| Document Number | File Name | Year | Version | Document Type | Download |
|---|---|---|---|---|---|
| Industry Communication on Interim Measures Pending Update of Variation Addendum | 2020 | 1 | Guideline | Download PDF | |
| 2.01 | General information guideline | 2019 | 10 | Guideline | Download PDF |
| 2.02 | Quality and Bioequivalence | 2019 | 2 | Guideline | Download PDF |
| 2.08a | Interim Variations Addendum for Human and Veterinary Medicine | 2020 | 1 | Guideline | Download PDF |
| 2.09 | Clinical guideline | 2019 | 2 | Guideline | Download PDF |
| 2.14 | Guideline for Patient Information Leaflet for Human Medicines | 2019 | 2 | Guideline | Download PDF |
| 2.16 | Guideline for Professional Information for Human Medicines | 2019 | 2 | Guideline | Download PDF |
| 2.58 | Submission in eSubmission format | 2019 | 1 | Guideline | Download PDF |
| 2.59 | Guideline for the APIMF Procedure | 2021 | 2 | Guideline | Download PDF |
| 4.01 | SA Guide to Good Manufacturing Practice | 2019 | 9 | Guideline | Download PDF |
| 9.125 | BAU variations communication | 2021 | 8 | Guideline | Download PDF |
| 9.127 | eCTD IMPLEMENTATION ROADMAP COMMUNICATION | 2021 | 1 | Guideline | Download PDF |
| 9.128 | PILOT: BAU NEW MEDICINE APPLICATIONS FOR REGISTRATION | 2021 | 2 | Guideline | Download PDF |