Communication to Industry – Implementation of Regulatory Information Management System (RIMS) – Update on Progress

30 Apr Communication to Industry – Implementation of Regulatory Information Management System (RIMS) – Update on Progress

Posted at 09:46h in

We want to provide a general update on the progress of the RIMS deployment that commenced at the end of March 2024. We have completed our migration processes for all eCTD applications and the priority eSubmission applications that were a work in progress – with some...

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29 Apr EDQM CEP 2.0 Implementation

Posted at 08:28h in

This document is intended to provide communication to industry on the changes of EDQM CEP and implementation of CEP 2.0 for all other new applications for orthodox medicines. This will be a “living document” and will be updated in line with changes observed from the...

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24 Apr Licence Application for the Importing and the Distribution Scheduled Substances

Posted at 11:21h in

An application form to obtain a licence or renew/amend a licence in terms of the provisions of the Medicines and Related Substance Act, 1965 Section 22C and 22D read together with Regulation 23 and 24 of the General Regulations to the Medicines Act as the case...

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24 Apr GWP Guideline for the Importers and Distributors of Scheduled Substances

Posted at 11:19h in

This guideline is intended to provide recommendations to applicants wishing to apply for a licence to import and /or distribute substances listed in the schedules in terms of the Medicines Act intended for use in the manufacturing and/or compounding of medicines or scheduled substances. Furthermore,...

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11 Apr SAHPRA IB Sealing and Unsealing

Posted at 14:07h in

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22 Mar Requests to use unregistered veterinary medicines under Section 21 of Act 101 of 1965

Posted at 13:47h in

This document provides guidance on access to unregistered medicines for animal use through the provisions of Section 21 of the Medicines and Related Substances Act, 1965 (Act 101 of 1965). Applicants are required to comply with the provisions of the Act and Regulations....

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22 Mar Section 21 Emergency Medicines Bulk Application Form

Posted at 13:43h in

Request For Use of An Unregistered Product In Terms of Section 21 of Act 101 of 1965...

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08 Mar Collection of Outstanding Retention Fees

Posted at 17:02h in

This document is intended to provide communication to the Medical Device Establishment Licence Industry in relation to the Appointment of Yellow Clip Financial Services....

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06 Mar Communication to Industry – Implementation of Regulatory Information Management System

Posted at 19:38h in

As you are aware, SAHPRA has been focused on progressing the digital transformation of the organisation over the past few years. We have different initiatives underway to digitalise our business processes....

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06 Mar Pharmacovigilance Process of Issuing Safety Recommendations to Applicants/HCRS For Implementation

Posted at 11:16h in

Kindly note that this communication serves to communicate two (2) processes that the SAHPRA Pharmacovigilance (PV) unit has revised. You are urged to take note of these revisions....

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