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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
541

Can you please advise if CADTH Common Drug Review publications can be used as evidence for efficacy, pharmacoeconomic or recommendation claims?

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540

Hello, Suppose a vaccine product launches a branded Facebook page: The rules surrounding promotional posts are relatively clear, but what are the guidelines are on content curation? For example, including a link to an article from a publisher such as the CBC that discusses the condition but with no mention of the brand, or sharing a post from a lifestyle blog that similarly does not reference the brand/vaccine but may be relevant to followers of the page. The Health Canada policy on "The Distinction Between Advertising and Other Activities" does not seem to include this particular type of scenario explicitly. Could you provide some guidance or a link to the relevant guidelines? Thank you.

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539

When submitting an APS for approval, can we submit the piece with the intent that it will be presented to HCPs in both a print format and a digital format as one submission? (Note - the content and layout of the piece will appear exactly the same in both modes of delivery).

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538

What are the implications, if any, for a Product having "monotherapy" in the dosing section vs in the indication section of the PM? Does it matter that it's under "dosing considerations" as opposed to "indication" if it's still on the Product Monograph? How would PAAB limit advertising for this? Would the sponsor only be able to mention monotherapy, if at all, if: (1) they use the verbatim statement from the PM, (2) they don't put that statement with the indication statement and (3) they don't make monotherapy the main theme of the APS?

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537

Can a sales rep use a slide deck that discusses the study design, inclusion/exclusion criteria, and patient characteristics for study in an indication for which they don't yet have approval?

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536

Hello. I work in the advertising industry, and have been discussing with a prospective client a direct mail piece in support of a prescription product. I understand that you cannot communicate the product name and specify what what malady it treats, but it must be a generic message advising to speak to their healthcare practitioner. My question is that if I were able to source a list of individuals who have reported having this condition, could I send this generic unbranded awareness piece to that identified person?

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535

The manufacturers of a drug would like to provide patients (via HCPs) with a wallet card that alerts the patient to show the card to healthcare professionals to remind them to check for potential drug interactions. This focused bit of information is consistent with Part III. Does this require PAAB review?

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534

Hello! We, working on behalf of a European based pharma-company, are planning to sponsor an industry symposium at a 'World Congress' being held in Canada, in 2017. The content of the symposium will be generated by external speakers/expert clinicians. There may be some information/published data presented, relating to the sponsor's and other licensed pharmaceutical products, within the speakers' lectures, related to the wider context of the 'management and treatment' of the condition/s. Do the slides and any other related scientific content, for a symposium within a 'World Congress' setting, need to be submitted for review and approval by PAAB? The sponsoring company's products are licensed in Canada. Thank you, in advance, for your guidance; we appreciate your support.

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533

For a piece which speaks to the safe handling of a drug product for HCPs, is fair balance required.

532

We have a PAAB-approved print piece that we would like to use in a digital environment. None of the content of the print piece will change, but the layout will be different. Would it suffice to submit the new layout with the approved print-piece e-file number or will you need to re-review the content (i.e., need a copy deck)?

Deputy Commissioner  

Patrick Massad
Deputy Commissioner

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