Project description

All EU/EEA countries have IT systems and public register data on medicinal products that have undergone the necessary authorisation procedures in order to be marketed. To date, there has been no common standard for how this data is described and stored in IT systems. This prevents efficient electronic data exchange and complicates various use cases in the healthcare sector (e.g. cross-border electronic prescriptions; the recording of electronic health records; the management of bottleneck situations, quality defects, recalls, etc.).

The UNICOM project will improve patient safety and healthcare provision. Among other things, it aims to address increased requirements in the dispensing of medicines due to cross-border patient mobility. Among other things, healthcare services should be able to quickly identify suitable medicines that meet the therapeutic requirements of the medicine prescribed in the country of origin. UNICOM is intended to accelerate the introduction of the new ISO-IDMP (Identification of Medicinal Products) standards. These standards are the prerequisite for a standardised description of medicinal product data (e.g. substances, composition, packaging, etc.). The need for this standardisation is also mentioned in EU regulations (e.g. Implementing Regulation (EU) No. 520/2012). This emphasises the strategic and substantive importance of this objective. See also the project summary in this video.

The project consortium brings together 41 partners from 19 countries, including 21 national medicines and eHealth agencies. We are playing a key and leading role in this project. Among other things, the core IT system PHAROS is being upgraded to the ISO-IDMP standard and the connection to the EMA's shared data systems (EMA SPOR Services) is being expanded. At EU level, the development of Europe-wide ISO-IDMP-compliant application forms is being organised. We are also working intensively with ELGA and other eHealth organisations to implement cross-border prescriptions.

Benefits of the project

The current digitalisation of the healthcare system makes a significant contribution to ensuring patient safety. The UNICOM project supports the implementation of common standards for the identification and provision of standardised, complete and high-quality data on all medicines available on the respective national and European markets.