EMA London Building

On-boarding of users to SPOR data services (updated document)

EMA Update Document

02 October 2018 version 2
Information Management Division

On-boarding of users to SPOR data services  (document published (02 October 2018 version 2))

In a Nutshell:

RMS and OMS data services were open to industry stakeholders in December 2017. Stakeholders were invited to start registering their SPOR users. As of today we have 604 Registered Industry Super Users and 336 Industry Users.

The registration of SPOR users is predominantly driven by the business process using the referential and/or organisation master data. The organisation in question should decide, depending on their circumstances (e.g. business process using the master data, organisational structures, etc.), how many users they need to register in SPOR.
This document starts with a brief introduction to the type of SPOR roles users can request, highlighting the role of the Super User and what companies should take into consideration when setting up user populations. The scenarios provided in this document may help you to consider the best options for your organisations.

Dieter Schlaps, ITCLS

Masterdata Management for IDMP – How to keep SPOR OMS and Internal Systems in Sync?

By Dieter Schlaps for IDMP1-News October 2018

Introduction to Masterdata Management IDMP SPOR OMS Sync

The spectrum of possible IDMP solution architectures ranges from web-tool, “EVWeb”-type solutions where (a potentially huge amount of) data will have to be entered manually to large-scale integrated solutions which include “Master Data Management” components to extract, transform and load data from source systems for IDMP submissions.

IDMP Solution Architectures

Figure 1: Range of IDMP Solution Architectures; from left to right:
Web-tool based solution, RIMS[1]-centered (or also “integral”) solution, RIMS with separate IDMP submission tool and Master Data Management based solution

As the European Medicines Agency (EMA) is implementing the SPOR (Substances-Products-Organisations-Referentials) databases, Master Data Management (MDM) based approaches are gaining much more attention, as MDM-based systems would already provide functionalities and tools to cope with the growth and changes of SPOR’s OMS-, RMS-, PMS- and SMS-databases[2].

This newsletter looks specifically at the Masterdata Management IDMP SPOR OMS Sync, i.e. Marketing Authorization Holders (MAHs), Marketing Authorization Applicants (MAA), Clinical Trial Sponsors (CTS) and Contract Manufacturer Organisations (CMOs). It shows whether and how Master Data Management can support the management of the address data and company information associated with these organisations that are used in the context of regulatory submissions and what the challenges are.

  1. The Organisation Management System (OMS) of EMA’s SPOR System

When EMA published its roadmap (in April 2015) towards her vision of an integrated Masterdata Management System that would manage pharmaceutical data about Substances, Products, Organisations and Referentials (“SPOR”) and would not only become the basis of Europe’s future IDMP implementation, but would also include a revision of the current EMA portfolio of systems and databases (e.g. EUDRAGMPD).

The targets of the Masterdata Management IDMP SPOR OMS Sync implementation were defined as follows:

  • Implement an integrated and harmonised MDM solution which will deliver standards compliant master data for Substances, Products, Organisations and Referentials (SPOR).
  • Data will be collected, managed and made available to the network, industry and wider stakeholder community, in compliance with legislative requirements and relevant standards for privacy, data protection and security.
  • Implement a new portfolio of services which will be supported by standardised data governance and lifecycle management.
  • Maximise the benefits realised throughout the implementation of the roadmap by involving and engaging effectively with stakeholders, leading to operating model simplification and efficiency improvements.

Through the SPOR Masterdata Management Solution, especially the “Organisations”, “Referentials” and “Substances” modules, EMA intends to collect basic data about the Organisations (Marketing Authorisation Holders (MAH), Marketing Application Applicants (MAA), Contract Manufacturers (CMO) and Clinical Trial Sponsor (CTS) Organisations) and Substances in order to provide unique IDs for these entities that shall be used in the IDMP submissions (“Products” module) to follow later in the five iterations. The “Referentials” module shall provide the controlled vocabularies that are needed in each iteration for the description of the products.

Today, SPOR OMS is live and contains approximately 5,700 organisations with a total of 48,318 location data records. Each record contains at least the English language version of the address, plus GPS coordinates and sometimes address data also in other local languages. The vast majority of these organisations are pharmaceutical companies (99% resp. 5,625 organisations), but there are also 52 EEA and 4 non-EEA Regulatory Authorities, plus 11 other industry organisations.

