Guidance on the GMP clearance of overseas medicine manufacturers
16th Edition
March 2008
The Therapeutic Goods Act 1989 (the Act) requires that the standard of manufacture, and quality control of therapeutic goods manufactured outside Australia, be taken into consideration for the registration or listing of those therapeutic goods on the Australian Register of Therapeutic Goods (ARTG), unless the goods are exempt from this requirement by the Act.
A sponsor applying to the Therapeutic Goods Administration (TGA) for registration or listing of a therapeutic good manufactured outside Australia, must provide an acceptable form of evidence to show that the manufacture of the goods is of an acceptable standard. This is referred to as Good Manufacturing Practice (GMP) clearance of overseas manufacturers.
The purpose of this guidance document is twofold. It is intended to provide information to sponsors and manufacturers on the acceptable form of evidence of GMP compliance for overseas manufacturers, and, outline how to submit such evidence to the TGA for assessment. It is not intended to provide a definitive list of the forms of evidence that are considered acceptable or unacceptable.