| Document Number | File Name | Year | Version | Document Type | Download |
|---|---|---|---|---|---|
| 9.126 | Reflection document on regulatory requirements for vaccines intended to provide protection against variant strain(s) of SARS-CoV-2 | 2021 | 1 | Guideline | Download PDF |
| 2.15 | Proprietary Names Guideline | 2019 | 6 | Guideline | Download PDF |
| 2.30 | SAHPRA – Biosimilar Medicines Guidance | 2014 | 3 | Guideline | Download PDF |
| 2.36 | Scheduling of Medicine Guideline | 2019 | 5 | Guideline | Download PDF |
| 2.37 | Scheduling for Prescribing by Authorised Prescribers | 2019 | Guideline | Download PDF | |
| 2.39 | Biological Medicines Pre-Registration Consultation Meeting Guidance | 2020 | 1 | Guideline | Download PDF |
| 2.60 | BIOLOGICAL MEDICINES STABILITY GUIDELINE | 2020 | 1 | Guideline | Download PDF |
| 2.61 | Biological medicines amendment guideline - to be implemented 17 April 2020 | 2021 | 4 | Guideline | Download PDF |
| 2.62 | SAHPRA SA NCL -COVID-19 LOT RELEASE GUIDELINE | 2020 | 1 | Guideline | Download PDF |
| 6.20 | Pre-Registration Consultation Meeting Material Checklist | 2015 | 1 | Guideline | Download PDF |