The Category D framework as it stands
SAHPRA's Complementary Medicines category was established 15 November 2013 under the Medicines and Related Substances Act 101 of 1965, and broadened on 25 August 2017 via Government Notice 859 in GG 41064 to add two sub-categories: discipline-specific medicines (aromatherapy, Ayurveda, homeopathy, TCM, Unani Tibb, Western Herbal Medicine) and modern supplement-type health supplements. The registration regime operates through call-up notices under section 14 of the Medicines Act, with continued rights of sale conditional on application by prescribed deadlines, GMP/GDP-compliant licensing under section 22C(1)(b), and indication restriction to LOW RISK uses (general health enhancement, relief of minor symptoms not related to disease).
The licensing portal sits at sahpracm.org.za. Licence categories range from DL01 (manufacture/import/export Cat D) through wholesaling and distribution variants. The 2020 Gauteng High Court ruling that struck down SAHPRA regulation of non-scheduled complementary medicines remains stayed pending appeal — GG 41064 regulations remain in force.
What the zinc picolinate / selenium move signals
SAHPRA's directive on paediatric zinc picolinate and selenium products is a directional signal. Per the regulator's notice, "any medicine sold that contains zinc picolinate or selenium intended for use in children does not qualify as a Category D (complementary) medicine. As such, their sale as a Category D medicine is illegal." Effective at publication, all such products intended for children must be reclassified to Category A and submitted for full registration as prescription or general medicines under Section 14(2) of the Medicines Act. Manufacturers and distributors have six months from the date of publication to withdraw existing stock. SAHPRA's stated rationale: variable bioavailability of zinc from picolinate ("the risk of side effects may be higher and unpredictable, and it is unsuitable as a source of elemental zinc supplementation in children"), unpredictable risk in paediatric dosing, and overdose risk for selenium outside famine/dietary-restriction contexts.
The implication for the wider complementary medicines category: SAHPRA is willing to reclassify on safety grounds even within established Category D ranges. Distributors should expect more directives, particularly on paediatric formulations and on ingredients with narrow therapeutic windows.
The JHB/CPT distribution reality
The South African longevity and wellness segment in Johannesburg (Sandton, Rosebank corridor) and Cape Town (V&A, Constantia, Sea Point) runs on a mix of locally licensed Category D brands and parallel-imported international supplements. SAHPRA's GMP guidelines were updated in April 2026, per Dr Andy Gray's regulatory column in Quicknews (8 May 2026), and SAHPRA remains a PIC/S member aligning to ICH Q10 pharmaceutical quality system standards. The eCTD format becomes mandatory for most human medicines applications (Cat A) but complementary medicines retain document-based submission pathways.
The operational signal: brand operators selling into SA wellness through Dis-Chem, Clicks or premium independent pharmacies need DL01-licensed importers, GMP-verified manufacturers, and indication language that fits LOW RISK Category D scope. Brands making disease-treatment claims get pulled into Category A and into SAHPRA's resource-constrained full-registration pipeline.