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+# ePI Consultation
+
+## What is ePI?
+
+[EU Common Standard for electronic product information (ePI)](https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/product-information-requirements#electronic-product-information-initiative-section) is authorised, statutory product information for EU medicines (the summary of product  characteristics [SmPC, intended for healthcare professionals], labelling [outer and inner packaging information] and package leaflet [PL, for patients / consumers]) in a semi-structured format created using the EU Common Standard. ePI is adapted for electronic handling and allows dissemination via the web, e-platforms and print. 
+
+## Consultation 
+
+EMA, national competent authorities and the European Commission are conducting an electronic product information (ePI) set-up project to develop an EU Common Standard for ePI. 
+
+An EU Common Standard for ePI refers to the technical features of ePI to be agreed by regulators and stakeholders. The documentation for the draft EU Common Standard is currently the subject of an open public consultation. 
+
+To facilitate stakeholder consultation, EMA is hosting half-day virtual workshops designed to inform on the standard and explore its future use. Feedback from the workshops will contribute to ensuring that the adopted Common Standard meets the needs of its future users, confirming they can access, view and disseminate product information in electronic format, ePI.
+
+## Workshops
+- The Information Workshop is aimed at stakeholders and partners. Attendance is not restricted. 
+- The Exploratory Workshop is aimed at technical participants with knowledge of development languages and REST API. Participants will require their own workstation with an XML editor, API developer and development environment. These are mandatory requirements, as these workshops involve participants carrying out hands-on development tasks.
+
+NB. Exploratory Workshop participants are strongly advised to attend the Information Workshop also to gain a full understanding of the context and hear background presentations.
+
+## Exloratory workshop
+
+The material to be used in the exploratory workshop will be managed [here](https://github.com/EuropeanMedicinesAgency/ePI-consultation).
+1. A FHIR xml template based on the Quality Review of Documents (QRD) template for human medicines. 
+2. An instance of the standard comprising xml, xsl and html files; 
+3. ePI API Specification (PDF) and the associated ePI API service list (Excel).
+
+## Contact
+
+For further information or clarifications please contact <[email protected]>.