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Questions mises à jour jusqu’au: 30 avril 2021

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749

We would like to disseminate a branded dosing app to HCPs via the Apple/Google stores. Since app stores are open to the public, is this possible if (A) the app description/screenshots are limited to name-only and (B) the app reviews are disabled? The app itself would be password protected, so could only be opened by HCPs (consumers could download the app but not open it).

Yes. The responsibility of the manufacturer is to ensure the entire consumer visible content does not go beyond “name, price, quantity”. This includes both the app store content (including search terms) and the portion of the app visible prior to verification. While disabling the “reviews” helps to mitigate risk, it is not required. If the reviews remain active however, the sponsor would be responsible for monitoring and moderating them. So disabling “reviews” can help avoid non-compliance with the regulations.

748

Hello what kind of references are required to make a claim about number of patients treated with drug/device X worldwide? and about availability in x number of countries? Does Data on file suffice? if not what other references would be expected to approve this claim?

Data on file would be acceptable for a claim about “# of patients treated with drug/device X worldwide”. Likewise, availability in X countries could be supported by data on file. Note that these claims should not be linked to or suggest safety or efficacy.

745

We have an 8 page print leave-behind detail aid that includes full dosing information. We are thinking of redoing this tool with a half page sized tear off flap that has key reminder information on the dosing. Does this flap have to contain all of the dosing information, or can it just contain e.g., the steps and an example calculation. Thanks.

This would require a separate review of the tear off pad to ensure it meets the standards of the code as a stand alone piece. Often information which is required in an APS is based on the specific claims made and whether or not those claims require qualification. That said, in theory it may be possible to create a half page piece with selective dosing information, however this will be highly dependent on the product’s monograph and claims being made. The selective dosing information would generally require a prominent disclaimer “For more information related to dosing and administration please refer to the product monograph” and any dosing related cautionary copy or safety related issues would likely be required in the APS. 

744

Change in Product Ownership – if Company A divests Product X to Company B, can Company B continue to use promotional material for Product X that was previously approved by PAAB for Company A during the DIN transfer, or only post-DIN transfer? If so, can it be used until the renewal date?

Please see Ask PAAB question #74.

741

Do OTC product materials require PAAB review? Does this change if they are rep delivered materials vs online (or other multi-channel mediums not driven by sales resp)?

Please see Ask PAAB questions #460, #429, #316 and #257. We suggest searching “OTC” on Ask PAAB.  

740

Dear PAAB, The Product Monograph of one of our products has been updated with a new indication. We want to send a message to physicians informing them that the PM for AAA product has been updated with the results of BB study. Since there is no claim/indication in this message, our understanding is that this message is PAAB-exempt. Can you please confirm? Thank you.

A message of “new indication” would be promotional (promotes the feature of a product) and incomplete (what is the new indication). This is not considered an exempt message. Please see PAAB section 1.5 for exempt messages. A message similar to “new data within the TMA” is also a promotional claim and does not fall under the exemption criteria.

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