Organisation Management Service (OMS)
The European Medicines Agency (EMA) has launched the Organisation Management Service (OMS) to support regulatory activities throughout the European Union (EU).
HumanVeterinaryData on medicines
This content applies to human and veterinary medicines.
The OMS manages one of the four domains of substance, product, organisation and referential (SPOR) master data in pharmaceutical regulatory processes.
You can access the OMS on the SPOR portal via this link:
The SPOR portal is compatible with Internet Explorer (version 10 and above) and Chrome (version 58 and above) web browsers.
The OMS service supports the implementation of ISO IDMP standards in the EU.
What the OMS is for
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 address for 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 may act as marketing authorisation holder in relation to one medicine but as a sponsor or manufacturer for another.
For more information, see:
Scope and expansion of the OMS
The content of the OMS is expanding incrementally. To initially construct the OMS dictionary, EMA used organisation data from five data sources, including the Article 57 (xEVMPD) database and EudraGMDP database.
The following data sets are available in the OMS:
- EU national competent authorities (NCAs)
- marketing authorisation holders (MAHs) for human and veterinary centrally authorised products (CAPs)
- MAHs for human nationally non-centrally authorised products (non-CAPs)
- manufacturers of human and veterinary CAPs and non-CAPs
- marketing authorisation applicants (MAAs) for human and veterinary CAPs
- maximum residue limit (MRL) applicants
- orphan designation organisations (supporting the IRIS platform)
- parallel distributors (supporting the IRIS platform)
- regulatory authorities
- sponsors of human CAPs and non-CAPs
- veterinary MAHs, MAAs for non-CAPs
If necessary, stakeholders may submit change requests for these data sets using the dedicated functionality in the EMA Service Desk.
EMA carries out a data mastering process managed by data stewards who follow a set of business rules and a data quality standard to 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.
EMA is constantly supporting the data integration of other systems using OMS data, identifying and prioritising any other sources of organisation data to include in the OMS in future.
Submitting change requests
EMA encourages users to request any changes needed to organisation data in the OMS using the change request functionality in the EMA Service Desk.
In order to submit a change request, users need an active EMA account with a SPOR user role. For more information, see SPOR user registration.
The first step is to search for and view the full details of an organisation and its locations 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 its location, they can ask to add a new location to the organisation;
- finds both the organisation and its location, but either of these is not 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 documents or 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.
Guidance and training materials
- How to register in SPOR: SPOR user registration
- Key OMS guidance documents available in OMS section of the SPOR portal include:
- A6 - Alternative access solution - guidance on how to submit a change request in EMA Service Desk;
- C – OMS Data Quality standards – Data quality standards applied in OMS;
- D - OMS Controlled Vocabularies - Controlled vocabularies used in OMS;
- E - OMS Change Requests - Rules and Supporting documentation required by change request type.
- Thorough overview of the OMS is available in the recording and presentation from OMS focused event held on 9 October 2024: OMS overview public webinar
Upcoming events and engagement opportunities
Quarterly public webinars
EMA organises public webinars every quarter to share updates on SPOR and XEVMP. These sessions cover the following:
- achievements from past quarter;
- plans for the upcoming quarter and year;
- key highlights for SPOR users.
For information on events featuring SPOR, please search using the keyword ‘SPOR’ in the events section of EMA’s website. There you can find both upcoming and past SPOR events:
Monthly Q&A clinics on Substances, Organisations or Referentials
EMA holds monthly sessions to answer questions on Substances, Organisations or Referentials (S,O,R).
For information on how to register for these sessions, please visit the respective event pages. To find the full list of event pages, use the keywords ‘Q&A clinic on Substance, Organisation, Referentials Management Services’ in the events section of EMA’s website:
Using the OMS for business processes
Using the OMS becomes mandatory when different business processes begin to rely on OMS data. For future integrations, EMA business teams will provide stakeholders with information on process changes and implementation timelines.
Overview of the main business processes relying on OMS data is available in:
Page update history
An update log is available to show the date and summary of changes to this webpage. It does not include updates to linked documents or minor edits like typos or broken link fixes.
The tracking of updates begins in March 2026.
9 March 2026
'Scope and expansion of the OMS', 'Submitting change requests', 'Guidance and training materials', and 'Using the OMS for business processes' sections updated