Road Map for Implementation of EU SPOR

While we wait for the EMA/ HMA to publish a road map to provide a timetable for the implementation of Product and Substance data services, we make do with progress with the finalisation of the implementation guide for SPOR Iteration 1. Version 1 of the IG was published at the beginning of the year, and this at least provided fairly dependable understanding of the data elements necessary for new and marketed human medicines. It has just been announced that Version 2 of the IG will not be published until February 22nd 2021, which is later than expected but at least it is something upon which to focus and plan! This version will provide detailed guidance about IDMP/SPOR business processes for Centrally-approved/ approvable products.
This critical milestone will then kick-off the 12-month transition period, during which there will be optional use of the full set of SPOR data services in the EU. Immediately following this, the 12-month implementation period will commence: after which SPOR becomes mandatory for Centralised procedures.


Thanks very much @andrew.thornley1!

Does anyone know if any systems will be fully retired once the mandatory date is reached? I’m interested to know what the fate of tools like XEVMPD will be.

Hi Jack

I believe the EMA will look to retire XEVPRM and replace it with FHIR

The last I saw, this would be with a 12 month period until the potential change.

It’s a difficult one to call. The EMA has a stated intention to migrate its XEVMPD dataset to SPOR. Whether this will be a two-step process, starting with CP products, is anyone’s guess!

Okay thank you Andy, good to know! I’ll be interested to follow the timelines if you hear any more.