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.

On this page: Readiness for inspection | Meeting with TGA | 6a: Applying for a new TGA manufacturing licence | 6b: Applying for GMP certification

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 - external site.

2. Go to the Manufacturers menu and select Licence Application.

   

   This will open a New Licence Application screen.

   

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

   

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.

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.

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.

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.

It will ask you to save the document before creating a new Manufacturer, select Save and then select New Manufacturer again.

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.

   

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

   

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.

   

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

   

4. Click on the Validate button to validate your application

   

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

   

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.

   

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

   

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.

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:

• Australian Regulatory Guidelines for Prescription Medicines (ARGPM)
• Australian Regulatory Guidelines for Over the counter (OTC) Medicines (ARGOM)
• Australian Regulatory Guidelines for Listed Medicines and Registered Complementary Medicines
• Australian Regulatory Guidelines for Biologicals (ARGB)

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 there appears to be acceptable evidence for you to apply for a GMP clearance via one of these pathways.

To apply for GMP certification:

1. Log in to TGA Business Services - external site

2. Go to the Manufacturers menu and select Certification Application

   

   This will open a New Certification Application screen.

   

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

   

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

   

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.

   

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

   

7. Click on the Validate button to validate your application

   

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

   

9. After submitting your application, the following screen will appear. Select Continue to proceed with lodging your application to the TGA

   

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