Section 22C is the operative provision
It is the licensing section, and it is the reference to cite. Manufacture, import, export and wholesale are licensed under it, and the licence names the establishment and the activity.
[ NATIONAL · ZA ]
South Africa
A health products regulatory authority that licenses manufacturers and runs its own inspection programme.
What this page does not claim
SPEQ synthesis for orientation. It does not determine what applies to a specific product, and an adopted version can move without this page moving with it. Confirm the instrument in force with the authority before relying on it.
Who regulates here (1)
MIDDLE EAST & AFRICA
What makes a requirement binding here
The Medicines and Related Substances Act 101 of 1965, as amended. Section 22C is the licensing provision: it is the section under which manufacturers and wholesalers are licensed, and it extends to medicines, medical devices and in vitro diagnostics. Licensing of South African manufacturers under section 22C took effect from 2 May 2004.
Through a section 22C licence held by the establishment, and inspection against it. The regulatory authority licenses manufacture, import and export, and runs its own inspection programme. Findings bear on the licence itself rather than on a separate renewable certificate, which changes what a finding means: it is a condition on the permission to operate rather than a document to be closed out by a deadline.
WHAT TRANSFERS
PIC/S evidence is recognisable and the licence is not transferable. South Africa participates in PIC/S, so an inspection outcome from another participating authority is legible and can support the authority’s assessment of a foreign site. SPEQ has not decoded ICH participation, so dossier expectations should be confirmed against the authority’s own guidance. The section 22C licence is South African and must be held by the establishment doing the regulated activity.
Operating here
Devices and IVDs sit under the same Act
The Act covers medicines, medical devices and in vitro diagnostics. A company with a combination portfolio deals with one statutory framework, and licensing obligations reach product families that are separately regulated in many markets.
Findings attach to the licence
Where there is no separate renewable certificate, an inspection finding is a condition on the thing that permits supply. Remediation timelines should be set as supply risk from the day a finding is raised.
A 1965 Act, substantially amended
The principal Act is old and has been amended repeatedly, including the changes that created the current authority. Read it as amended; the unamended text will misstate both the institution and the provisions.
What practitioners get wrong
- Cite section 22C when the licensing obligation is the point. It is the provision that carries manufacture, import, export and wholesale licensing.
- Because findings attach to the licence rather than to a certificate, there is no renewal date to work back from — the exposure is continuous and begins when the finding is raised.
- The Act reaches medical devices and IVDs as well as medicines. A device company that expects a separate regime finds the same statute and the same authority.
- SPEQ has not decoded ICH participation for South Africa. Confirm dossier expectations against the authority’s guidance rather than assuming an ICH-region submission transfers.
Questions about South Africa
Which law governs medicines manufacturing in South Africa?
The Medicines and Related Substances Act 101 of 1965, as amended. Section 22C carries the licensing of manufacturers and wholesalers and extends to medicines, medical devices and in vitro diagnostics.
When did manufacturer licensing under section 22C begin?
Licensing of South African manufacturers under section 22C took effect from 2 May 2004.
Does the same Act cover medical devices?
Yes. Medicines, medical devices and in vitro diagnostics all fall under the Act, and licensing under section 22C reaches them. A company with a mixed portfolio deals with one statutory framework and one authority.
ADOPTED, AT A PINNED VERSION
What binds here, and which edition
SPEQ has not decoded a pinned adoption edge here yet. That is a gap in this catalog, not a finding about South Africa: requirements still arrive through the authorities below, and the edition in force is theirs to state.
What influences it
Participation changes which evidence transfers, and which edition of a harmonized guide the local instrument is likely to pin.