Requesting variations to your manufacturing licence

A step-by-step guide

4 August 2017

This is a step-by-step guide for Australian manufacturers of therapeutic goods (other than medical devices) applying through TGA Business Services to vary an in-force manufacturing licence for an Australian manufacturing site under section 40B of the Therapeutic Goods Act 1989. If you have any questions, contact the Manufacturing Quality Branch.

This process should not be used for requesting:

Please notify us before making any change to your licence, because some changes require prior approval.

You cannot request a variation to your GMP certification via TGA Business Services. You should email these requests to Manufacturing Quality Branch.

You can request to vary details of the manufacturing licence such as the licence nominees (Persons in control of Quality Control and Production) and manufacturing authorisations (eg: dosage forms and manufacturing steps et cetera). Refer to Section 40B of the Therapeutic Goods Act 1989 for more information.

Commencing a licence variation application

  1. Log in to TGA Business Services.
  2. Click on Your TGA to open the dropdown menu and select Manufacturer Information.

    Screenshot: The Your TGA dropdown 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 filtering by Identifier

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

    Screenshot: Clearance highlighting Vary Application button

  6. Under Variation: Application Details, you will see:
    • the original tracking number - the tracking number of the current approved document
    • the tracking number - the new tracking number for the replacement application
    • two radio buttons - Change Details and Change Status.
  7. Select the Change Details radio button. (The Change Status button is used to request us to suspend or cancel the licence.)

    Screenshot: Application Details highlighting Change Details

Variation application types

You can vary your application by editing a number of fields, including:

Requesting a change to the licence nominees (Persons in charge of Production and Quality Control)

  1. On the Primary site tab, you will see the name of the current Person in charge of Quality Control and an editable field where you can enter the name(s) of the new nominee(s).
  2. Enter the name(s) of the new nominee(s) for Person in charge of Quality Control or Person in charge of Production. Attach the nominee's current resume.

    Screenshot: Primary Site tab with Person in charge of Quality Control and Person in charge of Production fields highlighted

Supporting documents

  1. On the Supporting Documents tab you may attach a cover letter detailing the reason for the change and the date of its effect.

    Screenshot: Application Variation screen with Supporting Documents tab highlighted

Under Regulation 21 of the Therapeutic Good Regulations 1990, the licence holder must inform the Secretary as soon as practicable when there is any change to those in charge of production and/or quality control and provide the name, qualifications and experience of the replacement person(s).

The licence remains in force and manufacturing operations can continue while we review your licence variation.

Requesting a change to manufacturing authorisations

  1. On the Primary Site tab, you can edit the Manufacturing Items table (eg: dosage forms, manufacturing steps, et cetera) to add, remove or edit existing items.
  2. To add an item, select the Add button at the bottom of the table.

    Screenshot: Manufacturing Items highlighting the Add and Remove buttons

  3. This will open a pop-up dialogue window. Make the appropriate selection from the dropdown menu for each field.
  4. When you are finished, click on Save Item to add the new item.

    Screenshot: Manufacturing Items dialog box with options highlighted

The dropdown menu is linked to TGA code tables for manufacturing type, sterility, manufacturing class, dosage form, product code and manufacturing steps. Further information about the TGA code tables is available in the Code tables in the public information on TGA Business Services.

Supporting documents

  1. On the Supporting Documents tab, attach a current Site Master File (SMF). Please also attach a cover letter detailing the requested change(s) and the proposed date of the change.

    Screenshot: Application Variation screen with Supporting Documents tab highlighted

Changes to the items you are authorised to manufacture may require prior approval and an onsite inspection before the licence can be varied.

  • Do not commence additional manufacturing operations until an updated licence has been granted.

Changing the manufacturer name or address

  • Do not use this process for licence transfer requests
  • Do not use this process for primary manufacturing site relocations

You can change the manufacturer's name on the Client Details tab.

  1. Select the Manufacturer Name field and click on the X to clear the field.
  2. Type in the new manufacturer name and/or site details.

    Screenshot: Manufacturer Details screen with Manufacturer Name and Manufacturer Site Details fields highlighted

Supporting documents

  1. On the Supporting Documents tab, attach a current Site Master File (SMF). Please also attach a cover letter explaining the name change and the proposed date of the change.

Adding a secondary site

You can request to add a secondary manufacturing site to your licence.

You need prior approval to add a secondary site. The site must be inspected before we can grant an updated licence.

Secondary sites must meet the requirements outlined under section 38A of the Therapeutic Goods Act 1989 in the Therapeutic Goods (Multi-Site Manufacturing Licences) Guidelines of 2010.

  • Do not commence additional manufacturing operations until an updated licence has been granted.
  1. On the Secondary Site tab, click on the Add Secondary Site button at the bottom of the window.

    Screenshot: Secondary Site tab with Add Secondary Site button highlighted

  2. This will open a pop-up dialogue window. You will see two radio buttons for Existing Site and New Site.
    • If you are changing the details of an existing site, select the Existing Site radio button and fill in the site details fields.
    • If you are entering a new site, choose the New Site radio button and fill in the site details fields.
  3. When you have entered all the necessary details, click on the Save Site button to save them.

    Screenshot: Secondary Site screen with radio buttons and site details fields highlighted

Supporting documents

  1. On the Supporting Documents tab, attach a current Site Master File (SMF). Please also attach a cover letter detailing the requested change and the proposed date of the change.

Completing & submitting your licence variation application

  1. When you have entered all the variations you wish to request, 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

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

    Screenshot: Succesful validation pop-up window

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

    Screenshot: Vary application screen with Submit button highlighted

  4. When you click on Submit you will be shown an advice screen, which advises you to complete a declaration and 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

  5. Click on Continue to submit your application.

There is currently no fee for submitting a licence variation.

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

Reviewing your variation application

We will review your variation application to determine whether an inspection is required. We may ask you for additional information to assist with our review.

If inspection is not required, we will let you know whether the variation is approved.

If an inspection is required, we will determine whether:

  • this should be conducted as part of the next routine inspection
  • a special inspection covering the scope of the variation is required.

Version history

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