EMA public consultation on draft common EU standards for ePI

The European Medicines Agency (EMA) is consulting the public on draft common EU standards for electronic Product Information (ePI).

You can read more about ePI here.

About the draft common standard for ePI

The draft EU common standard for ePI is part of the ePI set-up project, started by EMA, national competent authorities and the European Commission in 2021. It aims at developing a common electronic standard for product information, carrying out a proof-of-concept exercise for implementing the standard and creating a roadmap for implementation across the EU.

EMA will publish progress updates and details of stakeholder consultations and share these with patients, healthcare professionals, academia and the pharmaceutical industry.

An EU Common Standard for ePI refers to the technical features of ePI to be agreed by regulators and stakeholders.

The consultation is being carried out on the following documents:

EMA information workshops

EMA is also holding an information workshop on 5 July and an exploratory workshop on 8 July 2021 for stakeholders and partners. You must register by 18 June. More information on the workshops here.

What is the role of the public consultation and workshops?

The public consultation and workshops are designed to inform stakeholders on the electronic standard and explore its future use. Feedback from the workshops will contribute to ensuring that the adopted EU common electronic standard meets the future needs of stakeholders to access, view and disseminate product information in electronic format.

Where can you provide feedback on the consultation?

You can provide feedback on the consultation via the survey here.

What are start and end dates of the consultation?

Start date: 7 June 2021

End date: 31 July 2021