Guidance documents specific to Category D - Complementary Medicine:
SAHPRA Warning: COVID-19 – Caution for the use of Health Products
Guideline 7.01: Complementary Medicines - Discipline-Specific - Safety and Efficacy (June 2016 - version 3)
Guideline 7.02: Complementary Medicines - Roadmap and Transitional Arrangements (September 2019 - version 2)
With respect to licensing of facilities, this Guideline is not applicable to any product associated with the cultivation or manufacture of Cannabis-related pharmaceutical products. Intended licence holders must instead refer to SAHPRA Guideline 2.44–Cultivation of Cannabis and Manufacture of Cannabis-related pharmaceutical products for medicinal and research purposes
Guideline 7.03: Complementary Medicines - Use of the ZA-CTD Format in the preparation of a Registration Application (April 2019 - version 3.1)
Refer to Guidelines 7.01, 7.04 and 7.05 for specific guidance for each section of a CTD application.
Guideline 7.04: Complementary Medicines - Health Supplements - Safety and Efficacy (June 2016 - version 2)
Guideline 7.05: Complementary Medicines - Registration Application ZA-CTD - Quality (June 2016 - version 1)
Annex A: Stability testing (June 2016 - version 1) (see Guideline 7.05)
Annex B: Naming and labelling conventions for active ingredients in complementary medicines (September 2019 - version 1)