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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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ZIP001UTILV128-Aug-20157 KB
ZIP002za regionalV128-Aug-20154 KB
ZIP004ZA utilV22.115-Nov-20167 KB

General [ 35 ]

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2.30BiosimilarsV311-Aug-2014589 KB
2.30Biosmilars showing changesV315-Aug-2014595 KB
2.32Wound dressingsV102-Jul-2012211 KB
2.35Labelling of medicines containing sugarsV108-Dec-2015132 KB
2.35Labelling of medicines containing sugars showing changesV108-Dec-2015134 KB

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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2.33Post-marketing reporting of ADRs to human medicines in South AfricaV519-Jun-2017634 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