TGA Australian manufacturing licences and overseas GMP certification

This is a step-by-step guide for: - Australian manufacturers of therapeutic goods (medicines, active pharmaceutical ingredients (APIs) and biologicals, human blood and blood components and haematopoietic progenitor cells) applying for a manufacturing licence for an Australian manufacturing site - Australian sponsors of therapeutic goods manufactured overseas applying for good manufacturing practice (GMP) certification of the overseas manufacturer - overseas manufacturers inspected by the TGA Published 1 December 2021