29 November 2016 EMA/412376/2016 Information Management Division

Referentials Management Services RMS operating model

Table of contents 1. Executive summary ................................................................................. 2 2. RMS operating model............................................................................... 2 2.1. Key features and benefits of the RMS operating model .............................................. 3

3. RMS process in the regulatory context .................................................... 4 3.1. NCA synchronisation with RMS ............................................................................... 4 3.2. Industry submission of regulatory applications and pre-registration of Referentials data 5

4. RMS user process .................................................................................... 6 4.1. Provisional Terms ................................................................................................. 7

5. RMS business process particulars ............................................................ 7 6. Referentials List release plan .................................................................. 8 7. Implementation of the RMS operating model .......................................... 9

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1. Executive summary This document is intended to provide both guidance and information for stakeholders who are supporting the implementation of SPOR and for all stakeholders who will be using SPOR data management services. Referential data is the data used to categorise other data within applications and databases. It is usually referred to as look-up, controlled vocabularies, dictionaries, lists or domain values. Typical examples of referential data are pharmaceutical forms, countries, units of measurement, routes of administration, etc. Referentials Management Services (RMS) is one of the first projects to be delivered as part of the phased implementation of SPOR data management services and a key enabler for the implementation of ISO IDMP in the EU. The scope of RMS is to provide a single source of referential data to be used in support of the EU Regulatory Network and pharmaceutical industry, with consistent mechanisms to update and consume Referentials Lists. The key to the delivery of RMS will be the RMS operating model (common process) and range of business services to support it. Referentials data, which is comprised of Referentials Lists and Terms, will support ISO standard 11239 (pharmaceutical dose forms, units of presentation, routes of administration and packaging) and ISO standard 11240 (units of measurement) as well as additional controlled vocabularies needed for the creation of messages for ISO standards 11615 (medicinal products) and 11238 (substances). These Lists and Terms will be available through a web user interface and via an Application Programming Interface (API).

2. RMS operating model Regulators and industry require access to Referentials Lists for core regulatory procedures and submissions. Today, the management of Referentials data is rather complex with over a hundred different reference dictionaries or Lists maintained by different data owners (e.g. EDQM, BfArM, ISO, MSSO). In addition, regulators and industry currently use reference Lists in various different formats, that change throughout the year as new versions are issued, and must adhere to different change request forms, change request processes and associated service level agreements (SLAs) to update or register new Terms. The RMS operating model will deliver a centralised and single source of Referentials master data. A range of business services will enable more consistent and effective management of this data through common processes and exchange formats. Central to the RMS operating model is EMA’s role as data broker, liaising with maintenance organisations and data owners to consolidate Referentials Lists into a single place and in a common format. EMA will also provide data management services that will enable regulators and industry to adopt a common process for accessing, updating and (for NCAs only) translating Referentials data (this is not an exhaustive list of services) for their regulatory submissions. This will improve the efficiency and consistency of the management of Referentials data across the EU network. The diagram below (Figure 1. sets out the relationships between the participant organisations within the RMS operating model.

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Figure 1. RMS stakeholder interactions

*EMA will be the maintenance organisation for ‘units of measurement’ until BfArM can fully maintain it

2.1. Key features and benefits of the RMS operating model The RMS operating model comprises a number of key features, agreed with all stakeholders, which include: 

EMA will act as the broker to provide Referentials data management services to the EU network (please see Section 5 and Figure 4 for exceptions). EMA data stewards will maintain Referentials data and will make it available in a structured format and, where relevant, in line with ISO IDMP standards;



EMA will host Reference Lists from different maintenance organisations (WHO, EDQM, MSSO, BfArM, etc). EMA will be the maintenance organisation for new Lists where no maintenance organisation currently exists. (The process for introducing new Lists to RMS, usually as a result of the introduction of new Telematics systems, entails stricter change control and is detailed in the user manual held within RMS);



The RMS system will be accessible to stakeholders through a web portal and via an API. This will enable them to access Referentials data management services, to request changes to existing RMS data or to request inclusion of new data;



EMA will provide a common process which requires industry and other parties to request preregistration of new Terms or updating of existing Terms in the RMS system before submitting any regulatory application to the relevant NCA (NOTE: This pre-registration is already enforced in some

