Category A Unregistered Products

1. PURPOSE:

The Section 21 Unit (Category A Medicines for Human Use) of the South African Health Products Authority (SAHPRA) processes and evaluates applications from applicants (treating practitioners) for access to unregistered medication within South Africa (SA). The applicant establishes whether there is a need for a certain medicine; if the Category A medicine for human use is unregistered within South Africa, the applicant will submit a Section 21 application (Category A Medicines).

The Section 21 application framework also allows for access to unregistered veterinary medicines and unregistered complementary medicines but the application procedures differ vastly for these unregistered medicines. It is important that the application is sent to the appropriate Section 21 unit for veterinary or complementary medicine Section 21 applications. Consult the “Key Contacts” section of the SAHPRA website for this information or click on the link provided: Key Contacts

2. Legislative framework:

The legislative framework for access to unregistered Category A Medicines is enabled by Section 21 of the Medicines and Related Substance Act, Act 101 of 1965, as amended: Authority may authorise the sale of unregistered medicines, medical devices or IVDs for certain purposes

  1. The Authority may in writing authorise any person to sell during a specified period to any specified person or institution a specified quantity of any particular medicine, medical device or IVD which is not registered.
  2. Any medicine, medical device or IVD sold in pursuance of any authority granted under subsection (1) may be used for such purposes and in such manner and during such period as the Authority may in writing determine.
  3. The Authority may at any time by notice in writing withdraw any authority granted in terms of subsection (1) if effect is not given to any determination made in terms of subsection (2).

A Section 21 application for Category A Medicines for Human Use is processed and evaluated by staff in the Section 21 Unit of the South African Health Products Regulatory Authority (SAHPRA), which operates within the terms set out in Section 21 of the Medicines and Related Substances Act 101 of 1965. This is read together with Regulation 29 of the General Medicines Regulations:

3. Processing Section 21 (Category A Medicines for Human Use) applications:

To initiate a Section 21 request, an applicant shall complete the Section 21 application. A completed application form must be accompanied by the prescribed fee and must contain at least the information as prescribed by regulation 29(2).

SAHPRA has implemented a submission portal for Section 21 applications for Category A Medicines for Human Use only. Section 21 applications for other categories of health products will not be processed.

No manual application forms will be processed.

Applications for Category A Medicines for Human Use: An online submission portal is accessible for Section 21 applications. Applicants can access the submission portal for authorizations in the main menu: E-SERVICES > Section 21 Applications.

Supporting documents (e.g. proof of payment, Microbiological Culture and Sensitivity (MC &S) report, informed consent, etc.) for online applications for Category A medicines for human use should be attached in the online application. Following consideration of the request, the Section 21 Unit may either authorise the sale of the unregistered medicine, request additional information from the applicant, or deny the request.

A decision letter is sent via e-mail to the applicant, which will inform them whether their application was approved, required additional information or rejected with reason/s.

4. Turnaround time for response to a Section 21 Application:

Section 21 unit aim to evaluate and make a decision regarding an application within 3 working days, of receipt of the application via the online system. There are in fact, cases, where this turnaround time, might be prolonged i.e. substances, unfamiliar medication which requires extensive research to be done by the evaluators, further information is requested from the applicant.

5. Unregistered Products Guidelines

6. Frequently Asked Questions for a Section 21 Application