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:...
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...
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....
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...
Dear Applicants, Following the communication and internal engagement on the interpretation of the Fees Gazette for Variation fees, the South African Health Products Regulatory Authority (SAHPRA) will apply the following calculation approach on fees to allow the new fee gazette to then adequately granulate the position...
The South African Health Products Regulatory Authority (SAHPRA) has released key updates affecting technical files within the SAHPRA eCTD repository, accessible via the following location: SAHPRA eCTD. These updates include: A revision to the Submissions Type Matrix, aligned with the new portal restrictions on variations groupings. ...
