The European Medicines Agency (EMA) hosted recently a webinar targeting PMS users within the PLM portal framework. Important topics covered included the implementation of ISO IDMP, an overview of the PMS data model, data mapping and migration, delta descriptions, and access roles via the Product User Interface (UI) or Application Programming Interface (API). The EMA is currently in the process of transitioning from xEVMPD (Article 57) to PMS. To ensure preparedness, please verify your access to the Product Management Service (PMS).
Key highlights shared by the EMA for 2024 include:
- The initiation of the first Enrichment process focusing on manufacturers’ information, designed to facilitate the implementation of the European Shortages Medicines Platform (ESMP).
- Users equipped with RIMS featuring an API connector (gateway) will gain access to all product data starting from Q2.
- Product User Interface (UI) users (excluding those accessing via their RIMS gateway) will gain access to CAPs data in Q2 and NAPs data in Q4.
- An imminent update to Chapter 1 (Registration requirements) and Chapter 2 (Data elements) of the Implementation Guide is anticipated.
Don’t miss our coming FREE WEBINAR: “ISO IDMP Key Updates”. Registrations are open. You can register here: ISO IDMP Key Updates Webinar
Feel free to reach out to us to stay updated and obtain further details regarding implementation timelines and steps necessary to prepare for the IDMP transition. [email protected]
