Archive

30 Mar Submission of Post-Importation Testing Exemption requests for Biological and Biosimilar Medicines

Posted at 09:35h in

As of the 1st of April 2022, the post-importation testing exemption requests for Biological and Biosimilar medicines should be submitted as per the requirements of Guideline 2.04. For submission process, please refer to section 3.0 Post-Importation Testing Exemptions (PITE)....

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07 Mar Communication to industry – 7.04 Health Supplements Safety and Efficacy

Posted at 16:39h in

The purpose of Guideline 7.04 (Complementary Medicines - Health Supplements Safety and Efficacy) is to provide clear guidance with regard to the safety and efficacy (SE) requirements for registration of Health Supplements as a subset of complementary medicines in South Africa in the Common Technical...

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03 Mar Requests: Existing Category D (Complementary Medicines) Registration Applications (07 October 2021)

Posted at 11:01h in

The corresponding stakeholder notice dated 07 October 2021 regarding the opportunity to update online the application details and/or the submission before review refers.

A further opportunity to resubmit an existing application on the CM portal is made in Phase 2 which is foreseen to extend to...

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22 Feb Priority Review Requests Communication

Posted at 19:16h in

SAHPRA has a policy to make provision for priority review, for the assessment and registration of medicines that treat serious diseases and is of major public interest....

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09 Feb Medical Device Establishment Licence Renewal Process

Posted at 12:30h in

License Renewal Q and A to support communication

Archives

Version 1

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07 Feb Medical Device Establishment Licence Renewal – ISO13485 Certificate Communication

Posted at 22:48h in

This document has been archived....

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01 Feb Transitional Arrangements for Medical Devices

Posted at 11:13h in

2017 Apr...

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01 Feb Medical Device Establishments: License Requirements

Posted at 11:12h in

2016 Sep...

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01 Feb Disinfectants Status of Antiseptics and Germicides

Posted at 11:10h in

2016 Jul...

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01 Feb Class A Medical Devices

Posted at 11:09h in

2017 Sep...

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