197 - When submitting a file for review by the provincial governments for the purposes of securing or improving reimbursement status, do any of the materials need to be submitted to PAAB? Thank you for your help.
-
The Health Canada Policy document "The Distinction Between Advertising and Other Activities" has a section on formulary kits. The kits are materials prepared for review by pharmaceutics and therapeutics formulary committees, on which a decision to include a drug product in a formulary may be based. Such information may not be advertising provided the information is limited to that which would normally be required to support such an application. If this is the case, there is no need for PAAB review. Where such an information package is disseminated, in whole or part, to a wider audience simultaneously, or at a later date, it may be advertising to promote the sale of the drug concerned. In these cases, the material should be submitted for PAAB review. Note that the PAAB has received complaints from provinces about unrequested promotion that should have been PAABed.
