Posted Wed, 15 Feb 2023 18:53:42 GMT by Kristiina Puusaari

Dear PLM Portal users,

The updated Chapter 7 of the EU IDMP Implementation Guide (EU IG) is available on the EMA website.

This version provides information on the approach followed by the European Medicines Agency (EMA) to enable the transformation, migration and availability of authorised product data to the PMS.

Specifically, chapter 7 now describes the following aspects:

·        migration rules of CAP data into PMS;

·        migration rules of NAP data into PMS;

·        match and merging rules of data from SIAMED II and xEVMPD;

·        the Art.57-SIAMED II-PMS data mapping, including the transformation rules that will be applied to the data during the migration into PMS.

The publication of Chapter 7 replaces the previously released Annex I to Chapter 7.