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When designing the layout of an APS, there is very specific guidance regarding minimum font size, proportionality of font size and acceptable limits of those proportions. We would be interested to receive guidance surrounding acceptable proportions of a nabisco. There will always be case-specific variables to consider such as colour, margins, shape, etc. however, isolating for the dimensions of a nabisco alone, what would be the threshold at which its proportions become objectively prominent? In terms of a percentage of total area of:

• the various standard display ad dimensions
• a printed APS
• a visually distinct section over which the nabisco is placed

Any guidance on this issue would be greatly appreciated as it would help designers go forward in the true spirit of a nabisco and bring an element of objectivity to what is often a very subjective discussion.

Hi @jennifer-carroll, would the keyword-based search functionality still be a best practice in the case of a restricted access informational website designed to cover the multi-step answer to a common hospital logistical question "How do I order medicine Z, prepare it, and dispose of it?" (with no mention of therapeutic indication)?

Hello @jennifer-carroll
We combed the resources to understand the difference between types of submissions and types of APS. Section 3 of the ARO detailer document lists time-sensitive APS and launch APS for products in Health Canada's Priority Review as acceptable types of APS for ARO. The eFiles submission form itself offers the possibility of filing both ARO and pre-NOC concurrently.
Patient survival rates showed such a marked improvement that Health Canada deemed it necessary to add the indication under Priority Review. Without timely approval of these materials, which we had expected to accomplish using ARO-2 pre-NOC, patients will not have timely access to compassionate treatment. Is there any way to have a lower level ARO applied to a standard pre-NOC submission?

Hello @jennifer-carroll
Thank you for the added clarity. There is no mention of ARO2 being inapplicable to pre-NOC submissions; the PAAB submission form indeed allows the possibility of selecting both options together.
As this concerns an additional indication for an available existing drug, and the APS is a drug access and reimbursement form, we believe it would be in patients' best interest to have this APS available on the day that Health Canada completes the Supplemental Priority Review. Is there anything that can be done to accommodate the time-sensitive nature of patient access to therapy?

Health Canada is currently reviewing a sponsor's Supplemental New Drug Submission
(SNDS) under Priority Review, to add an additional indication to an already-approved drug. This meets the requirements for both the ARO-2 and the pre-NOC APS submission processes, yet I can't find confirmation in the literature that the two processes are compatible. The intention is to follow the requirements/limitations imposed by both processes. As they both require a letter from the sponsor to attest to the circumstances, would a single consolidated letter from the sponsor be acceptable? Also, as both processes have their own exceptional timelines, would the shorter timeline (ARO-2) supersede the longer (pre-NOC)?