Resources Demo Page

UNICOM – general information

2020UNICOM Fact SheetShort introduction to UNICOM Action lines, objectivesPDF File
2020BADI Bulgarian Drug Regulatory Affairs e-Congress (June 2020)The slides present the objectives pursued by UNICOM to a EU regulatory authority and Bulgarian key stakeholders not directly active within the UNICOM consortium.PDF File
2020HL7 FHIR / Unicom Joint Meeting (May 2020)Karl Stroetmann presents the objectives purused by UNICOM and its implementation challenges including the synergies to be found with SDOs such as HL7/FIHR.PDF File
2020Commentary published in the review VaccineCommentary published in the open source journal Vaccine on December 2 2020. It details the urgent actions needed to ensure we can track and trace the global use of COVID-19 vaccines.
PDF File
2021UNICOM Citizen Survey Results (Feb-March 2021)Summary of results from a survey of public opinion performed on what is important regarding patient care and empowerment when travelling outside one’s home country, specifically related to medicine The associated task is ‘Define Patient Use Cases in Cross Border Settings’PDF File

IDMP and related standardisation(s)

2020Working Document: Gap Analysis of Existing and Need for New Standards and ProfilesWork package 1 focuses on IDMP-related standards and terminologies; its first deliverable is concerned with gaps in existing standards and profiles, and the arising need for adapted and new ones.PDF File
2020Medicinal Product, Marketing Authorization,
Pharmaceutical Product and Package Medicinal Product: Briefing Note by Jean Gonzague Fontaine (GSK)
The slides provide an overview of the relations between • MPID• PhPID• MA• PCID (and then, DCID) and explain the possible hierarchy
between these IDs.
PDF File
2020IDMP related standards and terminologies applied to pharmacovigilance:
Presentation Individual Case Safety Report. Briefing note by Anja van Haren
The slides briefly describe the expected benefits of IDMP implementation for the pharmacoviguilance domain.PDF File
2021Working Document: Requirements for a new ISO logical model
The document raises requirements for the development of a new IDMP logical model, to serve as a reference to implementers and developers of specific data models. It presents what is meant by a “logical model”, provides several references which document logical models and their conceptual, standardised framework. PDF File
2021The UNICOM Project Pilot Product List: Presentation to the HL7 BR&R Workgroup (26/01:2021)The slides show how the products pilot list which will be tested by UNICOM are the pivotal element which will help make IDMP truly operational.PDF File

