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

AdoptedLegal effective date: Reference Number: 3BR3a

English (EN) (43.39 KB - PDF)

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