The following table shows where the organisations are located: Approximately 13.68% (779) are located in the United Kingdom and approx. 11.75% in Germany (669); the shares of the each of the other countries are lower than 10%. Indian, Chinese and US companies are obviously underrepresented currently with only 0.3%, 0.02% and 2,35%, respectively.

Table 1: Listing of countries where OMS organisation are located

When a product submission is to be carried out, then it must refer to the OrganisationID as well as the LocationID given in the OMS for the MAH, MAA, CTS or the CMO companies, as is described above. If there is no data available, or the data is incomplete or wrong, the MAH has to request a corresponding OMS data change (which may take some time…).

Therefore, to avoid any delays in the submission process, the MAH has to make sure, that all the organisations (manufacturers, MAH, MAA; CTS) that are referred to in the product documentation/ dossier are already available in the OMS system long before the product is to be submitted and that the data are correct!

  1. How to Align Internal and External Organisation Databases

Assuming that an hypothetical MAH company uses a RIMS system to collect the data about products that are to be/ have been submitted and registered world-wide, and an internal company database, within which the data about the worldwide sites of the MAH company are kept, the process to synchronise the organisation data that resides in RIMS and/or the Organisaton Database looks very much like the sketch in the following figure:

Synchronisation of organisations external with internal data

Figure 1: Synchronization of Organisation between internal and the OMS system with the process flows for the registration of a new MAH company site (I) or adding a new external manufacturer/CMO (II)

  • When a newly founded site of the MAH’s company is to be included, e.g. as a manufacturer for a product or as a MAH/MAA, then the internal Organisation Database should first contain the details about that site, especially the address information. Therefore the Internal OrgDB is “the source of truth”, and the IDMP Office which coordinates the MAHs IDMP data maintenance activities has to make sure that the new site is entered into OMS as new organisation/location. The Organisation ID/ Location ID is to be retrieved and to be stored in the Internal systems (Internal OrgDB and RIMS).
  • When within the product dossier, specifically in module 3.2.P.3.1 – the Manufacturers document – a new (external) Contract Manufacturer is listed, then it needs to be located in EMA’s OMS system. The address details described there need to be verified against the dossier document, and, when the data is correct, the Organisation and Location Ids of the organisation should be entered into the RIMS system (and eventually other internal systems where the data about external manufacturing partners are kept…).
    So, in this case, the OMS system is “the source of truth”, and the internal systems “only” refer to that OMS data record.
    Should the CMO not be available in OMS, the MAH needs o request the addition of the CMO company, providing documented evidence about the respective CMO, e.g. a copy of the companies’ registration record, a copy of the Manufacturing or GMP license.
  1. The Potential Role of Masterdata Management IDMP SPOR OMS Sync in the Alignment of Internal and External Systems

When the number of organisations are low (< 50), the processes as described in the previous chapter might still be managed “manually”, e.g. combining and analysing periodical reports as well as change notifications from the internal and external systems, e.g. using Excel. But when the number of companies to be handled exceeds 150, or there is a large base of product registrations with distributed product responsibilities (and a large pool of RIMS users), then a more sophisticated solution will be needed.

Commercially available Master Data Management (MDM) systems are made to handle situations like these. The following abilities and features qualify MDM systems to be used for the purpose of organisation data synchronisation between the internal systems (RIMS and Internal OrgDB) with the external systems (SPOR-OMS, RMS etc.):

  • Carry out comparisons between organisations stored in internal and external systems, by comparing company names and address details, using exact and fuzzy matching.
  • Set up rules to accept or to reject a match based on the measures of similarity, with the option to define “acceptable” and “non-acceptable” deviations.
  • Keep an MDM internal list of the matching data tuples from internal and external systems.
  • Define workflows, roles and permissions to handle deviations, e.g. to correct a data error in an internal system, to request a missing CMO or MAH in OMS.
  • Use interfaces to directly access the internal and the SPOR OMS systems via APIs.
  • Set up recurring processes to look for changes in the internal and external systems that require updates in OMS or the internal systems.
    accept and handle notifications coming from internal and/or external systems making aware of a change in the data records stored in the respective system(s).
    start workflows to handle the detected discrepencies and/or deviations.
  • Allow to track the progress of the handling of deviations, completed and open tasks throughout the enterprise.

