The template of submission form is populated by the API supplier and subitted to SAHPRA during submission of the APIMF record....
The template of Standardised Content for Letters of Access is populated by the applicant to authorise SAHPRA to review the APIMF record for new registration applications or variations....
The certification unit is processing a large number of applications with administrative queries, which then results in the delay of generating the revised registration certificate. The unit will be introducing a pilot to include administrative screening on receipt of all certification variation applications. The revised...
Position Paper
Proposal to Applicants for Dossier Processing Fee - SADC MRH Collaborative Registration Procedure Initiative - A stepwise approach to increased efficiency and effectiveness
As the initial step to improve efficiency, the SADC Medicines Regulators Forum is proposing a semi-centralised approach to the joint...
SAHPRA commits adequate required resources for implementing, maintaining and continually improving the quality management system to achieve objectives....
This document should be completed by the applicant to ensure the inclusion of all necessary Bioequivalence Trial information....
Residues Overall Summary (ROS) should be completed for pharmaceutical products intended for food producing species....
The formulation and API characteristics, including the route of administration and species, are factors which may affect requirements to waive bioequivalence studies (i.e., to compare the rate and extent of absorption between two formulations containing same active substances). Applicants must submit the following relevant information...