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Questions mises à jour jusqu’au: 4 octobre 2021

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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?

Note that an ungated website is accessible by consumers and therefore will be subject to consumer regulations. In addition, it will be direct to HCPs and therefore is subject to the PAAB code. This is regardless of whether it is branded or unbranded. In short, yes, this piece requires review and gating requirements will be based on the content you wish to house on the site and if it meets consumer regulations or not. Note that if this is a prescription product, the content likely exceeds that which is permissible in a consumer accessible space.

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?

This email would require PAAB review. Please see Clarification regarding digitization of APS: Helping healthcare product manufacturers plan for the evolving COVID-19 operational context, which states “Emails used to distribute digitized APS in an unsolicited fashion DO NOT fall under the person-to-person correspondence exemptions in the PAAB code or advertising regulation exemptions in the Health Canada Policy Document “The Distinction Between Advertising and Other Activities”. These emails with attached APS are subject to PAAB review.” Think of virtual lunch information emails as digitized APS in this case example.

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?

When studies from outside of the TMA are used, they should meet the standards of high-quality evidence. This means that they are randomized control trials which have been published and peer-reviewed. As the current scenario does not appear to meet these requirements, it would not be accepted. If you would like further information on your specific scenario, you can submit the study for an opinion through the PAAB opinion process.

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

A manufacturer can choose to promote on HCP platforms which have a mechanism in place to ensure the validity of the users as HCPs. If this third party can effectively deliver on assurances they provided you, this sounds as though it would be an acceptable gating mechanism.

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.

Our understanding of the term “product photos” refers to pack shots. It is acceptable to have pack shots in a consumer space, as long as no content on that pack shot goes beyond the consumer regulations (name, price, quantity). If there are claims or additional information on the pack shot, they should be blurred out.

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