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Hello, I am the author of the Clinical Guide to Probiotic Products Available in Canada (and In the US). This is a resource independently reviewed by a group of experts in the field and published annually online and in print. Our project is supported by the unrestricted educational grant provided by the Alliance for Education […]

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The product I’m working on can be self-administered by the patient. Part 3 includes the steps for self-administration, however nurses have created their own instructions for patients to self-administer. The nurse instructions don’t adhere exactly to the product monograph (their instructions include more details). Is there a way to support the nurses in producing a […]

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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 […]

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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 […]

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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. […]

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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 […]

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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 […]

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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 […]

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In the PAAB Fair Balance guidance, for lowest level FB, it states « messages which do not relate to the healthcare product (e.g. disease information) ». Question is: If the message does not relate to the product and only disease info, why would we require any FB at all? it is not advertising. Or could you provide […]

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We want to develop an unbranded, ungated website that we plan to send to ASC. The content is about adherence and as such is appropriate for all audiences. Can we develop unbranded promotional tools, like banner ads on NEJM, that direct HCPs to this site? The content and execution of this tool will impact the […]

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What type of gating is required for a HCP website for a schedule 1 product (narcotic)? is de-indexing considered a form of gating? What type of information can be available pre-gate? can information around a patient support program be made available pre-gate for a schedule 1 (narcotic) product? Yes, de-indexing is considered a form of […]

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My client is preparing an HCP website that will include brand promotion as well as offer samples. The site will be 'gated' which will involve a landing page that asks the viewer if they are a Canadian physician and require that they input their license number. Does the website require a validation process to ensure […]

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Hi PAAB, I was wondering if expert guidelines for treatment option algorithms (first line, second line) are allowed to be included in branded pieces directed at HCPs. The goal would not be to compare treatments but to see under which situations / for what patients a therapy would be preferred. (Patient profile?) Thanks for your […]

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Can HCP branded materials and Patient branded materials utilize the same creative? If not, how different must the 2 be? What elements (colours, key features) can be shared between the two campaigns? Please see Q&A #123.

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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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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 […]

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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 […]

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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 […]

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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 […]

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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 […]

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