FYI post-approval change/preclearance exemption/what requires review/PAAB scope
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218
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219 - Hi Patrick. We're looking to place a card within packs of our prescription product, directing patients to our website. The card will contain no promotional claims. Only content would include: product and company name. Please go to www.xxxxxxxxxx.com Since the piece will essentially be part of the product packaging, I wanted to ask if this would fall under review of PAAB or HC? Also, as there are no product claims, would this be exempt from review? Thanks!
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218 - Dear PAAB, We are interested in building a small electronic questionanire that reps will use to ask the doctors some questions about how they feel certain things are a problem in their practice when managing their XXX[disease state] patients? The questionnaire would be unbranded, make no mention of any treatments. Would this be considered PAAB exempt?
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209 - I work for a drug company and want to sponsor a grant for the Patient groups to reach out to patients to videotape their journey through their disease and experience with a new treatment they are on (our drug). We will be hands off for details and production of this video and it will be put on their site to share with other patients -- do we need to tell them to PAAB the video and are their any other requirements we need to follow? Can we also post a link to their site with the video? Thank you very much!
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208 - Hi there I was wondering if we would need to PAAB-approval formulary announcements to physicians if conditions for benefit on the formulary in their province are to be listed in the announcement. Example for coverage on provincial plan: Patients are over 4 years old. Cared by a physician experienced in managing seizures associated with LGS. Already on two or more antiepileptic drugs in whom topirimate, lamotrigine and other expensive drugs are ineffective or inappropriate. Thank you
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200 - I am a Strategic Account Manager for a Pharma Company in Toronto. My clients are Director Level and higher in Hospitals and we would like to produce a slide kit for meetings with Hospital Executives which provides information on our company (history, mission statement, values), examples of unrestricted educational grants that have been requested by organizations, information on our supply chain process and stability, PAAB approved educational & safety booklets for HCP and patients and a list of our hospital products which are approved for sale in Canada. The presentation will not include an product claims or promotional statements. Based on the PAAB Code, please confirm if this presentation is exempted from PAAB Review as it does not contain any communications in which claims, quotations and references are made for healthcare products.
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190 - Hi there, If a company wants to write a private letter to MPs, Senators, government officials (elected or appointed) with regards to their product, issues a company is facing with regards to approvals/existing regulations/legislation etc, does that letter require PAAB approval? To what extent are pharmaceutical companies required to submit letters to government officials to PAAB for review/approval?
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189 - Dear PAAB: We have a HCP-directed APS for a congress announcing "Company A name" and "Product B name" are "now here" in Canada. An offer to "visit at Conference Booth XXXX" is included. There are no further product / therapeutic claims. Is this exempt from PAAB preclearance review, as per the "now available" exemption in S6.6?; and If so, may we include product branding elements / visuals and maintain exemption? Thanks!
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177 - We have a new product under review by Health Canada. A part of the approval is the preparation of the Risk Management Plan, which includes a slide deck for HCPs outlining the safety issues with the medication. Should this slide deck be PAAB approved? if yes, how do we go about this, given that PM is not yet approved?
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164 - I intend to send out a PAAB-approved promotional piece to physicians in a direct mail campaign for an OTC product. I was also considering including a product coupon. The coupon will display the brand name, package shot and discount amount. There will be no claims. Should the coupon be submitted to PAAB, given that it will be distributed in the same envelope as a promotional piece?
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159 - If we were to have a backorder situation for one of our products and we wanted to inform pharmacies of this fact by way of a letter or fax to help prevent a backorder, would this letter/fax need to be PAAB approved? I was reviewing section 6.2 for clarification, and believe that it does not need submission to PAAB (I believe it's an institutional message), however I'm not entirely sure?
