EMA: Guideline on the declaration of the quantitative composition / potency labelling of biological medicinal products that contain modified proteins as active substance.

This guideline outlines the approaches to be followed for declaring the quantitative composition / potency labelling of medicinal products that include modified proteins as their active substance, taking into account the product class and the clinically established declared value (e.g. international unit, mass unit) for the non - modified product, the method of assay (biological or physico - chemical), and relevance of the potency assay (i.e. correlated with clinical efficacy).