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Guidelines

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Complementary [ 6 ]

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9.72Complementary Medicines submitted for registration - right to saleV124-Apr-2016155 KB

eCTD [ 18 ]

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2.26ZACTD and ZA eCTD Implementation road mapV612-Feb-2016274 KB
2.27 eCTD checksums V101-Mar-201333 KB
2.27eCTD checksumsV22.115-Nov-201674 KB
2.28Questions & Answers on Implementation of eCTD in South AfricaV315-Nov-2016361 KB
2.29Implementaion guidance of SA eCTD M1 specification v2.1 & validation criteria v2.1V11.210-Apr-2017114 KB

General [ 35 ]

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2.13Implementation of Post-registration amendments guidelineV129-Jun-2015291 KB
2.15Proprietary name for medicines showing changesV501-Dec-2014728 KB
2.15Proprietary name for medicines V528-Nov-2014590 KB
2.24Guidance General and Module 1V510-Jul-2012924 KB
2.25Pharmaceutical and Analytical CTD /eCTDV412-Aug-20141 MB

Good Manufacturing Practices [ 12 ]

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4.09Inspections involving GMP inspectorsV112-Jul-2006166 KB
4.10Wholesalers to Export Medicinal ProductsV117-May-2016210 KB

Human [ 16 ]

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2.17Safety-related Package Insert Notifications (SR-PINs) showing changesV304-Aug-201793 KB
2.20Package inserts for human medicines standardised texts - showing changesV407-Jul-20151 MB
2.20Package inserts for human medicines standardised texts V407-Jul-2015320 KB
2.31Fixed dosage combination products for HIV, AIDS, TB, MalariaV201-Aug-2012309 KB
2.33Post-marketing reporting of ADRs to human medicines in South Africa showing changesV519-Jun-2017643 KB

Medical Devices and In Vitro Diagnostics [ 7 ]

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8.07Medical Device Quality ManualV201-Aug-2017440 KB
8.10Questions & Answers: Licensing of Medical Device EstablishmentsV129-Dec-201797 KB

Veterinary [ 13 ]

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3.12Veterinary orphan productsV114-May-2012149 KB
3.12Veterinary Orphan ProductsV107-May-2012149 KB
3.13Veterinary Antimastitis ProductsV104-Nov-2013343 KB

[ 1 ]

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2.33Post-marketing reporting of ADRsV318-Aug-2014484 KB