D4.12 Prototype presentation of ISO IDMP compliant data feed to eHealth consumers

This project has received funding from the European Union’s Horizon 2020 research and innovation programme under the Grant Agreement No. 875299 Project acronym: UNICOM Project full title: Up-scaling the global univocal identification of medicines in the context of Digital Single Market strategy Call identifier: H2020-SC1-DTH-2019 WP4 IDMP implementation at National Drug Agencies D4.12: Prototype presentation of ISO IDMP compliant data feed to eHealth consumers Version: 1.0 Status: Final Dissemination Level1: PU Due date of deliverable: 30.11.2023 Actual submission date: 30.11.2023 Work Package: WP4: IDMP implementation at National Drug Agencies Lead partner for this deliverable: SE -MPA Partner(s) contributing: FAMHP/AFMPS/FAGG, AGES, INFARMED, EESAM, TEHIK Deliverable type2: R Main author(s): Rutt Lindstrom TEHIK (Estonia) Paul De Troch FAMHP (Belgium) Carlos Mendes INFARMED (Portugal) Triin Mäesalu EESAM (Estonia) Georg Neuwirther Harald Laimer AGES (Austria) AGES (Austria) 1 Dissemination level: PU: Public; CO: Confidential, only for members of the consortium (including the Commission Services); EU-RES: Classified Information: RESTREINT UE (Commission Decision 2005/444/EC); EU-CON: Classified Information: CONFIDENTIEL UE (Commission Decision 2005/444/EC); EU-SEC Classified Information: SECRET UE (Commission Decision 2005/444/EC) 2 Type of the deliverable: R: Document, report; DEM: Demonstrator, pilot, prototype; DEC: Websites, patent fillings, videos, etc.; OTHER; ETHICS: Ethics requirement; ORDP: Open Research Data Pilot UNICOM – D4.12: Prototype presentation of ISO IDMP compliant data feed to eHealth consumers 2 Revision history Version Date Changes made Author(s) 0.1 19.04.2023 First draft, template outline Pelle Persson 0.2 25.04.2023 AGES data feed description added Astrid Roth 0.3 06.07.2023 “Ingredient role” updated Harald Laimer 0.4 11.11.2023 Background, description of work process Rutt Lindström 0.5 13.11.2023 Belgian data feed description added Paul de Troch 0.6 15.11.2023 Portuguese data feed description added Carlos Mendes 0.7 16.11.2023 Terminology and dependencies Rutt Lindström 0.8 19.11.2023 IG introduction and review of the earlier work Rutt Lindström 0.9 22.11.2023 Review of the document Georg Neuwirther Harald Laimer 0.10 23.11.2023 Review of document, formatting and creating the final version Paul De Troch, Georg Neuwirther, Harald Laimer, Goedele Louwagie, Carlos Mendes, Toomas Silla 0.11 27.11.2023 Reivew Tor-Arne Berg 0.12 29.11.2023 Final reivew Pelle Persson, Christer Backman Statement of originality This deliverable contains original unpublished work except where clearly indicated otherwise. Acknowledgement of previously published material and of the work of others has been made through appropriate citation, quotation or both. Resource consumption estimate: Person months SEMPA 0,1 (for creation of this document) FAMHP/AFMPS/FAGG 0,3 (for creation of this document) AGES 0,25 (for creation of this document) INFARMED 0,25 (for creation of this document) EESAM, TEHIK 0,5 (for creation of this document) UNICOM – D4.12: Prototype presentation of ISO IDMP compliant data feed to eHealth consumers 3 Deliverable abstract The deliverable summarises outcomes of prototype data feeds from NCA systems to eHealth and other national data consumers. Four member states (Austria, Belgium, Estonia, and Portugal) worked together to analyse the requirements from stakeholders and other related specifications, identified relevant data sets and worked on its representation nationally required formats (e.g. ClamL, HL7 FHIR format). Analysis and implementation considerations were added to the deliverable report. Common findings when creating the prototypes are included in this report and made available for other WPs and stakeholders. Earlier UNICOM deliverables and work items were revisited during this process to make sure to reuse the knowledge and assets built during the project. Keywords: IDMP, NCA, ISO, Data feed, eHealth, Terminology, FHIR This document contains material, which is the copyright of the members of the UNICOM consortium listed above and may not be reproduced or copied without their permission. The commercial use of any information contained in this document may require a license from the owner of that information. This document reflects only the views of the authors, and the European Commission is not liable for any use that may be made of its contents. The information in this document is provided “as is”, without warranty of any kind, and accept no liability for loss or damage suffered by any person using this information. © 2019-2023. The participants of the UNICOM project. UNICOM – D4.12: Prototype presentation of ISO IDMP compliant data feed to eHealth consumers 4 Revision history ........................................................................................................................................ 2 Deliverable abstract .................................................................................................................................. 3 List of abbreviations ................................................................................................................................. 5 Executive summary .................................................................................................................................. 7 Background .............................................................................................................................................. 8 .1 Contents of the deliverable .......................................................................................................... 8 .2 Source materials .......................................................................................................................... 8 .2.1 Related UNICOM deliverables ............................................................................................. 8 .2.2 Related specifications .......................................................................................................... 8 Prototypes of providing data to eHealth Organisations ........................................................................... 9 .1 Belgium (FAMHP/AFMPS/FAGG)................................................................................................ 9 .2 Austria (AGES) ........................................................................................................................... 10 .3 Estonia (EESAM, TEHIK) ........................................................................................................... 10 .4 Portugal (INFARMED) ................................................................................................................ 12 Common findings ................................................................................................................................... 13 .1 Comparison of published data from different countries .................................................................. 13 .2 Challenges associated with different code systems .................................................................. 14 .3 EMA SPOR SMS .................................................................................................................... 15 .4 EMA SPOR RMS ................................................................................................................... 16 .5 WHO ATC............................................................................................................................... 16 .6 EDQM Standard Terms .......................................................................................................... 17 .7 National code systems ........................................................................................................... 18 .8 SNOMED CT .......................................................................................................................... 18 .9 MedDRA ................................................................................................................................. 