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procedures, for example, eAF. At present, if the Term is not on the eAF, it will need to be requested via email before the eAF can be submitted); 

Once Terms are pre-registered there should be no further need for checking the Terms by industry or NCAs. NCAs and industry can focus on applications without undertaking validation of Referentials data against RMS. EMA will undertake a data quality check upon pre-registration of new Terms or updating of existing Terms. For example, for Terms owned by EDQM, EMA will liaise with EDQM to validate changes and for ATC codes EMA will check the WHO website to validate the Terms;

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All translations of Terms will be undertaken by NCAs only. Functionality to translate List names will not be provided;

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All organisations will need to register legacy and national specific Terms with EMA that are within the scope of post-authorisation procedures. The registration of legacy Terms cannot be undertaken in bulk; they will need to be registered one by one.

3. RMS process in the regulatory context Diagram below summarises at a high level the activities undertaken by industry, NCAs and EMA specifically focusing on the NCA synchronisation with RMS, industry submission of regulatory applications and pre-registration of Referentials data. Figure 2. RMS process in the regulatory context

3.1. NCA synchronisation with RMS Note: Describes Step A on Figure 2

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

In the new operating model, NCAs will need to maintain mappings within their databases with the corresponding EMA Referentials data held in RMS;



NCAs will undertake data mapping of their local source data against SPOR data in order to enable ongoing alignment of data with RMS. Following RMS go-live, NCAs will submit to EMA the necessary change request(s) to add new Terms and update existing Terms to ensure the Referentials Lists in RMS accurately reflect their local data. Change requests can be submitted manually or programmatically;



EMA will process these requests and publish updated/new data in the Referentials Lists and will confirm to NCAs once the Lists are updated.

EMA can also act in a way similar to NCAs in relation to Centralised Authorisation Procedures (CAPs) in that they can process applications and request changes to Terms.

3.2. Industry submission of regulatory applications and pre-registration of Referentials data Note: Refer to Steps B and C on Figure 2 

When there is a need to update data in RMS, industry will pre-register a new Term or request an update to existing Terms in the RMS system before submitting a regulatory application to NCAs, by submitting a change request;



EMA will process these requests and publish updated/new data in the Referentials Lists and will confirm to industry once the Lists are updated;

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Only after EMA confirms that the Referentials Lists have been updated should industry submit a regulatory application form with the updated/new Referentials data to NCAs;

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NCAs will process the regulatory application form and confirm the outcome of the application to industry: 

Please note that NCAs will be able to process applications without the need to validate Referentials data against RMS (as long as the Referentials data feeding through to the application form is from a List that is available in RMS at that time: Not all Lists will be integrated into RMS at go-live; Lists will gradually be added over time). This is because EMA will undertake a data quality check upon pre-registration of new Terms or updating of existing Terms. For example, for Terms owned by EDQM, EMA will liaise with EDQM to validate changes and for ATC codes EMA will check the WHO website to validate the Terms;



Should an NCA disagree with a Term as used by industry, they should ask industry to update the Referentials List before re-submitting the regulatory application with the correct Term;



While NCAs can request new Terms and updates to Terms on behalf of industry, NCAs are encouraged to advise industry to make these requests as this will simplify NCA processes in the longer term.



Information relating to service level agreements will be shared separately.

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4. RMS user process Figure 3 illustrates the steps a user should follow when using Referentials data in regulatory applications. While this example refers to eAF, the process is generic to all regulatory applications and can be applied to other systems that may integrate with RMS in the future e.g. CESSP, CT Portal. Figure 3. RMS user process

When preparing the regulatory application form (in this example, the eAF) industry will need to check the Referentials data in the form to see if it is correctly reflected in RMS: Referential Term does not appear on eAF or is incorrect 

If the Referential Term required does not appear as an option in the eAF form, the industry user will need to access the RMS system to submit a change request to EMA in order to pre-register new Referential Terms;

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If the Referential Term does appear in the eAF form but is incorrect, the industry user will need to access the RMS system to submit a change request to EMA to update the Referential data;

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EMA will process the change request and confirm to industry when the Terms have been registered or updated and published in the relevant Referentials List;

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

The refreshed data in the updated Referentials List will automatically be pulled into eAF;

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Once EMA confirms the updates have been processed in RMS, industry can select the correct Terms in the eAF to complete and submit the regulatory application to NCAs via eAF.

