EMA draft position paper on potential medication errors in the context of benefit risk balance and risk minimisation measures

This position paper is intended to provide guidance on how potential medication errors should be addressed in the context of benefit risk balance assessment and risk minimisation measures. Specifically, the paper focuses on potential medication errors caused by confusion of a newly introduced medicinal product with established medicines that contain the same active substance and are similar in appearance and/or name but different in some other attributes such as, for example, strength, dosing and route of administration.

Posted on the EMA webiste, 1 June 2012