19 .10 UCUM ................................................................................................................................. 19 .11 Country and language codes ............................................................................................. 19 Annex ..................................................................................................................................................... 21 .1 Belgium IDMP mapping SAM ......................................................................................................... 21 .2 Austrian IDMP mapping ............................................................................................................. 51 .3 Screenshots of Estonian prototype solution ............................................................................... 56 .4 Portuguese IDMP Mapping ........................................................................................................ 59 UNICOM – D4.12: Prototype presentation of ISO IDMP compliant data feed to eHealth consumers 5 List of abbreviations Abbreviation Complete form AGES Österreichische Agentur für Gesundheit und Ernährungssicherheit API Application Programming Interface BfARM Bundesinstitut für Arzneimittel und Medizinprodukte CTS Communication and Tracking System EESAM Estonian State Agency of Medicines EMA European Medicines Agency EMRN European medicines regulatory network EU IG EU Implementation Guide EU-NTC EU Network Training Centre FAMHP/AFMPS /FAGG The Belgian NCA -> acronym in the different languages: EN_FAMHP (Belgium) Federal Agency for Medicines and Health Products FR_AFMPS Agence Fédérale des Médicaments et des Produits de Santé NL_FAGG Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten FHIR Fast Healthcare Interoperability Resources ICH International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use IDMP Identification of Medicinal Products INFARMED, I.P. Autoridade Nacional do Medicamento e Produtos de Saúde I. P. MPD Medicinal Product Dictionary MPM Medicinal Product Management system, BE NCA’s internal database to store data of medicines authorized for the Belgian market NCA National Competent Authority (for medicinal products) NCP National Contact Point (for cross-border services) NOMA Statens Legemiddelverk NVR New veterinary regulation OMS Organisation Management Services PMS Product Management Services REST Representational State Transfer UNICOM – D4.12: Prototype presentation of ISO IDMP compliant data feed to eHealth consumers 6 RMS Referentials Management Services SAM SAM (Source Authentique de Médicines, authentic source of medicine, the Belgian medicine data exchange database SE MPA Swedish Medical Products Agency SMS Substance Management Services SPMS SPMS – Serviços Partilhados do Ministério da Saúde, EPE SPOR EMA service delivering quality data management services for substances, products, organisations and referentials (SPOR) to power EU regulatory activities. SPOR = S(MS), P(MS), O(MS), R(MS) TEHIK Health and Welfare information Systems Centre (Estonia) UI User Interface xEVMPD Extended Eudra Vigilance medicinal product dictionary UNICOM – D4.12: Prototype presentation of ISO IDMP compliant data feed to eHealth consumers 7 Executive summary ISO/CEN IDMP (in short, IDMP) is a set of 5 standards for identification of medicinal products. In Europe. Adoption of IDMP in the regulatory processes has been led by the European Medicines Agency (EMA). Together with adoption of the IDMP data structure, EMA SPOR services were created to support the regulatory processes. IDMP in its full complexity is designed for multiple use cases. The UNICOM project has demonstrated the value of implementing IDMP in different countries' regulatory systems. It has also proved, that a subset of IDMP data is relevant and usable for the eHealth domain, including cross-border ePrescription and eDispensation. In most countries, information about authorised medicinal products is published by the NCA in a public registry and/or provided to eHealth consumers. If or how this data is used by the eHealth applications (for example, digital prescribing) varies a lot across different countries. The interoperability of medication data relies on using similar data structures and vocabularies. This is crucial for cross-border services, where medication data from different countries need to be comparable and univocally identifiable without having direct access to source data or other country's national references. It is also the key for making real-world-data usable for secondary use, which brings additional challenges regarding the longer timespans needed for detailed medication data. UNICOM partners and the eHealth-Network in Europa are addressing this topic. In the illustration below, we see a simplified medicinal product data pipeline from regulators to data consumers. This deliverable describes the status of prototype implementations of the Austrian, Belgian, Estonian, and Portuguese medicines agencies’ output to eHealth organisations which is marked with a bright green circle. UNICOM – D4.12: Prototype presentation of ISO IDMP compliant data feed to eHealth consumers 8 Background .1 Contents of the deliverable This document covers the status of the different local prototype implementations concerning the data feed from the four engaged NCAs to their local eHealth organisations. It also describes common findings that need to be addressed in next steps. This document consists of the following parts: - Chapter 1: Brief background information with references to relevant sources and guidance materials - Chapter 2: Current data feed from NCAs to national eHealth organisations - Chapter 3: Common findings, Business and technical considerations related to agreeing on a harmonised data feed - Annex – Illustration of national prototypes, and prototype data structures .2 Source materials .2.1 Related UNICOM deliverables • D4.14. Delivery of selected ISO IDMP medicinal product data for cross-border pilots • D5.1. Business requirements for the adoption of IDMP in eHealth Services. • D5.2. Guidelines for IDMP-based Cross-Border ePrescription / eDispensation & Patient Summary. • D5.7. Common minimum data set for implementation in the national NCA and eHealth solutions. • D9.1. An analysis of the IDMP medicinal product identification data provided by NCAs (and SPOR) compared to that needed in MPD for clinical care and for secondary uses. • D9.3. Report on the Specification(s) and delivery technology for IDMP data delivery from NCA to MPD. • D9.4. IDMP Implementation guidance for pharmacy system suppliers (focus on patient medication list) - Common minimum data set. .2.2 Related specifications • UNICOM Implementation Guide • European Medicines Agency’s ISO IDMP implementation guide • HL7 Electronic Product Information • MyHealth@EU cross-border services • SNOMED CT drug model for national extensions • SNOMED CT medicinal product model specification • eHDSI Specifiaction UNICOM – D4.12: Prototype presentation of ISO IDMP compliant data feed to eHealth consumers 9 Prototypes of providing data to eHealth Organisations Each involved agency has its own data feed in place that must be updated according to IDMP concepts and eHDSI needs. The eHealth Network is working on relevant specifications that will lead to harmonised implementations in the future. The following subchapters provide a short overview of the current NCA interaction with eHealth organisations. In the annex prototype data structures of involved NCAs are shown. .1 Belgium (FAMHP/AFMPS/FAGG) SAM, the current eHealth data exchange system FAMHP, the Belgian NCA, maintains the medicinal products authorised for the Belgian market in its “Medicinal Product Management system” (MPM). FAMHP shares those data 3 with eHealth partners through the SAM database (Source Authentique de Médicines, authentic source of medicines). SAM is also fed by 4 other Organisations: NIHID (INAMI/RIZIV, the Belgian National Institution for Health and Disability Insurance), BCFi-CBiP (the Belgian Centre for Pharmacotherapeutic information), FPS Economy (the Federal Public Service of Economy), APB (the national federation of self-employed pharmacies). 