Guideline for Submission of Extension Applications

Guideline for Submission of Extension Applications

This guideline is intended to provide guidance to applicants who intend to submit extension applications for registration. It represents the South African Health Products Regulatory Authority’s (SAHPRA) current position on the safety, quality and efficacy of these medicines.

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Document Number: SAHPGL-CEM-PRE-03
Version: 1
Date Updated: 24/03/2024
File Type: www
Category: Guideline
Unit: CEM Pre-reg, Clinical Evaluations Management, General ECTD & human medicines