Electronic product information (ePI) for human medicines in the EU

On 31 January 2019 the European Medicines Agency (EMA) published draft key principles for the development and use of electronic product information (ePI) for medicines for human use in the EU. Stakeholders and members of the public can submit comments using an online form until 31 July 2019.

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.

For more detailed information on draft key principles for ePI refer below link.

https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/electronic-product-information-human-medicines-european-union-draft-key-principles_en.pdf