Understanding SAHPRA Category D Medicine Manufacturers and regulations

A short companion to the full guide, How to Assess South African SAHPRA Category D Supplement Manufacturers: Regulatory Requirements versus Illegal Quality Practices.

Author: Carmi Wilmans (BSc Hons Regulatory Pharmacology, University of Pretoria)

Date: 13 November 2026

Version: 1.0

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Why this was written

South African health supplements and complementary medicines are regulated as Category D medicines by SAHPRA. Consumers, retailers and marketplaces often judge Category D manufacturers against the wrong standard: registered Category A pharmaceutical testing, US supplement marketing practices, or buyer expectations shaped by misinformation. The result is two opposite errors. Lawful, well-run manufacturers are labelled as substandard for not doing things the law does not require, while sellers who lack the basic licences that actually determine whether a product was lawfully made are never questioned. This summary sets out the most common errors on both sides, answers the questions that come up most often, and lists what a consumer should check.

When you buy a health supplement, you are entitled to understand the regulatory framework behind the product. Not all supplements are manufactured, tested or distributed under the same conditions. Knowing what SAHPRA requires helps you make more informed decisions about the products and brands you trust.

The five biggest mistakes when evaluating a brand or manufacturer

Misunderstanding assays for active ingredients in finished products: Local (South African) manufacturers must provide COAs with assays for all raw materials before manufacturing begins. The finished product is therefore not assayed again; SAHPRA (Guideline 7.05) recognises quantification by input, based on the raw material assay. Imported finished products, however, require finished product assays for each of the active ingredients.
Third-party testing means better quality: An external laboratory’s involvement alone does not establish superior product quality. Its competence, relevant SANAS accreditation scope, method validation, sampling and what is actually tested matter more than a generic “third-party tested” claim. Manufacture in an appropriately SAHPRA-licensed facility operating under GMP is a fundamental requirement. An unlicensed manufacturer relying on isolated third-party results to imply compliance is a major red flag.
Expecting access to proprietary information without first signing an NDA. COAs and supporting quality documents may contain commercially sensitive supplier, formulation and specification information. Providing a quality statement, a redacted COA or fuller disclosure under an NDA allows manufacturers to demonstrate transparency while protecting proprietary information.
Confusing a distribution licence, manufacturing licence and 3D product approval. These establish different things. The specific product must appear on the 3D lists attached to BOTH the manufacturing and distribution licences. Listing on a distributor’s 3D list alone is insufficient: the licensed manufacturer must also be identified, with supporting documentation and its own 3D list showing that specific product.
Expecting registration documents that do not yet exist. No Category D products have been called up for registration, so registration numbers do not exist. However, all complementary medicine products, ingredients, claims, intended uses and categories should be recorded on a 3D list reviewed and approved by SAHPRA before finalisation. Products remain eligible for sale under the applicable conditions pending call up for formal registration.

Five requirements buyers often don’t know about:

Licensing that covers both manufacturing and distribution. A single DL01 licence may cover both activities. If the seller holds only a DL03 distribution licence, it must identify who the licensed manufacturer is and provide its DL01 documentation. The specific product must appear on the 3D lists attached to both licences, or the combined licence where one covers both activities. A distribution-only (DL03) licence with no licensed manufacturer behind it is a major red flag. Imported products sold with only a DL03 (imports not allowed) should also be reported.
The Responsible Pharmacist's name and SAPC registration number. This is a licensing requirement and public information. A company has no legitimate reason to withhold it.
Every imported finished product must have a South African issued COA containing an assay test. Locally manufactured products offer a level of verification that imports cannot match. A local manufacturer must hold a certificate of analysis, including an assay, for every raw material it uses. The identity, quality and purity of all ingredients are therefore established before manufacturing even begins. An importer does not control or verify the raw materials that go into its product. For that reason, every batch of an imported finished product must have a certificate of analysis from a South African laboratory, confirming the identification and assay of the finished product. The foreign manufacturer’s certificate of analysis is still required, but it does not replace this South African testing.
Excipients, capsule shells and packaging also need controls and COAs too. Quality checks extend beyond active ingredients. Fillers, empty capsules, bottles, lids and seals need appropriate specifications, receipt checks and approval before use.
Labelling and claims. The mandatory disclaimer ("This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use"). Claims are only allowed as listed on the approved 3D list under the claims/intended use section. "FDA approved", food-safety certificates and ISO 9001 are not substitutes for a SAHPRA manufacturing and distribution licence.

