The TGA, Australia has updated several updated guidance documents on aspects of Australian manufacturing licences and overseas GMP certification.
1) Applying for a manufacturing licence for an Australian manufacturing site
This updated step-by-step, 47 page guide (version 2.2, Dec 2021) with minor updates to include remote and hybrid inspections and revised licence issuing processes 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
Further information is available here.
2) Requesting variations to your manufacturing licence
This updated a step-by-step, 20 page guide (version 1.2, Dec 2021) with minor editorial changes is for Australian manufacturers of therapeutic goods (other than medical devices) applying through TGA Business Services to vary an in-force manufacturing licence for an Australian manufacturing site under section 40B of the Therapeutic Goods Act 1989.
Note that variations to your GMP certification for an overseas manufacturer cannot be requested via TGA Business Services. These requests should be emailed to to Manufacturing Quality Branch.
Further information is available here.
3) Suspending, revoking and TGA initiated variation of conditions of a manufacturing licence
This updated 11 page guide (version 1.2, Dec 2021) with minor editorial changes will assist Australian manufacturers to understand how TGA manufacturing licences can be suspended or revoked.
Further information is available here.