Guidance documents specific to Category D - Complementary Medicine:
General Notices Communication to Stakeholders: Guideline 7.04: Complementary Medicines - Health Supplements: Safety and Efficacy (Annexures M-O and relevant amendments) (03 March 2022) Communication to Stakeholders: Guideline 7.06: Complementary Medicines - Guidance on Specified substances (02 February 2022) Communication to Stakeholders: Guideline 7.02: Roadmap and transitional process for regulation of complementary medicines (17 December 2021) Communication to Stakeholders: APPLICATIONS - Certificate of free sale for Category D medicines (Complementary Medicines) (15 November 2021) Communication to Stakeholders: REQUESTS - Review of detained product at a port of entry as a Category D medicine (27 October 2021) Communication to Stakeholders: REQUESTS - Existing Category D (Complementary Medicines) Registration Applications - CM applications submitted for registration (07 October 2021) Addendum: REQUESTS: Existing Category D (Complementary Medicines) Registration Applications (24 February 2022) Communication to Stakeholders: Licensing of Complementary Medicines Manufacturers, Wholesalers, Distributors, Importers and Exporters (12 February 2020) SAHPRA Warning: COVID-19 – Caution for the use of Health Products (30 March 2020) Guidelines Guideline 7.01: Complementary Medicines - Discipline-Specific - Safety and Efficacy Guideline 7.02: Complementary Medicines - Roadmap and Transitional Arrangements With respect to licensing of facilities (section 3.1), this Guideline is not applicable to any product associated with the cultivation or manufacture of Cannabis-related pharmaceutical products containing Tetrahydrocannabinol greater than 0,001 percent. Intended licence holders must instead refer to the SAHPRA Guideline 2.44 – Cultivation of Cannabis and Manufacture of Cannabis-related pharmaceutical products for medicinal and research purposes on www.sahpra.org.za. Guideline 7.03: Complementary Medicines - Use of the ZA-CTD Format in the preparation of a Registration Application 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 Annexure A: Category Decision Tree Guideline 7.05: Complementary Medicines - Registration Application ZA-CTD - Quality Annex A: Stability testing (June 2020 - version 2) Guideline 7.06: Complementary medicines - Guidance on Specified Substances Annex 1: Caffeine Guideline 4.01: SA Guide to Good Manufacturing Practice for Medicines Note: SA GMP Guideline should be consulted for the local requirements, as contained in the linked document. SA GMP is reliant on PIC/S GMP which may be used for general guidance on GMP with specific reference to those documents indicated below. These updated links are provided here for your convenient reference: Guideline 4.02: SA Good Wholesaling Practices for Wholesalers Templates Validation Template 6.18: Validation Template for Electronic Applications for Registration of Complementary Medicines Guideline Comment Template: SAHPRA CM Guideline Comment Template Documents for Comment Guideline COMP_02: Guideline On A Roadmap And Transitional Process For The Regulation Of Category D Medicines published for public comment (Deadline: 17 October 2023 by 16:00) SUBMIT COMMENT: Click here for access to the SAHPRA website and the document.
(June 2020 - version 3.1)
(December 2021 - version 2.3)
(June 2020 - version 3.2)
(March 2022 - version 4.3), including:
Annexure B: Motivation for the inclusion of a non-listed Substance as Health Supplement
Annexure C: Allowable levels and claims: Probiotics
Annexure D: Allowable levels and claims: Prebiotics
Annexure E: Allowable levels and claims: Vitamins
Annexure F: Allowable levels and claims: Minerals
Annexure G: Allowable levels and claims: Proteins and Amino acids
Annexure H: Allowable levels and claims: Animal Extracts, Products and Derivatives
Annexure I: Allowable levels and claims: Fats, Oils and Fatty Acids
Annexure J: Allowable levels and claims: Carotenoids
Annexure K: Allowable levels and claims: Polyphenols (including Bioflavonoids)
Annexure L: Allowable levels and claims: Aminosaccharides
Annexure M: Allowable levels and claims: Saccharides
Annexure N: Allowable levels and claims: Enzymes
Annexure O: Allowable levels and claims: Other
(June 2020 - version 2), including:
Annex B: Naming and labelling conventions for active ingredients in complementary medicines (June 2020 - version 2)
(January 2022 - version 3.2), including:
Annex 2: Menthol
Annex 3: Camphor
Annex 4: Cannabidiol (CBD)
(July 2019 - version 7)
(November 2019 - version 2.1)
(June 2020, version 2) [editable PDF version]