2 other partners intervene, notably: Smals (Federal organisation delivering IT services to the governmental social and health Institutions) and eHealth Belgium (maintainer of the eHealth platform). Those seven partners make up the SAM governing body. The format of the xmls exchanged is agreed upon within the governing body. Methodology followed to construct an IDMP compatible exchange prototype (see section 4.1): The information tags in the current protocol have been inventorised. Examples of information in these tags have served to determine corresponding FHIR tags. The extensions suggested by EMA in the implementation guide have been reused where applicable. If no mapping was possible, an extension was defined to be able to send this information. The newly created extensions are highlighted in yellow in the table in annex (section 4.1). Belgium also sends a lot of national identifiers. These national identifiers are highlighted in orange in the table in annex. They will require the definition of additional system values in the CodeSystem. Lessons learnt: − A lot of extensions (242 out of 355 fields) are needed to be able to send current data in an IDMP-compatible way. − Not all IDMP data are sent − New system values in the CodeSystem (see section 3.2.5) will have to be created. Next steps: − The IDMP compatible messages should be reconverted by xsd to the current protocol to prove that all information needed is present in the IDMP compatible message. − The Belgian NCA is currently IDMP-aligning the MPM data-model and completing the MPM SPOR codes in MPM (UNICOM D4.9). 3 Only public data, e.g. manufacturers of active substances are confidential and hence are not shared. UNICOM – D4.12: Prototype presentation of ISO IDMP compliant data feed to eHealth consumers 16 At the time of writing this report, EMA SMS was not providing a live data feed yet. The codes need to be downloaded as a file with 200.000 rows, which includes substances used as active ingredients as well as excipients. .4 EMA SPOR RMS EMA SPOR Referentials Management Services (RMS) is the terminology service to support central data management for the European regulatory domain, combining external sources such as EDQM, WHO ATC, and internal EMA sources. It uses an internal numbering system for terminology and product lifecycle management purposes - this means recoding concepts from source code systems, and adding concepts when needed (for example, adding concepts to the pharmaceutical form list, where no agreement on EDQM level could be reached). Mappings to source code systems are provided if they exist. Using EMA SPOR RMS, OMS and RMS terms is mandatory for the data exchange between regulators and applicants. NCAs and MyHealth@EU are aware that mappings between code systems are currently needed. FHIR can handle several code systems for one data element. The coding should represent the same meaning, expressed with different code systems. The example below illustrates how the NCA can preserve the original numeric code from RMS, and thus use the mappings provided by EMA, to enrich the data with the actual ATC code. Such approach is helpful for the data users, because then they do not have to manage the mappings themselves. Due to the additional administrative effort to maintain this information it might be better to either agree on one code system or to provide a centralised mapping service. .5 WHO ATC Anatomical Therapeutic Chemical Classification System (ATC) has been known and used since 1976. ATC is widely used in prescription systems, clinical decision support systems, and even on physical pharmacy shelves. UNICOM – D4.12: Prototype presentation of ISO IDMP compliant data feed to eHealth consumers 17 In RMS, WHO ATC has been recoded with RMS codes. The list owner is considered WHO, and EMA is allowed to add concepts that are pre-accepted for use in the source system but will come into effect in the future. For example, concept L01FX25 ‘mosunetuzumab’ is recoded as 200000033781 ‘mosunetuzumab’ in RMS and marked with a status ‘Current’ in November 2023. In WHO ATC this concept will not be valid before 01.01.2024. Asynchronicity like this causes a discrepancy that may affect FHIR validation for downstream users who use official ATC as the source code system and rely on standard FHIR terminology services for mapping and validation. As ATC codes are used far beyond the simple classification needs, this finding must be addressed in a future concept of the EMA RMS system to reduce the workload on downstream users and ensure consistency of data. .6 EDQM Standard Terms EDQM Standard Terms are a code system of about 900 terms in 35 languages. These terms are used in European marketing authorisation applications, labelling, reporting, etc. It is designed to support regulatory processes but has been also adopted by eHealth community in Europe. eHealth Network guidelines for ePrescription and Patient Summary, recommend EDQM terms for capturing medicinal product data concerning dose form, route of administration, unit of presentation, and package types. There are 16 RMS lists originating from EDQM Standard Terms. These lists are considered one code system when expressed in EDQM codes, but 16 different code systems when expressed in RMS codes. This discrepancy may be confusing for implementers but is unlikely to cause significant technical errors. EMA states that they may add concepts to these RMS lists when the concepts are pre-accepted by EDQM but not yet valid in the source code system. As with ATC, adding concepts that are not yet active in the source system, may lead to mapping and validation errors in downstream systems. If EDQM codes have a role in your national infrastructure (including cross-border services), additional coding may be added to product data to ensure the mapping is present in the data and validated by the NCA. Due to the additional administrative effort to maintain this information it might be better to either agree on one code system or to provide a centralised mapping service. EDQM Standard Terms as well as RMS provide a useful addition to lists of terms by adding properties to dose forms. UNICOM – D4.12: Prototype presentation of ISO IDMP compliant data feed to eHealth consumers 18 These dose form attributes provided by EDQM as well as EMA can be used for creating decision logic in ePrescription systems and other clinical processes. .7 National code systems National code systems are used in every country, and they are likely to keep their importance in the national infrastructure, at least in processes that need to handle legacy data. It is up to the NCA to ensure that the transition to new code systems or mapping from the old code systems is transparent and reliable. It is possible to publish mappings as a separate resource or provide product data with multiple coding. It is worth mentioning, that countries also use national flavours of international code systems. For example, the Estonian ATC has been enriched to include codes for all combinations of ingredients, extending the code system where the official ATC stops at a group concept. In most countries, EDQM terms has been used for dose forms for a long time, but with local codes, not with official EDQM codes. These local variations may be deeply rooted in clinical systems (including decision support mechanisms) and discontinuing them may be a slow or unnecessary process. Thus, significant changes in that regard should be analysed carefully. .8 SNOMED CT UNICOM deliverable 9.1 “An analysis of the IDMP medicinal product identification data provided by NCAs (and SPOR) compared to that needed in MPD for clinical care and for secondary uses” highlights the importance of SNOMED CT for clinical decision support systems. SNOMED CT can be used for coding single data elements, such as dose form or route of administration, or provide a full product as a concept with a sufficient data model to describe the product. For both UNICOM – D4.12: Prototype