Importing Research Materials into South Africa: SAHPRA, SARS and the Zero De Minimis

There is no consignment value small enough to make an import into South Africa invisible. Two authorities have to be satisfied and they ask different questions: the South African Health Products Regulatory Authority (SAHPRA) decides whether the material may enter at all, and the South African Revenue Service (SARS) decides whether it has been correctly declared and what is owed ^[1][8]. The threshold that used to keep small parcels out of the VAT net — a customs value of R500 or less, under section 13(3) of the Value-Added Tax Act read with paragraph 1(v) of its Schedule 1 — is being repealed outright ^[5]. And a restriction was never a tax: a permit requirement attaches to what the goods are, not to what they cost.

That distinction is the whole of this article. Most of the trouble people have importing laboratory material into South Africa comes from treating a low-value shipment as a low-consequence one. The declared value determines the money. The classification determines whether the parcel moves at all.

SAHPRA or SARS: which one is holding your parcel?

SAHPRA is a statutory body established under section 2A of the Medicines and Related Substances Act, 1965 (Act 101 of 1965) to regulate medicines, scheduled substances, clinical trials, medical devices and in vitro diagnostics ^[4]. Its Regulatory Compliance Unit is the part that sits at the border, responsible for ensuring that health products at ports of entry meet the importation requirements of the Medicines Act and the general regulations ^[1]. SARS separately administers prohibitions and restrictions on behalf of other departments under section 113(8)(a) of the Customs and Excise Act, 1964, and publishes a consolidated Prohibited and Restricted list organised by Harmonised System tariff heading ^[8].

So a customs officer is usually not the person deciding your case. The restriction is flagged from the tariff line, the consignment stops, and it waits for another agency's paper. "It cleared customs" and "it was released" are two different events, and the second can be weeks behind the first.

Where the shipment lands matters too. SAHPRA's guideline names seven health-product ports of entry: O. R. Tambo International Airport, King Shaka International Airport, Durban Harbour, Cape Town International Airport, Cape Town Harbour, Port Elizabeth Airport and Port Elizabeth Harbour ^[1]. Your supplier's courier chooses the routing unless you specify it.

What the zero de minimis actually changed

The relief being removed was narrower than most people think. National Treasury's explanatory memorandum sets it out: under section 13(3) of the VAT Act, the proviso to section 38(1) of the Customs and Excise Act and paragraph 1(v) of Schedule 1 to the VAT Act, goods with a customs value of R500 or less were exempt from the import VAT imposed by section 7(1)(b) — but only where no customs duty was payable under Schedule 1 of the Customs and Excise Act. A separate R100 threshold covered printed books and periodicals imported by post. The 2025 Taxation Laws Amendment Bill removes the thresholds below which no VAT is levied ^[5].

The administrative move came first. SARS announced in August 2024 that its long-standing concession — a flat rate of 20 per cent in lieu of customs duties, and no VAT, on goods below R500 — would have VAT added from 1 September 2024 as an interim measure, with the flat rate reconfigured into World Customs Organization categories from 1 November 2024 ^[6]. The VAT-free small parcel disappeared at the border in late 2024; the legislation is catching up.

What none of this touched is the part that actually stops laboratory consignments. No amendment to a tax threshold changes a permit requirement. Budget accordingly: invoice, plus freight, plus any duty on the tariff line, plus VAT on the uplifted customs value, plus a clearing agent's fee, plus SAHPRA's prescribed fee where an application is needed — payable before the application is reviewed ^[1][2].

Is it a medicine, a scheduled substance, or a chemical?

Everything else hangs on this, and it is decided by law rather than by the label on the carton. Under the Medicines Act, a "scheduled substance" means any medicine or other substance prescribed by the Minister under section 22A ^[4]. The listing attaches to the substance. Describing material as research-use-only changes which pathway applies, not whether one applies — the designation states an intended use rather than granting an exemption. Section 22A itself contemplates research: the Act provides for authorisation of the most tightly controlled Schedules to an analyst or researcher for education, analysis or research, and separately prohibits import or export of specified Schedule 5, 6, 7 and 8 substances without a permit ^[4].

A parallel regime catches material the Medicines Act does not. The Hazardous Substances Act, 1973 (Act 15 of 1973) empowers the Minister of Health to declare substances into groups and to control their importation, manufacture, sale and use, with a licence required to deal in declared Group I substances ^[10]. A consignment can sit outside the medicines regime and still be restricted.

Be honest about the uncertainty here. For many research peptides the classification is not obvious from a catalogue name, and the tariff heading a courier's broker picks — often a generic organic-chemical line — is a guess, not a determination. If it matters, get it in writing: a tariff determination from SARS, and a written enquiry to SAHPRA describing the substance, its intended laboratory use and the proposed heading.

The documents a consignment has to travel with

SAHPRA's ports-of-entry guideline is unusually concrete. Imported medicines and health products must be accompanied by the licence issued under section 22C(1)(b), and by either the registration certificate issued under section 15 or a section 21 authorisation where the product is unregistered. Narcotics and psychotropic substances — the guideline names Schedules 5, 6, 7 and 8 — may only be imported under a permit issued in terms of sections 22A(9) and 22A(11). And the shipping documents must correspond with the SAHPRA approvals ^[1].

