illev Pharma East has a highly educated and dedicated team of international experts with many years of experience in Pharmaceutical industry.

25 January 2023

Update on the EMA Checklists for Changes & Variations for Type II non-clinical variations


The European Medicines Agency (EMA) has updated its Validation Checklist for Type II (non)clinical variations. The validation Checklist for Type II quality variations was already issued in May 2021. These checklists are intended to help applicants prepare high-quality submissions that comply with legal and regulatory requirements and avoid common mistakes. Type II variations, as defined by the Variations Regulation, are those that may have a significant impact on the quality, safety, or efficacy of a medicinal product and are not an extension of the marketing authorization (line extension). The EMA’s Q&A website on Type-II variations and the Variations Guideline provide more detailed information on the classification and grouping of changes, as well as the requirement for an updated Risk Management Plan (RMP) for new or modified therapeutic indications. For further information, applicants can refer to the EMA’s websites on Improving the quality of submissions and Type-II variations: questions and answers.