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GMP clearance guidance update

29 March 2019

As part of our on-going review and improvement of existing guidance material, we have published an updated version of the GMP clearance guidance (V18.2).

Some of the updates included in version 18.2 are:

  • Guidance on the stop clock process for CV applications
  • Guidance on how to interpret the status of your application.

The existing version of the guidance will be archived and will no longer be accessible.

We strongly encourage you to familiarise yourselves with, and start using the updated version of the GMP clearance guidance.

Enquiries and feedback

The TGA welcomes feedback that helps processes be improved. We would welcome any feedback you have on the updated GMP clearance guidance.

You can find our contact details on: Manufacturing therapeutic goods.