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

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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... (PDF/29.24 KB)

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First published: 01/02/1998
Last updated: 01/02/1998
Legal effective date: 01/03/1998
CVMP/IWP/029/97-FINAL

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

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Current effective version

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... (PDF/29.24 KB)

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