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

  • Email
  • Help
Current effective version

Adopted guideline

Reference numberEMA/CHMP/BWP/85290/2012
Published21/03/2014
Effective from01/09/2014
KeywordsDeclaration, quantitative composition, product labelling, biopharmaceuticals, modified proteins, potency, unit, clinical practice, product information
DescriptionThis 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.


Document history

First version

Current version

Adopted guideline


Overview of comments


Draft guideline

In operation: 01/09/2014–present


Published: 21/03/2014


Published: 25/03/2013


Related content


How helpful is this page?

Average rating:

 Based on 0 ratings

Add your rating:

See all ratings
0 ratings
0 ratings
0 ratings
0 ratings
0 ratings
    

Tell us more