Besides these features the MDM solution also must allow to handle different regulatory environments, i.e. the European scenario including SPOR, but also an upcoming US scenario and other regions where other external databases (Dun and Bradstreet Database (DUNS)?) will or could be used as reference databases.
In the interest of better product data quality and reduced compliance risks, it probably is wise to implement the process of Organisation Management with a worldwide perspective and these other, non-European scenarios in the minds from the beginning.

  1. Conclusions and Outlook to the Masterdata Management IDMP SPOR OMS Sync

In the preparation for the upcoming IDMP standard a company needs to understand which internal and external data stores are be the sources-of-truth that shall be used for IDMP submissions. Once the sources are identified, a data governance process needs to be set up that includes the nomination of an IDMP office and the implementation technology tools, e.g. Master Data Management, in order to guarantee completeness and correctness data throughout the product’s lifecycle. When e.g. organisation data is missing or incorrect at the time of submission, it may mean that the IDMP product data record cannot be submitted technically or will be rejected as being incomplete. As this may result in a delay of the go-to-market of a new product, very significant financial losses might occur.


[1] RIMS: Regulatory Information Management System

[2] RMS: Referentials Management System, OMS: Organisations Management System, PMS: Products Management System and SMS: Substance Management System

EMA London Building

Organisation Management Services (OMS) Update (August 2018)

Overview of OMS Change Request Process (updated)

16 August 2018
Information Management Division

This document is intended to provide both guidance and information for stakeholders who are supporting the implementation of the SPOR programme and for all stakeholders who are using OMS
data services. The information here applies to both human and veterinary stakeholders; however, there may be different impacts experienced by industry stakeholders and regulatory bodies (mainly NCAs).

OMS data services opened to stakeholders in December 2017. They were invited to start registering their SPOR users and to begin requesting changes and additions to the organisation data content. Since the launch, the uptake of OMS has been very good, with over a thousand change requests submitted in the first six months. OMS change requests are one of the key aspects of the service. They enable the creation of a new organisation, the addition of a location or updating of an existing organisation and/or locaton data. The process itself is simple and consists of three steps: submission, validation and approval.


OMS Operating Model (updated)

21 August 2018
EMA/459105/2016 version 5
Information Management Division

This document is intended to provide both guidance and information for stakeholders who are supporting the implementation of the SPOR programme and for all stakeholders who will be using RMS data management services. The information applies to both human and veterinary stakeholders; however, there may be different impacts experienced by NCAs and industry stakeholders.

In the OMS operating model, the stakeholders, new process and functional capabilities are the key components to ensure delivery of the service. This document describes the range of services available for stakeholders to use, the process to register organisation data or request data updates. It also outlines stakeholder interactions and identifies roles. The high-level concept of the OMS Operating Model is shown in Figure 1 below.


Dieter Schlaps, ITCLS

Text Mining for IDMP – Kill or Cure?

EMA London Building

Brexit Drug Supply

Brexit Drug Supply

Brexit – is the after Brexit drug supply in Europe at risk?

The German Federal Association of Pharmaceutical Manufacturers (BAH) sees the Brexit drug supply in Europe at risk, when Britain leaves the EU on the 29.3.2019. Neither the UK itself nor the EU, in the opinion of the BAH, are well enough prepared. Accordingly, one of the tasks of the industry,  is therefore to check whether their approval processes are currently underway with the participation of Great Britain.

So “who” and “what” in the Brexit drug supply is affected and “in which way”?

Quelle Bild: EMA Survey to industry – key figures

Source image: EMA Survey to industry – key figures 

EMA moving to Amsterdam

One of the consequences of the Brexit is that the EMA will relocate to Amsterdam, Netherlands, where it will be operational by 30 March 2019 at the latest. The move is connected to a new building in Amsterdam and follows a tight schedule. Find here the milestones that the EMA has set itself for this project and the current status.


