{"id":18,"date":"2019-06-07T21:22:02","date_gmt":"2019-06-07T21:22:02","guid":{"rendered":"http:\/\/sahpracm.org.za\/catd\/?page_id=18"},"modified":"2025-04-16T20:52:32","modified_gmt":"2025-04-16T18:52:32","slug":"guidelines_docs","status":"publish","type":"page","link":"https:\/\/sahpracm.org.za\/catd\/cm-home\/guidelines_docs\/","title":{"rendered":"Guidelines"},"content":{"rendered":"\r\n

Guidance documents specific to Category D - Complementary Medicine:<\/p>\r\n\r\n\r\n\r\n

General Notices<\/span>

<\/strong><\/p>\r\n

SAHPRA Fees: <\/strong>Regulations Regarding Fees Payable In Terms Of The Provisions Of The Medicines And Related Substances Act, 1965 (Act No. 101 Of 1965)<\/a> (12 February 2025)<\/p>\r\n

Communication to Stakeholders: <\/strong>Guideline 7.04: Complementary Medicines - Health Supplements: Safety and Efficacy (Annexures M-O and relevant amendments)<\/a> (03 March 2022)
<\/strong><\/p>\r\n

Communication to Stakeholders: <\/strong>Guideline 7.06: Complementary Medicines - Guidance on Specified substances<\/a> (02 February 2022)
<\/strong><\/p>\r\n

Communication to Stakeholders: <\/strong>Guideline 7.02: Roadmap and transitional process for regulation of complementary medicines<\/a> (17 December 2021)<\/p>\r\n

Communication to Stakeholders: <\/strong>APPLICATIONS - Certificate of free sale for Category D medicines (Complementary Medicines)<\/a> (15 November 2021)
<\/strong><\/p>\r\n

Communication to Stakeholders: <\/strong>REQUESTS - Review of detained product at a port of entry as a Category D medicine<\/a> (27 October 2021)
<\/strong><\/p>\r\n

Communication to Stakeholders: <\/strong>REQUESTS - Existing Category D (Complementary Medicines) Registration Applications - CM applications submitted for registration<\/a> (07 October 2021)
<\/strong><\/p>\r\n

Addendum:<\/strong> REQUESTS: Existing Category D (Complementary Medicines) Registration Applications<\/a> (24 February 2022)<\/p>\r\n

Communication to Stakeholders:<\/strong> Licensing of Complementary Medicines Manufacturers, Wholesalers, Distributors, Importers and Exporters<\/a> (12 February 2020)<\/p>\r\n

SAHPRA Warning:<\/strong> COVID-19 \u2013 Caution for the use of Health Products<\/a> (30 March 2020)<\/p>\r\n<\/div>\r\n\r\n\r\n

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Guidelines<\/span>

<\/strong><\/p>\r\n

All SAHPRA Guidelines: Click here<\/a><\/p>\r\n

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Guideline 7.01: <\/strong>Complementary Medicines - Discipline-Specific - Safety and Efficacy<\/a>
(June 2020 - version 3.1)<\/p>\r\n\r\n\r\n

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Guideline 7.02: <\/strong>Complementary Medicines - Roadmap and Transitional Arrangements<\/a>
(December 2021 - version 2.3)<\/p>\r\n

With respect to licensing of facilities (section 3.1), this Guideline is not<\/strong> 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<\/strong><\/a> \u2013 Cultivation of Cannabis and Manufacture of Cannabis-related pharmaceutical products for medicinal and research purposes<\/strong> on www.sahpra.org.za<\/a>.<\/em><\/p>\r\n\r\n\r\n

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Guideline 7.03:<\/strong> Complementary Medicines - Use of the ZA-CTD Format in the preparation of a Registration Application<\/a>
(June 2020 - version 3.2)<\/p>\r\n

Refer to Guidelines 7.01, 7.04 and 7.05 for specific guidance for each section of a CTD application.<\/em><\/p>\r\n\r\n\r\n

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Guideline 7.04:<\/strong> Complementary Medicines - Health Supplements - Safety and Efficacy<\/a>
(March 2022 - version 4.3), including:<\/p>\r\n

Annexure A: <\/strong>Category Decision Tree
Annexure B:<\/strong> Motivation for the inclusion of a non-listed Substance as Health Supplement
Annexure C:<\/strong> Allowable levels and claims: Probiotics
Annexure D:<\/strong> Allowable levels and claims: Prebiotics
Annexure E:<\/strong> Allowable levels and claims: Vitamins
Annexure F:<\/strong> Allowable levels and claims: Minerals
Annexure G:<\/strong> Allowable levels and claims: Proteins and Amino acids
Annexure H:<\/strong> Allowable levels and claims: Animal Extracts, Products and Derivatives
Annexure I:<\/strong> Allowable levels and claims: Fats, Oils and Fatty Acids
Annexure J:<\/strong> Allowable levels and claims: Carotenoids
Annexure K:<\/strong> Allowable levels and claims: Polyphenols (including Bioflavonoids)
Annexure L:<\/strong> Allowable levels and claims: Aminosaccharides
Annexure M:<\/strong> Allowable levels and claims: Saccharides
Annexure N:<\/strong> Allowable levels and claims: Enzymes
Annexure O:<\/strong> Allowable levels and claims: Other<\/p>\r\n\r\n\r\n

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Guideline 7.05:<\/strong> Complementary Medicines - Registration Application ZA-CTD - Quality<\/a>
(June 2020 - version 2), including:<\/p>\r\n

Annex A:<\/strong> Stability testing (June 2020 - version 2)
Annex B:<\/strong> Naming and labelling conventions for active ingredients in complementary medicines (June 2020 - version 2)<\/p>\r\n\r\n\r\n

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Guideline 7.06:<\/strong> Complementary medicines - Guidance on Specified Substances<\/a>
(January 2022 - version 3.2), including:<\/p>\r\n

Annex 1:<\/strong> Caffeine
Annex 2:<\/strong> Menthol
Annex 3:<\/strong> Camphor
Annex 4:<\/strong> Cannabidiol (CBD)<\/p>\r\n\r\n\r\n

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Guideline SAHPGL-INSP-02:<\/strong> SA Guide to Good Manufacturing Practice for Medicines<\/a>
(Sep 2022 - version 8)<\/p>\r\n

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:<\/em><\/p>\r\n