Who can hold a SAHPRA registration

SAHPRA regulates medicines under the Medicines and Related Substances Act, 1965 (Act 101 of 1965). Regulation 16 under the Act governs who may apply for registration, so an Indian exporter cannot hold one directly.

SAHPRA's General Information Guideline (version 12, December 2023) lets three kinds of applicant apply: a person or juristic person residing and doing business in South Africa, a close corporation incorporated there, or a South African company with a resident responsible delegated person and a resident authorised person.

The same guideline expects overseas manufacturers to meet the same or equivalent GMP standards as South African ones. Where SAHPRA lacks acceptable evidence, its Inspectorate can inspect the site before approving registration, and it may request more documents or reject a site.

The practical result is simple. Your counterpart is a South African entity that applies, holds the certificate and answers to SAHPRA. M Care Exports supplies that entity with the product and the manufacturer-side file. See our South Africa market page.

Reliance and recognition pathways

SAHPRA's Reliance Guideline (SAHPGL-BAU-01, version 7, 9 June 2026) sets three pathways.

  • Abridged review relies on full assessment reports from a recognised regulatory authority (RRA), so SAHPRA does not evaluate all the data itself.
  • Verified review checks a submission against information already approved by SAHPRA or an RRA, rather than evaluating it afresh.
  • Recognition would accept an RRA's decision directly under a recognition agreement. Version 7 states that SAHPRA is still negotiating those agreements.

The clinical and the quality and bioequivalence evaluations can follow different pathways, so one product may use more than one.

The RRA list in that version names the EU centralised and decentralised procedures, Health Canada, the MHRA, Japan's PMDA, Swissmedic, Australia's TGA, the US FDA and WHO-listed authorities. It does not name India's regulator, and the guideline says public assessment reports will not be accepted. A WHO-prequalified product follows SAHPRA's WHO Collaborative Registration Procedure. Our guide to WHO prequalification versus national registration explains that route.

GMP reliance is narrower. SAHPRA applies reliance to PIC/S, WHO, African Medicines Agency and ZAZIBONA inspections. For a finished product, a site approved by a recognised regulator within the previous three years can qualify if dosage form grouping, product type and activities match, though meeting those conditions does not guarantee acceptance. GMP certificates and inspection reports must be in English, and SAHPRA will not accept a desk-top or virtual inspection report, or a certificate issued after one.

Section 21 access to unregistered medicines

Section 21 lets SAHPRA authorise a person to sell a specified quantity of an unregistered medicine to a specified person or institution for a set period. SAHPRA's guideline (SAHPGL-CEM-S21-02, version 6, 30 October 2025) treats this as exceptional access, where conventional therapies are ruled out, have failed or are unavailable. Affordability alone is generally not a significant reason.

Who applies depends on the route:

  • Named patient: the health care provider responsible for the patient.
  • Multiple patient: the intended prescriber, or a provider designated by the health establishment, for planned treatments or emergency stock.
  • State procurement: the State applies through the multiple patient process and flags it as State procurement.

The application names the licensed entity responsible for supply and explains why a South African registered medicine cannot be used. Regulation 29 also asks for evidence of the manufacturer's GMP compliance. The importer needs a section 22C(1)(b) licence and written evidence that the sponsor or patent holder agrees. Schedule 5 to 8 substances also need a permit. Authorised stock may not be exported, and progress reports fall due every six months.

Importer and wholesaler licensing

SAHPRA licenses manufacturers, importers, exporters and wholesalers or distributors under section 22C(1)(b). An importer may not import a medicine without that licence. Importing an unregistered medicine also needs SAHPRA's written authorisation under section 21 of the Act.

SAHPRA's import and export guideline (SAHPGL-INSP-RC-02, version 2) says a licence runs for five years from issue, and every application needs a responsible pharmacist. Licensing reviews GMP and a quality system that covers purchasing, storage, distribution, temperature control, counterfeit medicines and recalls.

Before you ship, ask your buyer for a copy of the licence and confirm it covers the product category and premises. For temperature-controlled lines, agree storage and transport too, with our cold chain validation service.

National Department of Health tenders

Public-sector medicine contracts are run by the National Department of Health, which publishes contract circulars with an HP reference. HP09-2026SD, for solid dosage forms, runs from 1 May 2026 to 30 April 2029. The provincial health departments, the South African Military Health Service and Correctional Services participate.