Source image: EMA Relocation to Amsterdam Main milestones

Brexit preparedness: EMA to further temporarily scale back and suspend activities

Next phase of business continuity plan aimed at securing essential public and animal health activities

The EMA will launch the next phase of its business continuity plan on 1 October 2018. This will allow the Agency to safeguard core activities related to the evaluation and supervision of medicines, while it has to intensify its preparations for the physical move to Amsterdam in March 2019 and cope with significant staff loss. The temporary cuts in activities are required because it has also become clear that the Agency will lose more staff than initially anticipated. Staff who will not relocate to Amsterdam have already started to leave the Agency and this trend is expected to ccelerate.

In addition, due to the employment rules in the Netherlands, 135 short-term contract staff will no longer be able to work for EMA. Overall, EMA expects a staff loss of about 30%, with a high degree of uncertainty regarding mid-term staff retention.

Authorisation holder of national approved human medicinal products

Subject to any transitional arrangements that may be included in a possible withdrawal agreement, the EU rules on medicinal products for human use and veterinary medicinal products are no longer applicable to the UK after Brexit. In particular, this has the following consequences in the different areas of EU pharmaceutical legislation:

EU law requires that license holders be established in the EU (or in the EEA);
Some activities have to be carried out in the EU (or in the EEA), e.g. Pharmacovigilance, batch release, etc .;
In a note from the European Medicines Agency (EMA), the EMA warned license holders to respond far in advance and proactively in order to avoid drug implications.

Authorisation Holder of centrally approved medicinal products

The EMA has made the necessary changes in the processes of centrally authorised medicines in a list of questions and answers (Q & A) on the topic. You can download the Q & A list here.

Overview of concerned MAH and Admission Processes

Industry survey

EMA carried out a Brexit-preparedness survey in 2018 to gather information from marketing authorisation holders for centrally authorised products on their plans to update their marketing authorisations in preparation for Brexit.

The main objective was to to gather information on the timelines for submission of the necessary regulatory changes and identify any centrally authorised products potentially at risk of supply shortages.

EMA sent the survey to marketing authorisation holders of 694 centrally authorised products (661 human and 33 veterinary products) either located in the UK or with an important step in their regulatory processes in the UK, such as quality control, batch release and/or import manufacturing sites, QPPV and pharmacovigilance system master file (PSMF).

According to EU law, the marketing authorisation holder, the QPPV, the PSMF and certain manufacturing sites need to be based in the EEA for a company to be able to market a medicine in the EU.

The companies analysed were based in the United Kingdom (UK) or perform the following functions in the UK:

  • headquarters
  • manufacturing
  • quality control
    Batch Release
  • import
  • Master file of the pharmacovigilance system (PSMF)

It is strongly recommended that pharmaceutical companies affected by the Brexit report the necessary changes to maintain EMA approval as early as possible and no later than the end of the fourth quarter of 2018 to ensure timely processing.



Dieter Schlaps, ITCLS

SMS, G-SRS, GINAS, EU-SRS Current Status July 2018

SMS, G-SRS, GINAS, EU-SRS Current Status of the IDMP Substance Submodel Implementations in Europe and the US

By Dieter Schlaps for IDMP1-News July 2018

The SMS, G-SRS, GINAS, EU-SRS Current Status as of July 2018 is beeing summarised in this blog article.

FDA’s G-SRS System

In FDA2‘s G-SRS1 system, the substance is registered per type, as defined in the IDMP4 standard (e.g. chemicals, proteins, polymers, structurally diverse, nucleic acid, etc.) and then, certain criteria apply to distinguish substances in each category from one another (e.g., chemical structure, DNA sequence etc.). When enough information is available and validated, a substance is assigned a unique identification (UNII- Unique Ingredient Identifier) code, which can be used as a quick way to refer to that substance in the future. Until the UNII code is defined, the substance exists in G-SRS as a “concept”.

