SAHPRA Section 21: importing unregistered medicines into South Africa

South Africa allows medicines that are not registered locally to be used only with written permission from the South African Health Products Regulatory Authority (SAHPRA). That permission is a Section 21 authorisation, named after section 21 of the Medicines and Related Substances Act 101 of 1965. It is the route hospitals, specialists and licensed importers use when a patient needs a medicine that has no South African registration.

This guide explains what Section 21 allows, the types of application, who does what, the steps and documents, and the conditions that matter to an exporter in India. The South Africa import guide has the country summary, and how named-patient supply works explains the general model.

What Section 21 allows

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. SAHPRA's Section 21 guideline, version 6 of October 2025, treats access as exceptional, for cases where conventional therapies have been ruled out, have failed or are unavailable. It says affordability alone is not usually a reason to approve.

The importer also needs its own licence. 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 the Section 21 authorisation. The online portal handles applications for Category A medicines for human use, according to SAHPRA's Section 21 FAQs.

Types of Section 21 application

The State uses the multiple patient process for urgent public sector procurement. Clinical trial supplies, including comparators, follow SAHPRA's trial approvals instead, as covered in comparator sourcing for clinical trials.

Who does what

• Treating practitioner. Applies through the portal, provides the clinical motivation, obtains witnessed informed consent where required and takes full clinical responsibility. SAHPRA's FAQs are clear that a patient cannot complete the application.
• Licensed importer or wholesaler. Holds the section 22C licence, is named on the application, imports and supplies the product, and shows the Section 21 letter with the other import documents at customs.
• SAHPRA. Its Section 21 Unit evaluates the application, may raise queries and issues the outcome letter.
• Exporter in India. Supplies product information, GMP evidence and batch certificates, clears Indian export controls and ships to the licensed importer.
• Sponsor or patent holder. May be asked to agree to the use. A patent holder can tell SAHPRA that its patented unregistered medicine may not be brought in by another importer without consent.

How an application runs, step by step

1. The practitioner confirms the need. Registered options are ruled out, have failed or are unavailable, and the quantity is set at six months of treatment or less.
2. The licensed importer agrees to be named. It confirms it can handle the product, including cold chain or scheduled substances.
3. The exporter provides the dossier. A supplier in India sends a proforma invoice, product or prescribing information from another regulator, evidence of registrations held elsewhere, the GMP certificate and a certificate of analysis.
4. The practitioner applies online. The application goes in through the SAHPRA portal under E-Services, Section 21 Applications, with the fee paid. The portal user manual says the fee is waived for public health care institutions registered on the portal.
5. SAHPRA evaluates. It aims to decide within three working days of a complete application. A status of Queried means SAHPRA needs answers or documents before it can continue.
6. The outcome letter is issued. It arrives by email and sits in the application's documents tab.
7. The importer orders and the exporter ships. If the product is unapproved or new in India, the exporter first needs a CDSCO export no objection certificate, as explained in Indian export rules buyers should know.
8. The importer clears and supplies. The importer presents the Section 21 letter at customs and delivers to the hospital or pharmacy.
9. The practitioner reports. Progress reports are due every six months and 30 days after treatment ends, and a new application for the same patient needs the earlier report first.

Changes to an approved application, such as a different practitioner or importing company, need a resubmission with the reason stated.

Documents and timeline

A typical Section 21 consignment carries the authorisation letter naming the applicant and the licensed importer, the prescription and clinical motivation, product information, the GMP certificate and a certificate of analysis for each batch, evidence of sponsor or patent holder agreement when requested, and a proforma invoice, commercial invoice, packing list and air waybill with matching details. The document checklist builds the list for a given product.

Total: roughly 2 to 4 weeks from request to delivery. These are planning estimates, not published service times, and the lead-time estimator breaks them down.

Controlled substances and other conditions

• Scheduled substances. Specified Schedule 5 to 8 substances need an import permit under section 22A(11) of the Act in addition to the Section 21 authorisation. On the Indian side, narcotic and psychotropic exports need a per-consignment authorisation from the Narcotics Commissioner, which requires the importing government's original import certificate and cannot be amended or extended (Central Bureau of Narcotics).
• No re-export or advertising. Medicines supplied under Section 21 may not be exported again or advertised.
• Patents. Check sponsor and patent questions early for generic or biosimilar versions of medicines still under patent. See biosimilars vs reference biologics in named-patient supply.
• Orphan medicines. Section 21 is also the route for rare disease medicines that are not registered in South Africa, and the orphan medicine access guide covers the wider options.

Shipping, duties and VAT

Talks on restoring nonstop flights between India and South Africa were still under way in mid-2026, so freight to Johannesburg, Cape Town or Durban usually connects through Dubai, Doha, Addis Ababa or Nairobi. Courier service is usually 3 to 6 days door to door for small, non-controlled parcels consigned to the licensed importer, and air cargo 5 to 10 days including clearance. For 2 to 8°C products, plan for passive shippers qualified for at least 72 to 96 hours, with data loggers, and the cold-chain transit checker compares options.

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 importer holds the licence and the authorisation. World Bank WITS data shows 0 percent duty on HS 3004 medicines, and imported medicines are reported to carry VAT at the standard rate, which SARS confirms stayed at 15 percent. The landed cost calculator applies these figures.