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About this guideline
Overseas publication date: 5 June 2014
Note: To be read in conjunction with the Guideline on the use of near infrared spectroscopy by the pharmaceutical industry and the data requirements for new submissions and variations (EMEA/CHMP/CVMP/QWP/17760/2009 Rev2)
Categories: Quality | Specifications and analytical procedures and analytical validation
TGA annotations
Prior approval by the TGA (e.g., via a Category 3 application) is necessary before implementation of any of the changes identified in Table 3 in this Addendum.
- 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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For more information see International scientific guidelines adopted in Australia.