In last week’s GINAS[1] meeting, FDA[2]‘s and NCATS[3]‘ teams reported about the current status of FDA’s implementation of the IDMP[4] substance standard [1], and, indeed, a lot has been achieved:

  • The final versions of the ISO Standard 11238 on Substances (https://www.iso.org/standard/69697.html ) and its Implementation Guideline 19844 (https://www.iso.org/standard/71965.html ) with all annexes are published in this month (July 2018)
  • Version 2.2 of G-SRS is now in productive use at the FDA
  • The version 2.2 of the public G-SRS will be released in a few weeks, watch website https://tripod.nih.gov/ginas/#/.
  • The currently available version 2.1 of the public G-SRS already hosts more than 100.000 substances and concepts.
  • Programmatic communication with the G-SRS database is possible through the GINAS RESTful[5] API[6] (https://tripod.nih.gov/ginas/#/gsrs/api ), allowing substance searching, registration, browsing, updating. Figure 1 shows and example that downloads substances with all details in a simple query.
  • Version 2.2 allows individual configuration by the registered user, e.g. which properties of a substance and which substance types are to be listed in the G-SRS views.
  • With version 2.2, G-SRS has become more modular and more extendable than previously, which also should make interfacing and synchronization with other substance databases easier.
  • For the production versions, from now on FDA will only support UNIX-based platforms, however. But Windows-based systems will be available for test and/or development environments.
    At the same time, interested parties, that would be interested to develop and maintain a Windows-based G-SRS are welcome and should contact FDA’s GINAS team.
G-SRS API Example
Figure 1: G-SRS API: Example Download of substance details in JSON format. The URL <uri>https://ginas.ncats.nih.gov/ginas/app/api/v1/substances?view=full</uri> retrieves the full data of the first ten substances as a single JSON file.

The following figure shows a screenshot of FDA’s internal G-SRS system, that links information about the product, its registrations and the substance information in a common interface.

FDA Internal G-SRS API
Figure 2: FDA’s internal G-SRS System, where product registration information is linked to IDMP substance information ([1])

An updated G-SRS data set will be available end of July.

For versions 2.3ff. FDA now plans to address the following topics [1]:

  • Inclusion of Orphan Drug Application Codes, indications and other product-related information
  • Develop modules for Specified Substance Groups 2-4
  • Start entering Specified Substance Group 1[7] information
  • Continue to develop better forms and presentation of data
  • Expand quality (impurities) and pharmacology (targets, metabolite, cyp and transporter information)
  • Deploy full instances with all public data at Open FDA and NLM
  • Establish mechanism for system-system communication
  • Integrate G-SRS into a clinical trial registry system (C-DISC)

European Activities around SMS and EU-SRS

The following activities concerning the SMS, G-SRS, GINAS, EU-SRS Current Status are carried out in Europe:

Substance Pilots to assess the validity of Article 57 substances and carry out mappings to G-SRS:

In Europe with the (IDMP-non-compliant) substance information being available in Article 57 database, there is first-of-all the need to map these information into the IDMP data model, to clean-up the data and then to match it against the G-SRS system.

The following figure shows how the EMA team led by Dr. Herman Diederik (Medicines Evaluation Board, Amsterdam, Netherlands) is carrying out this challenging task:

Substance Mapping XEVMPD to G-SRS
Figure 3: Substance mapping from xEVMPD/ Article 57 to G-SRS ([1])

Business Case and Implementation of a European Substance Registration System (EU-SRS)

The business case that was presented to the 92nd Heads of Medicines Agencies (HMA) (19 – 21 June 2018, Sofia, Bulgaria) describes why an IDMP-compliant Substance Management System is regarded indispensable for a successful implementation of SPOR, the European Framework for IDMP. Without unique identification and reliable characterization of substances used in product compositions, extensive additional efforts will be continuously be spent to check, correct and communicate substance data provided by industry to regulatory agencies.

The data lists that are used today for the selection of the substances and/or the declaration of strength for product composition in electronic Application Form (eAF), as currently provided by EUTCT / EudraVigilance are highly error-prone and not unambiguous.

At last, the HMA meeting endorsed the business case which now allows to start the EU-SRS project.

The Dutch Medicines Evaluation Board will lead the implementation of EU-SRS.

European Substances Validation Group (SVG)

The HMA meeting also endorsed the establishment of the European Substances Validation Group (SVG), which will assemble European (NCA/EMA) substance experts that will govern the contents and enable Europe-wide use of substance information, and it also endorsed the full cleansing of the current substances list to a baseline of quality that supports the required processes.

