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

Version 1.0, August 2017

4 August 2017

Suspending and revoking manufacturing licences

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.

Manufacturer requests to suspend or revoke a licence

If you wish to stop manufacturing therapeutic goods, you need to ask us to suspend or revoke your manufacturing licence [as per section 41(1)(d) of the Therapeutic Goods Act 1989]. You can make this request via TGA Business Services.

To request any other changes to your manufacturing licence, apply to vary your licence.

When we suspend or revoke a licence at your request we will not issue you a notice of intent. However, we may withdraw the revocation if you ask us to in writing within 90 days of the revocation date (as per section 41AAAA Therapeutic Goods Act 1989).

How to make a request to suspend or revoke a licence

You can ask us to suspend or revoke your manufacturing licence by applying through TGA Business Services.

  1. Log in to TGA Business Services at https://www.ebs.tga.gov.au/
  2. Click on Your TGA to open the dropdown menu and select Manufacturer Information.

    Screenshot: the Your TGA drop-down menu showing Manufacturer Information selected

  3. Search for your licence. One way to do this is to filter by Identifier, or you may search for your licence using other fields or filters.

    Screenshot: Manufacturer Information highlighting Identifier

  4. When you locate your licence, double-click on it to open the licence.
  5. Click on the Vary Application button at the top of the screen.

    Screenshot: TGA eBS Manufacturer License screen with Vary Application button highlighted

  6. Under Variation: Application Details, you will see to see two radio buttons; Change Details and Change Status.
  7. Select the Change Status radio button, then select the Status tab.

    Screenshot: Change Details and Change Status radio button, with Change Status and Status highlighted

  8. On the Status tab you will see a Select new status field and three radio buttons.
  9. Select the Suspend radio button if you wish to suspend your licence. Select the Cancel radio button if you wish to request us to revoke your licence
  10. Email a notification letter for your application addressed to the Assistant Secretary, Manufacturing Quality Branch. Your letter should address:
    • your request to suspend your licence or have it revoked
    • the reason why you wish to suspend your licence or have it revoked
    • how long you would like your licence suspended for or the effective date of the revocation

    The licence holder must sign the letter [as per section 38 of the Therapeutic Goods Act 1989).

    Email the letter to the Manufacturing Quality Branch. Please include the application tracking number in the email subject line. You can find the application tracking number on the Variation Application screen.

    Screenshot: Tracking numbers

  11. Click on the Validate button to validate your application. If validation fails, the system will advise you which areas you need to complete.

    Screenshot: Vary application screen with Validate button highlighted

    You will receive a pop-up message to advise you your application has been successfully validated.

    Screenshot: Successful validation pop-up window

  12. Click on the Submit button to submit your validated application.

    Screenshot: Vary application screen with Submit button highlighted

  13. When you click on Submit, a window asking you to complete a declaration will open. This window provides instructions on how to complete and submit the declaration, and offers you the option to cancel your application or continue with your submission.

    Screenshot: Cancel/continue window with Continue button highlighted

  14. Click on Continue to submit your application.

There is currently no fee for submitting a request to suspend or revoke.

See the TGA website for more information on when a manufacturer statutory declaration is required.

TGA-initiated suspension or revocation

Why we suspend or revoke licences

We may suspend or revoke a licence for any of the reasons listed in section 41(1) of the Therapeutic Goods Act 1989. Where we propose to revoke or suspend a licence, other than at the request of the licence holder, we would issue a notice of intent to revoke or suspend, unless we consider there is imminent risk.

Imminent risk

If we consider there is imminent risk of death, serious illness or serious injury, we may immediately suspend or revoke a manufacturing licence without notice of intent, as prescribed in section 41(2) of the Therapeutic Goods Act 1989.

We may also take other regulatory actions depending on the nature of the risk.

Process

This section describes the typical process for how TGA initiates and actions the suspension or revocation of a manufacturing licence.

1: Notification of intent

When we intend to suspend or revoke a manufacturing licence, we will usually advise you in writing of our intention to suspend or revoke the manufacturing licence.

We are not required to issue a notice of intent if we consider there is an imminent risk of death, serious illness or serious injury, as prescribed in section 41(2) of the Therapeutic Goods Act 1989.

2: Delegate's decision

The Secretary's delegate will decide whether to suspend or revoke your manufacturing licence under subsection 41(1) of the Therapeutic Goods Act 1989, and will take into account any information submitted in response to our notification of intent before making a decision.

3: Publishing our decision

When we decide to suspend or revoke your manufacturing licence we will:

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

4: Returning your licence

The manufacturing licence belongs to us. If your licence has been revoked you are required to return it as requested in the decision letter.

5: Your ongoing obligations

If your manufacturing licence has been suspended or revoked:

  • it becomes an offence to manufacture, supply or export a therapeutic good from the manufacturing site, in accordance with section 35(4) of the Therapeutic Goods Act 1989.

TGA initiated variations to your licensing conditions

We may impose new conditions, or vary or remove existing conditions of your licence, in accordance with section 40(2) of the Therapeutic Goods Act 1989. We will notify you of any such decision in writing.

In accordance with section 40(3) of the Therapeutic Goods Act 1989, any changes to conditions (whether to vary or remove conditions or impose new conditions) take effect:

  • on the day the notice is given if there is an imminent risk of death, serious illness or injury
  • on the day specified in the notice in any other case. This must be at least 28 days after notice is given unless the person has agreed to an earlier day.

Version history

Version Description of change Author Effective date
V1.0 Original publication following consultation with industry in January 2017 Manufacturing Quality Branch August 2017