presentation of ISO IDMP compliant data feed to eHealth consumers 19 approaches, mappings between RMS and SNOMED CT would be needed. There are no official direct mappings available at the time of writing this report (e.g. for substances, EMA SMS and SNOMED CT both use INN notation, but there is no official mapping). However, some links between terminologies exist. EDQM dose form – SNOMED CT mapping and MedDRA – SNOMED CT mapping are both provided and regularly maintained by SNOMED International. There are NCAs in the UNICOM consortium (Norway, Spain) who already provide data to the national SNOMED CT release centre, who then transforms the regulatory data into SNOMED CT concepts. This transformation allows the clinical systems to leverage the analytical power of SNOMED CT terminology and use medication data in a more computable way. More information about how SNOMED CT maps to IDMP, and how regulatory data can be expressed and distributed using the SNOMED CT concept model and terminology can be found in SNOMED International guidance materials for understanding international medicinal product model and drug model for national extensions. .9 MedDRA Medical Dictionary for Regulatory Activities (MedDRA) is used for indications and adverse effects in regulatory product data. MedDRA is also fully incorporated in EMA RMS, recoded with RMS codes, and having MedDRA code provided as the source. Information about indications and adverse effects are extremely important for the clinical systems, many of which prefer to use SNOMED CT for this purpose. This is possible with a 2-step mapping: RMS-MedDRA mapping is provided by EMA and MedDRA – SNOMED CT mapping is provided by SNOMED International. At the time of writing this report, NCAs did either not include this data at all or there are different ways to provide indications in a structured or text form. .10 UCUM Unified Code for Units of Measure (UCUM) is widely used in eHealth and beyond - not only for medicinal product information, but also in laboratory results and other measurements. In eHealth services UCUM notations are generally used as codes for units of measurement, which is the preferred code system for units in FHIR. In the EMA RMS list, the same concepts are coded with RMS codes, and mapping from RMS units to UCUM is provided if it exists. RMS uses UCUM as one source for the code system for units of measures, leaving a possibility to deviate from it. .11 Country and language codes ISO Country codes and BCP-47 language codes are both used widely in all the information systems far beyond healthcare. In EMA RMS these lists are provided but recoded with RMS codes. In RMS, BCP-47 is declared as the source system for languages, but ISO is not declared as the source for country codes. While country codes can be coded with RMS codes in FHIR, language usually has a strict connection to the FHIR All languages value set, which is based on BCP-47. Using RMS codes for language in R5, would require a workaround with an extension. UNICOM – D4.12: Prototype presentation of ISO IDMP compliant data feed to eHealth consumers 20 UNICOM – D4.12: Prototype presentation of ISO IDMP compliant data feed to eHealth consumers 21 Annex .1 Belgium IDMP mapping SAM The newly created extensions are highlighted in yellow in the table below. Belgium also sends a lot of national identifiers. These national identifiers are highlighted in orange in the table below. Field NCA data BE Example value Cardinality FHIR version meta.versionId createdDate meta.createdDate lastModifiedDate meta.lastModifiedDate id 62bc31918ab5583c18aceab1 1...1 MedicinalProductDefinition.[product]Classification samId SAM661219-00 0...1 MedicinalProductDefinition.[product]Classification usage VETERINARY 1...1 MedicinalProductDefinition.domain status Authorised 1...1 RegulatedAuthorization.status cti 188684 1...1 RegulatedAuthorization.identifier strength 12.5 mg 1...1 Ingredient.substance.Strength.textPresentation or Ingredient.substance.Strength.textConcentration + Ingredient.substance.Strength.extension[language ] strengthFr 12.5 mg 1...1 Ingredient.substance.Strength.textPresentation or Ingredient.substance.Strength.textConcentration + Ingredient.substance.Strength.extension[language ] strengthNl 12.5 mg 1...1 Ingredient.substance.Strength.textPresentation or Ingredient.substance.Strength.textConcentration + Ingredient.substance.Strength.extension[language ] UNICOM – D4.12: Prototype presentation of ISO IDMP compliant data feed to eHealth consumers 22 Field NCA data BE Example value Cardinality FHIR strengthDe 12.5 mg 1...1 Ingredient.substance.Strength.textPresent ation or Ingredient.substance.Strength.textConcen tration + Ingredient.substance.Strength.extension[l anguage] authorisationDate [1997, 11, 25] 1...1 RegulatedAuthorization.relatedDate.date DateTime publicationRadiation ONWAAR 1...1 MedicinalProductDefinition.[product]Class ification authorisationNumber BE-V188684 1...1 RegulatedAuthorization.identifier authorisationStatus Authorised 1...1 RegulatedAuthorization.status statusEffectiveDate [1997, 11, 25] 1...1 RegulatedAuthorization.relatedDate.date DateTime nameEn Kalmivet 1...1 MedicinalProductDefinition.name.product Name + MedicinalProductDefinition.name.country Language.language + MedicinalProductDefinition.name.type nameNl Kalmivet 1...1 MedicinalProductDefinition.name.product Name + MedicinalProductDefinition.name.country Language.language + MedicinalProductDefinition.name.type nameFr Kalmivet 1...1 MedicinalProductDefinition.name.product Name + MedicinalProductDefinition.name.country Language.language + MedicinalProductDefinition.name.type UNICOM – D4.12: Prototype presentation of ISO IDMP compliant data feed to eHealth consumers 23 Field NCA data BE Example value Cardinality FHIR nameDe Kalmivet 1...1 MedicinalProductDefinition.name.productName + MedicinalProductDefinition.name.countryLanguag e.language + MedicinalProductDefinition.name.type pgNumber NAT/V/0002 1...1 MedicinalProductDefinition.productClassification pgName Kalmivet 1...1 MedicinalProductDefinition.name.productName + MedicinalProductDefinition.name.countryLanguag e.language + MedicinalProductDefinition.name.type pgNameEn Kalmivet 1...1 MedicinalProductDefinition.name.productName + MedicinalProductDefinition.name.countryLanguag e.language + MedicinalProductDefinition.name.type pgNameNl Kalmivet 1...1 MedicinalProductDefinition.name.productName + MedicinalProductDefinition.name.countryLanguag e.language + MedicinalProductDefinition.name.type pgNameFr Kalmivet 1...1 MedicinalProductDefinition.name.productName + MedicinalProductDefinition.name.countryLanguag e.language + MedicinalProductDefinition.name.type pgNameDe Kalmivet 1...1 MedicinalProductDefinition.name.productName + MedicinalProductDefinition.name.countryLanguag e.language + MedicinalProductDefinition.name.type pcNumber NAT/V/0002/001 1...1 RegulatedAuthorization.identifier pcName Kalmivet 1...1 MedicinalProductDefinition.name.productName + MedicinalProductDefinition.name.countryLanguag e.language + MedicinalProductDefinition.name.type UNICOM – D4.12: Prototype presentation of ISO IDMP compliant data feed to eHealth consumers 24 Field NCA data BE Example value Cardinality FHIR pcNameEn Kalmivet 1...1 MedicinalProductDefinition.name.productName + MedicinalProductDefinition.name.countryLanguag e.language + MedicinalProductDefinition.name.type pcNameDe Kalmivet 1...1 MedicinalProductDefinition.name.productName + MedicinalProductDefinition.name.countryLanguag e.language + MedicinalProductDefinition.name.type pcNameFr Kalmivet 1...1 MedicinalProductDefinition.name.productName + MedicinalProductDefinition.name.countryLanguag e.language + MedicinalProductDefinition.name.type pcNameNl Kalmivet 1...1 MedicinalProductDefinition.name.productName + MedicinalProductDefinition.name.countryLanguag e.language + MedicinalProductDefinition.name.type blackTriangle ONWAAR 1...1 MedicinalProductDefinition.additionalMonitoringIn dicator orphanDrug ONWAAR 1...1 RegulatedAuthorization.status + RegulatedAuthorization.type withdrawalPeriodFR Sans objet. 