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699 - A pharma company wishes to produce an Unbranded video that will be used by reps for a call with HCPs. The video will feature a patient campaign that has already been approved by PAAB. There are no claims being made in the video, and it just provides an emotional story behind the campaign. Would this be considered PAAB exempt?
• Jennifer Carroll -
698 - Could you clarify a few points for us: 1 - Is a product indication (verbatim from the product monograph) seen as a claim by PAAB? 2 - If a detail piece, journal ad etc., contains only branding colours, brand name and product indication, does PAAB need to review this or is it exempt? 3 - Per question 2 above, if the piece also contains imagery related to the indication, does that change the PAAB review requirement? Thanks for the clarification.
• Jennifer Carroll -
682 - If we create a survey asking about the impact of using intravenous vs. subcutaneous drugs on clinic/hospital resources (personnel, time, money) - and we don't mention the therapeutic area, disease state or a specific drug (neither brand nor non-proprietary name will be mentioned), would this survey be exempt from PAAB pre-clearance?
• Jennifer Carroll -
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?
• Jennifer Carroll -
660 - A IMC Member is questioning their obligation to submit slides to PAAB under the IMC Code Section 9.6 which states: "9.6 Speaker Training (Faculty Training) and Workshops 9.6.1 General Principle 9.6.1.1 For learning programs, irrespective of the format, on new products, new indications or disease state or significant label changes (i.e. patient safety), a need may arise to train an appropriate number of Health Care Professionals who are recognized experts on this information so as that they may disseminate this information to their colleagues for the benefit of Canadian patients. A product or indication is considered “new” up to one year after its initial marketing. " Assuming we are referring to a new drug or new indication. If the slides for these programs are developed by a scientific committee consisting of HCPs and the slides are then presented by HCPs to other HCPs - do these slides require PAAB approval since they make reference to a specific drug/use?
• Jennifer Carroll -
652 - I understand that for international conferences held in Canada the following conditions need to be meet for being exempt for PAAB review according to (Health Canada policy document “The Distinction Between Advertising and Other Activities) I. the conference must clearly be an international event, e.g., a significant proportion of the conference delegates are from other jurisdictions, II. the material must emanate from the parent company of the manufacturer, III. the material must only be for use within the confines of the conference, and IV. the material is prominently identified as not being authorized for sale in Canada. The question I have is for the use of material that is non-branded and no product specific that ...
• Jennifer Carroll -
648 - We have a product indicated for the treatment of 'drug-resistant Condition-X'. Since this disease inherently links to drug therapy, I do not see how we can produce PAAB-exempt disease education materials. Does this seem like a fundamental limitation of the Code (6.6vii)? Could we produce exempt materials describing 'resistant' or 'refractory' Condition-X instead?
• Jennifer Carroll -
642 - Is an unbranded conference booth display targeting HCPs, that leverages creative from a help-seeking DTC campaign exempt from review? There is no mention of product or treatment options, just disease info only. However, other APS that are part of the DTC campaign (same branding) do contain mention of treatment options, however in a balanced presentation.
• Jennifer Carroll -
640 - Code s6.6(i) states that materials independently prepared with industry involvement limited to sponsorship/distribution are exempt from review. Can you confirm if 3rd party influencer/blogger social media posts are therefore exempt from review, if industry involvement is limited to paid sponsorship?
• Jennifer Carroll -
619 - We’re working on a new product launch and our client is looking to do a PAAB-exempt pull up banner (just product logo and legal text), however, this product has received an NOC/c approval. Are we required to put the NOC/c box on the banner, which disclaimer sea the indication statement?
• Jennifer Carroll -
615 - Hi, I have a question regarding receiving pre-clearance from PAAB regarding promotional material related to a new product that has been approved under the NOC/c (Notice of Compliance with conditions) policy, as stated in the Qualifying Notice received from HC? Is this mandatory, or optional? Thank you!
• Jennifer Carroll -
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.
• Jennifer Carroll -
576 - We are in the process of developing a tool that will highlight a product's reimbursement program. It would state "reimbursement navigation assistance available for Product X" and would include a tear pad with necessary information to be completed by an HCP. This tear sheet would not be provided to patients, but would be faxed directly to the manufacturer. In addition, this tool would not include any product/promotional claims, only the name of the product would be mentioned. Given that messages limited to name and price are exempt from PAAB review, would "reimbursement navigation" also be considered exempt? If not, is there any way to make this tool exempt?
• Jennifer Carroll