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Addendum to EMA/CHMP/CVMP/QWP/17760/2009 Rev 2: defining the scope of an NIRS procedure

We have adopted this International Scientific Guideline - EMA/CHMP/CVMP/QWP/63699/2014.

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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.
  • All documents and other content published by the European Medicines Agency (EMA) on this website are under the copyright and other intellectual property rights ownership of the EMA. Please refer to Legal notice | European Medicines Agency for further information.

For more information see International scientific guidelines adopted in Australia.

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