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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
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)?

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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Deputy Commissioner  

Patrick Massad
Deputy Commissioner

To view the PAAB
Code of Advertising Acceptance
click here
Pharmaceutical Advertising
Advisory Board
Upcoming meeting

February 27, 2018

PMPRB Changes; Industry Outlook and Impact – What you should know

Welcome & breakfast: 7:00 a.m.
Conference: 7:30 sharp - 9:00 a.m.

Click here to register