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)

Guideline 7.01: Complementary Medicines - Discipline-Specific - Safety and Efficacy
(June 2020 - version 3.1)

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Guideline 7.02: Complementary Medicines - Roadmap and Transitional Arrangements
(March 2021 - version 2.2)

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.

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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.

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Guideline 7.04: Complementary Medicines - Health Supplements - Safety and Efficacy
(June 2020 - version 4), 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

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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)

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Guideline 7.06: Complementary medicines - Guidance on Specified Substances
(June 2020 - version 3), including:

Annex 1: Caffeine
Annex 2: Menthol
Annex 3: Camphor

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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

Validation Template 6.18: Validation Template for Electronic Applications for Registration of Complementary Medicines
(June 2020, version 2) [editable PDF version]

Guideline Comment Template: SAHPRA CM Guideline Comment Template

Guideline 7.04: Complementary Medicines - Health Supplements - Safety and Efficacy; Annexures M, N published for public comment (Deadline: 30 June 2021)

Guideline 7.06: Complementary Medicines - Guidelines on Specified Substances; Annexure 4: Cannabidiol (CBD) published for public comment (Deadline: 30 June 2021)

SAHPRA Notice: Stakeholder notice regarding Annexure 4: Cannabidiol (CBD)

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