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 OMSon the SPOR portal via this link:
SPOR data management services
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.
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 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:
Organisation Management Services (OMS) operating model
Reference Number: EMA/459105/2016 Version 6Summary: Organisation Management Services OMS operating model
English (EN) (461.54 KB - PDF)
First published: Last updated:
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, 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.
Data sets | Status of data mastering | Submission of OMS change requests |
---|---|---|
Marketing authorisation holders (MAHs) forhuman and veterinary centrally authorised products (CAPs) MAHs forhuman nationally authorised products (NAPs) Marketing authorisation applicants (MAAs) forhuman and veterinary CAPs Maximum residue limit (MRL) applicants EU national competent authorities Regulatory authorities | Complete | Users may submit change requests |
EudraVigilance organisations to support user management | Complete | Users may submit change requests |
Orphan designation organisations (supporting the IRIS system) | Complete | Usersmaysubmit change requests |
Sponsors of human CAPs and NAPs | Complete | Users not yet able to submit change requests |
Manufacturers of human and veterinary CAPs and NAPs | Mastering of manufacturers is ongoing. Target to complete - by the end of Q4 2019 (aligned with CESP dataset module) | Timing of the submission of change requests to be communicated in Q4 2019 |
Parallel distributors (supporting IRIS platform) | Completed | Users may submit change requests |
Veterinary MAHs, MAAs for NAPs | Ongoing | Users may submit change requests |
For information on who is responsible for registeringand updating OMS data onmanufacturers, see:
Manufacturer organisations in the OMS dictionary
Reference Number: EMA/465039/2018Summary: Who in the context of marketing application submissions (applicant, MAH or manufacturer), will be responsible for registration/updating organisation data about manufacturers in the OMS?
English (EN) (416.34 KB - PDF)
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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.
Submitting change requests
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:
Overview of OMS change request process
Reference Number: EMA/440168/2018 Version 2
English (EN) (188.17 KB - PDF)
First published: Last updated:
OMS Data Quality Standard
English (EN) (759.29 KB - PDF)
First published:
- 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 for business processes
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)
Reference Number: EMA/819524/2017 Version 2
English (EN) (458.15 KB - PDF)
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- (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
Reference Number: EMA/551661/2016 version 3Summary: SPOR data management services high level changes
English (EN) (368.77 KB - PDF)
First published: Last updated:
Related content
SPOR user registrationData on medicines (ISO IDMP standards): OverviewSubstance, product, organisation and referential (SPOR) master data
Introduction to OMS services and activities - industry webinar (21/10/2021)
External links
SPOR data management servicesSPOR Learning Module: OMS01 - Overview of OMS (YouTube)EU Electronic Application Forms
Contact point
How can we help? EMA ServiceNow
Topics
Data on medicines