HPA Archives - SAHPRA

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...

01 Oct Traceability Guideline – Implementation Roadmap

Posted at 14:35h in

Dear Applicants, This roadmap outlines the phased implementation of unique product identification requirements for all health products in South Africa, transitioning from batch-level to unit-level serialisation across primary, secondary, and tertiary packaging levels....

26 Aug Medicines Certificate of Registration Renewal Implementation Framework

Posted at 14:24h in

This document outlines the approach that the South African Health Products Regulatory Authority (SAHPRA) has undertaken to implement the process of the renewal of the certificate of registration for medicinal products, ensuring a consistent approach to benefit all stakeholders, thereby guaranteeing that quality, efficacious, and...

Archive