Medicinal gases

Medicinal gases such as oxygen and nitrous oxide are classified as medicinal products under European pharmaceutical legislation, and must be manufactured in accordance with Good Manufacturing Practice (GMP), specifically EU GMP Annex 6, which addresses the unique aspects of medicinal gas production. These gases are used for therapeutic purposes such as respiratory support and anesthesia.  As medicinal products, they require manufacturing and distribution licenses and a marketing authorisation which describes manufacturing and quality control. In order to maintain patient safety EIGA members must have a pharmacovigilance system as outlined by the European Medicines Agency (EMA).

Medical device gases

Medical device gases, including nitrogen, and argon, are regulated under the Medical Device Regulation. These gases are not used for direct therapeutic purposes but support medical procedures such as cryotherapy and plasma coagulation.  They require CE marking and technical documentation demonstrating safety and performance.