Prevention of medication errors in the EU

The European Medicines Agency (EMA), has released two draft good practice guides that aim to improve the reporting, evaluation and prevention of medication errors by regulatory authorities and pharmaceutical industry throughout the EU.

With the entry into force of the EU pharmacovigilance legislation in 2012, reporting of all suspected adverse reactions resulting from medication errors became mandatory. Pharmaceutical companies and national regulatory agencies in the EU Members States are obliged to enter these adverse events in EudraVigilance. The primary purpose of the two guides released today is to support industry and regulators in the implementation of these legal requirements. The deadline for stakeholders to send their comments to EMA is 14 June 2015.

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