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Document |
MS Word | Updated | |
|---|---|---|---|
| Checklist for submission of section P9 (Quest 3+ system) | |||
|
Application For Biopharmaceutics Classification System (BCS) Biowaiver |
Download | Download | Aug-2024 |
|
Application For A Biowaiver: Additional Strength |
Download | Download | Dec-2021 |
|
Bioequivalence Study Report Submission Checklist |
Download | Download | Aug-2024 |
|
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 & EC inspection | |||
|
NPRA/434/03-1 Borang Permohonan Pemeriksaan untuk Program Komplians NPRA bagi Pusat Kajian Bioekuivalens (Dalam Negara) |
- | Download | Feb-2024 |
|
NPRA/434/04-1 Borang Permohonan Pemeriksaan untuk Program Komplians NPRA bagi Pusat Kajian Bioekuivalens (Luar Negara) |
- | Download | July-2022 |
|
NPRA/434/07-1 Borang Permohonan Pendaftaran & Pemeriksaan Jawatankuasa Etika |
- | Download | July-2022 |
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Application Form Inspection for Listing of Bioequivalence Centre ASEAN Mutual Recognition Arrangement for Bioequivalence Study Report of Generic Medicinal products. |
- | Download | May-2021 |
| Application form for evaluation on the need for BE study inspection | |||
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NPRA/434/12-1 Borang Permohonan Penilaian Penentuan Keperluan Pemeriksaan Kajian BE |
- | Download | July-2022 |
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NPRA/434/12-1-L1 Maklumat Penilaian Penentuan Keperluan Pemeriksaan Kajian BE |
- | Download | July-2022 |
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NPRA/434/13-1 Manual Permohonan Penilaian Penentuan Keperluan Pemeriksaan Kajian BE |
Download | - | Sept-2023 |
|
NPRA-434-17-1 BEDE Submission Checklist |
- | Download | Feb-2024 |
Application Forms and Checklist
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