1...1 AdministrableProductDefinition.routeOfAdministra tion.targetSpecies.withdrawalPeriod.value (value + code) + AdministrableProductDefinition.routeOfAdministra tion.targetSpecies.code + AdministrableProductDefinition.routeOfAdministra tion.targetSpecies.withdrawalPeriod.extension[lan guage] UNICOM – D4.12: Prototype presentation of ISO IDMP compliant data feed to eHealth consumers 25 Field NCA data BE Example value Cardinality FHIR withdrawalPeriodNL Niet van toepassing. 1...1 AdministrableProductDefinition.routeOfAdministra tion.targetSpecies.withdrawalPeriod.value (value + code) + AdministrableProductDefinition.routeOfAdministra tion.targetSpecies.code + AdministrableProductDefinition.routeOfAdministra tion.targetSpecies.withdrawalPeriod.extension[lan guage] targetSpeciesPublication ONWAAR 1...1 AdministrableProductDefinition.routeOfAdministra tion.targetSpecies.extension[Publication] conditionalApproval ONWAAR 1...1 RegulatedAuthorization.status atcCodes 1...* atcCodes.en Acepromazine 1...1 MedicinalProductDefinition.[product]Classification. display atcCodes.code QN05AA04 1...1 MedicinalProductDefinition.[product]Classification. code atcCodes.deprecated ONWAAR 1...1 MedicinalProductDefinition.[product]Classification. extension[status] atcCodes.id 53298a85014ed41f3ccfc3ae 1...1 MedicinalProductDefinition.[product]Classification. extension[referenceM] targetSpecies 1...* targetSpecies.id 52ab0c84be45d7429c9f0712 1...1 AdministrableProductDefinition.routeOfAdministra tion.targetSpecies.extension[referenceM] targetSpecies.sporId 100000109056 1...1 AdministrableProductDefinition.routeOfAdministra tion.targetSpecies.code targetSpecies.en Cat 1...1 AdministrableProductDefinition.routeOfAdministra tion.targetSpecies.display + AdministrableProductDefinition.routeOfAdministra tion.targetSpecies.extension[language] targetSpecies.code Fe 1...1 AdministrableProductDefinition.routeOfAdministra tion.targetSpecies.extension[code] UNICOM – D4.12: Prototype presentation of ISO IDMP compliant data feed to eHealth consumers 32 Field NCA data BE Example value Cardinality FHIR packs.supplyProblem.reason.mouseOverNl De productie van een geneesmiddel bestaat uit verschillende stappen die elk onderworpen worden aan strenge controles en waarvan geen enkele stap kan overgeslagen worden. Indien er tijdens deze controles problemen worden opgemerkt, wordt dit ogenblikkelijk onderzocht. Indien het niet mogelijk blijkt om deze problemen direct op te lossen, moet de fabrikant de productie tijdelijk stil leggen om de kwaliteit van dit geneesmiddel te kunnen garanderen. 1...1 PackagedProductDefinition.marketingStatus.exten sion.reason.more + PackagedProductDefinition.marketingStatus.exten sion[language] packs.supplyProblem.reason.mouseOverFr La fabrication d’un médicament comporte plusieurs étapes, dont chacune est soumise à des contrôles stricts et dont aucune ne peut être omise. Si des problèmes sont détectés lors de ces contrôles, une enquête sera immédiatement ouverte. S’il est impossible de résoudre ces problèmes immédiatement, le fabricant devra suspendre temporairement la production du médicament afin de garantir la qualité de ce médicament. 1...1 PackagedProductDefinition.marketingStatus.exten sion.reason.more + PackagedProductDefinition.marketingStatus.exten sion[language] packs.supplyProblem.reportedBy.version 0 1...1 PackagedProductDefinition.marketingStatus.exten sion.report.version packs.supplyProblem.reportedBy.createdDate 1.656.581.177,101000 1...1 PackagedProductDefinition.marketingStatus.exten sion.report.createdDate packs.supplyProblem.reportedBy.lastModifie dDate 1.656.581.177,101000 1...1 PackagedProductDefinition.marketingStatus.exten sion.report.lastModifiedDate UNICOM – D4.12: Prototype presentation of ISO IDMP compliant data feed to eHealth consumers 33 Field NCA data BE Example value Cardinality FHIR packs.supplyProblem.reportedBy.id 52ab0c86be45d7429c9f417e 1...1 PackagedProductDefinition.marketingStatus.exten sion.report.referenceM packs.supplyProblem.reportedBy.en Company 1...1 PackagedProductDefinition.marketingStatus.exten sion.report.text packs.supplyProblem.reportedBy.deprecated ONWAAR 1...1 PackagedProductDefinition.marketingStatus.exten sion.report.status packs.supplyProblem.impactHCP.version 0 1...1 PackagedProductDefinition.marketingStatus.exten sion.impact.version packs.supplyProblem.impactHCP.createdDate 1.656.581.177,967000 1...1 PackagedProductDefinition.marketingStatus.exten sion.impact.createdDate packs.supplyProblem.impactHCP.lastModified Date 1.656.581.177,967000 1...1 PackagedProductDefinition.marketingStatus.exten sion.impact.lastModifiedDate packs.supplyProblem.impactHCP.id 5db84f7b90d93207d8ca49b7 1...1 PackagedProductDefinition.marketingStatus.exten sion.impact.referenceM packs.supplyProblem.impactHCP.mouseOverE n - 1...1 PackagedProductDefinition.marketingStatus.exten sion.impact.more + PackagedProductDefinition.marketingStatus.exten sion[language] packs.supplyProblem.impactHCP.mouseOver Nl 1...1 PackagedProductDefinition.marketingStatus.exten sion.impact.more + PackagedProductDefinition.marketingStatus.exten sion[language] packs.supplyProblem.impactHCP.mouseOverF r 1...1 PackagedProductDefinition.marketingStatus.exten sion.impact.more + PackagedProductDefinition.marketingStatus.exten sion[language] packs.supplyProblem.impactHCP.type SUPPLY_PROBLEM 1...1 PackagedProductDefinition.marketingStatus.exten sion.impact.type packs.supplyProblem.impactHCP.subType HCP 1...1 PackagedProductDefinition.marketingStatus.exten sion.impact.subtype UNICOM – D4.12: Prototype presentation of ISO IDMP compliant data feed to eHealth consumers 34 Field NCA data BE Example value Cardinality FHIR packs.supplyProblem.impactHCP.order 50 1...1 PackagedProductDefinition.marketingStatus.exten sion.impact.order packs.supplyProblem.impactHCP.level 1 1...1 PackagedProductDefinition.marketingStatus.exten sion.impact.level packs.supplyProblem.impactHCP.en - 1...1 PackagedProductDefinition.marketingStatus.exten sion.impact.text + PackagedProductDefinition.marketingStatus.exten sion[language] packs.supplyProblem.impactHCP.code 50 1...1 PackagedProductDefinition.marketingStatus.exten sion.impact.code packs.supplyProblem.impactHCP.en PackagedProductDefinition.marketingStatus.exten sion.impact.text + PackagedProductDefinition.marketingStatus.exten sion[language] packs.supplyProblem.impactHCP.fr - 1...1 PackagedProductDefinition.marketingStatus.exten sion.impact.text + PackagedProductDefinition.marketingStatus.exten sion[language] packs.supplyProblem.impactHCP.de 1...1 PackagedProductDefinition.marketingStatus.exten sion.impact.text + PackagedProductDefinition.marketingStatus.exten sion[language] packs.supplyProblem.impactHCP.nl - 1...1 PackagedProductDefinition.marketingStatus.exten sion.impact.text + PackagedProductDefinition.marketingStatus.exten sion[language] packs.supplyProblem.impactHCP.deprecated ONWAAR 1...1 PackagedProductDefinition.marketingStatus.exten sion.impact.status packs.commercialisationStatusPresent.id 62bc31918ab5583c18aceade 1...1 PackagedProductDefinition.marketingStatus.exten sion[referenceM] UNICOM – D4.12: Prototype presentation of ISO IDMP compliant data feed to eHealth consumers 35 Field NCA data BE Example value Cardinality FHIR packs.commercialisationStatusPresent.dateCo mmercialisationStatus [2007, 4, 1] 1...1 PackagedProductDefinition.marketingStatus.dateR ange.start packs.commercialisationStatusPresent.comm ercialisationStatus Yes 1...1 PackagedProductDefinition.marketingStatus.status .extension[YesNo] packs.commercialisationStatusPresent.additionalInfoEn 1...1 PackagedProductDefinition.marketingStatus.exten sion[addinfo] + PackagedProductDefinition.marketingStatus.exten sion[Language] packs.commercialisationStatusPresent.additionalInfoFr 1...1 PackagedProductDefinition.marketingStatus.exten sion[addinfo] + PackagedProductDefinition.marketingStatus.exten sion[Language] packs.commercialisationStatusPresent.additionalInfoNl 1...1 PackagedProductDefinition.marketingStatus.exten sion[addinfo] + PackagedProductDefinition.marketingStatus.exten sion[Language] packs.commercialisationStatusPresent.additionalInfoDe 1...1 PackagedProductDefinition.marketingStatus.exten sion[addinfo] + PackagedProductDefinition.marketingStatus.exten sion[Language] packs.commercialisationStatusPresent.public ation ONWAAR 1...1 PackagedProductDefinition.marketingStatus.exten sion[publication] packs.commercialisationStatusPresent.comm ercialisationType PRESENT 1...1 PackagedProductDefinition.marketingStatus.status packs.commercialisationStatusPresent.limited Availability ONWAAR 1...1 PackagedProductDefinition.marketingStatus.status .extension[limitedAvailability] packs.derogationImport ONWAAR 1...1 PackagedProductDefinition.marketingStatus.status .extension[derogationImport] packs.dateAvailabilityDerogation PackagedProductDefinition.marketingStatus.status .extension[dateAvailabilityDerogation] UNICOM – D4.12: Prototype presentation of ISO IDMP compliant data feed to eHealth consumers 36 Field NCA data BE Example value Cardinality FHIR packs.noteFrDerogation PackagedProductDefinition.marketingStatus.status .extension[noteFrDerogation] packs.noteNlDerogation PackagedProductDefinition.marketingStatus.status .extension[notenlDerogation] packs.noteEnDerogation PackagedProductDefinition.marketingStatus.status .extension[noteEnDerogation] packs.packComponents 1...