European Medicines Regulatory Network adopts EU common standard electronic product information

publication date: November 29, 2022

Dissemination of impartial and up-to-date information on all medicines available to patients in the EU through electronic channels

The European medical market currently offers many substances with various medicinal properties, coming from many sources, often purchased from foreign distributors. Medicines are imported by the Member States of the European Union depending on the demand. Due to the multitude and variety of substances available on the medical market, in order to ensure consumer safety, it is necessary to provide access to comprehensive information on the substance admitted to the market, its properties, effects and possible side effects. Both the persons responsible for dispensing the medicine and the consumers purchasing them should have such knowledge.

The European Medicines Regulatory Network has adopted a common standard for electronic product information (ePI) on medicines in the European Union, the initiative aims to provide better and wider access to the database containing data on a specific medicinal substance. The information made available via electronic channels is primarily to be reliable, up-to-date and available to all interested parties. The establishment of common EPI standards in the European Union will streamline the process of providing and updating information provided to patients, consumers and healthcare professionals, thanks to which decisions regarding the consumption of a given substance will be more informed.

What does the abbreviation ePI mean?

ePI, or Electronic Product Information for Human Medicines in the European Union. According to the definition formulated and made available by the European Medicines Agency, it is statutory authorized product information for medicines (i.e. SmPC, PL and labeling) in a semi-structured format created using a common EU electronic standard. ePI is adapted for electronic handling and allows for dissemination via the World Wide Web, e-platforms and printing. ePI meets the key principles. The European Medicines Agency indicates that there are currently several definitions of the term electronic product information, but in order to harmonize and streamline work on this issue, adopting a common definition for the entire EU is not only beneficial but also necessary.

What does electronic product information contain?

1. Patient Information Leaflet

2. Summary of drug characteristics for healthcare professionals.

The above documents, in accordance with the EU directive, are attached to each drug marketed in the EU. Their availability is important because they explain how a given drug should be used and prescribed.

EPI system efficiency

Information posted in the ePI database will be updated on a regular basis and immediately as soon as new information becomes available. The structured nature also provides new opportunities to personalize product information to individual needs and make it more accessible to users of different skills.

The ePI system is constantly improved to make access to it as simple as possible and actually accessible and understandable for all interested parties. In the future, the introduction of automatic update notifications, access to supporting video or audio content and online tools for reporting adverse reactions are postulated. In addition, under the EU4Health programme, the European Medicines Agency will regularly publish progress updates and share results with patients, healthcare professionals, academia and the pharmaceutical industry.

In order to ensure more efficient operation of the ePI system, the European Medicines Agency and national competent authorities should cooperate and implement new solutions in stages. The aim of the European Medicines Agency is to create a database for all medicines approved for human use in EU countries.

Thanks to the implementation of the ePI system, the PI management itself will be more effective, by enabling changes to be made to all attachments and products available in the PI database, thanks to the use of available technologies in the development of the ePI system, it is possible to eliminate many errors that occur during manual performance of tasks related to data entry .

Is ePI really accessible to everyone?

The ePI system has introduced numerous solutions facilitating access to the database for all interested in its content. Solutions ensuring universal access to the database have been introduced in accordance with the needs of each group of people, and in particular adapted to recipients with various disabilities. The use of large fonts and high contrast of the screen will make it easier for recipients with visual impairments to receive information contained in the system. Audio formats have been introduced for the blind. The idea is to provide full and balanced information about products in formats appropriate to the needs of users.

Key EPI Principles

The EU common ePI standard is based on Fast Healthcare Interoperatiability Resources FHIR, an international technical standard that describes data formats and elements, and an application programming interface for electronic health record exchange. FHIR also supports the exchange of information on medicinal products, substances and reference data links in the European Medicines Regulatory Network.

Sources used:

KG LEGAL \ INFO BLOG