EU patient groups to review package leaflets for new medicines
This article was originally published in SRA
Executive Summary
Patients’ and consumers’ organisations in the European Union will from now on be able to take part in the review of medicine package leaflets at the time of marketing authorisation, rather than just at the time of the five-year renewal, the European Medicines Agency has announced1. PCOs will continue to be involved in reviewing the summaries of European Public Assessment Reports that are routinely published by the EMEA for approved medicines.