Communication to industry Archives - Page 4 of 23

29 Jan SAHPRA Engagement Portal – Type II Pilot Variation Applications: Submission Window and Fee Processing Clarification

Posted at 15:23h in

The South African Health Products Regulatory Authority (SAHPRA) refers to Type II variation applications submitted under the Type II Pilot Programme and acknowledges the challenges experienced by certain applicants in finalising payment due to the different pricing calculation method applied through the Portal, as per...

27 Jan Notification of an Update to the Product List(s) of a Medical Device Establishment Licence

Posted at 14:19h in

1.1 On 01 June 2017, the President of the Republic of South Africa signed into effect Amendment Act 72 of 2008 (and effectively therefore also Amendment Act 14 of 2015), which broadened the regulatory scope of the Medicines and Related Substances Act, 1965 (Act 101...

27 Jan Amendment of a Medical Device Establishment Licence

Posted at 11:54h in

On 01 June 2017, the President of the Republic of South Africa signed into effect Amendment Act 72 of 2008 (and effectively therefore also Amendment Act 14 of 2015), which broadened the regulatory scope of the Medicines and Related Substances Act, 1965 (Act 101...

12 Jan Clinical Trial Insurance for New Clinical Trial Applications

Posted at 13:26h in

This document has been archived....

05 Jan Electronic Submission of Serious Adverse Events (SAE) Reports – E2b Reporting

Posted at 15:09h in

This document has been archived....

18 Dec Communication on Vaccines Containing Thiomersal as Preservative

Posted at 10:29h in

Thiomersal (also referred to as thimerosal or ethyl mercury) has been included as a preservative in some vaccines, notably those intended for multi-dose use....

18 Dec Variations Communication

Posted at 08:27h in

With reference to the communication issued on 30 June 2025 (HPA05-2025/26, Version 5), SAHPRA wishes to inform all holders of certificates of registration that the current predefined submission window for Type II variation applications (including related changes bundled variation submissions) within the period 02 January...

10 Dec SAHPRA Engagement Portal – Launch Update

Posted at 12:52h in

SAHPRA wishes to inform you of a fee discrepancy identified on the SAHPRA Engagement Portal affecting the following submission types:...

18 Nov Core Business Escalation Procedure

Posted at 10:18h in

This document intends to provide clarity on SAHPRA’s Core Business Escalation procedure, to enable effective and efficient communication between SAHPRA and its stakeholders....

17 Nov Clinical Trials Committee Meeting and Submission Dates for 2026

Posted at 13:45h in

Applicants are advised to submit clinical trial applications before the due date. Applicants submitted after the due date will not be accepted....

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