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I forgot to mention that we would use these in both branded and sometimes unbranded tools.

My client would like to work with KOLs to include real MRI scans for an APS. The scans would be of patients that fit in the product's indication. An agreement would be obtained to use the scans, yet we would use a fictional name for the patient. Are there any other considerations that we would need to consider from a PAAB perspective? Would we need a letter from the medical department to confirm that the scans fit the indication?

My client is creating a branded APS for patients who have already been prescribed the Rx product in question. They would like to use this opportunity to ask the patient to go to a separate site to respond to non-medication-related questions as they would like to do market research specifically with patients who are using the app. Responses would be anonymous and aggregated. Is it acceptable to direct patients from a branded APS to a non-branded market research questionnaire?

For an unbranded tool, can you give a list of study types that might be permissible for disease messages (diagnosis and symptoms), therapeutic options messages and for class MOA messages?

If there is only one product available on the market within a particular category, would the tool be considered exempt from preclearance if the tool talks about the MOA of the category?

My client will be attending a national conference. There will be KOLs presenting studies about the product's efficacy as well as a head-to-head study as part of a symposium. The talks are 3rd party at arm's length. Would this be PAAB exempt?

We currently use the mechanism "Automated cross-validation based on an abstraction from user-level data" in the D.5 section of PAAB Guidance for gating mechanisms. However, the recent online training mentions that it is necessary to use a "Validated License Number" which may suggest a verification from a third party or in-house verification.
It may be a misinterpretation, but we would like to make sure the current methodology we are using is valid for our future projects and that the guidelines are not subject to any change in a near future.

@admin Thank you for this advisory.

1. Does the font for the indication of product B need to be the same size as the font of product A?

2. If an APS mentions product A by brand name, is it acceptable to refer to product B by its generic name?

A client wants to create a branded reminder tool that physicians would give to their patient to help them remember to take their medication. We read section 2.8 and we are wondering if there are any additional details that we should keep in mind (ie. monetary value or other).

A client is considering creating an unbranded vaccine site to raise awareness on the importance of vaccination with consumers. There would be a mention that the site was created by company X, but no promotion of the brand itself.

As part of the website, they want to add a functionality where the consumer can enter their postal code and a list of nearby locations where they can get a vaccination would appear. They only have access to the list of locations that carry their vaccine brand. Would this partial list be acceptable? Also, would it be acceptable to inform the consumer that these sites are known to carry brand X vaccine?

I realize we need a list of references for HCP-targeted information. Are we required to annotate the references if the medical department confirms in a letter that the content is accurate as per the references?

Is it acceptable to refer to a patient organization disease information sheet which strictly discusses the disease state (no brands nor treatments mentioned), in an HCP APS?

My client has a learning program that is unbranded that has been developed by 3rd parties. We realize that this does not require PAAB review. Our question is regarding the communication of the learning program; the content of the promotion consist of the name of the learning app, an image and a logo that identify the therapeutic area, directions and a QR code to access the online site of the learning program, logo of the program.

The invitation would be disseminated via an interactive banner in online medical journals, fax and email (the last two will be managed by a 3rd party and the list will not be shared with the sponsor).

Do the communication materials needs to be reviewed by PAAB? Is it acceptable for the sponsor company to be mentioned, and vice-versa is it acceptable for the sponsor to not be mentioned in the communication assets?

A client has a device that they use in combination with several of their medication products. They want to train HCPs on how to use the device, without ever mentioning any product (no brand, no therapeutic category, no generic names) and no disease states. For example, they would mention to place the device in dominant hand, push this button, wait for click, etc... Does the client need to submit this type of training for PAAB review?

Content was created independently by a group of Canadian physicians where they provide information on how to differentiate between several disease states that closely resemble one another. They also included information from the consensus guidelines, which mentions all the therapeutic categories equally (no emphasis on any category, simply lists 1st line therapeutic category, 2nd line category, 3rd line category. My client was the sponsor for this project but the tool will remain unbranded (no product logo, no brand colours). Their sales reps will not be distributing the tool. A 3rd party will distribute the tool to Canadian physicians. Does this need to be reviewed by PAAB?

A client wants to develop videos to be used on social media. The videos will mention the disease state, but not the product itself. There will be no branding. There will however, be mention of a therapeutic class of products that is common for these patients to take in large quantities. This therapeutic class is not the sponsor's product class, but since the other therapeutic class is so common for these patients, it comes up in comments. Is this allowable?

Hi Jennifer, I have the same question but when I read your response, I am confused by the 'no' and then the 'PAAB code requires that the company name be disclosed except ...'. This particular project is not a help-seeking message.

@Jennifer-Carroll Hi Jennifer, I was not the one who originally asked this question but I am currently wondering pretty much the same thing. Did you happen to get a response from Health Canada on this by chance?

There is a study that was included in an Rx product monograph. However, only certain components of the study were included in the product monograph. Since the study was accepted to be included in the product monograph, would we be allowed to use the components within the study that were not included in the product monograph?

For a rare disease, product X is the only one in its category. There are treatment guidelines which refer to the category as part of the treatment. Is it possible to create a non-branded tool that is meant to be educational, not promotional, that includes the treatment guidelines?