Potency declaration/labelling for biological medicinal products which contain modified proteins as active substance - Scientific guideline
Table of contents
This 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.
Keywords: Modified proteins, potency, international standard
Concept paper on potency declaration / labelling for biological medicinal products which contain modified proteins as active substance (PDF/69.56 KB)Draft: consultation closed
First published: 14/03/2011
Last updated: 14/03/2011
Consultation dates: 17/02/2011 to 17/05/2011