European Medicines Agency (EMA) / Heads of Medicines Agencies (HMA) / European Commission (EC) workshop on electronic product information (ePI)

• Date:
  Wednesday, 28 November 2018, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

The objectives of this joint workshop are to agree with all stakeholders on common key principles for the use of electronic summary of product characteristics (SmPC) and package leaflet formats in the European Union (EU) and create a draft proposal of these key principles for public consultation.

The European Commission, HMA and EMA are working together to facilitate the development of electronic tools to improve access of patients and healthcare professionals to product information in the EU. Electronic formats bring new opportunities for summary of product characteristics and package leaflets.

As more Europeans gain access to information technologies, it is important to agree with all stakeholders on common key EU principles as to how electronic formats can be used to provide product information to EU citizens in accordance with existing legislation.

Video

Documents

Electronic product information for human medicines in the European Union – draft key principles

Draft: consultation closed Consultation dates: 31/01/2019 to 31/07/2019 Reference Number: EMA/849614/2018 Summary:

A medicine’s product information is regulated, scientifically validated information that assists healthcare professionals in prescribing and dispensing and informs patients and consumers about safe use. The development of electronic product information (ePI) is intended to improve access to up-to-date product information when and where it is needed. The European Medicines Agency, in collaboration with Heads of Medicines Agencies and the European Commission, has developed some key principles through stakeholder consultations to guide future development of ePI for medicines in the EU. 

We wish to ask the public whether they agree with the key principles we have identified and whether there is any additional topic that should be reflected. Comments should be submitted via an online form.

Report - European Medicines Agency (EMA) / Heads of Medicines Agencies (HMA) / European Commission (EC) workshop on electronic product information (ePI)

Agenda - European Medicines Agency (EMA) / Heads of Medicines Agencies (HMA) / European Commission (EC) workshop on electronic product information (ePI)

Adopted Reference Number: EMA/669345/2018

List of participants - European Medicines Agency (EMA) / Heads of Medicines Agencies (HMA) / European Commission (EC) workshop on electronic product information (ePI)

Presentation - Towards digital transformation of health and care (K. Kurgonaite and P. Tosetti)

Presentation - ePI: Getting the focus right (F. Tabatabaei)

Presentation - Opportunities for expanding access to produce information for medicines: a patient perspective (K. Immonen)

Presentation - Workshop on electronic product information (S. Jensen)

Presentation - Opportunities for expanding access to product information for medicines: Stakeholders’ needs and challenges’ from a perspective of a healthcare professional (D. J O'Loughlin)

Presentation - Electronic dissemination of product information (G. Bejeuhr)

Presentation - Current landscape - How does ePI fit in with other initiatives? (M. Diaz and J. Burgos)

Presentation - Overview of initiatives from the EMA-HMA mapping (R. Gonzalez-Quevedo)

Presentation - Current landscape: How does ePI fit in with other initiatives - AEMPS (C. Garcia)

Presentation - Collaboration with the Norwegian Pharmaceutical Compendium (V. Abyholm)

Presentation - Electronically structured coded PI Swedish (human and veterinary) (K. Sherwood)

Presentation - Fass – Electronic product information in Sweden (G. Englund)

Presentation - Digitising product information: Greater accessibility for public health and all patients (N. Knight and J. Moreland)

Presentation - E-PIL Belgium & Luxembourg Pioneer Pilot Project (N. Lambot)

Presentation - Product Information 4.0 “Gebrauchsinformation 4.0 (GI 4.0)” (G. Lang)

Presentation - A future perspective: Tailored, integrated digital health information

Presentation - Common electronic standard: potential features and use cases (E. Scanlan)