Submission Requirements/process & Timelines/eFiles
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624 - For an HCP targeted APS, are references required in the final layout of the piece after PAAB approval (i.e., a reference list at the end of the piece and superscripts throughout)? Or do references not need to be included in the layout once PAAB has approved the copy doc? Thanks!
• Jennifer Carroll -
620 - I have two questions as it relates to pre-NOC submissions. (1) What constitutes a 'final draft' PM? Typically a PM is not deemed 'final draft' by Health Canada until approximately 1 week prior to actual NOC. We would like to make pre-NOC submissions earlier than this. (2) Can we submit a full HCP Detail Aid as a pre-NOC opinion request, or are opinions limited to simple reviews, such as core creative?
• Jennifer Carroll -
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)?
• Jennifer Carroll -
521 - We currently have an APS submitted for PAAB review. We have experienced a delay in the project and we may not be able to respond to the last PAAB letter that we received for another 4-6 months. Is there an expiration on how long an unapproved e-file will stay open within our "Submissions" portal for PAAB to receive a response?
• Jennifer Carroll -
348 - We have an app that has already received PAAB approval last year. The client will receive NOC early July for a new indication and the app will have to be updated to include this new data. How much in advance can we submit the document pre the NOC for the new indication and what documents would we be required to submit ie annotated product monograph.
• Jennifer Carroll -
307 - With more 'digital detailing' from reps to physicians using iPads and tablets, many software platforms offer the ability to re-order slides in a presentation. As PAAB approves these materials do they approve them in the order reviewed only, or as individual slides / videos etc that can be re-ordered by a drug company without further approval?
• Jennifer Carroll -
281 - Please confirm the approval process for French websites. We submit the English copydecks and layouts for approvals. Once approved, we then submit the French copydecks for approval. Does the French copydeck require French layouts or can we submit the French copydeck with the English layout?
• Jennifer Carroll -
244 - 1. Is there a preference as to which comes first after a claim: the symbol (e.g. *) or the footnote number (e.g. 1)? "My product was tested and found to work."*1 or "My product was tested and found to work.1* 2. Should these be superscripted or just keyed in in a regular font (e.g. *) 3. Is there a separation required between footnote numbers and symbols? "My product was tested and found to work."1,* In AMA (American Medical Association) format the reference number would come first, separated by a comma, then the footnote symbol. The referencing would be superscripted. "My product was tested and found to work." 1,*
• Jennifer Carroll
