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PAAB Advisories and Guidance

Please send questions and comments to codequestions@paab.ca

Extension Request Form

Dear PAAB Clients,

Please take note of this important advisory about approval extensions.

Section 8.4.iii of the PAAB code states:
Under special circumstances, e.g. adjustment to a new 12 month advertising schedule or a delay in production of new material, the Commissioner may extend the PAAB clearance beyond the 12-month period. Extensions at no fee charge shall be restricted to no longer than two (2) consecutive months. Longer extensions shall be subject to the full fee applicable to the particular type of advertisement.

The new PAAB code was implemented on July 1, 2013. During the transition period which followed, the PAAB has been providing, on a case by case basis, extensions beyond the 2 month period to accommodate clients as they transition to the new code. As you know, we are nearing the end of the 1 year transition period. Therefore, effective immediately, extensions at no fee charge shall be restricted to no longer than two (2) consecutive months per PAAB code section 8.4.iii. Note that extensions are only provided under special circumstances.

All extension requests can be emailed to review@paab.ca with a completed Extension Request Form for each product; see attached. If you have any questions, please feel free to contact the PAAB office.

Regards,
Ray Chepesiuk
Commissioner

Click here to download

 

Advisories

PDF Guidance on Indication and Fair Balance Font Size (January 2017)

PDF Guidance on eFiles on Ticketing and Tagging (December 2016)

PDF Advisory regarding use of RAMQ in APS (April 2016)

PDF PAAB Code Change Q&A June, 2013

PDF Provincial Formulary Coverage Statements April, 2013

PDF Advisory: Formulary Inclusion Statements in Healthcare Product Advertising 2013/01/10
PDF PAAB Policy and Procedure for Exemption Requests 2011/08/30
PDF Policy Clarification - Opinions and Complete Submission Procedure 2010/04/21
PDF PAAB Advisory - 4 Day Turnaround for DTC and Opinions - April 2007 2007/04/01

 

PAAB Guidance Documents for Advertising

PDF Guidance on Adverising for Drugs with Notice of Compliance with Conditions (NOCc) (September 2017)

PDF Guidance on Risk Management Tools (September 2016)

PDF e-Detail Aid Submission Best Practices
PDF Guidance on which HCP materials require PAAB review
PDF Guidance for Advertising/Promotional Systems (APS) Which Are Openly Visible in Healthcare Professional (HCP) – Patient Interaction Areas
PDF PAAB Guidance Documents for Market Share Claims in Advertising
PDF Administrative Guideline for the Review of Pre-NOC Advertising Submissions
PDF Guidance on Branded Patient Information (July 2015)

Code Revision Guidance Documents

PDF Foreword to Guidance Documents July 2013
PDF Guidance on Indication Placement in Advertising - (March Update)
PDF Guidance on Generating the Three Base Fair Balance Levels - (June Update)
PDF Guidance on Base Fair Balance Level Selection and Placement - (June Update)
PDF Fair balance and Weblink Destination Examples - (July Update)
PDF Online Activities
PDF Guidance on Secondary Endpoints - (February Update)
PDF Guidance on Subgroup Analysis
PDF Guidance on Patient Reported Outcomes
PDF Guidance on Noninferiority Trials - (February Update)
PDF Guidance on Observational Studies
PDF Guidance on Bayesian Statistics
PDF Guidance on Pharmacoeconomic Studies
PDF Guidance on Promotional Monographs
PDF Guidance on Submission Process - (June Update)

 

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