Hello PAAB, wondering if a fictitious, unbranded patient would need to follow guidelines in terms of their treatment journey? In real life, HCPs do not always follow guidelines. i.e., if guidelines recommend Product X as first-line treatment, then Product Y as second-line treatment in refractory patients; could an unbranded patient profile show a patient being initiated on Product Y? 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 there, PAAB can provide approval to APS with links to PAAB acceptable pre-proof articles (see also Code section 3.1.2). However, it is the responsibility of the sponsor to ensure that there are no restrictions to the distribution of the pre-proof article prior to full publication (Code section 3.3).

Hey @Username In the consumer space, a standalone message such as “Get Brand X” can be acceptable when used strictly as a DTC reminder ad. However, a URL is rarely a standalone message. Its acceptability depends on the entire ecosystem around it, including: • the content that drives traffic to the URL • the content on the landing page • any content linked after the landing page If those connections change the overall impression or strengthen the implied message beyond a reminder ad, the URL may no longer be acceptable. Because of this, it’s essential to share all current and planned linked content during the review process. With the full context, the reviewer can guide you on whether the URL maintains an appropriate attitude of caution and meets PAAB requirements. It’s also important that any new materials that will link to this URL clearly communicate that a linkage will occur, so PAAB can assess the combined effect.

Happy New Year @dmauri This appears to be a specific question about a specific project and therefore would not qualify as a general question. As a general answer to a general question, we would advise that you should consider linkage principles and assess if linking to unacceptable content is occurring. By having the Canadian page as a subdirectory of the US site it looks like a link is being created. If you’d like to have an interactive discussion, please consider PAAB’s new short-call service which is a 20-minute billable session over the phone or web-conference where the specifics of the project can be discussed, and additional guidance can be provided. Please reach out to review@paab.ca to discuss options.

Hello @ebailey A search of the term "company" on the forum will return Q&A 744 which should answer the above question.

Hi, I am working in a therapeutic area that currently has no Canadian guidelines. A relevant standard-setting organization, on their website, acknowledges that there are no Canadian guidelines and directs HCPs to the US guidelines. Could this constitute adequate endorsement? Thanks!

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.