Manufacturing standards for overseas manufacturers

This section is for overseas manufacturers of therapeutic goods. You should also see 'Manufacturing basics' which includes information for all manufacturers of therapeutic goods.

According to the Therapeutic Goods Act 1989, the standard of manufacture, and quality control of therapeutic goods manufactured outside Australia, be noted in 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.

GMP clearance

Guidelines and standards