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).

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:

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 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:

Organisation Management Services (OMS) operating model

Reference Number: EMA/459105/2016 Version 6 Summary:

Organisation Management Services OMS operating model

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 table below contains information on when EMA will release different data sets into the OMS and when stakeholders may submit change requests for these data sets.

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. 

Data sets	Status of data mastering	Submission of OMS change requests
Marketing authorisation holders (MAHs) for human and veterinary centrally authorised products (CAPs) MAHs for human nationally authorised products (NAPs) Marketing authorisation applicants (MAAs) for human 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	Users may submit 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 registering and updating OMS data on manufacturers, see:

Manufacturer organisations in the OMS dictionary

Reference Number: EMA/465039/2018 Summary:

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?

EMA intends to expand the OMS by 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 prioritisation of releasing these data sets and may identify other sources of organisation data to include in the OMS in future.

Submitting change requests

EMA encourages industry users to request any changes needed to organisation data in the OMS using the change request functionality in the OMS interface.

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.  

For more information, see:

Overview of OMS change request process

Reference Number: EMA/440168/2018 Version 2

OMS Data Quality Standard

• 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 processes begin to rely on OMS data. EMA business 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 supplies 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 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 details manually. 

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

• (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, the IRIS system makes use of OMS data for orphan designation procedures. For more information, see Applying for orphan designation.

Parallel distribution

As of February 2019, the IRIS system makes use of OMS data for parallel distribution notifications. For more information, see Parallel distribution.

Other systems and processes

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

• EU clinical trial portal and database;
• Article 57 (XEVMPD) database.    

National competent authorities involved in the authorisation of human and veterinary medicines via 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 3 Summary:

SPOR data management services high level changes