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Assessed listed medicines evidence guidelines
V 1.1, August 2018
|Version||Description of change||Author||Effective date|
|V1.0||Original publication||Complementary and OTC Medicines Branch, TGA||March 2018|
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|