Archive

02 Jun Communication to industry – SAHPRA Statement on Regulation of Category D Medicines

Posted at 15:22h in

In response to the Supreme Court of Appeal (SCA) judgment on 11 April 2022 regarding the Alliance of Natural Health Products (ANHP), the Minister of Health recently released, for public comment, draft amendments to the General Regulations made in terms of the Medicines and Related...

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31 May Communication to Industry – Health Products Register Notification

Posted at 11:04h in

This document sets out to serve as a notification to all stakeholders on the status of the Health Products Medicines Register. This is a "living document" and will be updated as required. This communication is an interim document....

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29 May Implementation of the QOS and QIS

Posted at 12:11h in

This document is intended to provide guidance to stakeholders on the use of the newly implemented QOS and QIS....

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15 Mar Communication on Hard Copy Registration Certificates

Posted at 11:46h in

Please note that SAHPRA will continue to communicate registration certificates for both new medicines and relevant type || variation applications via e-mail to applicants until further notice....

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10 Mar Verification of Fees and Bank details

Posted at 08:36h in

The South African Health Products Regulatory Authority (SAHPRA) hereby advises applicants to verify SAHPRA banking details and the published fee Gazette before processing payments, even when a proforma invoice has been received on a SAHPRA letterhead....

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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...

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13 Feb Communication to Industry – Importing and operating unlicensed dental X-ray equipment

Posted at 17:55h in

It has come to the attention of SAHPRA that dental x-ray equipment can easily be purchased online by unlicensed retailers and are being imported to South Africa without any authorisation....

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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....

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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....

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27 Oct Clinical Trials Committee And Submission Dates For 2023

Posted at 12:19h in

2022 Oct...

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