Referentials and organisations management services

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This content applies to human and veterinary medicines.

The European Medicines Agency (EMA) has launched the Referentials management service (RMS) and Organisations management service (OMS) to support EU-wide regulatory activities. 

The RMS and OMS manage two of the four domains of substance, product, organisation and referential (SPOR) master data in pharmaceutical regulatory processes. They lay the data foundations for delivering the substance and product data management services

The SPOR services support the implementation of ISO IDMP standards in the European Union (EU). 

Users can access these data services directly online via the SPOR portal. 

Access the RMS and OMS on the SPOR portal using the button below:


Please note:

  • industry stakeholders should not register as new users with SPOR until October 2017 (see 'User registration' below);
  • the SPOR portal is compatible with web browsers Internet Explorer (version 10 and above) and Chrome (version 58 and above);
  • users may experience some service disruption from 17:00 to 18:00 (UK time) each day during June and July 2017, due to IT monitoring activities.

A specialised team of EMA data stewards will oversee the management of data and provide support to stakeholders. 

What the RMS is for

The RMS manages 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.

The RMS brings new and improved functionality over the EUTCT, as explained in the Referentials Management Service (RMS) and Organisations Management Services (OMS) user on-boarding plan

However, since the EUTCT also holds substance lists, it remains available until EMA launches the substance data management service

For more information, see the Referentials management services (RMS) operating model

What the OMS is for

The OMS manages organisation master data, comprising organisation name and location address, for organisations such as marketing authorisation holders, sponsors, regulatory authorities and manufacturers. 

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

For more information, see the Organisations management services (OMS) operating model

Guidance for stakeholders

The launch of the RMS and OMS in June 2017 does not immediately change any regulatory submission processes. 

However, EMA is consulting stakeholders on the benefits of using the SPOR services for different regulatory procedures. This will enable them to support regulatory submissions using systems such as:

The impact of using the SPOR services on individual national competent authorities and pharmaceutical companies will vary depending on the size, infrastructure and complexity of systems and processes in these organisations. 

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

User registration

EMA will invite national competent authorities and industry stakeholders to register their RMS and OMS users, starting with 'super users' who can authorise the registration of further users from the same organisation. 

However, the timetable is different for different stakeholders:

  • National competent authorities:
    • EMA invited national competent authorities to begin registering their super users and to use the RMS from June 2017;
    • these users should only begin using the OMS from October 2017, because it only contains a limited set of data at initial launch. 
  • Industry:
    • EMA will invite industry stakeholders to begin registering their super users and start using the RMS and OMS from October 2017.

For more information see the Referentials Management Service (RMS) and Organisations Management Services (OMS) user on-boarding plan.

User acceptance testing

EMA organised external user acceptance testing of the RMS and OMS in March-April 2017. The exercise was aimed at national competent authorities, terminology maintenance organisations, software vendors, service providers and developers of medicinal product dictionaries/databases. For more information, see the updated SPOR technical and business documents on the SPOR portal.

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Contact point

idmp@ema.europa.eu