No-one can bring unregistered medicines into SA without approval from Sahpra, and only licensed companies can do it. Those firms are subject to strict rules to make sure the medicines they import are safe to use1. The clinician
A doctor applies to Sahpra and explains why a patient needs access to the drug. If the request is approved, the physician must report on the person’s progress on the treatment. This includes any side effects that they may experience while using the unregistered medicine.The firm that will bring the drug into the country applies as a co-applicant with the doctor. A number of licensed pharmaceutical companies specialise in doing this.A patient must pay the admin fee and for the imported medicine.
There’s also nothing in SA’s laws that obligates manufacturers to apply to register drugs that are often requested through section 21, which would subject those drugs to the SEP and possibly bring down the price.When someone got access to a less expensive medicine through section 21, it can be bad news when a similar medicine is registered by Sahpra, because it nullifies the motivation that there are no other options for this person. The registered medicine may be more expensive.