Dormant drug status can trigger generic access to an alternate Canadian Reference Product
Pharma in Brief
FEBRUARY 8, 2024
On January 26, 2024, Health Canada published a Notice concerning its application of the definition of Canadian Reference Product ( CRP ) in the Food and Drug Regulations ( Regulations ). For instance, the generic drug must be βthe pharmaceutical equivalent of the [CRP]β and be βbioequivalent with the [CRP]β.
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