The EMA intends to migrate the Centrally Authorised Products (CAPs) and non-Centrally Authorised Products (non-CAPs) data held in the eXtended Eudravigilance Medicinal Product Dictionary (XEVMPD) and submitted by marketing authorisation holders (MAHs) under the Art.57 (2) legal obligations into the ISO IDMP-compliant data format and terminologies.
In addition to the data stored in XEVMPD, EMA intends to migrate the Centrally Authorised Products (CAPs) data held in its internal database called SIAMED II ultimately building the new ISO IDMP compatible repository [i.e. Product Management Services (PMS)] in PMS.
The transformed data will be loaded into the Product Management Service (PMS) hub with the following approach:
• allow the building of the new ISO IDMP compliant repository [i.e. Product Management Services (PMS)] from the data submitted under the Art.57 legal obligation and the data collected by EMA for Centrally Authorised Products;…
