The checklist must be used by the applicant for all new product submissions for human medicines only from 01 October 2025. This template shall be used on receipt of a new human medicine application for registration to verify that all the required information for evaluation has...
This letter shows routine inspection was carried out at a premises....
This letter grants permission to name of Technician of name of IB to remove the seal from the x-ray unit at the premises of the licence holder....
This letter grants permission to the licence holder to remove the seal from the x-ray unit at the premises in the absence of the Radiation Inspector....
The template of Amendment Schedule to APIMF holder is for API suppliers to complete to indicate any changes in the APIMF....
To be printed on the letterhead of the Holder of the Certificate of Registration...
To be printed on the letterhead of the proposed Holder of the Certificate of Registration...
The CEP Letter of access must be drafted on the latest approved SAHPRA letterhead...
The Validation Template is used on receipt of an application to verify that all required information has been supplied to the South African Health Products Regulatory Authority (SAHPRA) in order to evaluate an application for the renewal of the certificate of registration of a medicinal...