The 17th edition of the Guidance on the GMP clearance of overseas medicine manufacturers has been published and will be phased in over a 3 month period.
This document describes what constitutes acceptable evidence of an overseas manufacturer's GMP compliance and how to submit that evidence to the TGA. On the 15th August the 16th edition will be "retired", but up until that date applications for GMP preclearance can meet the requirements of either the 16th or 17th edition. (Source: www.tga.gov.au)
Last Updated on Wednesday, 25 May 2011 11:04
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