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Biowaiver Application Form: Biopharmaceutics Classification System (BCS)

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

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