IDMP-adapted submission forms and national implementations


Cross-border aspects


Presentations | Videos

2020Polypharmacy from a clinical perspective UNICOM partner Prof. Dr. R. Vander Stichele, Clinical pharmacologist at Ghent University, Belgium/ Senior Research Coordinator at I~HD, explains Polypharmacy concepts from a clinical perspective in the Horizon 2020 project C3-Cloud Webinar on 28 August 2020PDF File
2020White Paper written by nine SDOs, including CDISC, CEN, DICOM, GS1, HL7, IHE, ISO, LOINC and SNOMED International forming the Joint Initiative Council.Highlights from the JIC white paper include four standards-based initiatives that offer practical solutions to real-world problems. These initiatives include the International Patient Summary (IPS), the Identification of Medicinal Products (IDMP), COVID-19 and Genomics. The Joint Initiative Council’s SDOs work collaboratively to provide global, coordinated—not competitive—standards that address real-world healthcare issues.
PDF File
2020Presentation of UNICOM at SNOMED virtual expo-October 2020 – by Robert Stegmee and Jane MillarThe presentation describes the global problems tackled by UNICOM focusing more specifically on the relationship between IDMP and related terminologies. It explores also the role of SNOMED CT in this and informs about the ressources available to engage with the project.PDF File
2020Initial Gap Analysis on Standards Development -Presentation at HL7 International Work Group Biomedical Research & Regulation (BR&R) September 2020Those 4 slides briefly summarize the identified gaps in WP1 for the HL7 WG audiencePDF File
2020Keynote lecture by Prof. K. A. Stroetmann “Global patient safety through semantic interoperability – the univocal identification of medicinal productsPresentation made at a virtual evnet organized by the Tallinn Health Care College (THCC), Estonia in October 2020 on the theme: “Public Health & Healthcare in the Move — Opportunities and Challenges in Research, Practice and PolicyPDF File
2020Commentary written by some UNICOM participants published in the review VaccineCommentary published in the open source journal Vaccine on December 5 2020. The authors detail the actions needed to ensure we can track and trace the global use of COVID-19 vaccines.
PDF File
2021EHTEL factsheet: Towards a European Data Space for MedicinesThis factsheet explains why the concept of European Health Data Spaces is particularly relevant for medicinal products with a focus on pharmacovigilance. It also analyses what has already been done by Member States in this field, with Belgium as an example, and considers the necessary next steps.
PDF File
2021Ensuring COVID-19 Vaccine Traceability – Article published in the volume 21 of the review by several UNICOM WP leaders.After the article published in Vaccine highlighted the need for global monitoring of vaccine use, has asked the authors about the challenges of implementing such system in practice and possible measures to minimise the accompanying risks.PDF File
2021UNICOM curent status – Presentation for the International Pharmaceutical Regulators Programme (IPRP) on the 24th of FebruaryThis slides set presnet to a wide community of regulators on all continents the objectives, opportunities of exchange and expected results o UNICOM. It inists in particular on the standards gap analysis, the logical model and the Products Pilot List.PDF File
2021Use of EDQM to produce PhPID – Presentation at WG6 Pharmacy ISO/CEN on June 2 2021Results of an analysis of the terminology of dose forms of
the European Directorate for Quality in Medicines (EDQM) Standardized Terms for Dose Form to determine the (administrable) dose form for the production of the Pharmaceutical Product Identification (PHPID)
PDF File
2021IDMP in Europe What does it mean for you?I Presentation at the IHE Europe Experience Sessions on June 15.WP1 provides a global overview of the high level processes at stake while focusing on the most prominent 5 clincial impacts.PDF File
2021Update on UNICOM progresses: 2nd eHMSEG Communities Meeting
on May 27
The presentation provides an update (as of May 2021) on the work and results achioeved by the UNICOM WPs for the eHMSEG communityPDF File


OpenMedicine was a Horizon 2020 funded PHC, Grant agreement No.643796. UNICOM builds on the gaps recognized in OpenMedicine. Some relevant deliverables are listed below for reference as background material.
2016D1.3 Initial openMedicine infostructureThis deliverable’s goal is to present a multi standards framework that underpins solutions to identified issues in epSOS: the EU crossborder health data exchange specifications and its pilot results. In particular the identification of medicinal products and the attention to factors related to multiple contexts are addressed creating an infostructure, based on a multi standards framework.PDF File
2016D2.3 Final identifying and descriptive attributesThis deliverable’s goal is to present the final list of identifying and descriptive attributes of medicinal products. It also gives implementation recommendations based on the materials developed in other openMedicine deliverables. D2.3 has provided relevant input to D3.2, which will extend the attribute lists to special products.PDF File
2016D3.2 Identification and description of special productsThis report extends the solution towards supporting the identification and the description of such “special” products. Furthermore, it also presents the definition of alternative and complementary use cases where the unambiguous identification of such medicinal or/and pharmaceutical products is needed.PDF File
2016D4.1 Other descriptive needs, product administration and alternative treatmentsThis document presents clusters as a tool for grouping products with the same preselected attributes. It explores the concepts behind cluster formation and useful attributes which can help in a cross-border setting for such purpose.PDF File
2016D5.2 Meeting the substitution challenge: Member State regulations and core cross-border issues – results and recommendationsThis report reviews the initial openMedicine definitions of substitution and selection of a medicinal product at the point of dispensation in a community/retail pharmacy. the revised analytical framework concerning substitution and selection issues.PDF File
2016D6.3 Recommendations and Implementation RoadmapThis document presents some of the conclusions of the openMedicine project. Two high level and ten action-oriented recommendations are formulated. All of them, except one, address issues related to the univocal identification of a medicine when dispensing in a cross-border context an electronic prescription or when displaying a Patient Summary abroad. One recommendation addresses the issue of “substitution” in the EU.PDF File