The role of SMS vs. EU-SRS

The Substance Management Service (SMS) within SPOR will be the “substance list” that is to be used when substances are to be selected for an electronic submission. It will hold a key set of fields on substances for use in related regulatory use cases (SPOR). In contrast to SMS, EU-SRS will support unique identification of substances using a more extensive data model, validation rules as well as validated content. EU-SRS will generate the final identifier to the substance and will distribute this to SMS for use in regulatory processes.

EU-SRS will also be the primary tool for the SVG and will enable alignment and synchronization with the FDA substance system (G-SRS) to allow for maximal re-use of already characterized substances. [2]

Conclusion and Outlook to the SMS, G-SRS, GINAS, EU-SRS Current Status

In the first half year of 2018 there has been significant progress in IDMP substance management activities around the globe:

The IDMP standard and implementation guidelines for Substances 11238 and 19844 are in process of being published by the International Standards Organisation (ISO), FDA has made some significant achievements in the implementation of their G-SRS system and EMA has now finally endorsed a project to establish Europe’s first IDMP-compatible Substance Management System (EU-SRS).

The implementation of EU-SRS will last probably one year or more, but will ultimately lead to a better and more effective regulatory decision making in the Network, from which patients, regulators and industry will profit.


[1]  Overview of ISO IDMP, Substances and HL7 Patient Care WG (allergy-intolerance)
Joint HL7 Biomedical Research & Regulation WG and Patient Care WG Meeting, May 10, Madrid, Spain
Panagiotis Telonis (EMA), Christian Hay (ISO/GS1), Herman Diederik (EMA/CBG),
Larry Callahan (FDA), Frank Switzer (FDA), Tyler Peryea (NCATS/NIH), Noel Southall
(NCATS/NIH). Link: http://wiki.hl7.org/images/2/2d/PT_CH_LC_HD_IDMP_HL7_Joint_BRR-PC_May_2017.pdf [2]  Business case for implementation of EU-SRS – IDMP compliant substance management.
92nd Meeting of Heads of Medicines Agencies (HMA) (19 – 21 June 2018, Sofia, Bulgaria)


[1] GINAS is the project name of FDA’s substance database project and stood originally for “Global Ingredient Archiving System”. The system’s name name has been changed in the meantime into G-SRS, “Global Substance Registration System”, but the old project name is still in use.

[2] FDA: Food and Drug Administration

[3] NCATS: National Center for Advancing Translational Sciences

[4] IDMP: ISO Standard for the Identification of Medicinal Products

[5] RESTful: The REST (“Representational State Transfer”) architecture has been defined to allow “stateless” machine-to-machine communication between clients and web-based applications. “Stateless” means that all information that is needed to conclude the API request must be contained in the url (“uniform resource locator”) string. Methods like “GET”, “PUT”, “POST” etc. are provided by G-SRS for that purpose. The web application therefore does only need minimum access rights management and no further session management due to its stateless character.

[6] API: Application Program Interface – Set of functions for communication and data exchange with the G-SRS database

[7] IDMP Group 1 Specified Substances are multiple substance materials (Coatings, Colorants, Flavorants); Physical Form; Extracts

IDMP events

Ginas Meeting June 27th 2018 – Agenda and Webex

Ginas Meeting June 27th 2018 – Agenda and Webex

Reminder the next Ginas Meeting June 27th 2018. This meeting is fully public and anyone is welcome to attend. Please forward this meeting invite to any interested parties.

Here is the agenda:
• Status update of GSRS 2.2 release and what is planned in 2.3 release (Danny Katzel and Tyler Peryea)
• Windows support of GSRS (Danny Katzel and Tyler Peryea)
• Public data version of FDA-GSRS (Larry Callahan and Frank Switzer)
• Current situation of the EU-SRS project. (Frits Stulp)
• Discussion of current examples in the NCATS-SRS cloud. (Herman Diederik)
• Proposals of integration SSG2 and SSG3 ISO models for use in FDA-EU-SRS. (Herman Diederik)
Webex details below:
You can forward this invitation to others.

