UNICOM – Implementation of unambiguous identification of medicinal products in cross-border e-Prescription

The project is expected to give a powerful impetus to the implementation of ISO IDMP (medicinal product identifier) standards in medicines databases in EU Member States, supporting safe cross-border e-Prescribing/e-Dispensing and effective pharmacovigilance. When interoperable EU data on medicines taken by patients becomes available, there will be further benefits in the form of better health data to better support clinical decisions, patient empowerment, public health and clinical research. New opportunities will arise for the pharmaceutical industry, software developers, SMEs providing smart applications and others, thereby increasing their innovation potential and competitiveness.

A consortium of all relevant actors, with the critical mass necessary for EU-wide impact, will address the many challenges still to be overcome along the way. After 10 years of development, the IDMP suite of standards is ready for implementation. While some isolated implementation work has begun, the time has come for a more coordinated effort for large-scale implementation, contributing to this global interoperability effort and benefiting EU citizens. The ambition of the project focuses on converting key regulatory and clinical processes to use IDMP. These information value chains need to be transformed along their entire length, from data entry to data repositories to data use. The project’s work covers all three areas, focusing on the most challenging one, the implementation of EU and national SPOR (substances, products, organisations, references) databases, including the establishment of the EU Substance Reference System (EU-SRS). Such information is fundamental for cross-border e-Prescription, where safe dispensing may require reliable identification of substances in available products.

19 countries are represented, including 26 national drug and e-health agencies. Stakeholders are involved through their associations. The duration after the extension is 4.5 years.