Overview of Legal Framework for Authorization of Medicinal Gases in Switzerland

This document provides a detailed explanation of the legal framework governing the authorization of medicinal gases in Switzerland, focusing on the relevant therapeutic product legislation and the procedures involved. It serves as a guide for understanding the requirements and processes for obtaining authorization for medicinal gases as medicinal products.

Key Points Covered:
Legal Basis for Authorization:

The authorization process for medicinal gases in Switzerland is grounded in therapeutic product legislation, which sets the standards for safety, efficacy, and quality.
Scope of the Guidance:

The document outlines the purpose and applicability of the guidance for medicinal gases as medicinal products, clarifying the regulatory expectations for these products.
Types of Authorization:

Medical Devices: Medical gases may fall under the regulatory framework for medical devices.
Swissmedic Authorization for Medicinal Products: Swissmedic, the Swiss agency responsible for medicinal product regulation, issues authorizations for medicinal products, including medicinal gases.
Exemptions:

The document highlights any relevant exemptions to the authorization process, providing clarity on when certain gases or products may not require full approval.
Ready-to-Use Medicinal Products:

Swissmedic only authorizes ready-to-use medicinal products. However, certain products may require reconstitution before administration, which must be taken into account by applicants.
Authorization Requirements:

Applicants seeking authorization for medicinal gases must provide evidence of safety, efficacy, and quality in accordance with regulatory standards.
Authorization Procedures:

The document outlines two distinct procedures for obtaining Swissmedic authorization for medicinal gases. These procedures ensure that the products meet the required standards before they are placed on the market.
This comprehensive framework ensures that medicinal gases in Switzerland are subject to rigorous evaluation, ensuring their safety and effectiveness for therapeutic use.

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