Expanded Eligibility for Client Messenger Available Now

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In May 2024, PAAB launched a pilot of our Client Messenger exclusively for eligible ARO submissions in order to test the functionality with a limited segment of APS submissions. We are now ready to expand the eligibility for Client Messenger!

Product launches are a crucial time for manufacturers and agencies. With this understanding, PAAB has been assessing and implementing strategies to help expedite and smooth the review process for our clients during this time. In December 2023, we launched a pilot pre-NOC policy to allow for submission of any number of pre-NOC APS at any stage of product monograph development to help ensure that APS are ready to go for your launch.

To help the industry further expedite launch reviews, we will be expanding eligibility of Client Messenger to APS submitted as part of a new product or new indication launch, effective June 26, 2024.

Considerations for eligibility as a Launch APS:

• The APS is submitted as part of a new product or new indication launch. A “launch” product or indication means it has never been marketed in Canada before. Within your cover letter, please specify that your piece is a launch APS.

• The APS may be a pre-NOC or NOC submission. The 6-month eligibility window for messenger use begins with the earliest of the two listed occurrences:
o first launch submission post-NOC (with or without messenger use) or
o first pre-NOC submission which used messenger function

• APS submitted prior to the closure of this six-month eligibility window will remain eligible for Client Messenger use until approval or closure of the eFile.

• There is no limitation on APS type or audience pending it meets the definition of a launch APS and is submitted within 6 months of the initial launch submission.

• All other considerations for use of Client Messenger and relevant fees apply. Please see the Administrative Guidelines for Client Messenger Use.

Please note that we will continue to track utilization of this new service offering and make data-driven decisions on the breadth of APS eligibility. APS eligibility may widen or narrow as we find an appropriate balance between usage that is beneficial for our clients while also being a sustainable use of review resources. We will continue to communicate with the industry as changes are made.

To request Client Messenger, select ‘yes’ on the submission form field ‘Request Messenger Fee”. Our file coordinators will review your request and confirm that your eFile is eligible. Messenger can also be requested after initial submission by contacting review@paab.ca.

Want to learn more about Client Messenger and see some examples of when it can be used to help augment the speed of review? Visit our Administrative Guidelines for Client Messenger Use.

We hope to message with you soon!
The PAAB team.