* PackagedProductDefinition.containedItem.Item (reference) packs.packComponents.id 62bc31918ab5583c18aceab5 1...1 ManufacturedItemDefinition.Identifier.extension[r eferenceM] packs.packComponents.name Active Component 1...1 ManufacturedItemDefinition.Name packs.packComponents.packSizeAmount 20 1...1 PackagedProductDefinition.packaging.containedIte m.amount packs.packComponents.order 1 1...1 PackagedProductDefinition.packaging.extension[or der] packs.packComponents.authorisationCompon entCode 188684_mpc_001 1...1 ManufacturedItemDefinition.Identifier packs.packComponents.packContentType.id 576cf57f2e977111e27ffba6 1...1 ManufacturedItemDefinition.Identifier.extension[r eferenceM] packs.packComponents.packContentType.en Active Component 1...1 ManufacturedItemDefinition.ingredient and Ingredient.role.extension[display] and Ingredient.role.extension.[display.Language] packs.packComponents.packContentType.fr Composant Actif 1...1 ManufacturedItemDefinition.ingredient and Ingredient.role.extension[display] and Ingredient.role.extension.[display.Language] packs.packComponents.packContentType.de Wirkstoff 1...1 ManufacturedItemDefinition.ingredient and Ingredient.role.extension[display] and Ingredient.role.extension.[display.Language] packs.packComponents.packContentType.nl Actief Bestanddeel 1...1 ManufacturedItemDefinition.ingredient and Ingredient.role.extension[display] and Ingredient.role.extension.[display.Language] UNICOM – D4.12: Prototype presentation of ISO IDMP compliant data feed to eHealth consumers 37 Field NCA data BE Example value Cardinality FHIR packs.packComponents.packContentType.dep recated ONWAAR 1...1 ManufacturedItemDefinition.ingredient and Ingredient.role.extension[status] packs.packComponents.packagingType.en Blister 1...1 PackagedProductDefinition.package.type.display packs.packComponents.packagingType.code 4 1...1 PackagedProductDefinition.package.type.extensio n[FAMHPCode] packs.packComponents.packagingType.depre cated ONWAAR 1...1 PackagedProductDefinition.package.type.extensio n[status] packs.packComponents.packagingType.id 52ab0c86be45d7429c9f3ec0 1...1 PackagedProductDefinition.package.type.extensio n[referenceM] packs.packComponents.packagingType.edqm Code 30007000 1...1 PackagedProductDefinition.package.type.extensio n[edqmCode] packs.packComponents.packagingType.edqm Definition Container (usually multidose) consisting of two layers of which one is shaped to contain the individual doses. Strips and unit-dose blisters are excluded. 1...1 PackagedProductDefinition.package.type.extensio n[edqmDefinition] packs.packComponents.packagingMaterial.en PVC/ALU 1...1 PackagedProductDefinition.package.material.displ ay packs.packComponents.packagingMaterial.co de 222 1...1 PackagedProductDefinition.package.material.exten sion[FAMHPCode] packs.packComponents.packagingMaterial.de precated ONWAAR 1...1 PackagedProductDefinition.package.material.exten sion[Status] packs.packComponents.packagingMaterial.id 533d6b85014ed46615ab5043 1...1 PackagedProductDefinition.package.material.exten sion[referenceM] documents 1...* UNICOM – D4.12: Prototype presentation of ISO IDMP compliant data feed to eHealth consumers 38 Field NCA data BE Example value Cardinality FHIR documents.id 62bc7b631e5c015ab301b516 1...1 DocumentReference.identifier.extension[FAMHPC ode] documents.documentTypeEn Leaflet (FR) 1...1 DocumentReference.type.display documents.documentTypeCode Leaflet (FR) 1...1 DocumentReference.type.code documents.documentSectionEn National SPC, Leaflets and Labelling 1...1 DocumentReference.category.display documents.documentSectionCode National SPC, Leaflets and Labelling 1...1 DocumentReference.category.code documents.title Leaflet (FR) 1...1 DocumentReference.description documents.currentEffectiveDate [2023, 3, 16] 1...1 DocumentReference.period.start documents.uriFr https://int-app.yourict.net/pharmastatus/api/files/62bc7b631e5c015ab30 1b516 1...1 DocumentReference.profile.uri.url + DocumentReference.profile.extension.[display.Lan guage] documents.uriEn 1...1 DocumentReference.profile.uri.url + DocumentReference.profile.extension.[display.Lan guage] documents.uriNl 1...1 DocumentReference.profile.uri.url + DocumentReference.profile.extension.[display.Lan guage] documents.uriDe 1...1 DocumentReference.profile.uri.url + DocumentReference.profile.extension.[display.Lan guage] documents.currentFileVersion 2 1...1 DocumentReference.version documents.eparUrl 1...1 DocumentReference.profile.value[eparUrl].url documents.languages ["FR"] 1...* DocumentReference.profile.extension[language] authorisationType.en Marketing authorisation 1...1 RegulatedAuthorization.type.display authorisationType.code MA 1...1 RegulatedAuthorization.type.extension[FAMHPcod e] authorisationType.deprecated ONWAAR 1...1 RegulatedAuthorization.type.extension[status] authorisationType.id 52ab0c84be45d7429c9f064d 1...1 RegulatedAuthorization.type.extension[reference M] authorisationType.sporId 220000000061 1...1 RegulatedAuthorization.type.code UNICOM – D4.12: Prototype presentation of ISO IDMP compliant data feed to eHealth consumers 39 Field NCA data BE Example value Cardinality FHIR alloHomeo.en Allopathic 1...1 MedicinalProductDefinition.[product]Classification. extension[en] alloHomeo.code ALLOPATHIC 1...1 MedicinalProductDefinition.[product]Classification. code alloHomeo.deprecated ONWAAR 1...1 MedicinalProductDefinition.[product]Classification. extension[status] alloHomeo.id 615ee42b5c6d9b131e97d35d 1...1 MedicinalProductDefinition.[product]Classification. extension[referenceM] mah.id 62bc0787ac75b92c42c9e744 1...1 RegulatedAuthorization.holder.extension[referenc eM] mah.name Vétoquinol 1...1 RegulatedAuthorization.holder.Organization.name mah.legalFormCode SA-NV 1...1 RegulatedAuthorization.holder.Organization.exten sion[legalFormCode] mah.organisationId 0593 1...1 RegulatedAuthorization.holder.Organization.exten sion[FAMHPcode] mah.spor_id ORG-100021626 1...1 RegulatedAuthorization.holder.Organization.identi fier.value mah.kbo_id 403086072 1...1 RegulatedAuthorization.holder.Organization.identi fier.value mah.department_building 1...1 RegulatedAuthorization.holder.Organization.exten sion[department_building] mah.zoning 1...1 RegulatedAuthorization.holder.Organization.conta ct.address.line mah.street Galileilaan 1...1 RegulatedAuthorization.holder.Organization.conta ct.address.line mah.number 11/401 1...1 RegulatedAuthorization.holder.Organization.conta ct.address.line mah.postBox 1...1 RegulatedAuthorization.holder.Organization.conta ct.address.line UNICOM – D4.12: Prototype presentation of ISO IDMP compliant data feed to eHealth consumers 40 Field NCA data BE Example value Cardinality FHIR mah.postalCode 2845 1...1 RegulatedAuthorization.holder.Organization.conta ct.address.postalCode mah.city Niel 1...1 RegulatedAuthorization.holder.Organization.conta ct.address.city mah.region 1...1 RegulatedAuthorization.holder.Organization.conta ct.address.district mah.languageCode NL 1...1 RegulatedAuthorization.holder.extension[language ] mah.countryCode BE 1...1 RegulatedAuthorization.holder.Organization.conta ct.address.country mah.mail [email protected] 1...1 RegulatedAuthorization.holder.Organization.conta ct.address.telecom.value and RegulatedAuthorization.holder.Organization.conta ct.address.telecom.system medicinalProduct.id 62bc31928ab5583c18acebd9 1...1 MedicinalProductDefinition.