GMP clearance

A GMP clearance refers to approval of an overseas manufacturer of therapeutic goods following assessment of GMP evidence of standard of manufacturers from overseas regulators. Many applications for registration or listing of a therapeutic good on the ARTG are either delayed or rejected due to a lack of acceptable evidence of the standard of manufacture of the therapeutic goods. Therefore, sponsors are requested to obtain a GMP clearance of overseas manufacturers prior to submitting an application for registration, listing, or variation of a product.

See: Frequently asked questions about GMP clearance