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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
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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518

Commercial employee asked a presenter AFTER presentation at a scientific conference why DRUG X has not been included in his presentation. DRUG X has not yet been approved by Health Canada but belongs to the employee's company pipeline. DRUG X efficacy/safety properties have not been discussed. Does this interaction constitutes off label promotion?

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517

Is it possible to produce a teaser ad for a product? Does this ad need to be disease oriented "Something new in X disease area coming soon" or can a brand name be attached to it such as "Brand X coming soon"? Lastly, does this require PAAB review? Thanks you for your guidance.

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516

I am wondering if we are able to create stickers for our material to indicate that we have formulary however I would like to keep it simple and say something like "Now on formulary (special authorization) in your province" or "...in this province" without specifying the province itself. We would of course only place these stickers on tools where the province has received formulary and we would of course provide PAAB with an FYI as to what tools and where we would be placing the stickers. Is this doable?

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515

We would like to ask PAAB regarding the interchangeability of the term “starter pack” used to identify a traditional sample pack. Certain products have starter packs specifically designed to initiate patients on treatment and help avoid dosing errors and contain patient educational materials. Our question is whether it is possible to refer to a simple sample pack as a “starter pack” when it is not specifically designed as a starter pack and is not mentioned in the TMA?

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514

Good morning, Can we disclose the name of the company behind an unbranded website, when such is being asked in a specific tweet? Thanks in advance

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513

Section 3(1) of the Food/Drugs Act implies DTC-A is prohibited for products treating Schedule A diseases. Yet, there seems to be many approved DTC-A campaigns for STDs, Arthritis, etc. How is Section 3(1) being implemented in PAAB practice?

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512

Can you please clarify why product MOA can only come from the TMA, and not published, peer-reviewed in vitro studies? MOA is frequently characterized post-NOC, particularly for products where ‘the exact mechanism of action is unknown’.

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Commissaire adjoint  

Patrick Massad
Commissaire adjoint

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