Following the Engagement Portal webinar of 26 August 2026, this communication sets out the key activities and dates for the two programmes that sit with Health Products Authorisation (HPA) and confirms the requirements for their completion....
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...
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...
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....
New cover letter template for post-reg variations...
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....
This notice provides an update to industry regarding Type II variation pilot submission windows....
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...
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...
SAHPRA wishes to inform you of a fee discrepancy identified on the SAHPRA Engagement Portal affecting the following submission types:...