The European Medicines Agency (EMA) has communicated a series of significant updates regarding the Product Management Service (PMS). These changes place particular emphasis on non-Centrally Authorised Products (non-CAPs) and aim to provide stakeholders with clearer timelines and improved functionalities for regulatory processes.
Extended deadlines for data submission
The EMA has officially confirmed new timelines for the submission of structured data related to non-CAPs:
- Structured manufacturer’s data and pack sizes for non-CAPs (ULCM): The deadline has been extended until June 2026.
- Pack sizes for all other non-CAPs using xEVMPD, as well as structured pack sizes submitted through PMS PUI and API: The deadline has been extended until June 2027.
It is important to note that the deadline to submit structured manufacturer’s data for other non-CAPs, set for December 2026, remains unchanged.
Upcoming PMS releases – September 2025
Two key developments will be launched in September 2025 to enhance efficiency in data submission and management:
- PMS PUI – Bulk Write (22 September 2025): This functionality will allow Marketing Authorisation Holders (MAHs) to edit multiple products simultaneously within the PLM Portal. It will cover ESMP and shortages use cases, including data relating to manufacturers, manufacturing batch organisations (MBOs), structured package information and data carriers.
- PMS API – Write Access (25 September 2025): This release will enable MAHs to submit manufacturers and pack sizes data in bulk directly via API, streamlining the process further and facilitating integration with existing company systems.
Training and support initiatives
To ensure smooth adoption of these new functionalities, EMA has scheduled several training sessions and support activities:
- Webinars in October 2025:
- PUI Training – Bulk edit made easy (6 October 2025)
- API Training – Unlocking PMS API potential (16 October 2025)
- Monthly Q&A Clinics: These sessions will run from September to December 2025, offering stakeholders the opportunity to clarify specific questions and receive guidance directly from experts.
Need support?
For further information or assistance regarding these updates and their potential impact on your regulatory activities, please contact us at [email protected]
