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 | 6 | 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 | 2019 | 1 | Guideline | Download PDF |
4.01 | SA Guide to Good Manufacturing Practice | 2019 | 9 | Guideline | Download PDF |