EU Begins Transition to Electronic Product Information for Medicines

Regulatory NewsRegulatory News
| 31 January 2019 | By Zachary Brennan 

The European Commission (EC), the European Medicines Agency (EMA) and the Heads of Medicines Agency (HMA) on Thursday launched a six-month public consultation on the draft key principles that will form the basis for creating electronic product information (ePI) for medicines in the EU.

Derived from conversations with EMA, EC, HMA and various stakeholders, the draft key principles explain how ePI, which includes the package leaflet for patients and the summary of product characteristics for health professionals, is expected to expand access to unbiased, up-to-date and regulator-approved information for all medicines.

Due to their electronic nature, medicines information will be more accessible and have the ability to be rapidly updated, which is expected to help patients/consumers in making informed decisions about their treatment and help them to adhere to their medication regimes, the consultation says.

But the consultation also says that the use of ePI will not constitute a new legal obligation, and package leaflets will still be included in the packaging of all medicines.

And although all stakeholders, including pharmaceutical companies and regulators, will commit to implementing the common electronic standard for the creation of the ePI for all EU medicines, the consultation notes that timelines and processes for implementation “should be flexible to allow for variations in resources and priorities. A roadmap will be proposed by HMA and EMA to guide implementation,” the consultation says.

“Some early-adopter Member States may begin using ePI for their authorised medicines as soon as possible, whereas other Member States may have different priorities for implementation,” the consultation notes. “Also, some Member States may wish to implement ePI throughout the medicines authorisation process and use it as a vehicle for exchanges on the PI with the applicant during the assessment, whereas other Member States may wish to have the SmPC, labelling and PL converted to ePI format only once the evaluation process has been finalised.”

The consultation also explains how the ePI will interface with other eHealth initiatives.

ePI interoperability with cross-border prescription, electronic health records, the future European medicines web portal, pharmacovigilance systems, SPOR data management services, a future European common data model and national ePI systems must be considered in the design of EU ePI. Use of ePI in both an EU and global context should also be taken into account,” the consultation says.

Stakeholders and members of the public are invited to submit comments on these key principles via an online form until 31 July 2019.

Electronic product information for human medicines in the EU – draft key principles


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy