Dormant drug status can trigger generic access to an alternate Canadian Reference Product
Pharma in Brief
FEBRUARY 8, 2024
For instance, the generic drug must be “the pharmaceutical equivalent of the [CRP]” and be “bioequivalent with the [CRP]”. The Regulations require manufacturers of certain drugs – including prescription drugs – to provide this notice within 30 calendar days after 12 months without sales have passed.
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