Update on the EMA Checklists for Changes & Variations

To assist applicants preparing their submissions, the European Medicines Agency (EMA) has published pre-submission checklists for certain procedure types. According to the agency, the checklists "enable applicants to submit high quality applications that avoid frequent mistakes and comply with the legal and regulatory requirements, ensuring submissions can be validated speedily". In particular, the Validation Checklist for Type II (non)clinical variations has now been updated. There is also a Validation Checklist for Type II quality variations available which has been issued in May 2021.

Is it a Type II variation?

The ‘Variations Regulation’ defines a major variation of Type II as a variation which is not an extension of the Marketing Authorization (line extension) and that may have a significant impact on the quality, safety or efficacy of a medicinal product.

For more detailed information, the EMA Q&A website on Type-II variations lists questions that marketing-authorization holders (MAHs) may have on type-II variations. It provides an overview of the agency's position on issues that are typically addressed in discussions or meetings with MAHs. In addition, two checklists for type-II (non-) clinical and quality variations are provided. The filled checklist should be submitted as a word document with an application for type-II variations. Regarding the classification of changes reference is made to the agency´s questions and answers and regarding the variation category the variation scope laid down in the ‘Variations Guideline’ should be considered. In case of groupings the corresponding classification scopes should be indicated as many times as needed taking into account that one classification scope is to be indicated per variation. An updated Risk Management Plan (RMP) should be provided for a new or modified therapeutic indication. MAHs are requested to provide high-level explanation of the changes proposed to the RMP either in the Cover Letter or the Application Form.

For more information please see the EMA websites Improving quality of submissions and Type-II variations: questions and answers.