The divestiture of products between companies within the EU is a complex process that requires careful management of licensing, product registrations, and serialization compliance. This session will provide practical strategies for managing the transfer of products from Company A to Company B, with a focus on regulatory requirements related to product license transfers and ensuring seamless serialization continuity. Emphasis will be placed on understanding the critical role of the EMVO portal in the process, while addressing challenges such as unclear guidelines for managing contract manufacturing organizations (CMOs) and ensuring serialization compliance during the registration license transition. In this session, you will learn how to:

• Navigate the regulatory requirements for transferring product licenses and managing product registrations during a divestiture within the EU.
• Ensure ongoing serialization compliance throughout the divestiture process, with a focus on the EMVO portal and traceability.
• Address challenges in managing CMOs and transitioning registration licenses, including overcoming unclear or complex guidelines.

• What are the critical regulatory requirements for transferring product licenses and managing product registrations during a divestiture in the EU?
• How can companies ensure that serialization compliance is maintained throughout the divestiture process?
• What are the key challenges companies face when working with the EMVO portal during a product divestiture, and how can they be overcome?
• How can companies manage the complexities of contract manufacturing organizations (CMOs) during the product divestiture process?
• What practical strategies can be implemented to ensure smooth transition of registration licenses while adhering to serialization standards and maintaining traceability?

In the Harvesting Session the workshop moderators of the event will summarize the results of their discussions and highlight key findings from the World Cafés.