Suspending, revoking and TGA initiated variation of conditions of a manufacturing licence
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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 - external site.
Suspending, revoking and TGA initiated variation of conditions of a manufacturing licence
- Suspending, revoking and TGA initiated variation of conditions of a manufacturing licence (pdf,485kb)
- Suspending, revoking and TGA initiated variation of conditions of a manufacturing licence (docx,309kb)
We aim to provide documents in an accessible format. If you're having problems using this document, please contact the Manufacturing Quality Branch.
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
- Why we suspend or revoke licences
- TGA initiated variations to your licensing conditions
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