Type II Variation Final Assessment Report

The Final Variation Assessment Report (FVAR) plays a key role in evaluating changes to a medicinal product’s marketing authorization. It includes:

• Review of the applicant’s response to major objections
• Harmonization of product labeling and patient leaflets
• Updated benefit-risk assessment and overall conclusions
• Grounds for refusal of variation requests
• Major objections related to quality, non-clinical, clinical efficacy, and safety aspects
• Other concerns affecting the marketing authorization terms
• Proposed updates to the Summary of Product Characteristics, patient leaflet, and labeling
• Recommendations based on data review

The FVAR ensures regulatory compliance and supports decision-making on proposed changes.

Source: https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Templates/AR/Variation/CMDh_221_2006_Rev.6_2025_02_clean_-_RMS_FVAR_template.docx

Region: European Union