Obtaining a marketing authorisation for nitrous oxide

Abstract

OBJECTIVE: To prepare a Common Technical Document for nitrous oxide (NO) in accordance to European Guidelines, for submission to the Medicine’s Authority to obtain a Marketing Authorisation (MA) and to carry out a project feasibility study. METHOD: Directives and guidelines issued by the European Commission were followed to compile a dossier for NO in the Common Technical Document (CTD) format, in preparation of an abridged application. KEY FINDINGS: The Common Technical Document gave details on the Administrative Information (Module 1), Summaries (Module 2), Quality (Module 3) and Non- Clinical Studies (Module 4) consisting of a detailed scientific bibliography. The active substance manufacturer was inspected and accepted as an approved supplier. A feasibility study which was conducted proved the project feasible. CONCLUSION: The whole manufacturing process of nitrous oxide is well controlled and batches can be produced with a constant level of quality. NO has been used for 150 years for analgesia and anesthesia and has proven safe and effective. Even though its administration is not without risks, it currently has a niche role as an inhalational analgesic and sedative.