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Suspending, revoking and TGA initiated variation of conditions of a manufacturing licence

As part of the revised GMP fees and charges, this information has been updated to reflect changes in TBS.

Last updated

This guidance will assist Australian manufacturers understand how TGA manufacturing licences can be suspended or revoked.

It is not intended for:

  • overseas manufacturers
  • medical device manufacturers

We provide separate guidance on Revoking manufacturing licences for not paying the annual charge on our website.

If you wish to request a variation to the details of your licence, see our guidance on Varying a manufacturing licence.

When we revoke or suspend a licence we will:

  • notify you of our decision in writing
  • publish our decision in the Gazette or on our website [in line with subsection 41(6) of the Therapeutic Goods Act 1989]

Our decision is considered an 'initial decision' and you can request it be reconsidered under subsection 60(1) of the Therapeutic Goods Act 1989.

Suspending, revoking and TGA initiated variation of conditions of a manufacturing licence

Contents

  • Suspending and revoking manufacturing licences
    • Manufacturer requests to suspend or revoke a licence
    • How to make a request to suspend or revoke a licence
  • TGA-initiated suspension or revocation
    • Why we suspend or revoke licences
      • Imminent risk
    • Process
      • Notification of intent
      • Delegate's decision
      • Publishing our decision
      • Your ongoing obligations
  • TGA initiated variations to your licensing conditions
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