As you may be aware, the ongoing protest action in the National Department of Health (NDoH) Civitas building in Pretoria has significantly impacted key medicine regulatory functions of SAHPRA, including enabling access to unregistered medicines which may be life-saving for patients. As a result, SAHPRA has recently implemented revised arrangements to ensure uninterrupted provision of services regarding Section 21 authorisations for the sale and use of unregistered medicines for human use in South Africa.
SAHPRA has now implemented an online Section 21 submission portal for both new applications and reauthorisations (i.e. the renewal of authorisation for patients requiring ongoing care and the renewal of authorisation to hold bulk stock). This new system requires an online form to be submitted by applicants and provides a largely automated process.
The following links should be used to access the new processes:
New applications: https://goo.gl/forms/RcM1Kbh6Q9tEUy5Z2
Applicants who have not yet received feedback on previous submissions are requested to resubmit their applications using the above links in order to ensure the fastest possible turnaround.
SAHPRA will continue to maintain rigorous risk assurance standards for all Section 21 applications and processes, including ensuring ongoing patient confidentiality.