HPA Archives - SAHPRA

21 Aug Call for Stakeholders to Verify Their Records – Missing Applications for Variations

Posted at 13:51h in

The South African Health Products Regulatory Authority (SAHPRA) calls on industry stakeholders to verify their records and identify any variation applications that may have been submitted but remain unprocessed due to the transition to the new system. The applications that may have been affected were...

13 Aug Guideline for Health Product Traceability: Update on Implementation

Posted at 15:24h in

As part of implementing the Traceability Guideline on Health Products, the South African Health Products Regulatory Authority (SAHPRA)continues to engage with industry stakeholders, sector associations, and public-sector partners as the project moves from planning phase to delivery. An important part of this work is the survey...

14 Jul Extension of Submission Window for Type II Variations Pilot Project

Posted at 13:27h in

The South African Health Products Regulatory Authority (SAHPRA) hereby notifies all applicants and holders of certificates of registration that the submission window for Type II Variations Pilot Project , including related changes bundled variations submissions, has been extended to Friday, 31 July 2026....

10 Jun Application Letter Template: Post-registration Variations

Posted at 11:23h in

New cover letter template for post-reg variations...

16 Apr Variations Communication

Posted at 16:10h in

The South African Health Products Regulatory Authority (SAHPRA) notifies all applicants that Type II Variations Pilot submission window has been extended from 21 April 2026 to 30 April 2026....

27 Mar Variations Communication

Posted at 11:34h in

This notice provides an update to industry regarding Type II variation pilot submission windows....

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...

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:...

09 Oct SAHPRA ECTD Specification 3.1 and Guidance for Module 1 and Regional Information

Posted at 18:02h in

This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration, as well as variations, of medicines in eCTD format. It reflects the current situation and will be regularly updated with changes in legislation and experience gained. It is important...

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