Users can access the European Medicines Agency's (EMA) available master data services via the substance, product, organisation and referential (SPOR) portal. All users have read-only access. However, users need to register to carry out actions via the portal such as requesting changes to the master data held by EMA.
Users require an EMA accountwith SPOR user roles to log into the SPOR portal.
To obtain an EMA account and request SPOR user roles, please visit the EMA Account Management portal. This is a central point for managing access to EMA systems.
To request SPOR user roles, a user needs to be affiliated to a specific organisation in industry or a national competent authority.
Users who already have an active account for any EMA-hosted website or online application can use the same login credentials to log into the SPOR portal, but they still require SPOR user roles.
Benefits of registering
Registered users can use the SPOR portal to request changes or additions to the master data held by EMA.
The RMS and OMS supply master data to the electronic application forms (eAF) used for submitting applications to EMA and national competent authorities.
Users may need to make a change request for instance to include the correct referential or organisation data in their regulatory submissions or, in the case of the OMS, to access other EMA systems.
The SPOR services will eventually support a wider range of EMA business processes and EU-wide regulatory activities. EMA's business teams will provide stakeholders with information in advance, including process changes and implementation timelines.
Permission levels for industry
There are two types of industry user with different permission levels:
- Industry Super User;
- Industry User.
A user can apply to EMA as the first Industry Super User affiliated to their organisation, by following the guidance below:
Once approved by EMA, this Industry Super User will have permissions to approve or revoke any subsequent Industry Super Users or Industry Users affiliated to the same organisation.
EMA recommends that each organisation has at least two registered Industry Super Users.
The decision how many users to register with SPOR should be driven by practical concerns within each organisation, based on factors such as organisation size and structure. There are no technical or recommended limits on the number of registered users per organisation.
More information is available on the SPOR portal.