EVRF56/Rev 1 February 2024/Application form for major, minor variations and intermediate notifications91 DownloadsDownload Now!Size: 128 KBPublished: July 25, 2025

EVRF55/Rev 1 February 2025/Application for Annual notifications91 DownloadsDownload Now!Size: 127 KBPublished: July 25, 2025

EVRF44/Rev 4 April 2025/Status update request form93 DownloadsDownload Now!Size: 101 KBPublished: July 25, 2025

EVRF34/Rev 4 May 2024/Applicants screening checklist for Biologics135 DownloadsDownload Now!Size: 120 KBPublished: July 25, 2025

REGISTRATION CERTIFICATE_MC16_FORM108 DownloadsDownload Now!Size: 38KB

EVRF 79 Rev 0_July 2024 – QUALITY OVERALL SUMMARY109 DownloadsDownload Now!Size: 110KB

EVRF 74 Rev 1_May 2025 – APPLICATION FORM FOR RENEWAL OF PRODUCT REGISTRATIONS94 DownloadsDownload Now!Size: 57KB

EVRF 73 Rev 1_May 2025-MCAZ QUALITY INFORMATION SUMMARY107 DownloadsDownload Now!Size: 103KB

EVRF 07 Rev 05_September 2023-BIOWAIVER FOR ADDITIONAL STRENGTH INFORMATION FORM101 DownloadsDownload Now!Size: 66KB

EVRF 05 Rev 06_September 2023-BIOPHARMACEUTICS CLASSIFICATION SYSTEM BCS BASED BIOWAIVER INFORMATION FORM108 DownloadsDownload Now!Size: 73KB