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Special FeaturesLast update: September 23, 2020

Ask PAAB

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We have enhanced the Ask PAAB section to make it more user-friendly due to the growing number of questions. You can now select a category of interest from the drop down menu above to view existing question and answers or you can also do a search for questions that have been submitted to Ask PAAB since the beginning.

Most Recent Questions and Answers
770

Hello. We are turning some HCP Printed pieces into PDFs and would like to know the following: 1. If the printed tool has already been submitted and approved by PAAB, do we need to resubmit for it to be used as a PDF, even if there are no changes to content or flow? 2. If these PDFs are distribuited specifically to HCPs via direct links, do these links (which are de-indexed from Google) need to be gated, or password protected? Thank you!

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769

Hi, I just wanted to confirm that Patient Information is exempt from PAAB-clearance if it is direct from and consistent with the Product Monograph or when the information is solicited by the patient directly from the manufacturer (s. 1.5) AND if there’s no discussion of drug therapy (by product, class or category) and there is no discussion of drug issues (https://pmcq.qc.ca/en/ask-paab?question_id=321). As such, would a document explaining a PSP program created for HCPs to distribute to patients about reimbursement, logistics, etc. be exempt from PAAB review if it met all of the above requirements? Thank you in advance for your answer!

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768

I have a quick question regarding how PAAB should be represented on an approved material (branded and unbranded). Is the PAAB logo displayed on an approved material sufficient or do we also need to display the approval number on our materials?

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767

We are wondering about the regulations around a disease state information website created for HCPs, which does mention various treatment options but is non-branded (no product branding nor even company logo). Would such a site have to be gated, or is it sufficient to ensure the URL is not searchable by the general public? Along that same line, can company reps disseminate the website url to HCPs via printed materials (which would also go through the PAAB for review of course)? Or would we have to ensure that the company behind the website is unidentifiable in every way, including when disseminating the URL? In the case of the latter, what are some acceptable ways of disseminating the website URL to HCPs?

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766

We want to develop an unbranded, ungated website that illustrates on-label dosing scenarios from the product monograph. It is not a dose calculator. It will be a valuable resource for all HCPs which can answer onlabel dosing questions. Does it require PAAB approval ? Will gating be required?

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765

If you have a product approved for rare diseases and based on three single-arm studies from the 90's (where standard RCTs are unlikely to be available given patient numbers), are you limited to the data from the studies in the monograph or are you able to use newer, single-arm data to support your efficacy and safety claims?

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764

Are unadjusted p-values acceptable as part of a claim?

763

If a representative is conducting a virtual lunch and learn with PAAB approved materials, is a PAAB approval required to send the clinic attendees/office manager an email indicating the brand they will be speaking about (no claims), meeting link, date and time?

762

Hello, I'm planning an OLA and I would like to communicate this unbranded, not search engine (Google) indexed and not gated event registration page (but unique password and link needed to attend the event) through a 3rd party. If the 3rd party can guarantee that non-HCPs and non-Canadian HCPs cannot access the content or receive a communication from them (we would need something to have written proof that we did our due diligence on that end), is this sufficient from a PAAB perspective to use this 3rd party as a channel to drive Canadian HCP traffic? Thank you Bill

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761

Can a company website that contains Health Canada approved product monographs also contain brand logos and product photos? The website is not gated and publicly available.

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Jennifer Carroll
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