A medicine’s product information is regulated, scientifically validated information that assists healthcare professionals in prescribing and dispensing and informs patients and consumers about their medicine and its safe use.
The development of electronic product information (ePI) is intended to improve access to up-to-date product information on medicines when and where it is needed.
ePI is authorised, statutory product information for EU medicines in a semi-structured electronic format using the EU Common Standard.
The Common Standard was one of the key deliverables of an ePI project run by the European Medicines Agency (EMA), national competent authorities (NCAs) and the European Commission (EC) in 2021. A follow-on ePI pilot project, supported by the EU funding programme EU4Health, runs throughout 2022-2023 and will develop tools and guidance to pilot the use of ePI prior to implementation. The ePI pilot project will develop a minimum viable product (MVP) which envisages initial introduction of ePI at the beginning and end of the evaluation process.
The EU ePI Common Standard is based on Fast Healthcare Interoperability Resources (FHIR), an international technical standard describing data formats and elements and an application programming interface for exchanging electronic health records. FHIR also supports the exchange of information about medicinal products, substances, and related referential data in the European medicines regulatory network.
As an outcome of the call which was launched in 2022 for expressions of interest to join the ePI pilot project team in the role of Subject Matter Expert (SME), Katja Pečjak from Billev Pharma East (representative of Medicines for Europe) was invited to ePI project team as Subject Matter Expert.