Potential medication errors in the context of benefit risk balance and risk minimisation measures

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Current effective version

Adopted position paper

Reference numberEMA/CHMP/277591/2013
Published01/06/2013
Effective from01/06/2013
KeywordsMedication error, similar medicinal products, reference product, product confusion, error prevention
DescriptionThis document focuses on the impact of potential medication errors on the benefit-risk balance of medicinal products introducing changes in relation to an authorised/established product containing the same active substance.


Document history

First version

Current version

Adopted position paper


Overview of comments


Draft position paper

In operation: 01/06/2013–present


Published: 07/06/2013


Published: 01/06/2012


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