Guideline for temporary market authorization of medicinal gasses

Abstract

Medicinal gases play a critical role in modern healthcare, serving as essential therapeutic agents for various medical conditions. They comprise of medicinal products / drugs that are supplied as a gas or gas mixtures. Medical gasses whose mode of action is achieved primarily based on pharmacological, immunological or metabolic action in/on the body are classified as a medicinal gas. Therapeutic gases include Oxygen, Nitrogen, Nitrous oxide(N2O), mixture of nitrous oxide and oxygen, Nitric oxide (NO), Mixture of Nitric oxide with oxygen, Carbon oxide, mixture of carbon dioxide with oxygen, medical air (consisting largely of NMT 23.5% oxygen and NLT 19.5% nitrogen) and Helium, mixture of helium with oxygen. Gases designated for therapeutic purpose must undergo rigorous testing and meet standards before use. On the other hand, gases or gas mixtures in which mode of action is achieved primarily by physical in nature and not achieved primarily based on pharmacological, immunological or metabolic action in/on the body, such as gases for insufflations of the abdominal cavity for laparoscopy and gases for removal of warts (e.g. liquid nitrogen) are classified as medical device.