Starting Time

GSRS June Meeting
Wednesday, June 27, 2018
10:00 am | Eastern Daylight Time (New York, GMT-04:00) | 2 hrs

Meeting number (access code): 626 326 294

Meeting password: Js525YBA

When it’s time, join the meeting.


IMPORTANT NOTICE: Please note that this WebEx service allows audio and other information sent during the session to be recorded, which may be discoverable in a legal matter. By joining this session, you automatically consent to such recordings. If you do not consent to being recorded, discuss your concerns with the host or do not join the session.

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EMA Webinar Using OMS data in eAF (14.6.2018) Download

Using OMS data in eAF

(EMA SPOR webinar, 14 June 2018)


  1. About OMS
  2. Using OMS in eAF/CESP
  3. Submission of OMS Change Requests (CRs)
  4. Key messages
  5. OMS support & guidance
  6. Download Webinar (PDF)

1.) About OMS

2.) Using OMS in eAF/CESP

3.) Submission of OMS Change Requests (CRs)

4.) Key messages to Using OMS data in eAF

Using OMS data in eAF in a nutshell:

  • OMS dictionary (list of organisations with associated physical locations) can be used to support regulatory business processes
  • OMS content is growing and data quality is expected to improve over time
  • Business owner of the process using OMS data decides how/when to use it and mandates its use. OMS team will work closely with the business process owners
  • eAF will not mandate the use of OMS data, free text will still be available
  • CESP will mandate the use of OMS data in the form. Organisation data will have to be pre-registered in OMS and can be selected in CESP. This is not planned before Q3-2019 for Initial MA Applications
  • Applicants are advised to familiarise themselves with the use of OMS data and with the process before the use of OMS data will be mandated
  • Applicants and MAHs are responsible to register/update organisation data in OMS before regulatory submissions (e.g. Initial MAA, Var, Renewal)
  • Submission of OMS Change Requests for Veterinary MAH & MAAs for NAPs starts from September 2018

5.) OMS support & guidance

Reference documents accessible from the SPOR portal

  • OMS web user manual – guidance on OMS services, e.g. searching, exporting data, requesting CRs
  • SPOR user registration manual (how to register for SPOR)
  • SPOR affiliation template (to register the first industry super user)
  • Change Request  (CR) Validation in OMS
  • Organisation data quality standards in OMS
  • SPOR SLAs (SLA are indicative and will be reviewed in future)

Training videos

OMS training videos available to view on the @emainfo channel

EMA Website

EMA corporate website also includes SPOR related information, documents and material from webinars.

EMA Account Management Portal

To create a new EMA account in order to obtain access to EMA systems (including SPOR). To request SPOR user role.

Account Management Portal.

EMA Service Desk Portal

Service requests, issues, requests for technical support shall be submitted through the Service Desk Portal.

6.) Download Webinar







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Download SPOR API Documentation (version 1.14 published 9.1.2018)

Download SPOR API Documentation

Download SPOR API Documentation new edition ((version 1.14 published 9.1.2018) API schemas, OMS & RMS message formats and HL7) is accessible for interested parties for a free download in this website:

The latest version of the API specification incorporates the following additional information:

  • A description of how an implementing system must retain rowid elements in the creation, and later management, of change requests in RMS.
  • A description on the fields that have to be conditionally provided when dealing with both OMS and RMS change requests depending on the status and the data of such requests.
  • An explanation on how OMS retains compatibility for searching elements based on identifiers, even after they have been merged, and how the current identifier, of an element, is highlighted in the response data.
  • A description on what kind of change requests can be filed in OMS depending on the status of the referred organisation and/or location.
The API specification covers both RMS and OMS. This has been taken through consultation during April to July 2016 and the feedback has been incorporated in the specification (consultation is now closed).

Please note that in the SPOR API specification, the services are set out in Section 6 and those that are OMS-specific are marked 'O', RMS-specific are marked 'R', and services shared by both RMS and OMS are marked as  'RO'.

The documents have been shared with the SPOR Task Force and UAT testers.

For more details on IDMP SPOR please see the IDMP1 Wiki on IDMP SPOR

Download SPOR-API-Specification-1.14 published 09 January 2018 (PDF)



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Clinical Trials Portal