The bid conditions in that circular set the bar for an Indian supplier:

  • The bidder holds a valid licence to manufacture or import under section 22C(1)(b), supplied as a certified copy of the original.
  • Each item is registered under section 15, and the bidder is shown as the applicant on each medicine registration certificate. A bidder that is not the applicant must file a signed agreement with the applicant and show a qualifying link, such as a common parent company, part ownership of one by the other, or a technology transfer arrangement. Every party then needs the licence.
  • The bidder is on the Central Supplier Database with a valid tax compliance PIN. Foreign suppliers with no South African tax history complete an SBD1 questionnaire.
  • A contracted supplier needs the department's approval before supplying an alternative product, including one authorised under Section 21.

An Indian merchant-exporter therefore does not bid on its own. The bidder is a South African licence holder that normally holds the registrations. M Care Exports backs that partner with supply and documents through our government supply services. Contracts are re-tendered, so read the current circular before bidding.

The Indian-side document pack

SAHPRA publishes no checklist for Indian suppliers. The pack is the manufacturer-side evidence your South African licence holder needs for a dossier, a tender or a Section 21 request. A typical pack holds:

  1. A ZA-CTD or eCTD dossier, with South African Module 1 completed by the applicant. See dossier preparation.
  2. Current GMP evidence for every manufacturing, packing and testing site, and the site master file where requested.
  3. The manufacturer's licence, and a signed authorisation declaration where a third party makes the product.
  4. Registration status in other markets, plus assessment reports from a recognised regulator if you rely on one.
  5. Professional information and patient leaflet drafted to SAHPRA's format.
  6. A unit-pack sample with photographs of the final pack, as section 15(1) requires.

Your partner will vet us too. Our guide to verifying an Indian pharmaceutical exporter lists what to ask. To start, use request a medicine or open a trade account.

Frequently asked

Can an Indian manufacturer register a medicine with SAHPRA directly?

No. SAHPRA's General Information Guideline limits applicants to a person or juristic person residing and doing business in South Africa, a South African close corporation, or a South African company with a resident responsible delegated person and a resident authorised person. The Indian manufacturer stays in the file as the site that must show GMP compliance. In practice you appoint or work with a South African entity that becomes the registration holder, signs through an authorised pharmacist and answers to SAHPRA for the product.

Does SAHPRA accept an Indian approval for reliance review?

Not as a recognised regulatory authority. Version 7 of the Reliance Guideline, dated 9 June 2026, names the EU procedures, Health Canada, the MHRA, Japan's PMDA, Swissmedic, the TGA, the US FDA and WHO-listed authorities, and India's regulator is not on that list. A WHO-prequalified product follows the WHO Collaborative Registration Procedure. The guideline also mentions other collaborative procedures, and SAHPRA revises it often, so your South African partner should confirm which pathway fits before you plan timelines.

When can an unregistered medicine be imported under Section 21?

SAHPRA treats Section 21 as exceptional access. Conventional therapies must be ruled out, have failed or be unavailable, and affordability alone is generally not a significant reason. The application must explain why a South African registered medicine cannot be used, and it must name the licensed entity that will supply the product. The applicant is usually the treating health care provider, or a designated provider for multiple patient and State requests. SAHPRA authorises a specified quantity for a specified period, so authorisation is product-specific and time-limited.

Which licence does a South African importer need?

An importer needs a licence under section 22C(1)(b) of the Medicines Act. SAHPRA's licensing page lists licences to manufacture, import, export and act as a wholesaler or distributor. Licences run for five years from issue, and each application needs a responsible pharmacist. Importing an unregistered medicine also needs SAHPRA's Section 21 authorisation, and Schedule 5 to 8 substances need an import permit. Ask your buyer for a copy of the licence and check that it covers your product category before you ship.

What do public hospital tenders require from a medicine supplier?

The National Department of Health's contract circulars, such as HP09-2026SD, set the terms. The bidder must hold a section 22C(1)(b) licence to manufacture or import, offer items registered under section 15, and normally be the applicant on each registration certificate. A bidder that is not the applicant needs a signed agreement with the applicant and a qualifying link, such as common ownership or a technology transfer arrangement. Bidders register on the Central Supplier Database and supply a tax compliance PIN. Foreign suppliers with no South African tax history complete an SBD1 questionnaire. An Indian exporter usually supplies the South African licence holder that bids.

What does M Care Exports provide to a South African importer?

M Care Exports is an Indian merchant-exporter, trading since 2003, supplying originator brands through licensed Indian channels and generics from WHO-GMP certified manufacturers. We do not manufacture, and the GMP certification belongs to the manufacturer. For a South African importer we assemble the manufacturer-side file, quote registered and unregistered lines, and coordinate documents for dossiers, tenders and Section 21 requests. Send the molecule, strength and form through the request-a-medicine page and we will confirm sourcing.

Official sources

The regulators and official documents to check this guide against. Requirements change, so confirm the current version with the regulator before you file.

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