Hey @gmc

Yes, inclusion in the logo qualifies. The answer above is based on an older version of the code. The current code section 2.2 states: In all APS for pharmaceutical products, the brand or trade name, the non-proprietary or generic name and the Federal drug schedule of the product must appear in juxtaposition at least once within advertising copy and must be in good contrast and be legible.

It can appear anywhere in the piece as long as it appears at least once.

Good morning @gmc

Similar to Q&A 332, p=ns data from the PM clinical trials section may be included in advertising providing there are no conclusions or claims that extend beyond that found in the PM. This is possible regardless of whether it is primary, secondary or exploratory.

Hello @hannah

There is insufficient information to determine if the data would be considered off-label, but there is sufficient information to determine that it would not be acceptable data as post-hoc analyses are not considered high quality evidence. Per code section 3.1.1, clinical or therapeutic claims must be based on published, peer-reviewed, controlled, and well-designed studies with clinical and statistical significance clearly indicated. Review articles, pooled data, meta-analysis, post-hoc analysis, and observational studies are generally regarded as not being evidence to support claims in drug advertising. Data included in the TMA may be acceptable. As the data on file in this case is not in the TMA (PM), it is not acceptable for advertising claims.

Hey @natbourre

Without additional details, it’s difficult to provide specific direction. In general, providing an exhaustive list of things to keep in mind is not possible. As the tool is being given to patients, ensure it meets s.6 requirements for patient information, particularly regarding promotional claims, as well as the spirit of 2.8. If you are unsure if the tool would meet these criteria, we would recommend submitting for an opinion.

@danthony Thank you for the clarification!

Hello @gmc , hope you had a great long weekend.

A series submission would be acceptable for this type of APS if it meets the series submission requirements of 60% pick-up.

Hey @taylor-murphy

Please note that the guidance you are referring to states “Launch materials for products approved via Health Canada’s “Interim Order” or their “Accelerated/Priority Review” not “in priority review”. The submission guidance is for approved products. This means Health Canada has granted market authorization with a finalized TMA. Pre-NOC is based on a draft document. The eFile system does not programmatically screen the APS types. This is why the form lists the APS types that are applicable to ARO (i.e., to minimize delays that occur when our admin team needs to return submissions for adjustments).

Furthermore, please note that the first sentence of the previously referenced document clearly outlines PAABs mandate: “The PAAB mandate is to review advertising and promotional systems (APS) for approved pharmaceutical products.”. It also goes on to state “However, PAAB recognizes the importance of product launch timelines, and in this guideline, clarifies procedures for advertising review before Notice of Compliance (NOC) has been granted.” and “PAAB will accommodate pre-NOC submissions at the discretion of the PAAB Commissioner with respect to workload at the time of submission, and will not be subject to the standard turnaround time”.

The pre-NOC policy and the ARO pilot are both manifestations of our commitment to ensuring HCPs and patients receive timely information about therapies. It is important to avoid expediting reviews for materials that cannot be used in the marketplace (as the product is unapproved) at the cost of delaying the review of materials that could be immediately used in the marketplace.

Hello @username

No. Code section 3.1.1 states: Clinical or therapeutic claims must be based on published, peer-reviewed, controlled, and well-designed studies with clinical and statistical significance clearly indicated. Review articles, pooled data, meta-analysis, post-hoc analysis, and observational studies are generally regarded as not being evidence to support claims in drug advertising. Data included in the TMA may be acceptable.

HI @au3010

Assuming that the HCP has already been validated, it is acceptable to grant them access to a patient website. When this is being done, the context of the information that they are going to be provided, should be clearly defined. This means that there should be clear copy informing the HCP that they are being granted access to content designed for patients.

@jennifer-carroll thank you Jennifer!

@jennifer-carroll Thank you this was very helpful

@jennifer-carroll Thank you for your input, Jennifer! We'll take this all into consideration.

Hi @ramy

The original question was for an exempt APS and if there was an issuing linking to the PM. If it was linked to the PM, the ad is no longer considered exempt. As a PAAB reviewable APS, we likely would not object. The answer remains the same when applied to the scenario presented, i.e. the exempt APS is no longer exempt when it links to post gate PAAB approved content. However, as a PAAB reviewable APS, we may not object to this linkage if the content is acceptable.

@jennifer-carroll Thank you so much Jennifer

@eyim

The types of messages listed in section D are exhaustive. However, it is not exhaustive of how the principles might be demonstrated in a specific APS. We offer our opinion services if a company is unsure if an APS meets exemption criteria.

Please reach our to our admin team at review@paab.ca should you require assistance with this service.