Importing medicines into South Africa

The regulator

The South African Health Products Regulatory Authority (SAHPRA) regulates medicines under the Medicines and Related Substances Act 101 of 1965. Its Section 21 Unit handles requests to use medicines that are not registered in South Africa. Under regulation 6(2) of the General Regulations, a company may import medicines only if it holds a licence to import under the Act, and for an unregistered medicine it also needs SAHPRA's authorisation. Both points are set out in SAHPRA's Guideline for Section 21 access to unregistered medicines, version 6 (October 2025).

Legal routes for unregistered medicines

Section 21 lets SAHPRA authorise the sale of a specified quantity of an unregistered medicine to a specified person or institution for a specified period. The Act's definition of sale includes import and supply, so the authorisation must be in place before the medicine is imported. The guideline treats access as exceptional, for cases where conventional therapies have been ruled out, have failed or are unavailable, and says affordability alone is not usually a reason to approve.

Named patient applications

The health care provider responsible for the patient applies through the SAHPRA online portal and names the licensed importer or wholesaler that will supply the product. The application includes product information, registrations held elsewhere, GMP evidence for the manufacturer, the reasons a registered medicine cannot be used and, where needed, witnessed informed consent. The quantity must be six months of treatment or less. According to SAHPRA's Section 21 FAQs, the fee is R400 per application from 13 February 2025 and approval lapses after six months. The portal user manual says the fee is waived for public health care institutions registered on the portal.

Multiple patient and State applications

A hospital can apply to hold stock of an unregistered medicine for several patients or for emergencies, for example in intensive care or theatre. The fee is normally the Section 21 fee multiplied by the number of patients, with a single fee for listed use cases such as registered equivalents being out of stock or withdrawn, radiopharmaceuticals and once-off emergency items. The State uses the same process for urgent public sector procurement, and a separate track covers public health emergencies.

Conditions that affect exporters

The importing company must give evidence that the sponsor or patent holder agrees to the use of the product, and a patent holder can tell SAHPRA that its patented unregistered medicine may not be brought in by another importer without consent. Medicines supplied under Section 21 may not be exported again or advertised. Specified Schedule 5 to 8 substances also need an import permit under section 22A(11) of the Act. Clinical trial supplies follow SAHPRA's clinical trial approvals instead.

Documents a buyer usually needs

• Section 21 authorisation letter naming the applicant and the licensed importer
• Prescription and clinical motivation from the treating practitioner, with informed consent where required
• Product or prescribing information and evidence of registration elsewhere, if any
• GMP certificate for the manufacturing site and a certificate of analysis for each batch
• Evidence that the sponsor or patent holder agrees to the use, when the importer is asked for it
• Proforma invoice, commercial invoice, packing list and air waybill with matching details
• Section 22A(11) import permit for specified Schedule 5 to 8 substances

Timeline: a worked example

A specialist at a private hospital in Johannesburg needs a medicine for one patient. The medicine is not registered in South Africa and is available from a manufacturer in India.

Total: roughly 2 to 4 weeks from request to delivery. These are planning estimates, not published service times.

Shipping lanes from India

Talks on restoring nonstop flights between India and South Africa were still under way in mid-2026, so freight from Mumbai, Delhi, Chennai or Bengaluru to Johannesburg (JNB), Cape Town (CPT) or Durban (DUR) usually connects through Dubai, Doha, Addis Ababa or Nairobi. Express courier service is usually 3 to 6 days door to door for small, non-controlled parcels consigned to the licensed importer. Air cargo is usually 5 to 10 days including clearance. Scheduled substances and cold-chain lots should move as air cargo with the permits in place before departure.

CIP and DAP to the licensed importer are the usual terms, and FCA suits importers with their own forwarder. DDP is rarely practical because the South African importer must hold the licence and the authorisation and clear the goods.

Practical tips for buyers

• Agree with the licensed importer, before the application is filed, that it will be named on it and can handle the product, including cold chain or scheduled substances.
• Keep the product name, strength, pack size and quantity identical across the authorisation letter, invoice, packing list and air waybill. The guideline asks importers to show the Section 21 letter with the other import documents at customs.
• Check patent and sponsor questions early for generic or biosimilar versions of medicines still under patent, since a patent holder can object to supply by a second importer.
• Duty on HS 3004 medicines is 0 percent according to World Bank WITS data. Imported medicines are reported to be standard rated, and SARS confirms the standard rate stayed at 15 percent after the planned 2025 increase was reversed.
• Plan for reporting. The prescriber must send progress reports every six months and 30 days after treatment ends, and a new application for the same patient needs the earlier report first.