The purpose of the application is to give access and authorize the use of unregistered medicines for personal use, medicines which are not available in South Africa for up to six month supply.
Supplements are a subgroup of Medicines commonly referred to as Complementary Medicines, Health Supplements and are regulated under Medicines and Related Substances Act 101 of 1965.
Please note that information on medicines registration process can be found on SAHPRA website at www.sahpra.org.za. The format of your application must be in ZACTD format. The website contains all the relevant guidelines, regulations and application forms to assist you with compiling application for medicines registration. All applications for medicines registration must be submitted to SAHPRA for evaluation to determine safety, quality and efficacy of your product.
The South African Health Products Regulatory Authority (SAHPRA) is obliged to take precautionary measures in order to protect the public against the use of unsafe and unregistered products since safety, efficacy and quality of such products have not been validated.
The doctor’s prescription is not a requirement when applying for authorization for use of unregistered medicine. However, the role of the doctor in this regard is to ensure professional oversight in case of any adverse effects which may occur as a result of the use of unregistered medicines. In terms of Section 21 policy, applicants may not import more than 6 month supply of medicine for personal use.
An application for the use of unregistered medicine for personal use still has to be made to the Authority even if it’s a once off request. In terms of Section 21 Policy, the maximum quantity of unregistered medicine allowed is limited to 6 months’ supply.
Products in pharmaceutical dosage forms (pills, tablets, etc), with medicinal or health claims are regulated under the Medicines and Related Substances Act.
This is to ensure the safety, efficacy and quality of the products
are substantiated and guaranteed.
Kindly advise whether the products are for personal use or sale. You would need to apply to the Authority for permission to use the unregistered products for personal use through the Section 21 application process or in the event the products are for sale, application for the registration of medicine has to be submitted to the authority.
Information in this regard is available on the website of the Authority (www.sahpra.org.za).
A turnaround time of five (5) working days from receipt of complete application is allowed for a section 21 application.
Yes, A renewal application that includes a completed Progress Report form is required for continued use of same products.
The application will be reviewed by the Complementary medicines unit and can either be approved or rejected based on a number of factors.
No, the application fee is non-refundable.
Products that are of natural origin and purporting to be used for medicinal and or health purposes are regarded as Complementary medicines.
It is the responsibility of the Authority to ensure that these are safe to use and oversight by a professional prescriber/medical doctor will be required
Please note that you cannot import elsewhere based on the fact that it is cheaper, you need to source similar product/s locally.
A maximum limit of six months supply is allowed. Please arrange with Customs/Port Health to return it back to the supplier as it is more than 6months supply(allowable limit).
The new fees as per Government Gazette No 42474 are R330.