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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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2.22South African eCTD Validation CriteriaV2.111-Apr-2017281 KB
2.23 Guidance for the submission of regulatory information in eCTD format V111-Mar-2013737 KB
2.23Guidance for the submission of regulatory information in eCTD formatV212-Oct-2016854 KB
2.23Guidance for the submission of regulatory information in eCTD format - showing changesV213-Oct-2016862 KB
2.23Guidance for submission of regulatory information in eCTD formatV2.111-Apr-2017530 KB

General [ 35 ]

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2.06BiostudiesV607-Jul-2015730 KB
2.07DissolutionV516-Jul-2015353 KB
2.07Dissolution showing changesV516-Jul-2015278 KB
2.08Amendments showing changesV608-Aug-20123 MB
2.08AmendmentsV608-Aug-20121 MB

Good Manufacturing Practices [ 12 ]

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4.04Isolator technologyV110-Jun-2003201 KB
4.05Cephalosporin manufactureV110-Jun-2003146 KB
4.06Penicillin manufactureV109-Jun-2003146 KB
4.07Radiopharmaceutical manufactureV130-Jun-2015150 KB
4.08Site master fileV204-Oct-2010240 KB

Human [ 16 ]

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2.14Patient information leafletsV406-Jan-2014251 KB
2.14Patient information leaflets showing changesV406-Jan-2014254 KB
2.16Package insert - human medicinesV506-Jan-2014351 KB
2.16Package insert - human medicines - showing changesV506-Jan-2014690 KB
2.17Safety-related Package Insert Notifications (SR-PINs)V304-Aug-201781 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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3.07MRL and withdrawal periodsV112-Jan-2004608 KB
3.08Safety of veterinary biologicalsV112-Jan-2004171 KB
3.09Reporting of ADR'sV112-Jan-2004134 KB
3.10Recall of veterinary medicinesV112-Jan-2004269 KB
3.11Completing section 21 application formV112-Jan-2004284 KB

[ 1 ]

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