This guideline outlines the approaches to be followed for declaring the quantitative composition / 27 labelling of medicinal products that include modified proteins as their active substance, taking into 28 account the product class and the clinically established declared value (e.g. international unit, mass 29 unit) for the non-modified product, the method of assay (biological or physico-chemical), and 30 relevance of the potency assay (i.e. correlated with clinical efficacy). For product labelling, it is 31 considered important that the chosen unitage will not be confusing in clinical practice. The product 32 information for healthcare professionals and patients must clearly differentiate the modified product 33 from the non-modified product. This document also discusses the use of the activity unit to define a 34 quality attribute during product manufacture and control.
|Download document||Draft guideline on the declaration of the quantitative composition / labelling of biological medicinal products that contain modified proteins as active substance|
|Status||draft: consultation open|
|Consultation start date||25/03/2013|
|Consultation end date||01/10/2013|
|Email address for submissions||GLfirstname.lastname@example.org|