EMA to work with stakeholders to improve the product information for EU medicines

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15/11/2017

EMA to work with stakeholders to improve the product information for EU medicines

Stakeholder feedback sought on ongoing electronic initiatives

The European Medicines Agency (EMA) has published an action plan to improve the product information (PI) for EU medicines, an information package for patients and healthcare professionals that accompanies every single medicine authorised in the EU and explains how it should be used and prescribed. This action plan follows a report published by the European Commission in March 2017 which concluded that despite ongoing efforts to make the PI easy to read and useful, there is a need to improve how information on medicines is conveyed to patients and healthcare professionals.

One of the key areas of this plan is to explore how electronic or digital means can be used to improve accessibility to medicines’ information by patients and healthcare professionals.

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 ensure a comprehensive overview of all ongoing EU initiatives at the workshop, EMA will start a mapping exercise involving all stakeholders (patients and consumers, healthcare professionals, pharmaceutical industry and national competent authorities).

To facilitate this mapping exercise, stakeholders are invited to send an overview of initiatives on electronic/digital formats for the product information that they are aware of or working on. Feedback should be sent by end of February 2018 to ePI@ema.europa.eu or using the survey provided. This input will be considered for the organisation and participation in the 2018 workshop.

EMA’s action plan also includes other initiatives which will be implemented in a second phase. Their timelines may need to be adjusted in view of EMA’s business continuity plan in the context of Brexit and the Agency’s upcoming relocation to another EU country. These actions focus on:

  • how to make the package leaflet easier to understand for EU citizens;
  • updating the EU guidance available for companies to prepare the package leaflet;
  • strengthening patients’ input during the preparation of the package leaflet.

EMA and the European Commission are committed to working together with EU Member States to successfully implement these activities. All relevant stakeholders will also be involved as their input is crucial to ensure that their needs are addressed

The Agency has elaborated this action plan following discussions with representatives of patients and healthcare professionals and with experts from Member States.

The product information is approved by the regulatory authorities in the EU at the time of the medicine’s approval. It comprises the Summary of Product Characteristics (SmPC), intended for healthcare professionals, and the package leaflet (PL) for patients. It contains the conditions of use of a medicine and all the essential information needed for it to be prescribed and used safely.

Depending on the impact of EMA’s relocation on staff retention, the timelines proposed may need to be adjusted.

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