International scientific guideline: Paediatric addendum to CHMP guideline on clinical investigation of medicinal products in the treatment of lipid disorders

About this guideline

Overseas effective date: 1 Aug 2014

Categories: Clinical efficacy and safety | Cardiovascular system | Lipid disorders

Access this international scientific guideline

TGA annotations

In place of: EMEA/CHMP/EWP/350495/2009 Concept paper (provided for information 26 March 2010)

For more information see International scientific guidelines adopted in Australia.

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.