Definition of a new biological active substance in terms of active, passive immunity and immunomodulators which then constitute a new active ingredient in the context of part B of the Annex to Council Regulation (EEC) No 2309/93 - Scientific guideline

This document provides the definition of a new biological active substance in terms of active, passive immunity and immunomodulators which then constitute a new active ingredient in the context of part B of the Annex to Council Regulation (EEC) No 2309/93.

Keywords: Biological active substance, definition

Document

Position paper on definition of a new biological active substance in terms of active, passive immunity and immunomodulators which then constitute a new active ingredient in the context of part b of the annex to council r...

Adopted Reference Number: CVMP/IWP/029/97-FINAL Legal effective date: 01/03/1998