Official source
Source domain: health.gov.za
Collected on 17 September 2026
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Guidance on regulatory requirements for complementary medicines offered in national pharmaceutical tenders
The National Department of Health has published guidance, based on SAHPRA's clarification, for current and prospective bidders on what regulatory documentation they must submit for complementary medicines in national pharmaceutical tenders. It explains how licensing, product listing and third-party manufacturing arrangements are treated during bid evaluation.
Reference
https://www.health.gov.za/wp-content/uploads/2026/09/Guidance-on-Complementary-Medicines.pdf
The following information is provided to assist all current and prospective bidders in understanding the regulatory documentation required to enable the Department to validate complementary medicines during bid evaluation.
Inclusion of complementary medicines on the applicable SAHPRA product list through the DA02 amendment process
A holder of a valid Category A licence to manufacture, import or export medicines must have the relevant complementary medicines approved and included on the applicable product list through the DA02 amendment process, because no separate Category D licence is issued for complementary medicines. For bid evaluation the licence is considered together with the corresponding DA02 Product List.
the Category A licence holder must have the relevant complementary medicines appropriately approved and included on the applicable product list through the DA02 amendment process.
Submission of product formulation, intended-use or product-name changes to SAHPRA for review and approval
Where the name of a product offered in a bid or marketed by an applicant differs from the name on the applicable DA02 Product List, the difference is not assumed to be merely administrative, stylistic or non-material. The change must be submitted to SAHPRA for review and approval, as it may relate to a formulation change, intended-use change or product-name change.
Such changes must be submitted to SAHPRA for review and approval.
