ePI Common EU Standard
Gravitate Health is actively engaged in the public consultation which is seeking views on the EMA’s proposed Common EU Standard for electronic product information (ePI) for human medicines authorised in the EU. This technical standard is intended to be adopted for future use for ePI across the EU. The consultation will remain open until July 31, 2021. EMA has also hosted four half-day, virtual workshops to gather stakeholder feedback which will help ensure the adopted EU common standard meets the needs of future users in terms of accessing, viewing and disseminating product information in electronic format.
Gravitate Health team has participated to both the open information workshop and the exploratory workshop for technical specialists and is preparing a joint response to the survey. EMA will report on progresses, publish the outcomes of stakeholder consultations and share these with patients, healthcare professionals, academia and the pharmaceutical industry.
Further updates will be published on this website and our social media: stay tuned!
Background
Currently, product information of a medicine, which includes the package leaflet (“paper in the pack”), labeling and the summary of product characteristics (SmPC), is provided in paper form and attached to each medicine dispensed in the EU.
EMA, Heads of Medicines Agencies (HMA), and the European Commission are conducting an electronic product information (ePI) set-up project to develop an EU Common Standard for ePI.
The development of ePI is expected to improve access to up-to-date product information on medicines when and where it is needed. Moreover, the recent European Pharmaceutical strategy has highlighted how the “better use of product information in electronic format (ePI) could facilitate the delivery of information on the medicine to healthcare professionals and patients in the EU’s multilingual environment and support wider availability of medicines across Member States”.
Last year, EMA, the European Commission and Heads of Medicines Agencies (HMA) released a set of principles outlining a harmonised approach to ePI. The release of the principles followed a 2017 report from the Commission which identified ePI as a way to improve how EU citizens access information about medicines and an EMA workshop on the topic in 2018.
The ongoing consultation is conducted on:
- The ePI API Specification and service list;
- A FHIR XML template based on the Quality Review of Documents (QRD) template for human medicines;
- An instance of an ePI sample message provided in XML and HTML, along with a sample XSL transformation.
All the consultation documents are accessible HERE.
Key Sources
- European Commission (2017), Report on the Community code relating to medicinal products for human use, COM (2017) 135 final [PDF]
- EMA-HMA-EC (2020), Electronic product information for human medicines in the EU: key principles [PDF]
- Report from an EMA–HMA–EC workshop held on 28 November 2018, Electronic product information for medicines in the EU [PDF]
