Forum

@jennifer-carroll that makes sense, thank you for clarifying!

@jennifer-carroll Hello,

I have a follow-up question to this post, and regarding the exemption criteria 1.5Dii.

Would a message that simply states "Covered by private insurance" be considered exempt? Since it doesn't mention any statistics or number of patients, would it be viewed as similar to "now on provincial formulary”?

Appreciate your guidance!

@jennifer-carroll ok that clarifies things, thank you very much!

Hello,

PAAB distinguishes patients from consumers based on whether they have been prescribed/have received a product or not. Does the same logic apply to vaccines?

1. Would a branded APS promoting the vaccine (to people who haven't received it yet) be considered a DTC piece, and therefore allowed to be promotional within the scope of the Health Canada "The Distinction Between Advertising and Other Activities" guidance? Does this change depending on placement of APS (eg, social media ad vs HCP waiting room poster)
2. What would constitute a "patient" piece when it comes to vaccines? Would it only be materials given to patients after they have received the vaccine? And would such a piece need to be non-promotional like all other patient materials for pharmaceuticals or are they treated differently since vaccines are Schedule D?

@jennifer-carroll I will do that. Thank you for your help!

@jennifer-carroll apologies, I want to ensure I'm understanding this correctly since it has cost implications.

"we could consider each backup banner of the original intended banner as an iteration in the submitted eFile"

Each size of the banner is already being submitted as an iteration. Do you mean that each size of static backup also needs to be a separate iteration? Or can all the sizes of the static be submitted as ONE iteration?

For example, if a banner ad is to have 5 sizes, each with a static backup (content is the same across all animated and across all static), will that eFile submission contain 10 iterations or 6 iterations?

@jennifer-carroll Thank you for the clarification!

I have a follow up - can static backup banners for each size (which appear when the banner fails to load) be included in the same eFile as part of their respective size's iteration? Or do all the static backups need to be submitted as 1 separate iteration? I ask because the content of the static backup would be different from that of its animated counterpart.

Thanks for your guidance.

@supraja - Post moved

Hi @Jennifer-Carroll ,

I came across this post and am seeking clarification - https://forum.paab.ca/topic/2518/banner-ads-in-different-sizes/2

The latest Submissions Guidance I could find states - "In campaigns involving multiple banner ads, the individual banner ads should be submitted in separate eFiles".

However, following up on your response to the old post, can you please direct me to the new guidance which states multiple sizes of the same banner ad can be submitted in the same eFile? How would the fees be applied - would each size be considered an iteration? Also, we are not required to submit HTML or video files of the animated banners, correct?

Appreciate your help, thank you!

@jennifer-carroll Thanks very much, this is helpful!

Hello PAAB,

If a diagnostic test is required to determine eligibility for a drug, and we create a leave behind for HCPs explaining what the test is, how to order it, information on testing centres etc

1. Either without mentioning the drug name at all, and not having any branding elements tying to the drug
2. Or mentioning the drug name in a non-promotional, informational sense, also sans branding elements

Would such a piece be PAAB-exempt in one or both scenarios? Thanks for your guidance!

Hello,

I have a few questions regarding DTC SEM for vaccines:

1. I understand that SEM ads for Schedule D drugs can contain claims. However, what are the other differences in the regulations for SEO/SEM when it comes to vaccines?
2. Can keywords for a vaccine's SEM campaign include indication, patient population etc?
3. Can keywords for a vaccine's SEM campaign include competitor brand/generic/manufacturer names?
4. If the DTC SEM campaign is only reviewed by ASC (and not PAAB), then do PAAB's guidelines still apply?

I have scanned forum posts regarding SEM and read the guidance on online activities but couldn't find an answer when it comes to vaccines. Appreciate your guidance!

Dear PAAB,

We would like to combine a branded patient brochure and a branded patient risk management measure (approved by Health Canada and PAAB) together into a folder for dissemination to patients.
Since both pieces are non-promotional and would only be provided to patients already on the medication by their prescribing physician, can you advise if this would be compliant?

In the same context, can you please confirm that the folder in question be exempt from PAAB review if it only featured the brand logo with a simple label like Patient Materials?

Hello PAAB,

Are we allowed to use real patient images in patient and HCP materials, including images of patients from clinical trials (for newly approved products)? Do we need to include any disclaimers such as "Actual Product X patient" or "Not a real patient" depending on images used?

Hi @jennifer-carroll,

That answers any lingering questions I had, thank you so much for taking the time to explain!

Hi @jennifer-carroll,

Thanks for the thorough explanation, as well as for directing me to similar questions on the forum! I now understand that the modifications we have in mind would deem it a promotional monograph and require PAAB review.

You mention "The PAAB review would entail ensuring the visual treatments do not create emphasis and the logo/icons are not promotional", however, by nature, a promotional monograph is promotional, and colour treatments will certainly create emphasis not present in the original black-and-white PM. These aspects are a little unclear still (I assume the goal is to not create disproportionate emphasis), but we'll do our best to follow the guidelines and submit for review and feedback. Thank you!

Hello,

I have gone over the PAAB Guidance on Promotional Monographs and have a few questions:

1. If the only changes made to the PM are applying brand colours to the headers, sub-headers, bullet points etc throughout (without using any callouts or emphasizing any sections) and wrapping it in a branded cover, would it still be PAAB exempt? If not, then-

2. Could you please clarify this section-
   The product monograph (PM) within the promotional monograph should be presented verbatim. It should not contain visual treatments that create emphasis not present in the PM (e.g. bolding, underlining, boxing, capitalizing, shading, colour treatments, etc.).

If we were to create a promotional monograph with colour treatments, icons etc, then are we required to have an unmodified PM included as an insert?

3. Could you please clarify this section-
   A promotional monograph is considered to be promotional because it contains embellishments that emphasize benefits and features of the product. Hence, indication and fair balance is required.

If the promotional monograph doesn't selectively emphasize any section, and applies the same visual treatments throughout, then does it still need fair balance included? Is it still considered a promotional monograph?

Appreciate your help in interpreting this guidance, thank you!

@jennifer-carroll Thank you!

Hello,

I understand that when copydeck and layout are submitted together, the copydeck will be reviewed for content and the layout will be reviewed for positioning/visuals.

With the goal of developing our 2 core pre-NOC pieces as far as possible while we await NOC, we are considering submitting layout alongside copydeck in the initial PAAB submission.
Could you please advise on whether this would be permissible, and whether this would enable us to receive PAAB feedback on copy and layout 15 days after submission? On the same note, would we be able to submit a layout concept or draft (approved by manufacturer's med-reg dept) for that initial PAAB review along with the copydeck?

Would appreciate your guidance on this, thank you!

@jennifer-carroll Thank you for the clarification! If I am signed up to receive PAAB updates, then will I be notified when these new guidelines are released?

Hello, I have a 2-part question in relation to a product awaiting NOC:

1. Is it mandatory to submit the 3 levels of fair balance as a separate submission to PAAB, before we can use them in different APS? Or can they be submitted as part of 3 different APS (either pre- or post-NOC) as and when they are developed?

2. If we do a fair balance submission for pre-NOC review, does it count towards the limit of 2 pieces permitted for pre-NOC submissions?