30 Jun Communication to Industry – Variations Communication
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Normal submission of Type IA & IAIN, IB, II
The South African Health Products Regulatory Authority (SAHPRA) allows for variation submissions as follows:
- Type IA variations (inclusive of Type IAIN): a maximum of three (3) type IA variation changes (unrelated or related) is applicable for a product submission PER RESPONSIBLE UNIT.
- Type IB variations: a maximum of two (2) type IB variation changes (unrelated or related) are applicable for a product submission PER RESPONSIBLE UNIT.
- Type II variations: a maximum of one (1) variation is applicable for a product submission related variations criteria PER RESPONSIBLE UNIT.
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Document Number:
HPA05-2025/26
Version:
5
Date Updated:
30/06/2025
File Type:
pdf
Category:
Communication to industry