Type II Variation Preliminary Assessment Report

The Preliminary Variation Assessment Report (PVAR) evaluates proposed changes to a medicinal product’s marketing authorization. It includes:

• Scope of the variation
• Scientific rationale for recommendations
• Quality, non-clinical, and clinical aspects
• Risk Management Plan details
• Product characteristics, package leaflet, and labeling
• Major objections and concerns affecting authorization
• Requests for additional information from the Marketing Authorization Holder (MAH)
• Conditions for approval based on relevant directives

The PVAR ensures regulatory compliance and assesses the impact of proposed changes before approval.

Source: https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Templates/AR/Variation/CMDh_220_2006_Rev.5_2025_02_clean_-_RMS_PVAR_template.docx

Region: European Union