Formatting
The guidance document, Guidance on Generating the Three Base Fair Balance Levels, with respect to the highest level fair balance section headings, states that:
With the development of new platforms which may not allow for underlining functionality, or in situations where the underlined copy may be misinterpreted as a hyperlink, the sponsor may opt to replace underlining with a notably larger font size. Note that bolding and white space are still required.
"Utilisation clinique” vs. “Usage clinique”
Upon recent consultation, PAAB has ruled that, moving forward, both translations of the fair balance headline “Utilisation clinique” and “Usage clinique” will be acceptable regardless of the specific translation used within the sponsor’s French Terms of Market Authorization.
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In an effort to constantly serve our clients better, PAAB has unveiled a new electronic submission process(eFiles). Effective January 2, 2008 all submissions will have to be submitted via the eFiles system. Please have a Senior Official (Director level) send an email to the administration team at review@paab.ca with the contact information of the person(s) who will be designated as administrator(s) for your company. Click on eFiles, on the menu, then eFiles Tutorial for a tutorial on how eFiles works.
Please contact the admin team at PAAB if you need assistance with eFiles
The Accelerated Preclearance Pathway
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