Variations Communication

Variations Communication

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 2026 – 15 January 2026 is being extended to: 02 January 2026 – 30 January 2026.

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Document Number: HPA05-2025/26
Version: 6
Date Updated: 18/12/2025
File Type: www
Category: Communication to industry
Unit: General ECTD & human medicines, HPA, Regulatory Compliance