Revoking manufacturing licences for not paying the annual charge

3 March 2016

This guidance is for manufacturers with a TGA manufacturing licence.

We can revoke a manufacturing licence if you do not pay the annual licence charge on time. After a licence has been revoked, you must not manufacture a therapeutic good at that manufacturing site.

Holders of a manufacturing licence must pay an annual licence charge. If you no longer want your licence, you must:

  • pay the annual charge for the current financial year
  • request revocation of your manufacturing licence to the Manufacturing Quality Branch as soon as possible and by the end of the financial year. If you do not make this request in time, you will be liable for annual charges in the new financial year.

Revocation process when annual charge is not paid

We issue annual charge invoices to manufacturers with manufacturing licences at the beginning of the financial year.

Steps

Steps in the process for revoking a manufacturing licence because of non-payment of annual charge:

  1. Checking for payment of annual charge
  2. Sending notice of intent
  3. Preventing revocation
  4. Deciding to revoke licence
  5. Publishing decision
  6. Returning licence
  7. Continuing liabilities

Step 1. Checking for payment of annual charge

We check that annual charges have been paid.

Step 2. Sending notice of intent

If you have not paid an annual charge on time, we send you a notice (by mail and, if possible, by email) describing:

  • our intention to revoke the manufacturing licence
  • the date when we will revoke the licence (usually ten days from the date of the notice)
  • what you need to do to prevent revocation.

Step 3. Preventing revocation

If you do not want us to revoke the licence, either:

  • pay the annual charge
  • explain why you cannot pay the annual charge in full by the due date and request in writing to the Product Billing Team:
    • an extension of time to pay
    • OR
    • a payment plan.

Step 4. Deciding to revoke licence

If the TGA delegate of the Secretary decides, under paragraph 41(1)(f) of the Therapeutic Goods Act 1989, to revoke the manufacturing licence because you have not paid the annual licensing charge, we will advise you in writing of:

  • our decision
  • your right to seek an internal review of the decision under section 60 of the Act.

Step 5. Publishing decision

Following a decision to revoke a manufacturing licence for not paying annual charges we will:

Step 6. Returning licence

Return the licence; the licence belongs to us.

Step 7. Continuing liabilities

Once your manufacturing licence has been revoked:

  • You still need to pay the annual charge: annual charges are debts owing to the Commonwealth of Australia; you remain liable for any outstanding amount.
  • You must not manufacture a therapeutic good at that manufacturing site.
Version history
Version Description of change Author Effective date
V1.0 Original publication: Revocation of a manufacturing licence TGA 25 July 2012
V2.0

Change in title

Added step-by-step guide

Regulatory Services and Improvement Branch, including the Regulatory Guidance Team February 2016