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Manufacturing biologicals

This section is for manufacturers of biologicals. You should also see Manufacturing basics and Manufacturing inspections, which include information for manufacturers of all types of therapeutic goods.

Manufacturing principles

Different manufacturing principles apply to different kinds of biologicals.


  • Australian regulatory guidelines for biologicals (ARGB)
    Information for manufacturers, sponsors, health professionals and the general public on the legal arrangements in Australia for the supply and use of human cell and tissue-based therapeutic goods (collectively defined as 'biologicals')
  • Manufacturing FMT products
    Information for sponsors, manufacturers and providers of faecal microbiota transplant (FMT) products

Licence guidance

Licence and overseas GMP certification applications


Revoking manufacturing licences