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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
606

Hi! We would like to know what the role of PAAB is? Do you support innovation or the pharmaceuticals? This is not meant to be prejudiced in anyway. We've tried to work with pharmaceuticals to put a product that could eventually replace vaccines, replace the current international immunization plans, prevent outbreaks and epidemics.These are just starters. We've conducted full scale animal trials and safety trials and will soon be ready for Phase 1 trials for Universal Flu, HIV/AIDS, Cancer for leukemia and Hodgkin's, all enteric diseases and one to replace the immunization program. I see from PAAB's membership there are a lot of pharmaceutical and vaccine companies represented. We've approached several foundations, vaccine companies and pharmas and got similar "not interested" responses.
When we move ahead with this how do we not conflict with publishing certain types of diseases we're targeting with names of products and to announce we have found a way to replace current immunization programs without getting the ire of the scientific community?

How do we announce this on TV when the large pharmaceutical companies control them?

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605

Hi, We are a health clinic interested in running a publicly funded flu shot campaign for the public. We want have free coffee cards and lollipops to give to anyone who comes in and gets a flu shot. Are we allowed to advertise in a flyer and emails to the neighbourhood businesses specifying that anyone who comes in and gets a flu shot will get a lollipop ad free coffee cards? What are the regulations surrounding advertising our flu shot clinic? Thanks!

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604

What are the requirements/limitations for emailing of Enrollment Forms to HCPs for the purpose of enrolling their patients in a PSP? We have developed an Enrollment Form (approved by PAAB) of which we have a version that is a writeable PDF (text fields can be filled out on the computer) to then be printed and signed, and would like to email this Enrollment Form to HCPs directly via the reps. Could you please inform me if this contravenes any PAAB regulation? I was unable to find anything in the PAAB code that would suggest this. Thank you!

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603

Hi, We were thinking of providing our reps with iPad covers that have images from a campaign that we intend to launch. The iPad covers will be solely for the reps and won't have any sort of messaging on them, but will have the names of our brands. Do we need to put the covers through PAAB? Thanks.

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602
What is PAAB position on the use of the word NEW in the claim New in Canada. I know that NOW in Canada with only the brand (no other claim) is PAAB exempt, would NEW in Canada be too?
601
I have a question regarding MOA and Code Section 3.1. Suppose a TMA states that Product-X targets receptors A & B, with no additional information/limitations. It is known that Product-X also targets receptors D & E, although this information does not explicitly appear in the TMA (as it is not intended to be a repository of product information). Why would this additional information not be allowed under s3.1? We have seen s3.1 interpreted differently when applied to different sections of a TMA (eg. MOA has a highly conservative approach whereas other sections have greater latitude). Thank you.
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600
Regarding Code s3.1.1, does PAAB distinguish between different types of "pooled data"? For example a post-hoc pooled analyses of unrelated trials (low evidence), vs. a pre-specified pooled analyses of replicate trials (higher evidence)? Such pre-specified pooled analyses are commonly used in registration trials for certain therapeutic categories, and therefore interpretation of s3.1.1 could potentially be biased.
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599
Suppose a Product Monograph contains pooled data presentations (demographics, efficacy, safety, etc), but the individual data sets are from separately conducted and published studies, with no planned pooling. Would it be acceptable to report the individual data in APS, or would PAAB require it to remain pooled (and subject to the associated limitations). Traditionally pooled data are not regarded as high-level evidence, but in some cases Health Canada has requested the pooling of data, not the study design itself.
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598

Seeking some clarification on the response to Question #273. Can you confirm that the answer "It may be exempt if all the treatments are balanced" applies only if the piece in question is consumer-directed? We're assuming that HCP-directed exempt material (s6.6) can never mention treatments (balanced or not), otherwise it would be considered Editorial (s7.5).

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597

We have Data on File that was part of an NDS, but was not explicitly included in the TMA. We feel Health Canada has 'accepted' this DOF, by virtue of related label negotiations and direct correspondence. What type of proof would PAAB require to consider use of the DOF in APS: Sponsor Regulatory confirmation, Sponsor correspondence with Health Canada, contacting Health Canada directly on behalf of the Sponsor, etc?

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Commissaire adjoint  

Patrick Massad
Commissaire adjoint

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Code d’agrément de la publicité du CCPP
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19 février 2019

Un accès amélioré avec un régime national d’assurance-médicaments : réalité ou illusion?

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