Referential Term appears in eAF form and is correct 

If the required Referential Terms are available in the eAF form, industry can select the Terms in the eAF to complete and submit the regulatory application to NCAs.

Please note that information relating to service level agreements will be shared separately.

4.1. Provisional Terms There may be some instances where NCAs/industry can view a new Term in the eAF which does not yet appear either in NCAs’ Lists or on the maintenance organisation websites but has been created in RMS. These are ’provisional Terms’ which are currently being processed by EMA in conjunction with the relevant maintenance organisation. Any such new Terms which appear on the eAF (but not elsewhere) only appear on the eAF following validation by EMA and therefore do not require NCAs to undertake a validation process for the new Term. 

It is likely that EMA will be working with the maintenance organisations to either provide them with details they require to process the Term and/or review confirmation letters to ensure the Term has been approved and is pending publication only.

5. RMS business process particulars This section summarises exceptions where access to/changes to Referentials data are not possible via RMS but must be done via the website of the maintenance organisation itself. Making changes to Terms/Referentials Lists varies according to who is the maintenance organisation. Specifically, where EMA is the maintenance organisation, industry and NCAs can access and request changes to Referentials Terms via RMS. Where EMA is not the maintenance organisation, there are some exceptions in how to request changes to Referentials Terms: NCAs 

Can fully download and access all Lists available in RMS;



Can request changes to any Lists/Terms via RMS (except for changes to MSSO Terms, for which requests need to be sent direct to MSSO). The envisaged process is that NCAs will request changes for legacy Terms and new requests will come from industry;



NCA translators will receive RMS prompts to enter translations for relevant Lists;

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

To enter translations for other Lists not maintained by EMA, NCAs will need to go through their usual external processes. For example, for EDQM Terms, NCAs will need to follow the EDQM Standard Terms Working Party process to enter translations to Terms owned by EDQM. 

EDQM has agreed that EMA can create provisional Terms in the English language for Terms/Lists maintained by EDQM (to enable EMA to progress their work). However, EMA cannot accept requests for translations (provisional or otherwise) into other languages for EDQM Terms. Such translations will come centrally from EDQM as they wish to retain control for translations of Referentials Lists that they maintain.

Industry 

Can fully download and access Lists, pre-register and make change requests for new and updated Terms/Lists via RMS for EUTCT, EDQM and BfArM Terms/Lists;



For WHO/MSSO, industry can browse via RMS but will need to go directly to the maintenance organisation websites to download Lists and request changes to existing Terms or register new Terms.

Figure 4. RMS business process particulars

6. Referentials List release plan Referentials data will become available in RMS in phases over time. At go-live, the following Lists will be published:

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

Lists from EUTCT (e.g. shelf life type, target species);

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New Lists to support OMS (e.g. party classification);

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New Lists to support PMS (e.g. material);

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Updated Lists for ISO 11239 (pharmaceutical dose form, routes of administration and packaging) and 11240 (units of measurement) - (these Lists exist today in EUTCT in a very flat structure and at go live they will be structured with full ISO data elements).

Referentials data will subsequently be expanded with Lists to support ISO standards for products and substances: ISO 11238 – Referential data to support substance registration and ISO 11615 – Referential data to support products. Further Lists can also be added in the future upon request. EMA will notify industry, NCAs and other stakeholders when new Lists are published in RMS, after which change requests for those Lists can be submitted. Stakeholders should submit change requests in RMS for Referentials data only after it has been published in RMS and not before.

7. Implementation of the RMS operating model EMA will deliver SPOR data services through the phased implementation of SPOR. SPOR will be the home of an EU-wide source of validated data that can be re-used by EMA, NCAs and industry in support of regulatory activities (e.g. Pharmacovigilance, marketing applications or clinical trials) across the product lifecycle, for products that are regulated in the EU. SPOR services will be enforced when they become mandatory in given regulatory business process, for example industry submission of products to support Pharmacovigilance activities (human), industry submission of applications (human and veterinary). The enforcement may vary between Human and Veterinary stakeholders according to the implementation timescales and integration with other solutions. At RMS go-live, submission processes will continue as before and there will be no immediate process changes for stakeholders. Some changes in the current submission processes are being explored and consultation is taking place with stakeholders on these. More information will be provided in due course to explain any applicable process changes and timings.

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