Europe – Chapter 7 : Implementation of ISO standards for the identification of medicinal products in Europe

Chapter 7 : XEVMPD - PMS Migration guide

Migration of Article 57 data into IDMP/SPOR format and terminology

The EMA intends to migrate the data held in the eXtended Eudravigilance Medicinal Product Dictionary (XEVMPD) and submitted by marketing authorisation holders (MAHs) under the Art.57 (2) legal obligations since 2012, into the ISO IDMP-compliant data format and terminologies. The transformed data will be loaded into the PMS hub. This approach is expected to:

• allow building of the new ISO IDMP compatible repository [i.e. Product Management Services (PMS)] from the data submitted since 2012 under the Art.57 legal obligation;

• provide external stakeholders with services (i.e. API) for the access and retrieval of their own data previously submitted in Art.57 data format [i.e. via the eXtended Surveillance Medicinal Product Report message (XEVPRM)] transformed and remapped into the new data format and terminologies for further validation and enrichments;

• facilitate business continuity ensuring that PMS contains data comparable with what is available in the Article 57 database and currently supports the EMA business and regulatory processes until integration with PMS will be implemented;

• facilitate transparency and comprehension of the data transformed into the new format by stakeholders and owner of the data…