We at Asphalion are thrilled to share key updates that could significantly impact your interaction with the EMA’s PLM Portal:
– Data migration from xEVMPD and SIAMED to PMS has been completed. xEVMPD and SIAMED are now synchronized with PMS.
– From the 31st of May, PMS roles will be available for request, with access granted from the go-live date.
– Data enrichment for manufacturers and pack sizes (ISO IDMP) should be done by the end 2024.
– Public PMS product reports will be published on 31 May 2024, accessible without registration.
How can Asphalion help you?
- xEVMPD Maintenance: Analyzing 3rd ACKs and submitting pack size structure data through xEVMPD
- Data Enrichment in compliance with ISO IDMP
- Reviewing your product in PMS
- Correcting your data in PMS
For a full list of updated chapters and access to new guidance documents, visit the PLM Portal.
Stay tuned for more updates as we continue to navigate the evolving landscape of regulatory operations!
If you need assistance, contact us at: [email protected]