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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
679

In the fair balance when we direct customers to a site for the Product Monograph, should we direct them to the Health Canada Drug Database page or to our corporate page with the monograph? We have concerns with directing them to the Health Canada page as they do not always post the most up to date version of the Product Monograph or sometimes the French version is not available.

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678

We understand that a 'Made in Canada' claim can be made for a drug manufactured in Canada. Would the same be true for a drug first discovered in Canada (ie. 'Discovered in Canada')?

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677

We have a situation where previously-approved clinical data in our TMA has been removed. This was an editorial request from Health Canada, simply to make room for new content (as Health Canada often requests trade-offs in order to keep TMAs succinct). It does not reflect a change in approval of the data itself. Therefore, can you advise if this previously-approved TMA data can continue to be used in APS? Note, the data does not appear in published studies and is therefore considered Data on File.

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676

Hi Patrick - Would you be able to explain the rationale behind Code s3.7, and why combination products cannot reference the brand names of their individual components (only the generic names)?

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675

We run a website that contain unbranded disease awareness information as well as unbranded drug information. Are we permitted to leverage our website to run targeted ads that link to sponsored DIN-gated sites?

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674

Is it acceptable to compare the clinical trial inclusion/exclusion criteria among competitor products? We would like to make the point that patients with certain conditions were included in the trials for 1 product but not in trials for its competitors. I understand non-clinical information can be compared across products, and we wondered if inclusion/exclusion info was considered clinical or non-clinical. Could this be done in a branded context?

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673

A company has a product approved in the US. They have a booth at a Canadian convention. Can the company distribute product specific materials in the 'international' section of the booth as long they are in line with FDA approved label? If so, do these materials need to be reviewed/approved by PAAB too?

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672

Would materials used to train Healthcare professionals prior to using a product be items to be reviewed by PAAB, or do they reflect more Continuing education materials? The trainings would be done on site by medical science liaisons.

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671

It seems that materials that cite a product is available through the Special Access Program would be considered promotional. Are these types of materials reviewed and approved by PAAB, or are they strictly prohibited as alluded to in the Health Canada Guidance regarding special access programs? Without some notice, I don’t know how healthcare professionals know whether a product is available through SAP.

670

I have seen mixed messages as to whether PAAB review of prescription pharmaceutical advertising must be reviewed by PAAB. Can you confirm or refute that PAAB review is required?

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Commissaire adjoint  

Patrick Massad
Commissaire adjoint

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