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@jennifer-carroll This is great info. It is really helping us to understand the new guidance. I have a follow-up question regarding "Timepoints before the end of the extension study..." If the extension study protocol identified that data will be analyzed before the end of the extension study, but does not identify when, is that sufficient to qualify as a pre-planned analysis?

Thank you so much. And safety data from the extension study must be preceded by data from the Product Monograph correct?

@keoca The approved email of course would also be submitted to PAAB, and would be sent to verified hcps that we have consent to send such communications to.

If we were to create an approved email sent by reps to hcps to announce a PAAB approved DIN gated product website for patients, could we provide a deep link to allow the hcp to view the site for themselves?

Re: Guidance Regarding Duration of Clinical Trials Used as Reference Support in Advertising

Can you elaborate on as to what demonstrates that an extension study was pre-planned? If there was a registered protocol and after primary trial completion, participants were invited to register for the long-term extension, does that qualify as pre-planned? If yes, would publication of a post hoc interim analysis of that pre-planned extension study qualify under the guidance, or would only the final analysis qualify as reference support?

If a published, pre-planned extension study meets the requirements in the advisory, can the extension study's safety data appear following a presentation of safety data from the product monograph in an APS? Or is content related to the safety profile in an APS still limited to what appears in the product monograph? I was not clear on this aspect after reviewing the guidance that was released this past March.

Demo syringes (with no active drug or placebo liquid) will be given to hcps who request to do their own injection training with patients rather than utilize the Patient Support Program to do so. The demo syringes will have a sticker that includes the brand name but identifies the syringe as a demo, for training purposes only. The syringe will come in a box with the brand name, which again will identify the syringe as a demo for training purposes only. The box will also include instructions of how to operate the demo syringe and these instructions were provided by the manufacturer of the demo syringe. This syringe is used by many other products so the instructions of how to operate the demo model (activation/ how to reset) will not be unique to the branded product. Does this box with its demo syringe and instructions require PAAB review? Our team is split on this and we would appreciate clarification. If this project does require PAAB review do we submit pdfs of the components as one file or as a series of related files? Thank you!

One last question on this, I am also assuming, if only tabs are being added, that fair balance is not required on the back cover? Please confirm.

And if PAAB review is not required due to modifications being limited to the addition of tabs, should the Health Canada issued control number still be removed? The guidance suggests, if we are interpreting it correctly, that regardless of whether it requires PAAB review, only the Health Canada approved document should have the control number on it. Can you confirm?

According to the PAAB guidance on Promotional Monographs, a product monograph whose only modification is the non-selective addition of tabs for each heading throughout the product monograph would not require PAAB review. Are we still required to refer to it on the cover as a Promotional or Clinical Monograph if we are only adding in tabs to assist with navigation? And would colouring the tabs with brand colours (one colour for Part I, one colour for Part II, one colour for part III) make it subject to review?

@jennifer-carroll Does the exempt status change if the virtual booth as described has one other feature, a "details button" where visitors can learn about the booth owner (i.e. a corporate message with no product mention)?

For a virtual conference booth, if the booth only consisted of a panel with the brand logo, linking to the Health Canada approved PM, would this require submission to PAAB or is it exempt? We have been seeing other companies use this approach.