[product]Classification. extension[referenceM] medicinalProduct.samId SAM188684-00 1...1 MedicinalProductDefinition.[product]Classification. extension[samId] medicinalProduct.prescriptionNameEn Kalmivet 12.5 mg tabl. 1...1 MedicinalProductDefinition.name.extension[prescr iptionNameEn] medicinalProduct.prescriptionNameFr Kalmivet 12.5 mg comp. 1...1 MedicinalProductDefinition.name.extension[prescr iptionNameFr] medicinalProduct.prescriptionNameNl Kalmivet 12.5 mg tabl. 1...1 MedicinalProductDefinition.name.extension[prescr iptionNameNl] medicinalProduct.prescriptionNameDe Kalmivet 12.5 mg Tabl. 1...1 MedicinalProductDefinition.name.extension[prescr iptionNameDe] medicinalProduct.referenceAuthorisation 62bc31918ab5583c18aceab1 1...1 RegulatedAuthorization.identifier.extension[refere nceM] medicinalProduct.prescriptionNameEffective Date [1997, 11, 25] 1...1 MedicinalProductDefinition.name.extension[prescr iptionNameEffectiveDate] UNICOM – D4.12: Prototype presentation of ISO IDMP compliant data feed to eHealth consumers 41 Field NCA data BE Example value Cardinality FHIR legalBasis.id 52ab0c86be45d7429c9f3e15 1...1 MedicinalProductDefinition.[product]Classification. extension[referenceM] legalBasis.abbreviation FULL 1...1 MedicinalProductDefinition.[product]Classification. extension[abbreviation] legalBasis.en FULL - Article 2.8, 1st paragraph of Royal Decree 3/7/1969 1...1 MedicinalProductDefinition.[product]Classification. extension[en] legalBasis.fr AUTORISATION COMPLÈTE - Article 2.8, premier alinéa de l'AR du 3/7/1969 1...1 MedicinalProductDefinition.[product]Classification. extension[fr] legalBasis.de KOMPLETTE GENEHMIGUNG - Artikel 2.8, Absatz 1 des KE vom 3.7.1969 1...1 MedicinalProductDefinition.[product]Classification. extension[de] legalBasis.nl VOLLEDIGE VERGUNNING - Artikel 2.8, eerste alinea van het KB van 3/7/1969 1...1 MedicinalProductDefinition.[product]Classification. extension[nl] legalBasis.deprecated WAAR 1...1 MedicinalProductDefinition.[product]Classification. extension[status] authorisationComponents 576d28d1234e142368314cbf 1...* authorisationComponents.id 576d28d1234e142368314cbf 1...1 PackagedProductDefinition.packaging.extension[re ferenceM] authorisationComponents.code 188684_mpc_001 1...1 PackagedProductDefinition.packaging.extension[F AMHPCode] authorisationComponents.en 188684_mpc_1 1...1 PackagedProductDefinition.packaging.extension[e n] authorisationComponents.fr 188684_mpc_1 1...1 PackagedProductDefinition.packaging.extension[fr] authorisationComponents.de 188684_mpc_1 1...1 PackagedProductDefinition.packaging.extension[d e] authorisationComponents.nl 188684_mpc_1 1...1 PackagedProductDefinition.packaging.extension[nl ] authorisationComponents.routeOfAdministrations 1...* authorisationComponents.routeOfAdministra tions.en Oral use 1...1 AdministrableProductDefinition.routeOfAdministra tion.display UNICOM – D4.12: Prototype presentation of ISO IDMP compliant data feed to eHealth consumers 48 Field NCA data BE Example value Cardinality FHIR authorisationComponents.activeSubstances.i ngredient.leadMSVet ONWAAR 1...1 Ingredient.substance.extension[leadMSVet] authorisationComponents.activeSubstances.i ngredient.synonyms 1...* ["Acepromazinum"] 1...* Ingredient.substance.extension[synonyms] authorisationComponents.activeSubstances.i ngredient.category.id 62bc0715d3c5b37ef83bd736 1...1 Ingredient.substance.extension[category.id] authorisationComponents.activeSubstances.i ngredient.category.en Chemicals 1...1 Ingredient.substance.extension[category.en] authorisationComponents.activeSubstances.i ngredient.category.fr Produits chimiques 1...1 Ingredient.substance.extension[category.en] authorisationComponents.activeSubstances.i ngredient.category.de Chemikalien 1...1 Ingredient.substance.extension[category.de] authorisationComponents.activeSubstances.i ngredient.category.nl Chemische producten 1...1 Ingredient.substance.extension[category.nl] authorisationComponents.activeSubstances.i ngredient.category.deprecated ONWAAR 1...1 Ingredient.substance.extension[category.status] authorisationComponents.activeSubstances.i ngredient.ingredientStatus.en Active 1...1 Ingredient.substance.extension[ingredientStatus.e n] authorisationComponents.activeSubstances.i ngredient.ingredientStatus.code Active 1...1 Ingredient.substance.extension[ingredientStatus.c ode] authorisationComponents.activeSubstances.i ngredient.ingredientStatus.id 62013559ad3cef02b71f9576 1...1 Ingredient.substance.extension[ingredientStatus.re ferenceM] authorisationComponents.activeSubstances.i ngredienteq.id 62bc07638ab5583c18858b33 1...1 Ingredient.substance.referenceStrength.substance. extension.[referenceM] authorisationComponents.activeSubstances.i ngredienteq.en Acepromazine 1...1 Ingredient.substance.referenceStrength.substance. display + Ingredient.substance.referenceStrength.substance. extension[language] UNICOM – D4.12: Prototype presentation of ISO IDMP compliant data feed to eHealth consumers 49 Field NCA data BE Example value Cardinality FHIR authorisationComponents.activeSubstances.i ngredienteq.nl Acepromazine 1...1 Ingredient.substance.referenceStrength.substance. display + Ingredient.substance.referenceStrength.substance. extension[language] authorisationComponents.activeSubstances.i ngredienteq.fr Acepromazine 1...1 Ingredient.substance.referenceStrength.substance. display + Ingredient.substance.referenceStrength.substance. extension[language] authorisationComponents.activeSubstances.ingredienteq.de 1...1 Ingredient.substance.referenceStrength.substance. display + Ingredient.substance.referenceStrength.substance. extension[language] authorisationComponents.activeSubstances.i ngredienteq.businessId 10226 1...1 Ingredient.substance.referenceStrength.substance. extension.[code] authorisationComponents.activeSubstances.i ngredienteq.notes INN 1...1 Ingredient.substance.referenceStrength.substance. extension.[notes] authorisationComponents.activeSubstances.i ngredienteq.namesSynonyms Acepromazine Acépromazine Acepromazine Acepromazinum 1...1 Ingredient.substance.referenceStrength.substance. extension.[namesSynonyms] authorisationComponents.activeSubstances.i ngredienteq.innovation ONWAAR 1...1 Ingredient.substance.referenceStrength.substance. extension.[innovation] authorisationComponents.activeSubstances.i ngredienteq.type ACTIVE_SUBSTANCE 1...1 Ingredient.substance.referenceStrength.substance. extension[role] authorisationComponents.activeSubstances.i ngredienteq.sporId 100000087916 1...1 Ingredient.substance.referenceStrength.substance. code authorisationComponents.activeSubstances.i ngredienteq.leadMSHum ONWAAR 1...1 Ingredient.substance.referenceStrength.substance. extension[leadMSHum] authorisationComponents.activeSubstances.i ngredienteq.leadMSVet ONWAAR 1...1 Ingredient.substance.referenceStrength.substance. extension[leadMSVet] authorisationComponents.activeSubstances.i ngredienteq.synonyms ["Acepromazinum"] 1...