PHILIPPINE VARIATION GUIDELINES
Clinical documents as per ASEAN Common Technical Dossier (ACTD) part IV (where applicable). 8 MaV-2 Change of content of product labeling C 1. Product labeling refers to Package Insert (PI), Patient Information Leaflet (PIL), unit carton label, inner label and/or blister strips. 2. The change is not a minor variation and not within the scope of ...
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