Starting 1st of July 2025, the AEMPS mandates the use of Organisation Management System (OMS) for all new Market Authorization Applications and variations for medicinal products registered through National Procedures.
It will also be required for National Code requests in case of medicinal products registered through Centralized Procedures.
This requirement will ensure consistency and interoperability between IT Systems, allowing a smooth transition to the web-based eAF future implementation and adequate alignment with corrent Systems such as PMS (Product Management Service) and ESMP (European Shortages Monitoring Platform).
At Asphalion, we’re committed to guiding our clients through this transition smoothly, ensuring compliance and optimizing submission processes. Please don’t hesitate to reach out if you have any questions or need assistance with your applications: [email protected]
Read the whole information here: https://bit.ly/41TDNKj