Questions and answers

Licensing

Q: Can a brand refuse to identify its Responsible Pharmacist?

A: It has no legitimate basis to. The Responsible Pharmacist is a statutory requirement for a SAHPRA licence, the name appears on the licence (Regulation 23), the appointment is recorded with the SAPC, and SAPC rules require the Responsible Pharmacist's name to be displayed conspicuously over the main entrance of every pharmacy. If a company refuses: ask for its SAHPRA licence number and check it; search the SAPC register for the pharmacy and pharmacist; do not buy or list the product until it is resolved; and if you suspect the company is unlicensed or the appointment is nominal, report it to SAHPRA (hotline 0800 204 307) or lodge a complaint with the SAPC.

Red flag: a licensed company can answer licensing and responsible pharmacist identification questions in one email. If it cannot or will not, that is a red flag in itself. Proprietary information on suppliers or internal documents often require an NDA, however basic legal information such as a license number and pharmacist name & number should NEVER be withheld. Licensing and regulatory status is not proprietary information.

Q: Whose name goes on the label, and can a brand use its manufacturer's licence?

The label must name the holder of the SAHPRA distribution license; the manufacturer's name and address are optional, and no licence number is required. A brand cannot use its manufacturer's licence as its own.

Q: Is SAHPRA approval needed before launching a new product?

Yes, but not like category A medicine. Cat D Registration call up has not started yet, but the product must be added to the licence's 3D list (a licence amendment, DA01 or DA02) before sale, SAHPRA reviews and approves the product ingredients, intended use and claims before approving the updated 3D list. The latest SAHPRA approved 3D list must contain the product for it to be sold.

Q: Can a Responsible Pharmacist be part-time or shared?

Not really, the Responsible Pharmacist must exercise real, continuous control and be present on site during operating hours, which they cannot do reliably at 2 different sites. Proposed SAPC rules (August 2026, for comment) prohibit appointment while employed full-time elsewhere and treat nominal appointments as fronting.

Q: Are online marketplaces responsible for checking that sellers are licensed?

According to regulations yes, and must be licensed themselves since a platform that buys, stores or dispatches stock may itself be acting as a distributor needing a licence. SAHPRA investigates online sellers reported to it. Marketplaces allowing sellers to operate without required licences raise serious concerns about manufacturing oversight, traceability and accountability. Marketplaces are currently one of the biggest sources of unlicensed products reaching consumers in South Africa.

Red flag: if a marketplace has a product listed from a seller who is not SAHPRA licensed. Report any unlicensed sellers to marketplaces like Takealot or Amazon immediately. Food licences do not cover the sale of medicines. Request the SAHPRA license from the marketplace before using a product. If the marketplace cannot provide the SAHPRA license, report the seller and the marketplace to SAHPRA.

Q: How do I report an unlicensed or non-compliant product?

SAHPRA hotline 0800 204 307 or its online reporting facility; adverse reactions and quality problems to adr@sahpra.org.za.

Q: What does Category D mean?

Category D covers both discipline-specific complementary medicines and health supplements. These are not interchangeable regulatory categories.

Q: Can SAHPRA move a product from Category D to Category A?

Yes. In January 2026 it required children's products containing zinc picolinate or selenium to be registered as Category A medicines.

Q: Can a licensed food manufacturing facility produce supplements or "health foods" such as collagen?

No. Production of Cat D medicines (vitamins, collagen and herbal products) without a valid SAHPRA license is illegal in South Africa. Please report these companies.

Testing and quality

Q: Does an importer have to take capsules out of finished bottles for local identification and assay?

Yes, absolutely. A representative sample from each imported batch is tested by a South African laboratory, and the importer's Responsible Pharmacist releases the batch on the basis of the foreign COA as well as the local results and the batch documents. Two COA's (Foreign and local) are thus required.

Q: Does a finished product bought from another licensed South African manufacturer need re-testing?

No full re-testing. A quality agreement, the manufacturer's COA, documented receipt checks and the buyer's own release record are needed. The licensed manufacturer should already provide the potency and purity assays for each ingredient.

Q: Does every lot of raw material from a supplier need re-testing?

Identity must be confirmed on every lot whether imported or sourced locally; the COA should contain the assay and marker content and the vendor must be approved through a quality management process.

Q: What release tests does every capsule batch need?

Description, quantity by assay or input, uniformity of mass, disintegration (where dissolution is not a release test) and microbial limits.

