Challenge

The UNICOM project addresses a fundamental challenge in European healthcare: the lack of semantic interoperability in medicinal product information across Member States. At present, medicines and their components are often identified differently depending on the national context, language, or regulatory framework, which significantly complicates cross-border healthcare services such as ePrescriptions and eDispensation. This fragmentation not only hinders patient safety but also weakens the effectiveness of pharmacovigilance, obstructs regulatory harmonisation, and limits the potential of health data in research and clinical decision-making. UNICOM seeks to resolve this by accelerating the implementation of ISO IDMP (Identification of Medicinal Products) standards, which enable the unambiguous identification of medicines across Europe. The project responds to the urgent need for a unified system where any medicinal product, regardless of its commercial name or language of origin, can be accurately identified and safely dispensed in any EU country.

Solutions

UNICOM’s central achievement lies in the development and practical implementation of ISO IDMP-compliant systems across participating nations. The project has created a robust framework for integrating national drug and clinical databases with the European Medicines Agency’s SPOR (Substances, Products, Organisations, Referentials) system, including the realisation of the European Substance Reference System (EU-SRS). By enabling these systems to ‘speak the same language’, UNICOM facilitates the reliable identification of equivalent medicinal products throughout the EU. Key activities included the creation of IDMP/SPOR-compliant application forms for pharmaceutical companies, gap analyses of existing communication systems for decentralised marketing applications, and the deployment of IDMP-based IT solutions for national and cross-border ePrescription and eDispensation. Eleven national competent authorities (NCAs) for drug regulation and several eHealth authorities actively implemented these systems. UNICOM also extended the application of IDMP standards beyond regulatory contexts into clinical settings. This included piloting their use in electronic health records, clinical decision support systems, pharmacovigilance, and smart patient empowerment applications. The project further supported the adaptation of medicinal product dictionaries and clinical systems, ensuring compatibility with IDMP structures throughout the product lifecycle.

Results

The impact of UNICOM extends well beyond improved interoperability. One of its most tangible outcomes is the successful piloting of enhanced cross-border services, with an estimated 10,000 ePrescriptions and 1,000 patient summaries enriched with IDMP codes exchanged through the CEF (Connecting Europe Facility) infrastructure. Countries such as Croatia, Estonia, Finland, Greece, Portugal, and Spain were among the early adopters. By facilitating safer and more reliable exchange of medicinal product data, UNICOM contributes directly to improved patient safety, particularly in cross-border healthcare situations. The implementation of semantically harmonised data allows health professionals to access and interpret critical information regardless of its origin, reducing the risk of medication errors and enhancing the quality of care. The project has also empowered patients through smart information tools, which were tested with around 500 participants. In the broader ecosystem, the project strengthens Europe’s global competitiveness. It enables the pharmaceutical industry, software developers, SMEs, and digital health innovators to develop new tools and services based on a unified data framework. Moreover, IDMP-enabled data opens new avenues for public health research, allowing better tracking of treatment outcomes and more targeted identification of adverse drug reactions. UNICOM’s long-term legacy lies in its contribution to a more connected, efficient, and safer European healthcare system, built on the foundation of trustable, interoperable medicinal product data.