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.
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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
2021IDMP in a capsule (EN)IDMP in a capsule helps promote greater understanding about how IDMP standards “work” throughout the life-cycle stages of a medicinal product. In each stage -
from the initial stage of Development and Production through the final stage of Utilisation and Outcome Assessment - IDMP standards’ concepts and theory are explained as part of two stories: SweetDreams, a medicinal product, and Ingrid, its user.
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2021IDMP dans une capsule (FR)IDMP dans une capsule permet de mieux comprendre comment les normes IDMP “fonctionnent” tout au long des étapes du cycle de vie d’un médicament. À chaque étape - de l’étape initiale du développement et de la mise sur le marché du médicament à l’étape finale de l’utilisation et l’évaluation des impacts - les concepts et la théorie des normes IDMP sont expliqués dans le cadre de deux histoires : SweetDreams, un médicament, et Ingrid, son utilisatrice.PDF File
2022Working Paper on IDMP education and certification programsThis paper identifies five levels of required knowledge and describes applicable roles, possible means of education, instruction and certification. It also lists a number of prerequisites and recommendations which should be taken into consideration whilst developing the content and implementing educational modulesPDF File
2023IDMP σε κάψουλα (GRàΤο IDMP σε μια κάψουλα, βοηθά στην προώθηση της καλύτερης κατανόησης σχετικά με το πώς «λειτουργούν» τα πρότυπα IDMP σε όλα τα στάδια του κύκλου ζωής ενός φαρμακευτικού προϊόντος. Από το αρχικό στάδιο Ανάπτυξης και Παραγωγής έως το τελικό στάδιο Αξιοποίησης και Αξιολόγησης Αποτελεσμάτων, οι έννοιες και η θεωρία των προτύπων IDMP εξηγούνται ως μέρος δύο ιστοριών: το SweetDreams, ένα φαρμακευτικό προϊόν και η Ίνγκριντ,.PDF File
2023IDMP en una pildora (SP)Este documento es uno de los entregables de UNICOM. Ofrece una visión simplificada de cómo IDMP podría mejorar la seguridad en el ámbito de los medicamentos.Esta visión no implica la aprobación de UNICOM ni de ninguna de sus partes interesadas. Se ha redactado con carácter informativo y, por tanto, no tiene carácter normativo.IDMP en una cápsula, ayuda a promover una mayor comprensión sobre cómo podrían “funcionar” las normas IDMP a lo largo de las etapas del ciclo de vida de un medicamento. PDF File
2023IDMP in una capsule (IT)Questo documento fornisce una visione semplificata su come gli standard ISO IDMP
potrebbero supportare processi più sicuri nel settore dei farmaci. Questa visione non implica l’approvazione di UNICOM o di uno dei suoi stakeholder. È statascritta a scopo informativo e non ha quindi carattere normativo. “IDMP in a capsule” aiuta a promuovere una maggiore comprensione di come gli standard IDMP potrebbero “funzionare” durante le fasi del ciclo di vita di un medicinale. In ogni fase - da quella iniziale
dello sviluppo e della produzione a quella finale Introduzione al documento
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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.
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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
2021Working Paper:IDMP Coding Principles and Guidance for ICSRsThe working paper provides recommendations for practical IDMP implementation aspects (e.g.,PhPID generation) and for handling drug information in general (e.g.,grouping concepts, use of name parts), aimed at improvingICSR data management and pharmacovigilance analysisPDF File
2021Digital Application Dataset Integration (DADI) Project Question and Answers Version 2This document is for information only and is based on insights available at the time of its release. It will be updated regularly.PDF File
2022Working Document: 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 usesThis working paper describes MPD requirements, using the standards for MPD and how MPD are currently modeled and populated with high quality data to meet their business needs. It then describes what will likely be provided by the NCAs through IDMP, and then examines the gaps, uncertainties, challenges and possible mismatches between the requirements and the likely provision. Finally, it offers some insights into the issues and some recommendations for resolutionPDF File
2022FHIR TRAINING (EMA DADI FHIR variation forms)The slides introduce the Variation FHIR Message Conceptual Model, Mapping of Fields DADI UI to FHIR Message and explain how to extract information out of a FHIR messagePDF File
2022Working Document: Implementation Guidance for Identification of Medicinal Products (IDMP) in Medicinal Product DictionariesThis document provides implementation and mapping guidelines for use of Identification of Medicinal Product (IDMP) data within Medicinal Product Dictionaries (MPD). It includes different scenarios of implementation depending on the structure of the MPD. It gives an overview on the controlled vocabularies/terminology from Substances, Products, Organisations and Referentials (SPOR) from the European Medicines Agency (EMA).
It will help MPD providers to use IDMP data for prescribing and for dispensing, nationally and for cross-border care.
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2022Demonstrator: scenario-testing for HL7 FHIR conecthatons This set of slides describes the senario testing of Helen who is a 38 year old business lawyer. She lives in the UK and travels often to other European countries for work. She has Diabetes type 1 which she controls with medication (Humalog Mix50 daily). One PDF includes the notes while the other one also shows the notes.
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2023IDMP & FHIR for NCAsThe slides were explained during a specific webinar targeted at all European NCAs organised on March 10. It aims at bringing both business and IT people of recent strategic development related to IDMP implementation and iuse of the FHIR StandardsPDF File

European Substance Registration System

2020 Endorsed Implementation Plan for Substance ManagementThis deliverable presents the Implementation Plan for Substance Management, i.e. the roadmap for the EU Substance Reference System (EU-SRS) implementation. PDF File
2022EMA updated Substances listFrom 12/04/2022 onward, EMA is publishing the non-confidential substances data from their SMS system.xlsx File
2022Chemicals EU-SRS User Guide Pre-release The purpose of this document is to provide practical guidance for the registration of chemical substances in EU-SRS. It is intended to be used together with the EU-SRS Substance Maintenance Process which describes the workflow between EMA and SVG (under development).
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2022Proteins EU-SRS User Guide Pre-releaseRegistration of human and veterinary proteinsare in scope of this document. This document is intended tobe used together with the EU-SRS Substance Maintenance Process which describes the workflow between EMA and SVG(under development).The document is currently written mainly based on monoclonal antibodies (MAB’s). In the future the document will be complemented with information of other protein types.
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2022Polymers EU-SRS User Guide Pre-releaseRegistration of human and veterinary polymer substances are in scope of this document. This document is intended to be used together with the EU-SRS Substance Maintenance Process which describes the workflow between EMA and SVG (under development).
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2022Vaccines EU-SRS User Guide Pre-releaseNaming rules and building guidance for human vaccine substances in EU-SRS are in scope of this document. This document is to be used together with the general EU-SRS Substance Maintenance Processdocument/which describes in detail the workflow between EMA and SVG (under development).PDF File
2022Homoeopathic Substances EU-SRS User Guide Pre-releaseRegistration of human and veterinary homoeopathic substances are in scope of this document. This document is to be used together with the overall EU-SRS Substance Maintenance Process which describes in detail the workflow between EMA and SVG.
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2022Veterinary Vaccines EU-SRS User Guide Pre-releaseNaming rules and registration of veterinary vaccine substances arein scope of this document. Veterinary chemicals are treated like human chemicals and are therefore not in the scope of this document. This document is to be used together with the overall EU-SRS Substance Maintenance Process, which describes in detail the workflow between EMA and SVG.
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