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EMA's Pre-submission checklist for type II variation applications

The purpose of this checklist is to facilitate submission of complete and correct type II variation applications by marketing authorisation holders (MAHs).

EMA strongly recommends that this checklist is used in advance of submission of type II variation applications.

The use of such checklists helps to avoid the common submission errors and ensure that applications comply with the regulatory requirements.

The new pre-submission checklist for Type II variations could be referred here