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Australian manufacturing licences and overseas GMP certification

A step-by-step guide

19 March 2019

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6: Drafting and submitting your application

Submit either:

  • an application for a new TGA manufacturing licence (for an Australian manufacturer)
  • an application for GMP certification (by an Australian sponsor or agent acting on behalf of a sponsor of goods manufactured overseas)

Advise us of the date you expect to be ready for inspection in the cover letter you attach to the application or by email to the Manufacturing Quality Branch.

Take care when you complete your application to ensure the scope of your manufacturing operations, as specified in the Manufacturing Items table, fully reflects the activities you want to licence or certify.

Screenshot: Manufacturing Items table from the Application Variation form

Our inspection will be limited to the scope described in your application.

Readiness for inspection

To be ready for an inspection you must have:

  • completed constructing or fabricating the premises
  • taken functional control of the site (we may ask to see a certificate of occupancy or equivalent)
  • documented and implemented a quality system, in accordance with the requirements of the manufacturing principles and specifically tailored to your proposed manufacturing operations, that includes procedures, records and instructions for the management of:
    • quality systems such as deviation, change control, risk management, product quality review systems
    • documentation
    • materials
    • production operations, including master batch records
    • personnel matters including training, clothing and hygiene
    • validation and qualification
    • equipment assembly and calibration
    • maintenance, cleaning and sanitisation
    • environmental monitoring
    • pest control
    • complaints
    • recalls
    • returns
    • self-inspection
    • laboratory controls and operations
    • release for supply
  • qualified all relevant facilities, utilities and equipment to at least the Operational Qualification (OQ) stage
  • documented and approved protocols for qualification and validation post-Operational Qualification for all facilities, utilities, equipment and processes (including cleaning)
  • validated the manufacturing processes for Class 3 or Class 4 biologicals (given the inherent variation in biological processes)
  • employed, nominated and trained all key staff responsible for controlling manufacturing operations and quality assurance

Meeting with TGA

If you would like to meet with us before you submit your application, contact the Manufacturing Quality Branch and request a meeting. TGA staff are available to meet with new clients to discuss proposed plans and provide advice on the licensing and inspection process.

6a: Applying for a new TGA manufacturing licence

Submit your application for a new manufacturing licence and the necessary supporting documents as soon as possible.

Provide a cover letter as part of your application indicating when you believe you will be ready for an inspection. If you are not going to be ready by this date, notify the Manufacturing Quality Branch by email as soon as possible.

Applying for a manufacturing licence using TGA Business Services

To apply for a manufacturing licence:

  1. Log in to TGA Business Services.
  2. Go to the Manufacturers menu and select Licence Application.

    Screenshot: The Applications dropdown menu with Manufacturers options highlighted

    This will open a New Licence Application screen.

    Screenshot: New Licence Application screen

  3. Complete the mandatory fields denoted by a red asterisk (*) on the Client Details tab.

    Screenshot: Client details tab highlighted

Selecting the manufacturer name and manufacturing site address in the Client Details tab

If you are applying for a new manufacturing licence for an existing manufacturer, select Search to open the Manufacturing Information System (MIS) search dialog box.

Screenshot: Search button highlighted

In the search box, enter a search string by typing the name of the existing manufacturer you wish to obtain a manufacturing Licence for and select Search. Only Australian manufacturers should be visible in this search.

Screenshot: search box and button highlighted

If the manufacturer's name is already registered with the TGA, it will appear in the list for selection. Click on the manufacturer and select OK.

Screenshot: OK button highlighted

Important - If the manufacturer name is not already registered with the TGA, you will have to register the manufacturing site prior to proceeding with the application.

Ensure you have thoroughly searched the TGA database for the manufacturer's name before you select New Manufacturer. Duplicate entries created can result in extended delays to application processing times.

If you are unsure whether the manufacturer name you intend to use is available in the TGA database, please contact us prior to proceeding with your application.

If you are applying for a new manufacturing licence for a new manufacturer, select New Manufacturer to open the request for entry of a new manufacturer entry form.

Screenshot: New Manufacturer button highlighted

Enter all the required information about the manufacturer and the site address and upload at least one piece of evidence to support the request, then select Send.

Screenshot: New Manufacturer screen

Once TGA Business Services have registered the manufacturer and site address, you will be notified and may proceed with the application.

Typically, a new registration is complete within 1-2 business days from the date of request.

  1. Complete the mandatory fields denoted by a red asterisk (*) on the Primary Site tab.

    Screenshot: Primary Site tab highlighted

    Please select the activities intended to be undertaken at the licenced site(s). (Please note, multiple activities can be selected).

    Screenshot: Activity options highlighted

  2. If applicable, add a secondary site using the 'add secondary site button' on the Secondary Site tab. Complete the mandatory fields denoted by a red asterisk (*) in the Secondary Site window.

    Screenshot: Secondary Site tab highlighted

  3. Attach the required supporting documents on the Supporting Documents tab

    Screenshot: Supporting Documents tab with Add and Remove Attachment buttons highlighted

  4. Click on the Validate button to validate your application

    Screenshot: New Licence Application screen with Validate button highlighted

  5. To submit your application, click on the Submit button.

    Screenshot: New Licence Application window with Submit button highlighted

  6. After submitting your application, the following screen will appear, notifying you of the fees to be charged. Select Continue to proceed with lodging your application to the TGA or Cancel to return to the form.

    Screenshot: Fee required screen

  7. You will receive the following notification of a successful application submission.

    Screenshot: Successful application screen

6b: Applying for GMP certification

Provide a cover letter as part of your application indicating when you believe you will be ready for an inspection. If you are not going to be ready by this date, notify the Manufacturing Quality Branch by email as soon as possible.

We may reject your application if your sites are not ready for inspection.

GMP certification applications must be submitted by:

  • the Australian sponsor
  • OR
  • an agent acting on the Australian sponsor's behalf

All manufacturing steps are required to be GMP compliant unless they are exempt. However, GMP certification is not necessarily required unless the manufacturing step is recorded on the ARTG.

We offer guidance on the regulatory requirements relating to different types of medicines and biologicals, including:

Guidance is also available on which steps of prescription medicine manufacture require evidence of GMP compliance.

If you are unsure whether you need GMP certification, contact the relevant product regulatory area before you submit your GMP certification application.

Applying for GMP certification using TGA Business Services

Before you apply for GMP certification, check you cannot obtain GMP clearance via the MRA or CV pathway. We may not accept your application for GMP certification if you can apply for GMP clearance via one of these pathways.

To apply for GMP certification:

  1. Log in to TGA Business Services
  2. Go to the Manufacturers menu and select Certification Application

    Screenshot: Applications menu with Manufacturers selections highlighted

    This will open a New Certification Application screen.

    Screenshot: New Certification Application screen

  3. Complete the mandatory fields denoted by a red asterisk (*) on the Client Details tab.

    Screenshot: Client details tab highlighted

  4. Complete the mandatory fields denoted by a red asterisk (*) on the Primary Site tab.

    Screenshot: Primary Site tab highlighted

  5. If applicable, add a secondary site using the 'add secondary site button' on the Secondary Site tab. Complete the mandatory fields denoted by a red asterisk (*) in the Secondary Site window.

    Screenshot: Secondary Site tab highlighted

  6. Attach the required supporting documents on the Supporting Documents tab

    Screenshot: Supporting Documents tab with Add and Remove Attachment buttons highlighted

  7. Click on the Validate button to validate your application

    Screenshot: New Certification Application screen with Validate button highlighted

  8. To submit your application, click on the Submit button

    Screenshot: New Certification Application screen with Submit button highlighted

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