Public consultation on electronic package leaflets and summaries of product characteristics across the EU

12 March 2019

What should the package leaflets and labels of medicines for citizens and the summaries of product characteristics for healthcare professionals look like in the future? A public consultation on key principles about this has been launched throughout the EU, with comments to be submitted by 31 July.

It should be easier to read and access package leaflets, and a best practice should be developed for electronic package leaflets across the EU. These are some of the intentions behind a public consultation in the EU on a number of key principles for how the so-called product information should be developed in the future.

The product information covers the package leaflets that accompany medicines, any labels on and inside medicine packs as well as the summaries of product characteristics that are used by doctors, nurses, proprietary pharmacists and other healthcare professionals.

Patient organisations, healthcare professionals, researchers, companies, citizens and anyone interested can submit their comments online via this form by 31 July this year. The key principles and the consultation are in English.

Ambition: Improved delivery of information about medicines

The key principles intend to establish a common project framework, provide definitions for the different elements of the product information and describe how the electronic product information can be supported in all EU languages.

According to the key principles, the project aims to contribute to the continuous availability of unbiased, updated and regulator-approved information for all medicines across the EU. In addition, the delivery of this information should be improved in future so that an adequate amount and type of information is available to the patients and people who need it at the time of their convenience.

For example, electronic package leaflets can help ensure that updates about a medicine's use and side effects can reach patients and citizens faster.

Furthermore, the product information must be designed in such a way that it is accessible for all, including, for example, visually impaired people or those with poor reading skills.

The consultation is launched by the Heads of Medicines Agencies (HMA), which is currently chaired by the Danish Medicines Agency in Denmark, the European Medicines Agency (EMA) and the European Commission.

Please find more information on the website of the EMA: Public consultation on key principles for the electronic product information of EU medicines.

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