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389 - I would appreciate clarification of the Explanatory Note for 6.6 that says "Now on provincial formulary" (or equivalent). Does "or equivalent" allow you to mention a new strength and still be exempt? (e.g. The product is already on formulary but the product came out with an additional strength that was just added to the formulary and it is that new strength of Product X that is being announced as "Now on Provincial Formulary". Thank you!
FYI post-approval change/preclearance exemption/what requires review/PAAB scope
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