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    3. Submission Requirements/process & Timelines/eFiles
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    • Taylor Murphy

      Timeline and Requirements for Pre-NOC with ARO
      aro pre-noc • • Taylor Murphy

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      Jennifer Carroll

      Hey @taylor-murphy

      Please note that the guidance you are referring to states “Launch materials for products approved via Health Canada’s “Interim Order” or their “Accelerated/Priority Review” not “in priority review”. The submission guidance is for approved products. This means Health Canada has granted market authorization with a finalized TMA. Pre-NOC is based on a draft document. The eFile system does not programmatically screen the APS types. This is why the form lists the APS types that are applicable to ARO (i.e., to minimize delays that occur when our admin team needs to return submissions for adjustments).

      Furthermore, please note that the first sentence of the previously referenced document clearly outlines PAABs mandate: “The PAAB mandate is to review advertising and promotional systems (APS) for approved pharmaceutical products.”. It also goes on to state “However, PAAB recognizes the importance of product launch timelines, and in this guideline, clarifies procedures for advertising review before Notice of Compliance (NOC) has been granted.” and “PAAB will accommodate pre-NOC submissions at the discretion of the PAAB Commissioner with respect to workload at the time of submission, and will not be subject to the standard turnaround time”.

      The pre-NOC policy and the ARO pilot are both manifestations of our commitment to ensuring HCPs and patients receive timely information about therapies. It is important to avoid expediting reviews for materials that cannot be used in the marketplace (as the product is unapproved) at the cost of delaying the review of materials that could be immediately used in the marketplace.

    • palanski

      Updates to the PM during ongoing efile review
      • palanski

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      Jennifer Carroll

      Hello @palanski

      As a general rule of thumb, if the update has impact on the piece it should be submitted as a new file new fee. An example of an update that would not impact the piece would be reformatting the TMA headlines or grammatical revisions. Another example would be an update to add a new dose format, with no other updates to the TMA and all other information about the original format remains unchanged. If the piece speaks only to the original dosing format, this update to the TMA is unlikely to prompt a new file.

      Every case is different as there can be both small (note that even small changes may alter the context of existing claims) and large changes to TMAs, making it hard to define a threshold. All TMA changes would need to be considered in the review of the overall APS.

      Remember that significant unsolicited changes during an ongoing review are subject to a new review so if the revision to the TMA impacts the piece in anyway, it is within the Reviewer’s right to send the file back for a new review.

    • S

      Submission requirement for translation
      • Sil

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      Jennifer Carroll

      Hi @Sil

      No, it is not required that medical/regulatory staff review the translation. As a reminder, Code s.1.4G states “The sponsoring company shall be responsible for accuracy of translation of APS".

    • Jennifer Carroll

      748 - My question is in regards to PIS (Product Information Session) invite templates, Is there any restriction in our reps sending via email an invite to an HCP which has free text specifically to include the date, time, location and speaker. Thanks so much
      • Jennifer Carroll

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    • J

      Have the system requirements for eFiles changed since the June 2013 Guidance Document?
      • Jeff Kent

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      Jennifer Carroll

      The eFiles platform has greatly improved since 2013. The above restrictions do not apply anymore. We have upgraded the system to accept all file sizes and current formats including MP4 and Acrobat DC 2015. Please note that larger file sizes may take more time to upload. Thank you for bringing this to our attention. We will update the guidance document accordingly.

      If you have any file format related questions, please contact our eFiles coordinators at 905-509-2275.

    • E

      PAAB Required?
      • edinam

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      Jennifer Carroll

      Question 619 states NOC/c but can be extrapolated to NOC products as well. If the logo and model do not have implications for therapeutic use, the piece could be considered exempt. 496 addresses inclusion of pill visuals for further clarification. We would also advise consulting with the Innovative Medicines Canada Code of Ethical Practices about branding models.

    • Jennifer Carroll

      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

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    • 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

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    • Jennifer Carroll

      557 - When advertisers work with the PAAB for a pre-clearance approval what do they receive in terms of official approval?
      • Jennifer Carroll

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    • Jennifer Carroll

      539 - When submitting an APS for approval, can we submit the piece with the intent that it will be presented to HCPs in both a print format and a digital format as one submission? (Note - the content and layout of the piece will appear exactly the same in both modes of delivery).
      • Jennifer Carroll

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    • 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

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    • 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

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    • Jennifer Carroll

      448 - If a copy deck was first developed in French, can we submit it for review in French, or would it need to be translated to English and the initial review performed on the English?
      • Jennifer Carroll

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    • Jennifer Carroll

      414 - Hello PAAB, The approval on one of our APS's is going to expire and we would like to continue using this APS. What is the process to renew the PAAB approval? Do we need to resubmit everything for review even if nothing in the APS has changed? Thanks
      • Jennifer Carroll

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    • Jennifer Carroll

      407 - Does PAAB review and approve both the copy and the layout before they issue a PAAB approval reference number? Or is it only the copy which is reviewed and approved? Thank you.
      • Jennifer Carroll

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    • 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

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    • 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

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    • Jennifer Carroll

      294 - Hello, I have a piece that is being reviewed and will likely be available before my required date of 1st use. Is it possible to align the PAAB expiry with the timing of use of my piece.
      • Jennifer Carroll

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    • 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

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    • Jennifer Carroll

      279 - Dear Concern, What are the time lines and submission procedures in canada. what are the guidelines for OTS products in Health Canada (submission only)
      • Jennifer Carroll

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