Chiara Ottavianelli -

In March 2017, the European Commission (EC) published its report on current shortcomings in the summary of product characteristics (SmPC) and the package leaflet (PL) and how they could be improved in order to better meet the needs of patients and HCPs. From this first step, the project for the development of electronic product information (ePI) was started.

The ePI is a statutory product information for EU medicines which includes the SmPC, labelling for outer and inner packing and the PL in a semi-structured format. ePI is adapted for electronic handling and allows dissemination via the web, e-platforms and print.

The main aim of the ePI is to improve the access to an up-to-date product information on medicines when and where it is needed. The many subsequent consultations between EMA/HMA/EC and the many stakeholders involved in this project (pharmaceutical industries, HCPs, patients, etc.) have led to the definition of the ‘key principles’ of the ePI, which are:

  • complementarity to the paper version, which will remain in any case available to patients in the current modalities
  • freely accessible data
  • safety of the content which must be protected from unauthorized changes and must not contain promotional information
  • compliance with personal data protection legislation to ensure that patient privacy is respected
  • availability of all the official languages ??of the European Union, Icelandic and Norwegian
  • integrability with other digital health systems such as electronic prescriptions and computerized medical records

From the development of the ePI, several benefits are attended:

for public health

  • Certified information updated in real time
  • Quick and easy access to information
  • Additional features such as audio contributions, images, videos
  • Greater attention to patient needs
  • Support for patients with visual impairments and with low levels of literacy

for the management of regulatory procedures with health authorities:

  • Optimization of all work and information flows
  • Easy identification of any critical issues
  • Timely and precise exchange of updates within the document (increased efficiently and lower risk of errors)

National Competent Authorities, including AIFA, are involved in this project and in the upcoming months several national processes will be initiated for the implementation of the ePI.

Regulatory Pharma Net provides assistance during the whole product lifecycle and is ready to support on all regulatory needs related to ePI implementation.

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