Australia – Australian manufacturing licences and overseas GMP certification

This step-by-step guide is 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 GMP certification of the overseas manufacturer
  • overseas manufacturers inspected by the TGA

This guidance is not intended for: