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Questions mises à jour jusqu’au: 4 octobre 2021

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754

We are looking to develop a corporate email that would be sent by the reps to outline the opportunity to communicate virtually with them. The layout would be corporate branded with no mention of any brands. The content simply outlines the benefits of a virtual call and how to connect/steps to make a video call. Would this type of information be exempt from PAAB review?

An unbranded message encouraging HCPs to reach out to reps virtually, with no additional message about therapeutic areas, brands, or services, could be considered exempt. However, there are ways to render this type of message subject to the code (e.g. corporate tagline, brand mention, service claims, therapeutic claims etc.). As such, we recommend submitting for a formal exemption review. 

753

My question is in regards to PIS (Product Information Session) invite templates, Is there any restriction in our reps sending via email an invite to an HCP which has free text specifically to include the date, time, location and speaker. Thanks so much.

A product information session invite which is subject to PAAB review could have free text specifically to include date, time, location and speaker. This would be submitted as part of the review with clear direction and understanding that the free text is limited to this content. It would not be acceptable to have “free text” about the speaker or what they were going to be speaking about.

752

Hi PAAB, I was reviewing my brands promotional pieces that will need to either be updated or be sent for rePAAB over the next few months. Since some of the pieces were approved, we have had a product monograph update. However, for certain pieces it does not change the Terms of Market Authorization and in some cases the copy in the piece wouldn't need to be changed. The only part of the piece which would need to be changed is the date of the Product Monograph (e.g. brochure) within the references. Since we have significant print inventory, is it permissible to have these submitted as a rePAAB to be valid for the next year until the next update or rePAAB without updating the date of the product monograph within the piece? Please advise. Many thanks.

It would not be acceptable to submit for rePAAB with an inaccurate PM date as this would be misleading. The PAAB approves pieces for accuracy, and this would include the PM date. We would suggest considering the placement of a sticker over the PM date, with the accurate PM information, if the goal is to use up old stock.

751

Similar to question #711, if we have unpublished patient survey data that was independently collected from a patient association, could it be used in an unbranded tool? If yes, what exactly would be required as the source document

Please see AskPAAB question #551, which highlights acceptable uses of surveys and the caveat that there are many factors to consider when assessing the acceptability of a survey. Ask PAAB question #721 further elaborates on the use of surveys.

750

We are creating a gated patient website that will show clinics near the patient's location. After initial PAAB approval, is it possible to continue to update the list of available nearby clinics as they open/close/move? Or are those updates subject to PAAB approval again, even if it is within the approved year?

This type of change may be acceptable without resubmission within the one year. It is best to inform the reviewer of this intent at submission so that any potential concerns can be addressed.

747

Can branded DTC advertising include a claim of 'new' or 'now available'?

For prescription products and products for the treatment of a schedule A disease, a message of “new” or “now available” would be considered promotional and therefore would not be acceptable.

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