European Medicines Agency (EMA) / Heads of Medicines Agencies (HMA) / European Commission (EC) workshop on electronic product information (ePI)
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.
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Electronic product information for human medicines in the European Union – draft key principles (PDF/519.15 KB)
Draft: consultation closed
First published: 31/01/2019
Consultation dates: 31/01/2019 to 31/07/2019
EMA/849614/2018 -
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Report - European Medicines Agency (EMA) / Heads of Medicines Agencies (HMA) / European Commission (EC) workshop on electronic product information (ePI) (PDF/368.25 KB)
First published: 31/01/2019 -
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Agenda - European Medicines Agency (EMA) / Heads of Medicines Agencies (HMA) / European Commission (EC) workshop on electronic product information (ePI) (PDF/1.32 MB)
Adopted
First published: 05/11/2018
Last updated: 20/12/2018
EMA/669345/2018 -
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List of participants - European Medicines Agency (EMA) / Heads of Medicines Agencies (HMA) / European Commission (EC) workshop on electronic product information (ePI) (PDF/211.1 KB)
First published: 19/12/2018 -
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Presentation - Towards digital transformation of health and care (K. Kurgonaite and P. Tosetti) (PDF/778.27 KB)
First published: 19/12/2018 -
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Presentation - ePI: Getting the focus right (F. Tabatabaei) (PDF/976.54 KB)
First published: 19/12/2018 -
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Presentation - Opportunities for expanding access to produce information for medicines: a patient perspective (K. Immonen) (PDF/767.71 KB)
First published: 19/12/2018 -
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Presentation - Workshop on electronic product information (S. Jensen) (PDF/347.76 KB)
First published: 19/12/2018 -
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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) (PDF/1.52 MB)
First published: 19/12/2018 -
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Presentation - Electronic dissemination of product information (G. Bejeuhr) (PDF/1.58 MB)
First published: 19/12/2018 -
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Presentation - Current landscape - How does ePI fit in with other initiatives? (M. Diaz and J. Burgos) (PDF/166.42 KB)
First published: 19/12/2018 -
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Presentation - Overview of initiatives from the EMA-HMA mapping (R. Gonzalez-Quevedo) (PDF/401.13 KB)
First published: 19/12/2018 -
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Presentation - Current landscape: How does ePI fit in with other initiatives - AEMPS (C. Garcia) (PDF/782.5 KB)
First published: 19/12/2018 -
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Presentation - Collaboration with the Norwegian Pharmaceutical Compendium (V. Abyholm) (PDF/589.95 KB)
First published: 19/12/2018 -
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Presentation - Electronically structured coded PI Swedish (human and veterinary) (K. Sherwood) (PDF/495.3 KB)
First published: 19/12/2018 -
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Presentation - Fass – Electronic product information in Sweden (G. Englund) (PDF/1.72 MB)
First published: 20/12/2018 -
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Presentation - Digitising product information: Greater accessibility for public health and all patients (N. Knight and J. Moreland) (PDF/619.58 KB)
First published: 20/12/2018 -
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Presentation - E-PIL Belgium & Luxembourg Pioneer Pilot Project (N. Lambot) (PDF/460.68 KB)
First published: 20/12/2018 -
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Presentation - Product Information 4.0 “Gebrauchsinformation 4.0 (GI 4.0)” (G. Lang) (PDF/513.53 KB)
First published: 20/12/2018 -
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Presentation - A future perspective: Tailored, integrated digital health information (PDF/849.35 KB)
First published: 20/12/2018 -
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Presentation - Common electronic standard: potential features and use cases (E. Scanlan) (PDF/324.18 KB)
First published: 20/12/2018