RAMQ has informed PAAB that:
Additionally, the layout must not suggest that the authorized Federal indication is the reimbursement criteria (except where this is indeed the case).
When applying the above provisions, please keep in mind that off-label criteria are not acceptable in drug advertising per s3.1.
Additional consideration: RAMQ prefers that a URL linked to the RAMQ webpage containing the PDF “Liste des médicaments”, along with the date of access, also be presented somewhere within the piece (e.g. reference list).
Note that this advisory currently applies only to RAMQ and is supplemental the general provisions in the following PAAB advisories:
PAAB reviewing staff have been instructed to immediately begin applying this advisory to preclearance activities.
Ray Chepesiuk
PAAB Commissioner
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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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