Potency declaration/labelling for biological medicinal products which contain modified proteins as active substance

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Concept paper

Reference numberEMA/CHMP/BWP/776563/2010
KeywordsModified proteins, potency, international standard
DescriptionThis document reflects the need for a guideline for potency assignment of modified proteins. It shall apply to proteins for which an International Standard exists or where a clinical recognised unit exists (without an International Standard established) for the non-modified product.

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