Archive

20 Feb Guideline on Co-packaging of Medicines

Posted at 10:08h in

This guideline is intended to provide guidance to applicants regarding applications for registering co-packaged medicines. It represents the South African Health Products Regulatory Authority (SAHPRA) current thinking on co-packaging of medicines. SAHPRA reserves the right to request any additional information to establish the safety,...

Read More

17 Feb Communication to Industry – Pilot Application Process through the SAHPRA Service Desk

Posted at 09:22h in

As you are aware SAHPRA has embarked on a process to digitalise its business processes. We have recently concluded a pilot application process with Lot Release Testing Requests through the SAHPRA Service Desk and would like to kick off a process for taking in our...

Read More

07 Feb Guideline for Fixed Dose Combination Products (FDC Products) for HIVAIDS, Tuberculosis and Malaria

Posted at 18:59h in

This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of medicines....

Read More

20 Dec Pre-registration veterinary medicines tracker guide

Posted at 11:55h in

Kindly be advised that applicants may track the progress of their new veterinary medicine registration applications on the SAHPRA website....

Read More

19 Dec Certification Variation Screening – Type II Proprietary Name Change Applications and TOAs

Posted at 09:47h in

The purpose of this document is to provide feedback from the pilot of the administrative screening of all certification variation applications....

Read More

14 Oct Submission Form Template

Posted at 17:04h in

The template of submission form is populated by the API supplier and subitted to SAHPRA during submission of the APIMF record....

Read More

14 Oct Template of Standardised Content of Letter of Access

Posted at 16:55h in

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....

Read More

13 Oct Certification Variation Screening – Type II Proprietary name change applications and TOA’s

Posted at 11:06h in

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...

Read More

10 Oct Position Paper – Proposal to Applicants for Dossier Processing Fee (ZaZiBoNa)

Posted at 17:06h in

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...

Read More

20 Sep Over-arching: Good Review Practice Guide

Posted at 10:10h in

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...

Read More