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:
- 4 February 11:00-11:45 (CET) – registration link
- 13 February 10:30-11:15 (CET) – registration link
- 18 February 11:00-11:45 (CET) – registration link
- 25 February 11:00-11:45 (CET) – registration link
PUI guidance documents:
- PUI registration guide: support in completing the steps needed to gain access to the PUI.
- PUI navigation guide: support in navigating across the pages of the PUI.
- PUI known issues document: details of all known issues in the PUI and workarounds where available.
For inquiries, contact: [email protected] or visit the PLM portal forum.
Need assistance for your regulatory affairs? Contact us at: [email protected]