Another milestone: EURORDIS reviews 100th public document for the European Medicines Agency

medicine package information leafletEURORDIS has reached a milestone with the review of the 100th public document for the European Medicines Agency (EMA). EURORDIS volunteers and staff who are officially registered as experts with the EMA are eligible to review public documents, including medicine package leaflets, European Public Assessment Reports (EPAR) summaries, and safety communications.

The EMA initiated the systematic review of public documents in 2007 in order to verify that information for patients and consumers is written in clear, understandable, patient-friendly language. As stated in the Sixth annual report on the interactions with patients’ and consumers’ organisations of the EMA: “Experience acquired so far confirms the relevance of comments received with an average 30-50% of comments taken on board. The patients’ and consumers’ contribution helps improve the quality of the documents within the scope of this procedure”.

EURORDIS experts review primarily package leaflets and EPAR summaries for orphan medicines.

The patient experts who review the documents intended for the public attend a training session organised by the EMA on the review procedure. A training manual is also available on the EMA website. Medicine package leaflets and EPARs provide crucial information to help patients use their medicine correctly and safely. The package leaflets for medicines authorised via the centralised procedure at the EMA are valid in all EU Member States - in other words for some 512 million people.

Besides being available in medicine packages, medicine informational leaflets can be found on the EMA website in all EU languages, along with the EPARs and EPAR summaries.

If you find a medicine package leaflet or EPAR difficult to understand or unclear, you can contact EURORDIS Treatment Information and Access Director / Health Policy Advisor François Houÿez

Louise Taylor, Communications and Development Writer, EURORDIS


Page created: 02/04/2014
Page last updated: 31/03/2014
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