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Afin de soutenir la demande croissante, nous avons modifé la section Demandez au CCPP et l'avons rendu plus facile d'utilisation. Vous pouvez désormais sélectioner la catégorie qui vous interesse dans le menu déroulant et voir les questions qui ont déjà été posées et répondues. Vous pouvez également faire une recherche parmis les questions déjà soumises au CCPP depuis les débuts.

Questions et réponses les plus récentes
528

On a company website, would we be able to show a picture of a drug along with name, price, quantity and product monograph? Would we be able to also link this drug page to a medical device that it is intended to be used with?

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527

What is the equivalent of product monographs for NHPs? Is it the Product Label , the Product Insert, or the Evidence Summary Report that we are submitting to Health Canada? For instance, if we want to include some precise figures in the promotional material for HCPs, do we need to include them in the Evidence Summary Report? Also, to obtain the right to have a graph or a table in the promotional material to HCPs, is the mention of the figures enough in the document that acts as an equivalent to the Product Monograph, or do we need to include also the graphs/tables?

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526

On an unbranded, consumer-facing, disease state website, it is permissible to discuss differential diagnosis? As in, could you "compare" the symptoms of the website condition with another, similar condition with overlapping symptoms?

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525

Can you please clearly define what is meant by a non-clinical claim? Non-clinical claims can include anything from IMS data (#1 prescribed claims), dosing, administration and quality of life. How do these fit under one umbrella?

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524

Hi PAAB. Do communications sent in the context of a patient assistance program need PAAB preclearance? here is the situation. we have a patient assistance program for which we would like the vendor to use a standardized and automated system to communicate information pertinent to patient's enrollment status, notifications regarding reimbursement investigations, reminders of missing information to proceed with the service etc... The issue is that all of our Patient assistance programs are named after the therapeutic area (XYZ-Onclogy; XYZ hep C, XYZ HIV...) and within the body of the letter we have to specify the name of the product for HCP to know which product the communication is related to. These communications begin after a physician has made the decision to prescribe the product and decided to enroll his patient into the program either for reimbursement investigation or compassionate drug provision. We were wondering since we want the communication to be standardized (create template with blank space to be filled with the patient's name or initial and appropriate identifiers) and send through an automated system, and since the designation of the program mentions the indication (hep C for instance) and the body of the letter has the name of the product, do we need PAAB preclearance or would these type of communication be exempt as per PAAB code. thank you.

523

Hello, I would like clarification on how efficacy data and mechanism of action data can be presented together in a promotional piece. My understanding is the MOA is considered non-clinical and therefore must be physically separate from efficacy or clinical claims. Is this assumption correct? I am not sure why this would be. Can you please explain why I cannot mention how a product works and how well it works together in a page? Thank you,

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522

Can the "Summary Basis of Decision" from Health Canada be used for advertising claims?

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521

We currently have an APS submitted for PAAB review. We have experienced a delay in the project and we may not be able to respond to the last PAAB letter that we received for another 4-6 months. Is there an expiration on how long an unapproved e-file will stay open within our "Submissions" portal for PAAB to receive a response?

520

Health Canada's policy "The Distinction Between Advertising and Other Activities" states that materials emanating from a parent company presented during an International conference would not require PAAB review, provided that they are only used within the confines of the conference and are prominently identified as "not being authorized for sale in Canada". However, when a product presented in a promotional booth is approved in the US and in Canada as well, if: - all the material clearly specifies that all the information comes from the US labelling/Marketing Authorization, and - the target audience is from the US and not from Canada, even though some Canadian HCPs could be attending, will this be still considered as promotional activity in Canada and require a pre-clearance form PAAB?

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519

We are sending an announcement to HCPs informing them that a product is now covered on the provincial formulary and providing the the reimbursement criteria. My questions are: Are we required to include the reimbursement criteria? What level of fair balance is required?

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Commissaire adjoint  

Patrick Massad
Commissaire adjoint

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