Adventitious agent safety of urine-derived medicinal products

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Current effective version

Adopted guideline

Reference numberEMA/CHMP/BWP/126802/2012
Published29/05/2015
Effective from01/12/2015
KeywordsUrine-derived medicinal products, adventitious agents, investigational studies
DescriptionThis document considers various aspects of viral saefty of urine-derived medicinal products: it provides guidance in inactivation/removal of virus and its validation.


Document history

First version

Current version

Adopted guideline


Overview of comments


Draft guideline

In operation: 01/12/2015–present


Published: 29/05/2015


Published: 22/11/2013


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