Referentials Management Service (RMS)

The European Medicines Agency (EMA) launched the Referentials Management Services (RMS) in 2017 to support regulatory activities throughout the European Union (EU).
HumanVeterinaryData on medicines

This content applies to human and veterinary medicines.

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

The RMS service supports the implementation of ISO IDMP standards in the EU.

Access the RMS on the SPOR portal:

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.

This master data is intended to support EU-wide regulatory activities, by enabling stakeholders in the European medicines regulatory network to uniquely identify medicinal products.

The RMS data complies 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. At the time of RMS go live in 2017, EMA migrated existing lists from EUTCT into RMS, except for the substance list which will remain in EUTCT until it is migrated to the SPOR portal. Please use EUTCT for browsing and searching substance data.

Scope of the RMS

The RMS contains over 200 lists of controlled terms, which include:

  • Externally-managed lists: lists owned by external maintenance organisations, e.g. ATC Human and ATC Veterinary (WHO CC), MedDRA (MSSO), pharmaceutical dose forms, routes of administration and units of presentation (EDQM), etc.
  • Internally-managed lists: lists owned by EMA and consumed by different systems (e.g. eAF, IRIS, EudraCT, CTIS, OMS, SMS, PMS, UPD, SIAMED, etc.

EMA can add further lists upon request as long as they are intended for the exchange of medicinal product information.

EMA consolidates the referentials lists into a structured format in one single place, in line with the ISO IDMP standards, where relevant. It acts as data broker, or a 'one-stop shop', and liaises with maintenance organisations and data owners.

Users, including national competent authorities and stakeholders from the pharmaceutical industry, can access the referentials data through the SPOR web portal, or programmatically through the application programming interface (API).

Submitting change requests

Users can request changes or additions to referential data via the EMA Service Desk. 

They can ask for the:

  • creation of new lists or terms;
  • update of existing lists or terms;
  • deletion of terms.

To submit a change request, users need an active EMA account with a SPOR user role. For more information, see SPOR user registration. 

  • In some cases, change requests for referentials need to be submitted directly to the maintenance organisation instead of the EMA Service Desk. For more information on these exceptions and on how to submit a change request through Service Desk, please see  the “A6 – Alternative access solution” document available in the “Documents” section of the SPOR RMS portal.

Guidance and training materials

  • The following  guidance documents are available in the ”Documents” section of the SPOR RMS portal:
    • “F - RMS Web User Manual” – guidance on SPOR services, e.g. searching, exporting data,  translations, etc.
    • “A6 – Alternative access solution” – how to submit a change request in EMA Service Desk)
    • “Z - SPOR User Registration Manual” - how to register for SPOR
    • “Z2 - SPOR User Affiliation Template Letter” - how to register the first industry super user.
  • RMS overview public webinar: visit this event page to access the recording and presentation from this RMS-focused session held on 7 October 2024, providing a thorough overview of the RMS.

Upcoming events and engagement opportunities

SPOR and XEVMPD status update webinar: quarterly public webinars focusing on:

  • achievements from the past quarter;
  • plans for the upcoming quarter and year;
  • key highlights for SPOR users.

To find upcoming or past SPOR events, visit the events page and filter via the keyword 'SPOR'.

S, O, R Q&A clinics: monthly Q&A session to answer questions regarding  Substances, Organisations or Referentials (S,O, R). To participate, please register on the sessions’ event pages:

Using the RMS for business processes

The use of RMS becomes mandatory in the context of different business processes based on when the process begins to rely on the RMS data.

For future integrations, EMA business teams will provide stakeholders with information on any planned process changes and implementation timelines.

The timing of mandatory use may vary between human and veterinary stakeholders, depending on the business processes using the RMS data and their implementation timelines.

Please find an overview of the main business processes relying on RMS data:

Organisation Management Service (OMS) in processes and systems

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 April 2026.

23 April 2026

  • Updates across the page to information and links.

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