VARIATION FILING PROCEDURE IN EUROPE: A COMPLETE REVIEW

Abstract

MAH can proceed for any post approval change implementation through variation filing to EMA agency. This approach can be applicable for all categories of applications such as Central procedure (CP), National procedure (NP), Decentralized procedure (DCP) and Mutual recognition procedure (MRP). Variation changes are classified in to four types such as 1. Administrative 2. Quality 3. Safety, Efficacy and Pharmacovigilance and 4. Specific changes to plasma master files and vaccine antigen master files. Based on the criticality of the change variations are classified as Type IA/ IAIN; type IB and type II variations Type-IA/IAIN is for minor change; type IB is for moderate variation and type II variation is for major change. Type IA/IAIN are do and tell process, type-IB is tell wait and Do process and type II is tell approval and Do process. This article is only for educational purpose.