The European Medicines Agency (EMA) has issued some important updates regarding the Product Management Service (PMS) and the Product Lifecycle Management (PLM) Portal.
Non-CAP Data Load Complete!
The data load for non-Centrally Authorised Product (non-CAP) information into the PMS Product User Interface (PUI) is now fully complete. This means that all human non-CAP and CAP data is now available in read-only mode through the PUI on the PLM Portal.
You can now resume normal activities on the PLM Portal as the temporary restrictions, which were put in place to maintain platform performance during the data load, have been lifted.
Key Points to Note:
- Non-CAP data in the eAF: While the PUI now includes non-CAP data, please be aware that this data is not yet available in the web-based electronic Application Form (eAF). We are continuing to make performance improvements, and once these are complete, the non-CAP data will be available in the eAF.
- Read-only access: This update provides read-only access to both CAP and non-CAP data, a crucial milestone on our journey towards a fully data-centric target operating model.
Building on Recent Milestones:
This achievement builds on two significant milestones:
- The go-live of the PMS API for CAPs and non-CAPs in read-only mode for Marketing Authorisation Holders (MAHs) on 3 July 2024.
- The launch of the PMS PUI in read-only mode for CAPs on 31 May 2024.
Have Questions?
If you have any questions or require further clarification, feel free to reach EMA at [email protected], or you can post your queries via their PLM Portal Forum.
Do you have further inquiries? Contact us! We´re here to help: [email protected]
Note: Non-CAP products include those authorised through mutual recognition procedure (MRP), decentralised procedure (DCP), and national procedure (NAP).
