Good Morning @ebailey All files do not need to come back together. You can update the parent file and then apply across all the children files. In general, the parent file should be the one being resubmitted; however we understand that there may be practical reasons to resubmit a child file to get it to approval prior to proceeding with the rest of the children and the parent. When this is the case, please outline this for the reviewer. You may also reach out with an email to admin to confirm that the reviewers agree prior to resubmission.

Hello @username Apologies for not seeing this sooner. Thanks for your question. To clarify, iterative submissions (i.e. different iterations within the same PAAB eFile) do not require light blue shading. Blue shading is requested for child files that are part of a series. The blue shading is used to identify the common copy between the child and the parent eFile. However, whether you’re renewing an iterative submission or a series parent or child submission, you would shade the copy yellow. Once the submission is a renewal, it is more helpful to reference the backfile to which the copy is 100% pickup rather than shading it in relation to a parent file where the copy may be as little as 60% common. When using the “express renewal” feature, we will not require that the shading be adjusted by virtue of the way in which the “express renewal” platform functions and the nature of the guarantee that nothing has changed.

Hey @sabrinab Minimal changes such as those mentioned, would not void “direct pick-up”. We’d ask that you identify in the submission letter and highlight (versus shade) the specific instances. This can appear overtop of the shading. In this example it would not be considered direct pick-up. For efficiency sake, we’d ask that you identify the previously approved file, the content removed, and for extra support, providing the rationale can help.

@jennifer-carroll Thank you!

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.

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.

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".

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.

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.