Declaration of the quantitativecomposition/potency labelling of biological medicinalproducts that contain modified proteins as activesubstance

Current effective version

PDF iconAdopted guideline

Reference numberEMA/CHMP/BWP/85290/2012
Published21/03/2014
Effective from01/09/2014
KeywordsDeclaration, quantitative composition, product labelling, biopharmaceuticals, modified proteins, potency, unit, clinical practice, product information
DescriptionThis document provides guidance on the declaration of the quantitative composition/potency labelling of medicinal products that contain modified proteins as their active substance. It also discusses the use of the activity unit to define a quality attribute during product manufacture and control.


Document history

First version

Current version

PDF iconAdopted guideline


PDF iconOverview of comments


PDF iconDraft guideline

In operation: 01/09/2014–present


Published: 21/03/2014


Published: 25/03/2013


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