Application Forms and Checklist

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Document	PDF	MS Word	Updated
Checklist for submission of section P9 (Quest 3+ system)
Application For Biopharmaceutics Classification System (BCS) Biowaiver	Download	Download	Dec-2021
Application For A Biowaiver: Additional Strength	Download	Download	Dec-2021
Bioequivalence Study Report Submission Checklist	Download	Download	Dec-2021
Guide on How to Upload the BE Study Report and Other Relevant Documents in QUEST 3+ System Under Section P9	Download	-	Dec-2021
Application form for BE centre inspection
BEEC/F-003 Borang Permohonan Pemeriksaan untuk Program Komplians NPRA bagi Pusat Kajian Bioekuivalens (Dalam Negara)	-	Download	July-2020
BEEC/F-004 Borang Permohonan Pemeriksaan untuk Program Komplians NPRA bagi Pusat Kajian Bioekuivalens (Luar Negara)	-	Download	July-2020
Application form for evaluation on the need for BE study inspection
BEEC/F-017 Borang Permohonan Penilaian Penentuan Keperluan Pemeriksaan Kajian BE	-	Download	July-2020
BEEC/F-017-L1 Maklumat Penilaian Penentuan Keperluan Pemeriksaan Kajian BE	-	Download	July-2020
BEEC/F-018 Manual Permohonan Penilaian Penentuan Keperluan Pemeriksaan Kajian BE	Download	-	July-2020

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