Replacement of chlorofluorocarbons (CFC) in metered dose inhalation products - Scientific guideline

This document provides guidance on compiling the dossier for submission for the replacement of a chlorofluorocarbon propellant in an already authorised medicinal product. It identifies the considerations of quality, safety and efficacy which should be taken into account.

Keywords: Chlorofluorocarbons (CFC)

Current effective version

Replacement of chlorofluorocarbons (CFC) in metered dose inhalation products

Adopted Reference Number: 3BR3a Legal effective date: 30/12/1993