* Ingredient.substance.referenceStrength.substance. extension[synonyms] UNICOM – D4.12: Prototype presentation of ISO IDMP compliant data feed to eHealth consumers 50 Field NCA data BE Example value Cardinality FHIR authorisationComponents.activeSubstances.i ngredienteq.category.id 62bc0715d3c5b37ef83bd736 1...1 Ingredient.substance.referenceStrength.substance. extension[category.id] authorisationComponents.activeSubstances.i ngredienteq.category.en Chemicals 1...1 Ingredient.substance.referenceStrength.substance. extension[category.en] authorisationComponents.activeSubstances.i ngredienteq.category.fr Produits chimiques 1...1 Ingredient.substance.referenceStrength.substance. extension[category.fr] authorisationComponents.activeSubstances.i ngredienteq.category.de Chemikalien 1...1 Ingredient.substance.referenceStrength.substance. extension[category.de] authorisationComponents.activeSubstances.i ngredienteq.category.nl Chemische producten 1...1 Ingredient.substance.referenceStrength.substance. extension[category.nl] authorisationComponents.activeSubstances.i ngredienteq.category.deprecated ONWAAR 1...1 Ingredient.substance.referenceStrength.substance. extension[category.status] authorisationComponents.activeSubstances.i ngredienteq.ingredientStatus.en Active 1...1 Ingredient.substance.referenceStrength.substance. extension[ingredientStatus.en] authorisationComponents.activeSubstances.i ngredienteq.ingredientStatus.code Active 1...1 Ingredient.substance.referenceStrength.substance. extension[ingredientStatus.code] authorisationComponents.activeSubstances.i ngredienteq.ingredientStatus.id 62013559ad3cef02b71f9576 1...1 Ingredient.substance.referenceStrength.substance. extension[ingredientStatus.referenceM] This project has received funding from the European Union’s Horizon 2020 research and innovation programme under the Grant Agreement No. 875299 .2 Austrian IDMP mapping PZN AGES <Class code="0981417"> pharmaceutical registration number as record ID Medicinal Product Identifier - Manufactured Product → Manufactured Material → Code Trade Name APO Verlag <Label xml:lang="de" xml:space="default">CIPR OXIN FTBL 500MG</Label MUST (1..1) Short Name Medicinal Product Brand Name - Manufactured Product → Manufactured Material → Name Authorization Name AGES <Meta name="Bezeichnung_Arzn eispezialitaet_Zulassung" value="Ciproxin 500 mg Filmtabletten"/> MUST (1..1): Description according to Authorization and Monograph, Length 1...200 - Authorization Number AGES <Meta name="ZulassungsNumm er" value="1.2.40.0.34.4.17:118296"/> MUST (1..1) Marketing Authorization Number, Length: 1...30 - Authorization State AGES <Meta name="ELGA_Zulassungs status" value="GA - zugelassen"/> MUST (1..1) Marketing Authorization State - Authorization Holder AGES <Meta name="ELGA_Inhaber" value="Bayer Austria GmbH"/> MUST (1..1) Marketing Authorization Holder - Validity AGES <Meta name="ELGA_Gültigkeit" value="true"/> MUST (1..1) Validity: true/false - UNICOM – D4.12: Prototype presentation of ISO IDMP compliant data feed to eHealth consumers 52 Delivery State of the package APO Verlag <Meta name="ELGA_Medikation PackungsstatusLieferbar" value="true"/> MUST (1..1): Delivery State of the Package: true/false - Size / Weight of the package Warenverzeichnis <Meta name="GroesseGewicht" value="30"/> MUST (1..1): Size/weight of the package/tube/etc. Value range: 1...1000 Package Size – Manufactured Product → Manufactured Material → Quantity Value Unit to Size/ Weight Warenverzeichnis <Meta name="ELGA_Medikation Mengenart_code" value="2.16.840.1.113883. 6.8:mg"/> MUST (1..1):unit to the attribute 'GroesseGewicht', code (UCUM unit) and text (printname of the unit, see displayName in Value Set ELGA_MedikationMengenart) Package Size – <Meta name="ELGA_Medikation Mengenart_text" value="mg"/> Manufactured Product → Manufactured Material → Quantity Unit Prescription requirement state AGES <Meta name="ELGA_Medikation RezeptpflichtStatus_code" value="1.2.40.0.10.1.4.3.4. 3.7:100000072079"/> MUST (1..1): PrescriptionRequirementStatu s according to AGES/EUTCT - <Meta name="ELGA_Medikation RezeptpflichtStatus_text" value="Arzneimittel zur einmaligen Abgabe auf aerztliche Verschreibung"/> Package Type Container AGES <Meta name="ELGA_Packaging_ 01_code" value="1.2.40.0.34.5.219:1 00000073496"/> Package Type (Container) Package Type – UNICOM – D4.12: Prototype presentation of ISO IDMP compliant data feed to eHealth consumers 53 <Meta name="ELGA_Packaging_ 01_text" value="Blisterpackung"/> MUST (1..n), Code and Text Manufactured Product → Manufactured Material → Container Package Product ATC Code AGES <Meta name="ELGA_whoATC_0 1_code" value="2.16.840.1.113883. 6.73:J01MA02"/> OPTIONAL (0..10) ATC code and text according to AGES master data, code and text OID of WHO ATC list Length: 3...7 Manufactured Product → Manufactured Material → Generalized Material Kind → Code <Meta name="ELGA_whoATC_0 1_text" value="Ciprofloxacin"/> Text is either in German or English - perferably in German Route of Administration AGES <Meta name="ELGA_Medikation ArtAnwendung_01_code" value="1.2.40.0.10.1.4.3.4. 3.4:100000073619"/> MUST (1..15) Route of Administration, Code and Text Route of Administration <Meta name="ELGA_Medikation ArtAnwendung_01_text" value="zum Einnehmen"/> according to AGES/EUTCT/EDQM <Meta name="ELGA_Medikation ArtAnwendung_02_code" value="1.2.40.0.10.1.4.3.4. 3.4:100000073611"/> <Meta name="ELGA_Medikation ArtAnwendung_02_text" value="intravenöse Anwendung"/> Substance AGES <Meta name="ELGA_Substanz_0 1_code" value="1.2.40.0.34.5.156:1 708891"/> MUST (1..n) Substance, Code and Text according to AGES/EUTCT - <Meta name="ELGA_Substanz_0 1_text" value="CIPROFLOXACIN HYDROCHLORID UNICOM – D4.12: Prototype presentation of ISO IDMP compliant data feed to eHealth consumers 54 Active Ingredient AGES <Meta name="ELGA_ActiveIngre dient_01_code" value="1.2.40.0.34.5.221:1 00000091536"/> Consecutive number in sync with associated ELGA substance Active Ingredient – <Meta name="ELGA_ActiveIngre dient_01_text" value="CIPROFLOXACIN HYDROCHLORIDE"/> MUST (1..n), ActiveIngredient Code and Text Manufactured Product → Manufactured Material → Ingredient → Ingredient Substance → Code Ingredient Role AGES <Meta name="ELGA_Ingredient_r ole_01_text" value="active"/> MUST (1), fixed Text Active Ingredient Role Active Ingredient Strength AGES <Meta name="ELGA_Ingredient_l ow_strength_01" value="582"/> MUST(1…ngrouped), Ingredient low strength Text, English notation Active Ingredient Strength (Value) – Manufactured Product → Manufactured Material → Ingredient Quantity → Value Active Ingredient Unit AGES <Meta name="ELGA_Ingredient_l ow_strength_unit_01" value="mg"/> MUST (1…n-grouped), Ingredient low strength unit, Text Active Ingredient Strength (Unit) – Manufactured Product → Manufactured Material → Ingredient Quantity → Unit Reference Ingredient AGES <Meta name="ELGA_ReferenceI ngredient_01_code" value="1.2.40.0.34.5.221: 100000091536"/> MUST (1..n), Reference Ingredient Code and Text - <Meta name="ELGA_ReferenceI ngredient_01_text" value=" CIPROFLOXACIN HYDROCHLORIDE "/> UNICOM – D4.12: Prototype presentation of ISO IDMP compliant data feed to eHealth consumers 55 Reference Ingredient Strength AGES <Meta name="ELGA_Reference_ low_strength_01" value="582"/> MUST (1..ngrouped), Reference Low strength, Text, English notation - Reference Ingredient Unit AGES <Meta name="ELGA_Reference_ low_strength_unit_01" value="mg"/> MUST (1..n-grouped), Reference Low strength unit, Text - Pharmaceutical Dose Form AGES <Meta name="ELGA_Medikation Darreichungsform_01_cod e" value="1.2.40.0.10.1.4.3.4. 3.5:100000073870"/> MUST pharmaceutical Dose Form (1..10) , Code and Text Pharmaceutical Dose Form- <Meta name="ELGA_Medikation Darreichungsform_01_text " value="Infusionslösung"/> Text in German - Evaluation with first delivery Manufactured Product → Manufactured Material → form Code according to AGES/EUTCT/EDQM Interaction relevance AGES <Meta name="ELGA_Medikation WechselwirkungsRelevant " value="true"> MUST (1..1) InteractionRelevant: true/false - Domain <Meta name="Domaene" value="human"/> MUST (1..1) Domain (fixed value 'human') - UNICOM – D4.12: Prototype presentation of ISO IDMP compliant data feed to eHealth consumers 56 .3 Screenshots of Estonian prototype solution Illustration. Layout of the implementation guide, that includes narrative guidance as well as FHIR specification and example data. UNICOM – D4.12: Prototype presentation of ISO IDMP compliant data feed to eHealth consumers 57 Illustration. Product browser (included in the Testing Toolbox, and designed for the use case) with example data. UNICOM – D4.12: Prototype presentation of ISO IDMP compliant data feed to eHealth consumers 64 UNICOM – D4.12: Prototype presentation of ISO IDMP compliant data feed to eHealth consumers 65 UNICOM – D4.12: Prototype presentation of ISO IDMP compliant data feed to eHealth consumers 66