SPOR user registration
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 account with SPOR user roles to log into the SPOR portal.
To request SPOR user roles, a user needs to be affiliated to a specific organisation in industry or a national competent authority.
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, including the SPOR portal.
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. However, they will need to request SPOR user roles if they have not already done so.
Benefits of registering
Registered users can make requests via the SPOR portal for changes or additions to the master data held by EMA.
Currently, registered users can request changes or additions to referential and organisation data held in the Referentials Management Service (RMS) and Organisations Management Service (OMS).
Since the RMS and OMS supply master data to the electronic application forms (eAF) for submitting applications to EMA and national competent authorities, applicants may need to make a change request to provide correct information in their eAF.
Users can submit change requests for organisation data concerning:
- marketing authorisation holders for centrally authorised products (human and veterinary medicines);
- marketing authorisation holders for nationally authorised products (human medicines);
- marketing authorisation applicants for human and veterinary medicines (centralised procedure).
The SPOR services will eventually support a wider range of EMA business processes and EU-wide regulatory activities. For more information, see Substance Management Service (SMS) and Product Management Service (PMS).
Permission levels for industry users
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, by following the guidance below:
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.
EMA has invited industry stakeholders to register their RMS and OMS users. For more information, see Referentials and organisations management services.