Compliance

Compliance is not paperwork. It is the reason a medicine can be trusted.

Every medicine that enters South Africa should be able to answer three questions before it reaches a patient: what is actually in it, where did it come from, and can it be shown to be safe at the dose recommended. Compliance is the system that forces those answers to exist in writing, in advance, and to be produced on demand.

What compliance means for us

Compliance is not a claim a company makes about itself. It is a set of obligations under the Medicines and Related Substances Act, 1965, administered by the South African Health Products Regulatory Authority (SAHPRA). In practice it means we are licensed to import and wholesale complementary medicines, we operate from licensed premises, our products are handled as Category D complementary medicines, and every consignment enters the country through a declared, inspectable channel. The list of licensed complementary medicine importers is public and searchable on the SAHPRA website, so none of this rests on our say-so. 

It also governs what we are allowed to tell you. Regulation limits the claims that may be made for a herbal product, and we would rather describe what a formula is traditionally used for than overstate what it can do.

Why this matters to the person taking the medicine

A practitioner who prescribes our formula is putting their professional judgement behind it (medicines that weren’t legally imported, or that don’t meet SAHPRA requirements, are unlawful to sell and put the practitioners registration at risk!).
A patient is putting their health behind it.
Neither of them is in a position to test what is in the bottle, and neither of them should have to.

So we do it before the product ever reaches a shelf. In plain terms, that means we confirm the herbs are the correct species and the correct part of the plant, not a cheaper look-alike substituted somewhere up the chain. We test for heavy metals, pesticides and undeclared pharmaceutical ingredients, which are the three things that turn a herbal product into a health risk. We check the strength, because a formula that is too weak does nothing and one that is too strong is dangerous alongside chronic medication. And we keep records tied to every batch, so if a question is ever raised about a single bottle, we can trace it back to the manufacturer, the shipment and the date it entered the country.

None of that is visible in the packaging. A sealed box from a legal importer and a sealed box from a grey channel look identical on the counter. The difference is whether anyone checked, and whether anyone can prove it afterwards.

Watch out for look-alikes.

Some products on the market use the same formula names as ours and look almost identical. There’s no guarantee they meet the same safety, quality and efficacy standards we do.

Quick tip for spotting grey-market stock: check the label. Be wary of a product that has:

  • Only foreign text, with no English
  • No local supplier name or address
  • No batch number or expiry date
  • No ingredient list, or one without clear quantities
  • No SAHPRA disclaimer

Why we take this route

We could import faster and cheaper by ignoring all of it. Many do. We decline to, because the practitioner and the patient should not have to take our word for anything. The licence, the testing and the batch record exist so that they do not have to.

Compliance is slower. It is more expensive. It is also the only version of this business worth running.