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My question is specifically regarding a sales rep emailing a (known, consented) HCP one on one with: A) A one line message that a product has now received Health Canada approval with approved indication. No claims, data etc B) A request to HCP to discuss Patient Support Program which may include info on the PAAB approved patient enrolment form Is this communication different if a Medical Affairs staff member sends the email? thanks very much.
Yes this message requires review. B) Yes this would also require review. It remains an unsolicited message to promote a product or offering from the company and therefore would not be perceived as different if it came from medical affairs. We would also recommend reviewing industry codes such as the Innovative Medicines Canada Code of Ethical Practices which state that medical/regulatory/scientific personnel may not sign promotional materials. See question above.
If I am developing a patient brochure for a medication, I know I am restricted to Part 3 of the PM. However, structurally, am I able to flow content in a way that is more digestible and clear to the patient - or am I subject to the structure Part 3 lays out? I find the content jumps all around and is very challenging to follow, and I am looking to restructure so that the flow is more friendly from a patient information consumption perspective. Everything will be referenced to Part 3 as required. Is this ok?
You are not required to follow the same flow as part III. Review of the patient piece will assess that the revised flow does not emphasize or deemphasize aspects of the product or create links where they are not deemed to be acceptable.
I’ve reviewed your forum and website but my colleagues and I still have varying views. If a product receives Health Canada NOC, may an employee in a sales role email an HCP with this information with no efficacy claims? Would an employee in a medical affairs position be able to send same email? Is there a difference in who may send communication? Thank you.
We must first determine if this action is advertising by asking the questions in the Health Canada document “Distinction Between Advertising and Other Activities”. Who is providing the message? If the message is coming from a sales representative then the message is most likely advertising and therefore would require review. Has the information been solicited or is it unsolicited. If it is unsolicited, it may be advertising and therefore should be submitted for opinion or review. The document also asks the content of the message. A message of “now available” is exempt, however if any additional messages are included (e.g. indication or therapeutic category [direct or indirect, including visuals]), this may not be exempt. The distinction between advertising and non-advertising is not limited to “who delivers the message”. The other questions in the distinction document should be considered. If you remain uncertain if the activity is advertising or not, the PAAB can provide an opinion based on review of the copy and intended actions.
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.
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.
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.
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
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.
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.
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.
Jennifer Carroll
Réviseur principal en communications
Le Conseil Consultatif de
