International scientific guideline: Use of near infrared spectroscopy by the pharmaceutical industry and the data requirements for new submissions and variations

About this guideline

Overseas effective date: 1 December 2014

Categories: Quality | Specifications and analytical procedures and analytical validation

Replaces: CPMP/QWP/3309/01, EMEA/CVMP/961/01

Access this international scientific guideline

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.