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

Current effective version

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

Adopted Reference Number: EMA/CHMP/BWP/85290/2012 Legal effective date: 01/09/2014

Document history

Overview of comments received on 'Guideline on the declaration of the quantitative composition / potency labelling of biological medicinal products that contain modified proteins as active substance’

Adopted Reference Number: EMA/CHMP/BWP/692937/2013

Draft - Guideline on epidemiological data on blood transmissible infections - Rev 1

Reference Number: EMEA/CPMP/BWP/125/04. Rev 1