Organisation Management Service (OMS) | European Medicines Agency (2024)

This content applies to human and veterinary medicines.

The European Medicines Agency (EMA) has launched the OrganisationManagement Service (OMS) to support regulatory activities throughout theEuropean Union (EU).

The OMS manages one of the four domains of substance, product, organisation and referential (SPOR) master data in pharmaceutical regulatory processes.

Access the OMSon 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.

The OMS servicesupports theimplementation of ISO IDMP standardsin the EU.

The OMS provides a single source of validated organisation data that can be used as a reference to support EU regulatory activities and business processes.

It stores master data comprising organisation name and location addressfor organisations such as marketing authorisation holders, sponsors, regulatory authorities and manufacturers.

The data is mastered with unique identities (ID), labelled in the OMS as 'Organisation_ID' and 'Location_ID'.

Organisations are categorised in the OMS by type, such as‘Industry’, ‘Regulatory Authority’ or ‘Educational Institution’ and by size, such as‘Micro’, ‘Small’, or ‘Medium’.

The OMS does not define roles an organisation performs, which are context-specific. An organisation mayact as marketing authorisation holderin relation to one medicine but as a sponsor or manufacturer for another.

For more information, see:

The content of the OMS is expanding incrementally. To initially construct the OMS dictionary,EMA used organisation data from five data sources, includingthe Article 57 (xEVMPD) databaseandEudraGMDP database.

The table below contains information on when EMA will release different data setsinto the OMS and when stakeholders may submitchange requestsfor these data sets.

EMA carries out a data mastering processmanaged by data stewardswho follow a set of business rules and a data quality standardto cleanse, standardise and consolidate the data before its publication in the OMS dictionary.For more information, see the 'Data quality standard in OMS' document available on the SPOR portal.

For information on who is responsible for registeringand updating OMS data onmanufacturers, seeManufacturer organisations in the OMS dictionary.

EMA intends to expandthe OMSby including master data on other types of organisation, including:

• organisations supporting the clinical trial application procedure;
• contract research organisations (CROs);
• clinical trial sites;
• academic institutes;
• hospitals;
• wholesale distributors;
• MAAs, MAHs and manufacturers for herbal and homeopathic medicinal products;
• MAAs, MAHs and manufacturers for compassionate use medicines.

EMA will define the prioritisationof releasing these data sets andmay identify other sources of organisationdata to includein the OMS in future.

EMA encourages industry users to requestany changes needed to organisationdata in the OMS using the change request functionalityin the OMS interface.

In order to submit a change request, users needan activeEMA accountwith aSPOR user role. For more information, seeSPOR user registration.

The first step is tosearchfor and view the full details ofanorganisationand itslocations in the OMS. If the user:

• cannot find the organisation (as defined by name in a given country), they can ask to create a new organisation.
• finds the organisation but not itslocation, they can ask to add a new location to the organisation;
• finds both the organisation and its location, but either of theseisnot up-to-date, they can ask to update the organisation and/or location data;
• finds the organisation with an active status but the location with an inactive status, they can ask to update the organisation data or add new locations.

Users should include any relevant supporting documentsor information with their change requests, as described in the 'Change requests validation in OMS' guidance document available in the OMS section of the SPOR portal.

For more information, see:

• SPOR user registration
• the following guidance documents, available in the OMS section of the SPOR portal:
  • 'Change requests validation in OMS' (includes the supporting documentation needed for different types of change request);
  • 'Organisation data quality standards in OMS';
  • 'Definitions of OMS controlled vocabularies'.

Using the OMS becomes mandatory when different business processesbeginto rely on OMS data. EMAbusiness teams will provide stakeholders with information on process changes and implementation timelines. These timelines may be different in the human and veterinary domains.

Marketing authorisations, variations and renewals

The OMS suppliesmaster 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 integration enables applicants to select their organisation details rather than entering this information manually, saving time and reducing the risk of error. However, this is not yet mandatory and applicants can continue to add their organisation detailsmanually.

EMA expects that the Common European Submission Portal (CESP) data set module for marketing authorisation applications (MAA) will require the use of OMS data, following a transition period.For more information, see:

• Using Referential and Organisation data in the electronic application form (eAF)
• (20/08/2018)
• Webinar on using OMS and RMS data in electronic application forms (27/06/2018)
• Common European Submission Portal

Orphan designation

As of June 2018,theIRIS systemmakes use of OMS data for orphan designation procedures. For more information, seeApplying for orphan designation.

Parallel distribution

As of February 2019,theIRIS systemmakes use of OMS data for parallel distribution notifications. For more information, seeParallel distribution.

Other systems and processes

In the future, EMA plans to roll out the use of OMS data to support regulatory submissions inEU Telematics systems, such as the:

• EUclinical trialportal and database;
• Article 57(XEVMPD) database.

National competent authoritiesinvolved in the authorisationof human and veterinary medicinesvia the mutual recognition and decentralised procedures also plan to use OMS data in their Communication and Tracking System (CTS).

For more information on the main areas of change brought in by OMS services, see SPOR data management services high level changes.