Q: How long must batch records and retention samples be kept?

Batch records: one year after expiry or five years after certification, whichever is longer. Finished-product samples: at least one year after expiry. Starting-material samples: at least two years after release of the product.

Q: Can foods or cosmetics be made on the same lines as category D medicine?

Normally not; PIC/S GMP 5.17 allows it only where justified with cross-contamination controls.

Q: What does a GMP inspector check first?

Whether the licence matches reality, the Responsible Pharmacist and key personnel, the quality system, batch records and release, materials control, premises and equipment, and data integrity.

What are the adverse event reporting obligations?

SAHPRA's ADR guideline excludes unregistered medicines, so formal obligations apply on registration. GMP still requires a complaint and quality-defect system, and reporting serious reactions to SAHPRA is prudent.

Category A versus Category D

Aspect	Category A (conventional medicines, Schedules 0 to 8, for example paracetamol, antibiotics)	Category D (complementary medicines: herbal, vitamins, minerals and other health supplements)
Registration	Required before sale, with a full ZA-CTD dossier evaluated by SAHPRA	Not yet called up; sold under right-of-sale conditions on a licence 3D list, with the mandatory disclaimer
Scheduling and point of sale	Scheduled by active ingredient; Schedule 1 and above restricted to pharmacies and authorised prescribers or dispensers	Unregistered complementary medicines are generally treated as Schedule 0 (injectables excepted)
Licence and Responsible Pharmacist	Section 22C licence; Responsible Pharmacist required	The same
GMP code	PIC/S GMP Guide as adopted by SAHPRA	The same
Quantity of actives	Assay of each active at release and over shelf life	By assay or by input (Guideline 7.05)
Typical release tests	Identification, assay, related substances, dissolution, uniformity of dosage units, water, microbial limits	Description/Identification, quantity (assay or input), uniformity of mass, disintegration, microbial limits
Imported product	Testing as approved in the registration dossier	Each batch: Manufacturer COA plus local identification and assay on the imported finished product
Stability	Formal ICH-style programme submitted for registration, plus ongoing stability	Data supporting the shelf life (Guideline 7.05 Annex A) and ongoing stability under PIC/S GMP
Claims	Approved indications, including treatment of disease	Low-risk claims only, within Guideline 7.04 substances and doses
Labels, PI and PIL	Approved by SAHPRA at registration; registration number on label	Required by Regulations 10 to 12 but not pre-approved; "Complementary Medicine" wording and disclaimer
Pharmacovigilance	Full obligations, including a QPPV and 15-day reporting of serious reactions	Formal obligations apply on registration; complaint handling required under GMP

Testing flow: locally manufactured versus imported product

Stage	Locally manufactured capsule	Imported finished product
1. Licence	Manufacturer holds DL01 (manufacturing and distribution) for the site; product on its 3D list	Importer holds DL02 (or DL01); product on importer's 3D list; foreign site GMP evidence held DL03 licenses do not cover importing finished products.
	↓	↓
2. Raw materials	COA on approved specification; identity confirmed on receipt (organoleptic, TLC/FTIR); QC release	None controlled locally
	↓	↓
3. Manufacture	Verified weighings, validated blending, line clearance, fill-weight checks (quantification by input)	Not visible to the importer
	↓	↓
4. Finished-product testing	Release specification: description, mass, disintegration, microbial limits, quantity by assay or input	Foreign COA for each batch PLUS local identification and assay on the imported finished product in South Africa
	↓	↓
5. Who performs the tests	In-house QC laboratory or qualified contract laboratory under a written agreement; supplier for raw-material COAs	Foreign manufacturer (COA) and a South African contract laboratory (local identification and assay) COA
	↓	↓
6. Release	Batch record review and release by independent QA under the Responsible Pharmacist; retention sample kept	Release in South Africa by the importer's quality system under its Responsible Pharmacist; retention sample kept
	↓	↓
7. Optional	Independent third-party verification (periodic, voluntary)	Independent third-party verification (periodic, voluntary)

What cannot be outsourced in either case: the responsible pharmacist, QC function/ head of QC, control of sampling, in-process controls, batch release, retention samples, and ownership of out-of-specification investigations.

Key sources

This summary was written based on the published guidelines and regulations prescribed for GMP at the time of publication (V1 - Date of publication 13 November 2026), this is not legal advice. Check current versions of the source documents before relying on them.