The situation

All Marketing Authorisation Holders (MAHs) in the European Union (EU) and the European Economic Area are required to submit information on their authorised medicinal products to the Article 57 database of the European Medicine Agency (EMA) in accordance with Article 57(2) of Regulation (EC) No. 726/2004. It is a legally binding requirement from the EU pharmaceutical legislation.

Information on amendments to the terms of any Marketing Authorisation (MA) following variations, transfers, renewals, or withdrawals should be notified to the EMA no later than 30 days after authorisation.

As part of the IDMP SPOR (Substances, Products, Organisations and Referentials) project, the EMA will soon migrate the xEVMPD data to SPOR PMS (Product Management Service). But how can MAHs ensure data consistency between their own Regulatory Information Management (RIM) database and EMA’s xEVMPD database before the data will actually be migrated to SPOR PMS?

The problem

Let’s face it, although good progress has been made to implement SPOR, a lot still needs to be done. The iterative approach chosen by the EMA provided early access to Referentials and Organisations, allowing MAHs and other interested parties to benefit from these SPOR services. And that is not limited to MAH managing medicinal products for humans, it is also of benefit to the veterinary sector.

However, the EMA still needs to decide certain aspects of the implementation including whether replacing the Art 57 data submission format (XEVPRM) with the new ISO IDMP compatible format (HL7 FHIR (Fast Healthcare Interoperability Resources)) takes place only after all relevant application forms are released by the Digital Application Dataset Integration (DADI) project.

The implication

But now EMA’s data migration from xEVMPD to PMS is on the horizon and MAHs need to be certain that their data is consistent, avoiding costly corrections and resubmissions. It is time to start checking to avoid the implication of incorrect data to be migrated from xEVMPD to PMS. A lot of time and effort can be spared by ensuring data consistency between MAHs’ RIM and xEVMPD data before the migration will take place.

In summary

Time is of essence, no doubt. The longer MAHs wait to check on data consistency between RIM and xEVMPD, the higher the risk and cost of corrections will be. Corrections undertaken after the PMS data migration has been completed will be more complex and time consuming. Don’t delay as after all, MAHs are responsible for the data held at the EMA.

We will provide further details about options on how you can automate this process in a follow-up post, but please feel free to get in touch should you require any assistance.

Published by Olaf Schoepke

Passionate about sharing ideas with regulatory professionals in the human and veterinary medicinal product space.

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