Referentials and organisations management services
This content applies to human and veterinary medicines.
The European Medicines Agency (EMA) has launched the Referentials Management Service (RMS) and Organisations Management Service (OMS) to support EU-wide regulatory activities.
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.
The SPOR services support the implementation of ISO IDMP standards in the European Union (EU). A specialised team of EMA data stewards oversees the management of data and provide support to stakeholders.
Users can access these data services directly online via the SPOR portal.
Access the RMS and OMS on the SPOR portal using the button below:
The SPOR portal is compatible with Internet Explorer (version 10 and above) and Chrome (version 58 and above) web browsers.
EMA invited industry stakeholders to register 'super users' from 15 December 2017, and other users from January 2018 (see 'User registration' below).
What the RMS is for
The RMS stores referential master data, i.e. lists of terms (controlled vocabularies) to describe the attributes of medicinal products, such as lists of dosage forms, units of measurement and routes of administration.
The RMS data comply with the two ISO IDMP standards for:
- pharmaceutical dose forms, units of presentation, routes of administration and packaging (ISO 11239);
- units of measurement (ISO 11240).
The RMS replaces the EU Telematics Controlled Terms (EUTCT) system for providing controlled terms in multiple languages for the exchange of master data between information systems in the European medicines regulatory network.
The RMS brings new and improved functionality over the EUTCT, as explained in On-boarding of users to SPOR data services
However, since the EUTCT also holds substance lists, it remains available until EMA launches the substance data management service.
For more information, see the Referentials management services (RMS) operating model .
What the OMS is for
The OMS stores master data on organisations, comprising organisation name and location address, for organisations such as marketing authorisation holders, sponsors, regulatory authorities and manufacturers.
For more information, see the Organisations management services (OMS) operating model .
Guidance for stakeholders
The launch of the RMS and OMS in June 2017 did not immediately change any regulatory submission processes. However, EMA is consulting stakeholders on the benefits of using the SPOR services to support different regulatory procedures.
The RMS and OMS already supply master data to the electronic application forms (eAF) for submitting applications to EMA and national competent authorities for initial marketing authorisations, variations and renewals for human and veterinary medicines.
This enables users to select information supplied directly by these master data services when preparing a regulatory submission.
The integration of the OMS with the eAF enables applicants to select their organisation details rather than entering this information manually, saving time and reducing the risk of error.
The OMS currently contains master data on:
- marketing authorisation holders for centrally authorised products (human and veterinary medicines) and for nationally authorised products (human medicines);
- marketing authorisation applicants for human and veterinary medicines (centralised procedure).
EMA continues to expand the OMS by including master data on other types of organisation, including manufacturers, wholesale distributors, sponsors and clinical trial sites. EMA will communicate with stakeholders on future additions to the OMS.
EMA encourages industry users to start submitting their requests to update referential and organisational data (within the current scope of the OMS) using the new change request functionality provided in RMS and OMS interfaces.
For more information, see:
- Using referential and organisation data in electronic application forms
- Overview of OMS change request process (20/08/2018)
- Webinar on using OMS and RMS data in electronic application forms (27/06/2018)
For more information on the main areas of change brought in by the OMS and RMS services, see SPOR data management services - high level changes .
EMA is inviting 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.
The timetable is different for different stakeholders. EMA invited:
- national competent authorities to begin registering super users and to use the RMS from June 2017;
- industry stakeholders to begin registering super users from 15 December 2017, and other users from January 2018.
For more information, see On-boarding of users to SPOR data services
For more information, see SPOR user registration.
OMS user acceptance testing
EMA carried out user acceptance testing of OMS in March-April and September 2017, with users from national competent authorities, the pharmaceutical industry and software vendors.
The documentation, SPOR application programming interfaces (APIs), API schemas and the SPOR glossary can be found on the SPOR portal under the 'Documents' tab.