The purpose of this document is to provide feedback from the pilot of the administrative screening of all certification variation applications....
The document is a guide for the applicant to submit Expressions of Interest (EOIs) for evaluation of applications using the WHO pre-qualification collaborative registration process....
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...
This guide is intended to provide guidance to applicants on Good Review Practices. It represents the South African Health Products Regulatory Authority’s current thinking on the safety, quality and efficacy of medicines and the safety, quality and performance of medical devices. It is not intended...
Please note that the South African Health Products Regulatory has hereby extended the deadline date for comments on the Borderline Products guideline (SAHPGL-CRO-01) from the 5th of September 2022, to the 8th of November 2022....
This application form should be included in the South African Common Technical Document – Module 1 Administrative Information. The application form is to be used for an application for registration, variation or renewal of a medicinal product for Human or Veterinary use submitted to the South...
Business-As-Usual (BAU) is in the process of verifying submitted/received new medicine and variation applications. Industry is kindly requested to verify/confirm if all the applications that have been submitted to SAHPRA via BAU are being processed....