You are here

GMP clearance guidance

Version 18.1, January 2019

4 January 2019

Book pagination

Cancellation or reduction in scope by TGA

We may cancel or reduce the scope of your GMP clearance where:

  • you decline to contribute to the cost of a TGA on-site inspection
  • the manufacturer declines a TGA on-site inspection
  • the outcome of a TGA on-site inspection is unsatisfactory
  • an MRA partner or other regulatory agency withdraws GMP certification, or we receive other compliance signals
  • evidence submitted to us is subsequently found to be incorrect.

You will be notified by email of the intention to cancel or reduce the scope along with the reasons for it, and you will be provided the opportunity to respond.

Book pagination