23 Jul Frequently asked questions (FAQs) and common deficiencies for the submission of PEM Post-Registration variations
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This communication provides guidance which represents the current thinking of the South African Health Products Regulatory Authority (SAHPRA) on this topic. It does not establish any rights for any person and is not binding on SAHPRA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, please contact the PEM Post Registration Team on postregqualityvariations@sahpra.org.za
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Document Number:
PEM-POST-05-2024/25
Version:
5
Date Updated:
07/03/2025
File Type:
pdf
Category:
Communication to industry, FAQ