ABSTRACT

Variations are the amendments made to an approved product’s dossier after its original registration. They are the fundamental aspect of pharmaceutical product life cycle management. Variations notifications are informed to the Agency through Variation filing. According to the level of risk variations are categorized as Type IA/IAIN (Minor Change – “Do and Tell procedure”); Type IB (Moderate Change - “Tell, wait and Do procedure”); and Type II and Line extensions (Major Change – “Tell, approval and Do procedure”). This article describes the variations, types of variations, regulations, and submission process of variations in Europe. Keywords: Variations, Europe, Type IA/IAIN, Type IB, Type II, Line extensions and Variation filing
Publication date: 01/12/2022

https://ijbpas.com/pdf/2022/December/MS_IJBPAS_2022_6650.pdf

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https://doi.org/10.31032/IJBPAS/2022/11.12.6650