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We have enhanced the Ask PAAB section to make it more user-friendly due to the growing number of questions. You can now select a category of interest from the drop down menu above to view existing question and answers or you can also do a search for questions that have been submitted to Ask PAAB since the beginning.

Most Recent Questions and Answers
531

Re: Q#522 for use of Summary Basis Decision in advertising and you replied: "Yes. Provided the content referenced from it is not inconsistent with the product monograph", if data from the SBD does not appear in the PM, can we use it? It would not be 'inconsistent'. If PAAB considers the SBD the same weight as the PM, then it should be acceptable. Is this an accurate assessment?

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530

What is PAAB's position on proactively providing storage/stability information to customers that is different than what is in the Product Monograph, but which is supported by clinical data? We sell a product that requires refrigeration between 2-8 degrees. Our Med Info department receives many, many calls inquiring about temperature excursions outside of the labelled storage conditions. We have data to support the excursions. We would like to be able to proactively provide temperature excursion data to customers to make it easier for them to know what to do if they experience an excursion...and so that they would not always need to call us. Is this permitted?

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529

Hi, I have a question about 3.1 specifically the section regarding claims consistent with the limitations of the Health Canada Terms of Marketing Authorization. There are some on our team that believe this means we are not able to use data that is not within the PM regardless. There are others that believe if a claim is based on a similar study population, endpoint and outcomes are consistent with the monograph, it appropriate. We seem to go back and forth on this a great deal and I like to hear PAABs thoughts. Thanks

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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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Deputy Commissioner  

Patrick Massad
Deputy Commissioner

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Code of Advertising Acceptance
click here
Pharmaceutical Advertising
Advisory Board
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