III. REGISTRATIONS IN SOUTH AFRICA
Registrations are managed by the South African Health Products Regulatory Authority (SAHPRA).
Since 2013, SAHPRA, determined that complementary medicines are subjected to registration. The switch from a registration-free framework to an obligation for registration entails an administrative effort of all companies wanting to sell health supplements on the South African market.
From June 2020, only holders of a valid licence issued in terms of section 22C(1)(b) of the Medicines Act shall be permitted to manufacture, import, export or act as a wholesaler or distribute complementary medicines. Further from June 2021, any new manufacturers, importers, exporters, or wholesalers or distributors must hold a licence prior to manufacturing, importing, exporting, wholesaling, or distributing any Category D (complementary) medicines.
A timeline of the new framework as per SAHPRA is frequently updated.
To register, multiple documents must be provided upon registration:
- CTD Registration (SAHPRA local registration platform)
- GMP certificates of manufacturers
- GLP certificates of manufacturers
- Proof of compliance with the WHO Guidelines on Good Agricultural and Collection Practices (GACP) for Medicinal Plants, if applicable.
- CEP, confirmation of WHO API prequalification.
- Proof of registration in country of origin and registration in other countries.
- Certificate of Premises for the Storage of Foodstuffs.
- CoA and batch manufacturing documents should be available for all send samples.