The go-live of CTIS on 31 January 2022 is now less than two months away, and organisations throughout Europe and beyond are undergoing preparations for CTIS.
Users are reminded that certain preparatory steps must be taken before it is possible to use CTIS.
Sponsor organisations opting for the organisation-centric approach that are not yet registered in EMA’s Organisation Management System (OMS) must do so before using CTIS.
Registration in OMS can be done by visiting the OMS webpage of the Substances, Products,
Organisations and Referentials (SPOR) portal. An EMA account with a SPOR user role is required in order to register an organisation in OMS. Training materials for OMS can be found on the OMS webpage on the EMA website.
It is recommended to register in OMS as early as possible. Sponsors can consult the Help section of the SPOR portal for details on guidance and support for OMS.
Once registered in OMS, sponsor organisations opting for the organisation-centric approach must register their first high-level administrator, the Sponsor Administrator, via EMA Account Management prior to using CTIS.
More information on registration can be found on the EMA Account Management home page.