EMA to improve the product information for EU medicines

An action plan has been published by the European Medicines Agency (EMA) to improve the product information (PI) for EU medicines. The PI is an information package for patients and healthcare professionals, which is given with every medicine authorised in the EU, providing information on the safe use of the medicine and how it should be prescribed. At the time of the medicines approval the PI is also approved by the regulatory authorities in the EU. The PI is made up of the Summary of Product Characteristics (SmPC) for use by healthcare professionals and the package leaflet (PL) for patients.

Despite continual efforts to make the PI easy to read and more informative, the EMA is to work with stakeholders to improve how information on medicines is conveyed to the target audience of patients and healthcare professionals. This action plan follows a report published by the European Commission in March 2017.

A key area in the action plan outlines how electronic or digital means can be used to improve accessibility to medicines’ information for patients and healthcare professionals.

In the third quarter of 2018, the European Commission and the EMA will organise a multi-stakeholder workshop to develop key criteria for use of electronic formats. The EMA plans to start a mapping exercise involving all stakeholders (including patients, consumers, healthcare professionals, the pharmaceutical industry and national competent authorities) to ensure an extensive overview of all continual EU initiatives at the workshop.

Other initiatives included in the action plan will be implemented in a second phase. In view of the EMA’s business continuity plan in the context of Brexit and the Agency’s approaching relocation to another EU country, timelines may need to be adjusted.

Actions focus on:

  • Making the package leaflet easier to understand for EU citizens
  • Revising the EU guidance available for companies to prepare the package leaflet
  • Enhancing patients’ input in the preparation of the package leaflet.

The EMA and the European Commission are committed to working together with EU Member States to successfully enforce these activities. It is also crucial to include all relevant stakeholders as their input is key to ensure that their needs are met.

To read the action plan in more detail, please click here.