| Document Number | File Name | Year | Version | Category | PDF Template | Word Template |
|---|---|---|---|---|---|---|
| SAHPRA Variation Validation Template for eCTD | 2020 | 1 | Template | Download TEMPLATE | ||
| SAHPRA Variation Validation Template for eSubmission | 2020 | 1 | Template | Download TEMPLATE | ||
| 6.16 | New Registration Validation Template for eCTD | 2020 | 3 | Template | Download TEMPLATE | |
| 6.30 | New Registration Validation Template for eSubmission | 2019 | 1 | Template | Download TEMPLATE | |
| 6.31 | Summary of Critical Regulatory Elements (SCoRE) | 2021 | 3 | Template | Download Word TEMPLATE | |
| 6.32 | Bioequivalence Trial Information Form (BTIF) | 2021 | 3 | Template | Download TEMPLATE | Download Word TEMPLATE |
| 6.33 | Abridged review template | 2019 | 1 | Template | Download TEMPLATE | |
| 6.34 | Verified review template | 2019 | 1 | Template | Download TEMPLATE | |
| 6.38 | Additional Strength Biowaiver Application Form | 2021 | 3 | Template | Download TEMPLATE | Download word TEMPLATE |
| 6.39 | Biopharmaceutics Classification System (BCS) Based Biowaiver Application Form | 2021 | 3 | Template | Download TEMPLATE | Download Word TEMPLATE |