EMA Updated Timeline IDMP SPOR (June 2017)

Download EMA Updated Timeline IDMP SPOR June 2017

EMA Updated Timeline IDMP SPOR June 2017. EMA´s IDMP programm envisages the release of ISO IDMP compliant (11239 & 11240) Referential Management Services (RMS) and Organisation Management Services (OMS) on 19th June 2017 (subject to confirmation).

spor timeline June 2017

The scope of the release includes data content, functional capabilities and range of services:

  • A single source or Referentials data which will include updated lists from EU Telematics Controlled Terms – EUTCT (these are flat lists which have been structured with full ISO data elements), lists migrated from the EUTCT and new lists to support OMS
  •  Capabilities to standardise, cleanse, consolidate and publish a single list of organisations with their physical locations (also known as organisation dictionary). At the OMS go-live the list of organisations will include the NCA organisations and will gradually be expanded with additional data in Q3 (MAHs, MAAs, MRL applicants) and Q4 (Sponsors) 2017
  • Referential and Organisation data accessible via the SPOR web user interface and programmatically via the API (Application Programming Interface),
  • New process for NCAs and industry to register/update Organisation and Referential data,
  • Specialised team of EMA data stewards to oversee the management of data and provide support to stakeholders.

On-boarding of Users and Functionality Roll-Out

SPOR team has drafted a plan to manage on-boarding of users and functionality roll-out. It envisages the following:

User on-boarding

  • NCAs on-boarding to start in June
  • Industry on-boarding is planned to start in October (when the content of the OMS dictionary will include MAHs, MAAs and MRL applicants)

RMS and OMS functionality roll-out

  • NCAs use of RMS as of June
  • Industry use of RMS as of October
  • NCAs & industry use of OMS as of October (when the content of the OMS dictionary will include MAHs, MAAs and MRL applicants)

EMA will run a webinar on 19 June to present the on-boarding plan.
Additional webinars for stakeholders will be scheduled in the near future.

Download Additional Information

Link to EMA´s Page on Implementation of SPOR