Declaration of the quantitative composition/potency labelling of biological medicinalproducts that contain modified proteins as active substance - Scientific guideline

This 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.

Keywords: Declaration, quantitative composition, product labelling, biopharmaceuticals, modified proteins, potency, unit, clinical practice, product information