Guideline on medicinal products for the treatment of insomnia

We have adopted this International Scientific Guideline - EMA/CHMP/16274/2009.

Last updated

4 June 2024

About this guideline

Overseas effective date: September 2011

Replaces: pp. 359 - 370 of Rules 1998 (3C) - 3CC27a. Clinical Investigation of Hypnotic Medicinal Products (adopted by TGA July 1994)

Categories: Clinical efficacy and safety | Nervous system

TGA annotations: nil

Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.
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