HOTLINE 24/7/365 UK: +44 (0) 1483 212150
Jan 31
Medicine Bottle

European Six-Month Product Information Process Proposed

Product Information (PI) is provided with every medicine authorised in the European Union; its purpose being to inform patients and healthcare professionals alike of important factors, such as how the drug is to be administered, what it should be prescribed for, and potential side effects. The PI for human medicines marketed in the EU encompasses the Patient Information Leaflet (PIL) and the Summary of Product Characteristics (SmPC) for healthcare professionals.

Although hard copies of this information has been available in the product package for a long time (with EU pharmaceutical legislation having been introduced in 2005 to improve the quality of PILs); in a world increasingly reliant on technology, the importance of having such information available electronically is certain to increase.

To initiate conversation amongst stakeholders regarding how the Electronic Product Information (ePI) for human medicines should be used and developed in the European Union, the European Medicines Agency (EMA) in collaboration with the Heads of Medicines Agencies (HMA) and the European Commission (EC), have launched a brand-new six-month consultation.

Draft guidance surrounding the key principles of ePI was published as a joint EMA-HMA-EC collaboration today (31 January 2019). The PDF is split into subsections including how the guidance aims to complement current legislative framework; the ways in which it could benefit public health; and considers factors such as multilingual ePI.

These proposals have been formulated from numerous conversations and consultations held between the EMA, HMA and EC throughout 2018, including a workshop which was held at the EMA’s London headquarters on 28 November 2018.

Stakeholders and the general public are invited to submit their comments on the proposal via an online form until 31 July 2019. The final key principles for electronic product information for human medicines in the EU will be agreed after the consultation, when all comments received will have been considered.

For more information, please visit the EMA website.

PharSafer Comment

Looking to have a central repository for Patient information in the EU will benefit patients, especially if it covers the various official languages across Europe.

There will undoubtedly need to be the necessary safeguards in place to ensure that the most up-to-date versions of the PI are announced and published on the website once available; together with any timelines to make sure that the PI is uploaded when it should be.

This will be another compliance statistic for companies to adhere to.  

Share this News item:
FacebooktwitterlinkedinmailFacebooktwitterlinkedinmail