TRS 1067 - Annex 10: Regulatory considerations for the life cycle of medicinal oxygen

Overview

This regulatory consideration document provides recommendations for NRAs on the oversight of medicinal oxygen throughout its life cycle, covering production, quality control, storage, distribution and post-market activities. It also aims to support manufacturers, importers and distributors in understanding the regulatory requirements needed to ensure that medicinal oxygen consistently meets established quality and safety standards and is effectively delivered to patients.