Hello @gmc

Hard to say whether this is even acceptable without looking at the study, but as a general question, we can state that this would require highest level fair balance. It is an implied claim of efficacy which would likely require quantification from the study (i.e., presentation of data). If it was stopped due to safety concerns, that would also prompt inclusion of that information and render it subject to highest level fair balance. With respect to “what other data is required for it’s inclusion?”, this is a review specific question. Please submit for an opinion as there are a number of factors that would need to be considered.

Good Morning @ebailey

All files do not need to come back together. You can update the parent file and then apply across all the children files. In general, the parent file should be the one being resubmitted; however we understand that there may be practical reasons to resubmit a child file to get it to approval prior to proceeding with the rest of the children and the parent. When this is the case, please outline this for the reviewer. You may also reach out with an email to admin to confirm that the reviewers agree prior to resubmission.

Hey @supriya

We’re unclear about the request. We can provide an example of how to cross-reference:

Insert an asterisk ( * ) at the point in the text where you want to reference the footnote.

At the bottom of the page, add the corresponding footnote, also marked with an asterisk ( * ).

Cross-references must appear on the same spread as the claim.
Multiple claims can be linked to the same footnote if the footnote would be the same for each claim.

If this is not the question, can you please provide additional context.

@jennifer-carroll said in Imagery:

which exceeds name, price, and quantity, this copy should be blurred to prevent advertising to the general public.

Thank you!

@jennifer-carroll Amazing, thank you so much!

Morning @constance

If the product has not received NOC, a manufacturer cannot promote that a new indication is coming soon as this would be off-label promotion.

@jennifer-carroll Thank you very much for the very comprehensive and helpful response!

@jennifer-carroll Thank you!

Hello @username

Apologies for not seeing this sooner.

Thanks for your question. To clarify, iterative submissions (i.e. different iterations within the same PAAB eFile) do not require light blue shading. Blue shading is requested for child files that are part of a series. The blue shading is used to identify the common copy between the child and the parent eFile.

However, whether you’re renewing an iterative submission or a series parent or child submission, you would shade the copy yellow. Once the submission is a renewal, it is more helpful to reference the backfile to which the copy is 100% pickup rather than shading it in relation to a parent file where the copy may be as little as 60% common.

When using the “express renewal” feature, we will not require that the shading be adjusted by virtue of the way in which the “express renewal” platform functions and the nature of the guarantee that nothing has changed.

Good morning @caitlinbyrne

While “now available” as a stand-alone message is exempt, when it is paired with another marketing claim (route of administration), the piece is no longer exempt. This piece appears to require lowest level fair balance if restricted to the copy noted above.

Hello @tbalzarini

Thank you for bringing this to our attention. We will update shortly. In the meantime, the Health Canada “Guidance on Distinction Between Advertising and Other Activities for Health Products” resource should be consulted.

Hey @cchristopoulos

Descriptive statistics in an RWE do not preclude the use of the publication in an APS as long as they are pre-specified.

Good Morning @au3010

Please see Q&A 520

Good Morning @jennifer_cm

The letter should be from the national body to support that it is widely used by Canadian health professionals. If you would like confirmation prior to building out a piece, the PAAB opinion service can be used to assess the guidelines.

Good morning @jdilly11

Apologies for missing this question earlier.

It is possible. There are a number of things to consider, and the following should not be considered an exhaustive list.

The mechanism of disease (MoD) must be supported by an authoritative source. There should be no inference that a particular part of the mechanism is a more impactful target than another. There should be no explicit or implicit outcomes of targeting the MoD. There should be complete separation from the drug MOA and nothing that is inconsistent with or contradicts the TMA would be considered.

These are high-level guiding principles. All aspects of the Code should be considered when presenting MoD.

@jennifer-thomson

Please see PAAB Code section 3.4, and 4.2.2 as well as PAAB resource PAAB Guidance Documents for Market Share Claims in Advertising and Retention and Market Share Claims. The reference to "data" within these resources is to the data itself. An attestation letter alone is insufficient.

If a claim of #1 within a province can be supported by high quality data from a recognized source with acceptable methodological practices to reach such a conclusion, we can consider the claim. The piece would be required to have restricted distribution to the province mentioned.

Good Morning @alee

What a great question. This one got us thinking. 😊

We see your point if the sponsor can confirm that the cookies are tied strictly to cellular phones, this would appear to be sufficiently targeted to HCPs. Tablets, ipads, and other such devices are much less likely to be tied in a 1:1 ratio with the user (HCP). There should also be explicit cookie approval by the HCP after they have been validated as an HCP. During the review, ALL targeting information would have to be provided. The standard practices for targeting should still be applied.

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.