EMA launched Referentials Management Service
The RMS and OMS manage two of the four domains of substance, product, organisation and referential (SPOR) master data in pharmaceutical regulatory processes. They lay the data foundations for delivering the substance and product data management services.
Users can access information to these data services directly online via the SPOR portal.
EMA will invite national competent authorities and industry stakeholders to register their RMS and OMS users, starting with ‘super users’ who can authorise the registration of further users from the same organisation.
However, the timetable is different for different stakeholders:
National competent authorities:
EMA invited national competent authorities to begin registering their super users and to use the RMS from June 2017;
Update: EMA will invite industry stakeholders to begin registering their ‘super users’ from 15 December 2017 and other users from January 2018.
For more information see the Referentials Management Service (RMS) and Organisations Management Services (OMS) user on-boarding plan.