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

A new Guidance document is available for Marketing Authorisation Holders published by EMA to help improve the quality of variation and renewal applications.

11th July 2017

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.