Posted Fri, 09 Feb 2024 11:04:44 GMT by Caterina Scarpati

1. PMS Deep-dive Webinar - 22 February 2024 

EMA is organising a public webinar tailored for future PMS data users, i.e. current XEVMPD users, those involved in creating electronic Application Forms (eAFs), prospective users of European Shortages Monitoring Programme (ESMP), and anyone engaged in the management of product data. Stakeholders who are familiar with PMS activities are also invited.  

The webinar will cover key PMS-related topics, including IDMP implementation, PMS Data model overview, accessing PMS Data, Mappings & data migration, and Deltas analysis.  

Date & Time: 22 February 2024, 10:00 – 12:00 (CET).  

Registration form is available here

2. EU IDMP Implementation Guide (IG) Chapters’ release 

The PMS team is pleased to announce that the following EU IDMP IG Chapters are available online: 

  • Chapter 5 (v1): focusing on data access to medicinal products for human use.  

  • Chapter 5 Annex A: product data elements accessible by stakeholder group. 

  • Chapter 7 (v3): including updates on the business rules defined for the initial migration of data from XEVMPD and SIAMED II. This version also includes revision to sections previously published and examples for each scenario. 

  • Chapter 9 (v1): focusing on the process for submitting existing data on medicinal products authorised for human use – SIAMED II & XEVMPD to PMS deltas.