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Title: Obtaining a marketing authorisation for nitrous oxide
Authors: Scicluna, Claire Anne
Fenech, Victor
Azzopardi, Lilian M.
Keywords: Drugs -- Design
Nitrous oxide -- Therapeutic use
Nitrous oxide -- Case studies
Pharmaceutical industry -- Quality control
Issue Date: 2014
Publisher: University of Malta. Department of Pharmacy & The Malta Pharmaceutical Association
Citation: Scicluna, C. A., Fenech, V., & Azzopardi, L. M. (2014). Obtaining a marketing authorisation for nitrous oxide. Journal of Euromed Pharmacy, 04, 25-28.
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.
Appears in Collections:Journal of Euromed Pharmacy : issue 04 : 2014
Journal of Euromed Pharmacy : issue 04 : 2014

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