Guidelines – SAHPRA

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
(June 2020 - version 3.1)

Guideline 7.02: Complementary Medicines - Roadmap and Transitional Arrangements
(December 2021 - version 2.3)

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
(June 2020 - version 3.2)

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
(March 2022 - version 4.3), including:

Annexure A: Category Decision Tree
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

Guideline 7.05: Complementary Medicines - Registration Application ZA-CTD - Quality
(June 2020 - version 2), including:

Annex A: Stability testing (June 2020 - version 2)
Annex B: Naming and labelling conventions for active ingredients in complementary medicines (June 2020 - version 2)

Guideline 7.06: Complementary medicines - Guidance on Specified Substances
(January 2022 - version 3.2), including:

Annex 1: Caffeine
Annex 2: Menthol
Annex 3: Camphor
Annex 4: Cannabidiol (CBD)

Guideline 4.01: SA Guide to Good Manufacturing Practice for Medicines
(July 2019 - version 7)

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:

PIC/S: Guides to Good Manufacturing Practice for Medicinal Products, with regard to CMs refer to the documents highlighted below as may be applicable:
- PIC/S GMP Guide (Introduction)
- PIC/S GMP Guide (Part I: Basic Requirements for Medicinal Products)
PIC/S: Annexes of Guide to Good Manufacturing Practice for Medicinal Products, with regard to CMs refer to to Annexes which may be applicable, including but not limited to:
- Annex 1: Manufacture of sterile medicinal products
- Annex 7: Manufacture of Herbal Medicinal Products
- Annex 8: Sampling of starting and packaging materials
- Annex 9: Manufacture of liquids, creams and ointments