ARO Q&A #4: "Rush Requests" post ARO launch
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Q: Could you please let us know how much it would cost to do a rush review?
A: Please note that with the launch of the AROs pilot program, we will no longer be accepting "rush requests" for any APS type. The various ARO levels are set up to accommodate the degree of urgency or “rush” that the client is looking for. APS’ that were generally considered reasonable for a "rush request" are now available for submission under the AROs. To encourage transparency and equity across agencies and manufacturers, we are no longer accepting rush requests.
Here is a link to the fee schedule. We are happy to report that the fee schedule (including the base fees for each ARO level and the new supplemental page fees costs that apply to all submissions whether standard or ARO) are unchanged from the initial fee structure we first unveiled in the Features Document in November of 2021.
Note that while the new fee schedule has always included base review costs and supplemental costs for any potential combination of urgency level and submission properties, ARO only applies to the following APS types initially:
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Time-sensitive announcements (e.g., formulary coverage changes, guideline updates, product shortages, availability announcements, and so on)
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Updates to the information approved in prior APS (“minor updates” and “APS with little new content” as defined in the updated guidance on submissions)
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Initial launch materials for products approved via Health Canada’s “Interim Order” or their “Accelerated/Priority Review”
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Print pieces that are re-purposed to digital media (or vice versa) where the criteria for exemption from preclearance, outlined in the PAAB Guidance “Clarification regarding digitization of APS”, are not met.
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Risk Management Tools (RMTs)
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Patient information APS
This list has also been unchanged since the Features Document was published in November 2021.
If you want to make sure you haven’t missed any of the advisories or resources we’ve unveiled throughout the past eight months about modernization of the submission process, visit this webpage for one-stop access.
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