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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
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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669

If you are creating a corporate APS in a print format that lists a pharmaceutical company's products, do you also need to include some level of fair balance for those products?

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668

We will be offering OTC product samples through a third party sampling program. In the order brochure there will be a pack shot of the sample pack, brand name and dosing. Does this need to be PAAB approved?

Deputy Commissioner  

Patrick Massad
Deputy Commissioner

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

November 20, 2018

Patient Support Programs - Trending or Transformative

Dinner Meeting
Cocktails: 5:30 p.m.
Dinner: 6:15 p.m.
Panel Discussion: 7:00 p.m.

Click here to register