See AskPAAB question 639
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Is this "Ask PAAB" still active? We have submitted queries 4-weeks ago and did not see any responses? Could you please provide an update?
See AskPAAB question 639
Is the PAAB logo required to appear on HCP advertising or patient information approved by PAAB.
Yes. This also applies to editorials and corporate ads. Inclusion in RMTs is not permitted at all as these tools have not been reviewed for compliance with the Code. Health Canada has simply requested that PAAB review these tools to ensure they are non-promotional.
Hi Patrick, I have a question related to providing PAAB training. I remember few years ago you came to our company and you provided training. There have been many changes since then and I was wondering if you are still providing similar training. What is the cost associated with this type of activity?
Yes, we do still provide training as part of our ongoing commitment to help industry better understand the regulations. There are a few options. We provide in-house training, at a location of your choice. This is a 2 hour training session and the cost is $1000 plus travel expenses. We also offer national workshops once a year in Toronto and Montreal, which are full day sessions. This information can be found on the PAAB website under “About – Fee Schedule”.
Can you please confirm that use of a drug name along with its pharmacologic classification (eg. 'diuretic') is exempt from PAAB review? The therapeutic classification (eg. 'antihypertensive') would not be included, as this alludes to therapeutic use.
Please see answer to question 467.
Hi Patrick - I've read the 2019 Client Survey report on the PAAB website. Is there a plan to disseminate this more broadly, and what actions is the PAAB taking with regards to any of the specific survey results? Thank you.
The 2019 Client Insight research has been posted to the PAAB website and is available for access by the broader public. The PAAB is constantly working through the results to try and update processes and procedures. We will be looking to industry and the community to help shape new endeavours. Please follow us and stay tuned to the PAAB website, LinkedIn and Twitter (@ThePAAB) for opportunities to join new committees to help shape change.
For advertising a Rx or OTC drug to HCPs, could we add more safety information such as contraindication, warnings...beyond what is in the approved TMA? considering that it is for safety reason e.g. contraindicated in asthma patients (but not stated as such in the TMA). This would be based on a published study or guidelines.
Additional cautionary copy beyond the limitations of the TMA are acceptable and at the discretion of the sponsor. Note that the copy should be purely cautionary, and should not be positioned as a promotional or positive feature of the product and should not be comparative. Any claims would be subject to all requirements of the code for levels of evidence.
Hi Patrick, I often find it easier to apply PAAB code when I understand the rationale behind it. But I have struggled to understand the blanket application of section 3.1. In many instances, the PAAB requirement that claims remain "within the limitations of the TMA" makes sense - specifically when "beyond the limitations" is also off label. However, I am curious to know why efficacy and safety data from longer-term, follow-up of the pivotal trial population is not allowed - especially when we hear from physicians that this is the information they are most interested in. As long as there is no limitation on length of therapy, why not allow longer-term clinical information to be shared with physicians? What is the rationale for blocking it?
The rationale for limiting the duration of data presented to that which is presented in the TMA, is that this is the duration for which Health Canada has reviewed and assessed both the efficacy and safety. In order to present the data beyond this time point, we suggest submitting a revised TMA to Health Canada which demonstrates that they have reviewed the data out to the new time point. This can be as simple as copy such as “Results maintained out to 52 weeks” or something similar. At that point in time, we can review the long-term 52 week data.
Question 497 - Patient video for product use on company website , has Health Canada provided a response?
We have not received a response to date. We will pose the question to them again. Thank you for the follow-up.
We have an HCP piece approved by PAAB to be used as a print Leave-Behind. We would like to use a part of the content (unchanged) for a digital advertisement. Does is require to be submitted to PAAB as a new file?
Yes. PAAB reviews pieces in their entirety. Reproduction of part of a piece would not be representative of the full review and may not meet the full requirements of the code. The digital advertisement should be submitted for review as a new piece.
For further information, we refer you to the “Digitizing Print APS” section of the PAAB Guidance Document for the Submission Process.
We are in the early stages of planning a website for use by healthcare professionals and patients (gated appropriate for each) to access disease and product information for multiple therapeutic areas. For convenience, we wish to create on the ungated home page a link to a portal (also gated) housing accredited CHE for healthcare professional sponsored by the company, The user would be notified that they were leaving the main site and as mentioned they would have to pass through the gate of the CHE portal. Some of the accredited CHE may contain content not consistent with product TMAs. How do we avoid any linkage issues while offering convenience to healthcare professionals of going to one location?
This sounds like a specific project with many facets which should be considered. We suggest setting up a consult meeting or submitting for an opinion. As a starting consideration, please consider that content should be housed in different sections of the site to create a high degree of separation.