Breaking News | PMS User Interface edit functionalities now live for Industry users!

This is a major step towards enhancing data transparency and improving regulatory efficiency!

This is a major step towards enhancing data transparency and improving regulatory efficiency!
February 4, 2025

Do you have nationally authorized medicines via mutual recognition, decentralised or national procedures? Then this update is for you!!

The European Medicines Agency (EMA) has announced a significant update: PUI edit functionalities are now available for Industry users via the PLM portal! This milestone allows edits to pack size and manufacturer data for non-Centrally Authorised Products (non-CAPs)—key information for shortage reporting via the European Shortages Monitoring Platform (ESMP).

This update builds on previous advancements, including the PMS API (read-only mode) and the PUI read-only mode for CAPs and non-CAPs, gradually enhancing regulatory processes for Marketing Authorisation Holders (MAHs) and National Competent Authorities (NCAs).

Upcoming EMA Events & Support:

  • Training webinar: EMA held a public webinar on 28 January 2025 to showcase PMS released PUI edit functionalities (enrichment process). Consult the event web page to access presentation and recording.
  • Weekly Q&A clinics on PUI & API in February:

 

PUI guidance documents:

For inquiries, contact: [email protected] or visit the PLM portal forum.

Need assistance for your regulatory affairs? Contact us at: [email protected]

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