This content applies to human and veterinary medicines.

The European Medicines Agency (EMA) has launched the Referentials Management Service (RMS) to support regulatory activities throughout the European Union (EU).

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

Access the RMS on the SPOR portal.

 

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

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.

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

The RMS data comply 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. EMA has moved existing lists from EUTCT into RMS, except for substance-related lists which remain in EUTCT until EMA launches the Substances Management Services (SMS). Please use EUTCT only for browsing and downloading substances-related lists.

Scope of the RMS

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

EMA will expand referentials data with lists to support ISO standards for products and substances (ISO 11238 and ISO 11615). EMA can also add further lists upon request.

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 RMS. 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 through the website of the maintenance organisation instead of the RMS portal. For more information on these exceptions, see:

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.

EMA's business teams will provide stakeholders with information in advance, including on 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.

Marketing authorisations, variations and renewals

The RMS already 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, since June 2017.

This enables users to select information supplied directly by these master data services when preparing a regulatory submission.

For more information, see:

Orphan designation

As of June 2018, the IRIS system for orphan designation procedures makes use of a group of RMS controlled terms lists. For more information, see Applying for orphan designation. 

Other systems and processes

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

National competent authorities involved in the authorisation of human and veterinary medicines via the mutual recognition and decentralised procedures also plan to use RMS data in their Communication and Tracking System (CTS). 

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

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