Authorization of Medicinal Gases in Switzerland: Legal Framework and Procedures

This document provides a comprehensive overview of the legal framework for the authorization of medicinal gases in Switzerland. It details the therapeutic product legislation’s legal basis, the guidance document’s purpose, and its applicability to medical gases as medicinal products. Types of authorization covered include medical devices and Swissmedic authorization for medicinal products, along with any relevant exemptions. Swissmedic only authorizes ready-to-use medicinal products, which may require reconstitution prior to administration. Applicants must submit evidence of safety, efficacy, and quality for authorization. Additionally, the document outlines two distinct procedures for obtaining Swissmedic authorization for medicinal gases.

Region: Switzerland

Source: https://www.swissmedic.ch/dam/swissmedic/de/dokumente/zulassung/zl_hmv_iv/zl000_00_016d_wlzulassungvonmedizinalgasen.pdf.download.pdf/ZL000_00_016d_WL%20Zulassung%20Medizinalgas.pdf

Region: Switzerland