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Assessed listed medicines evidence guidelines

V 1.1, August 2018

17 August 2018

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Version history

Version Description of change Author Effective date
V1.0 Original publication Complementary and OTC Medicines Branch, TGA March 2018
V1.1

Modified evidence for low level indications, consistent with listed medicines evidence requirements. Removed cross-references to guidelines to avoid confusion.

Additional information on biopharmaceutic studies and biowaivers.

Clarified use of CORs.

Included cross-reference to 'Guidance for completing the application form for an assessed listed medicine'.

Amended pre-submission meeting process.

Corrected appeal of preliminary assessment decisions and timeframe for lapsing applications.

Other minor amendments.

Complementary and OTC Medicines Branch, TGA August 2018

Book pagination