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The Commission recommendations on improving the information contained on product leaflets for EU medicines are the basis of the European Medicines Agency's (EMA) newly published action plan on improving production information for EU medicines.
Under EU rules in place since 2001 medicines sold on the EU market should contain a package leaflet providing patients and healthcare professionals with information on the content and the use of the medicine. The Commission report to the European Parliament and Council published in March 2017 identifies a number of areas where improvements can be made, such as making the package leaflets easier to understand to all patient groups, improving the layout, and making product information available in both electronic and paper formats, one of the key areas of EMA's action plan.
EMA together with the European Commission will organise a multi-stakeholder workshop in the third quarter of 2018 to develop key principles for the use of electronic formats. To facilitate this process, EMA is launching a mapping exercise involving all stakeholders (patients and consumers, healthcare professionals, national authorities and pharmaceutical companies) to identify related initiatives by February 2018.
Methodology
The assessment was based on two studies requested by the Commission. These were the "PIL-S Study" – a study on package leaflets and the summaries of product characteristics of medicinal products for human use, and the "PILS-BOX Study" on the feasibility and value of a possible "key information" section in such leaflets and summaries. Both studies involved input from key stakeholders and from Member States. The EMA collaborated closely with the Commission for the preparation of this report. EMA and the Commission will work together with National Competent Authorities and relevant stakeholders to implement the action plan.
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