communications issued since approval of the TMA, if relevant) accompanied by a statement that these documents are also available upon request through a stated phone number. The definition of “Terms of Market Authorization” can be found in the Code and reads as follows: Information in the Product Monograph, labeling and product license and the document that assigns a Drug Identification Number (DIN), Natural Health Product number (NPN) or homeopathic product number (DIN-HM), including related product labeling material and prescribing information, authorized by Health Canada. When a Product Monograph is the basis of authorization, it should be linked. If authorization was granted based on a Product License, providing a link to that document would meet the requirements of section 7.3. The TMA document would be the basis for review of the ad.

Hey @vt Yes, you should ensure that the 4 criteria are still followed. These criteria still exist in the distinction document, they are just mentioned across the document and therefore not repeated in this section. For example, the “Content and Context Factors” section in the “Overview” states: • A message involving unauthorized health products or unauthorized indications, in a context such as educational activities, may be considered promotional if: • the message does not caution that the product’s safety and effectiveness are still under investigation and that Health Canada has not yet granted market authorization Within the Educational Activities section, things that could make the piece promotional are: • The limitations of the data and of the health products are not adequately discussed • Reports, edited scripts or recorded videos of the proceedings, in whole or in part, that concern a health product are disseminated by the sponsor or its agent to a wider audience These are in addition to the copy under the revised heading of “Canadian and International Conferences”. In general, if it is a Canadian conference, the content should be created by the Canadian office. If it is an international conference, the content should be created by the parent company and should be adequately disclaimed. Remember that the distinction document is not intended to be an exhaustive list, but a set of guiding principles with examples throughout to help assess context and content. The examples in the “Overview” section should be considered when evaluating individual activities.