That last line is what quietly fails consignments. A loosely worded invoice, a waybill naming a different consignee from the licence, a quantity that does not match the authorisation — each is a mismatch, and a mismatch is a hold. For legal entities importing samples for registration or analytical purposes, the guideline lists what must reach the port officials ^[1]:

• An application letter signed by the responsible pharmacist, with the importation details.
• A copy of the section 22C(1)(b) licence issued by SAHPRA.
• Shipment information: air waybill, tracking details and the port of entry.
• Certificates of analysis for the products.
• The commercial invoice, company details and proof of payment of the applicable fee.

The stated turnaround for a decision on a release application is four working days from receipt of a complete application including the fee ^[1]. "Complete" is doing a lot of work in that sentence. The same guideline describes a personal-import concession for travellers carrying prescribed medicine, turning on an original prescription and the prescriber's contact details ^[1]. That is a patient pathway, not a route for laboratory material, and treating it as one reliably ends in a detention.

Behind the border, the licensed-importer regime adds its own expectations: a quality management system, an authorised representative resident in South Africa, a responsible pharmacist answerable to both SAHPRA and the Pharmacy Council, records made contemporaneously and retained for five years, and storage that does not expose material to conditions capable of affecting its quality ^[3].

SAHPRA's own research-use-only import pathway

In one place SAHPRA has published, in plain terms, what it expects from an importer whose purpose is laboratory research. Guidance document MD027 sets out a section 21 authorisation for importing research-use-only in vitro diagnostic devices, and states that any entity or person located in South Africa intending to conduct non-clinical laboratory research may apply ^[2].

The conditions describe the regulator's mental model. The authorisation may specify that the material be used only by the individual or entity named in the application, and that only the batch number and quantity specified may be imported. Applications are processed within three weeks. Where one falls short, an observation letter goes back, the applicant has five working days to respond, and only two such rounds are permitted before rejection ^[2].

Be clear about the limit: MD027 governs in vitro diagnostic devices under the medical device regulations, not chemicals or scheduled substances, and it does not extend by analogy to a peptide. What it gives you is an explicit statement of what a South African regulator wants from a research importer — a named end user, a specified batch and quantity, labelling consistent with research use, and classification evidence from jurisdictions it recognises, listed as Australia, Brazil, Canada, the European Community, Japan, the USA and WHO ^[2]. Assemble that file whichever route your material falls under.

Who is the importer of record, and the R150,000 ceiling

Customs code 70707070 is the general code that lets a private individual declare goods without registering as an importer. It is not unlimited. SARS gave notice that, effective from 18h00 on 20 November 2025, an automated validation and rejection rule applies to declarations submitted by private individuals under that code: once cumulative imports reach R150,000 in a calendar year, further declarations are rejected and the individual must apply electronically for a formal customs code ^[7].

For a laboratory importing occasionally under a named individual, that is a hard ceiling with a date on it. For anything recurring, the individual route and the licensed route are different regimes rather than different amounts of paperwork: a section 22C(1)(b) licence sits with an entity that has a responsible pharmacist and a quality system behind it ^[3]. Deciding which one you are, early and in writing, saves more time than any shipping optimisation.

Detention is a storage event, not an administrative one

This is where the regulatory question becomes an operating question. A consignment on hold is a consignment in storage, in a bond store you did not specify and cannot inspect. In a hot-climate port that is the harshest leg of the journey, the one with no defined length, and the one that turns a clearance delay into a temperature excursion someone has to assess on receipt.

Plan against the distribution, not the target. Four working days is the guideline's stated turnaround for a complete release application ^[1]. The same authority's published performance on a different queue shows how wide these distributions run: a peer-reviewed assessment of generic-medicine registration reported median finalisation times of 1,470 calendar days under the predecessor Medicines Control Council process, 501 days under the backlog clearance project, and 68 and 73 days under two risk-based assessment pilot phases ^[9]. That is registration, not port release — a different process with different resourcing — but the lesson transfers: a regulator's turnaround is a distribution with a long tail.

• Send the documentation twice — inside the parcel and lodged with the clearing agent — so a hold caused by a missing page closes without a second shipment.
• State the storage condition on the waybill and invoice in the same words the storage line on the certificate of analysis uses, so the two never appear to disagree.
• Put a data logger in the shipment and read it on arrival. The hold is the interval you have no other evidence about, and an excursion you cannot document is one you have to assume.
• Appoint the clearing agent and confirm the port of entry before the supplier ships, rather than learning the routing from a tracking page ^[1].
• Match names exactly across licence, permit, invoice, waybill and consignee. A mismatch is a hold, and a hold is heat.
• Size coolant and packaging for detention plus transit, and record what you assumed so the assumption can be revised after the first real hold.

If you are importing into another African country

Do not generalise from South Africa. It has one of the continent's better-documented regimes, which makes it a useful worked example and a poor template. What transfers is the shape: a national medicines regulatory authority deciding admissibility, a customs administration deciding declaration and duty, some equivalent of a prohibited-and-restricted list keyed to tariff headings ^[8], and often a separate chemicals statute administered by a health ministry ^[10].

Regional structures sit above those — the ZaZiBoNa collaborative in southern Africa, the East African Community's medicines regulatory harmonisation programme, and the African Medicines Agency — but none replaces your national authority at the border. Where you cannot confirm a rule from a primary source, do not infer it from a neighbour or a freight forwarder's website. Write to the agency, cite the provision you believe applies, and keep the reply with the shipment records.