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Biowaiver Application Form: Additional Strength

This application form is designed to facilitate information exchange between the Applicant and Pharmacy and Poisons Board – Drug Product Evaluation & Registration Department if a biowaiver is requested for additional strength(s) of the submitted product(s). This form is not to be used, if the Applicant seeks to waive bioequivalence studies, based on the Biopharmaceutics Classification System (BCS), in which situation a separate "Biowaiver Application Form: Biopharmaceutics Classification System (BCS)" should be used.

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