You are here

GMP clearance guidance

Version 18.1, January 2019

4 January 2019

Book pagination

Step 4 - Creating your application

Accessing TGA Business Services

You need to be a TGA client to access TGA Business Services in order to submit an application. Only Australian sponsors or agents acting on behalf of an Australian sponsor can submit GMP clearance applications.

Direct any queries related to TGA Business Services to ebs@health.gov.au.

For more information see getting started with the TGA.

Creating a new application

  1. Go to TGA Business Services.
  2. To limit issues with functionality, distortion or performance, check that the internet browser you are using is compatible with the TGA Business Services system by selecting 'Browser Support' and following the provided guidance.

    Screenshot - footer - Description: In the footer of the TGA Business Services page the sixth option is 'Browser Support'.

    Make sure that your browser allows pop-up windows, or you will be unable to see the dialog boxes and complete the form.

  3. Select 'Log in to Business Services'.

    Screenshot - Login - Description: 'Login to Busienss Services' is the last option on the side menu.

    Before you create your GMP Clearance application, ensure you have read the required information contained in this guidance and have utilised the GMP Clearance Application Assistance Tool (CAAT).

  4. On the homepage select 'Applications' and from the dropdown menu under the 'Manufacturers' heading select 'Clearance Application'.

    Screenshot - Applications tab - Description: 'Clearance Application' is the second option under the 'MAnufacturers' heading.

    You will be taken to the 'Clearance Application' page which contains the application details section along with the following tabs:

    • Client Details
    • API/Product Details
    • Evidence
    • Fees and payments
    • Declaration

    Screenshot - tabs at top - Description: The Client Details tab is the first of five tabs.

    Throughout the e-form tabs there are mandatory fields notated by a red asterisk *, that needs to be completed in order to progress your application.There are also help icons notated by a yellow question mark

    Help icon available to assist you in preparing and submitting the application.You will be requested to save your progress at various stages prior to continuing.

Completing Application Details

  1. Under 'Application Details', you may wish to include your own reference description in the 'Applicant's Own Ref' text box to assist you in identifying this GMP clearance application. This is a free text field.

    Screenshot - Applciation Details - Description: Applciant's Own Ref is the first field, and is optional

  2. Select the 'Application Type' from the drop down list:
    • MRA
    • TGA GMP Certificate
    • CV - Non-Sterile API
    • CV - Non-Sterile Finished Product
    • CV - Sterile / Biotech API
    • CV - Sterile / Biotech Finished Product
    • CV - Contract Testing Laboratory
    • CV - Contract Steriliser

    Screenshot - Application Type - Description: Choose the application type from the drop down list

    This selection will determine the subsequent information required for the application.

    Important - It is crucial you select the correct application type to avoid unnecessary delays with your application. We use the information you enter to assist us in processing your applications and an incorrect selection here may impact your application.

    Additionally, once the application is submitted, the application type cannot be changed. A new application may be required if an incorrect selection is made.

    We urge all applicants to refer to step 2 and step 3 in this guidance and utilise the GMP Clearance Application Assistance Tool (CAAT) for assistance in identifying your application type prior to submitting a GMP clearance application.

  3. Once you have selected the application type from the drop down list, you will be asked to confirm your selection. Select 'OK' to proceed or select 'Cancel' to go back and change the application type.

    Screenshot - message from the webpage - Description: Are you sure you have selected the correct Application Type? Select the 'OK' button.

Completing Client Details tab

In the client details tab, whether you are a sponsor or an agent acting on behalf of a sponsor will determine the required information to be entered.

Some applicant and sponsor information will be pre-populated based on the Client ID you have logged in with. This information is based on the registered client details held by TGA.

If you wish to amend (add or remove) contacts, ask your organisation’s nominated TGA Business Services administrator to update these details.

Refer to TGA Business Services - Questions and answers for administrators or contact ebs@health.gov.au for assistance.

Sponsor

  1. If you are a sponsor you will need to select the address from the drop down menu in both the applicant and sponsor sections and proceed to instruction 12.

Agent acting on behalf of a sponsor

  1. If you are an agent lodging an application on behalf of a sponsor, you will need to choose who will be invoiced using the radio buttons.
    • Select 'Applicant' if you (the agent) is to be invoiced for the GMP clearance
    • Select 'Sponsor' if the sponsor is to be invoiced for the GMP clearance

    Screenshot - Sponsor - Description: There are radio buttons for the question 'WHo will be invoiced for this clearance?' Options are Applicant or Sponsor.

  2. You will then need to choose who should be contacted if we need further information in relation to this GMP clearance using the radio buttons.
    • Select 'Applicant' if you (the agent) is to be contacted about the GMP clearance
    • Select 'Sponsor' if the sponsor is to be contacted about the GMP clearance

    Screenshot - Contact Details - Description: There are radio buttons for the question 'Who to contact for further information'. Options are Applicant or Sponsor.

  3. Select the 'Contact Name' from the drop down list. The subsequent mandatory information will automatically populate based on the selection made.

    Screenshot - Contact Details - Description: Select the contact name from the drop down list.

    Note: If the contact is not displayed on the drop down list, your company's TGA Business Services administrator can update these details. Refer to TGA Business Services - Questions and answers for administrators or contact ebs@health.gov.au for assistance.

Selecting the manufacturer name and manufacturing site address

  1. Select 'Search' to open the manufacturer information system's search dialog box.

    Screenshot - Existing Manufacturer - Description: To search for a manufacturer in the TGA database select the 'Search' button next to 'Manufacturer Name'

    Important - Ensure you have thoroughly searched the TGA database for the manufacturer's name and address before you select New Manufacturer. Duplicate entries created can result in extended delays to application processing times and may require significant updates to your ARTG entry.

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

  2. In the search box, enter a search string by typing the name of the manufacturer you wish to obtain GMP clearance for and select 'Search'.

    Screenshot - MIS Search Dialog - Description: You cane nter a searchs tring to find a manufacturer in our database. Select the Search button to the right of the dialog box.

  3. 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 - Number of entries found - Description: There is a message stating how many entries were found, as well as the details for those entries.

  4. If the manufacturer selected has only one manufacturing site registered with the TGA, the existing manufacturing site information will automatically populate. Alternatively select the 'Manufacturing Site' from the drop down menu.

    Screenshot - Existing Manufacturing Site - Description: Select the manufacturing site from the drop down list.

  5. If your manufacturer and manufacturing site are already registered with the TGA proceed to Step 5 - Selecting your scope.

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

  6. If you need to request a new manufacturer and/or manufacturing site, save your application, then select 'New Manufacturer'.

    Screenshot - Existing Manufacturer - Description: The New Manufacturer button is below the phrase 'Manufacturer Name'

    Important - Ensure you have thoroughly searched the TGA database for the manufacturer’s name and address before you select New Manufacturer. Duplicate entries created can result in extended delays to application processing times and may require significant updates to your ARTG entry.

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

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

    Screenshot - Request for entry of a new manufacturer - Description: You will need to enter details of the new manufacturer. You can Browse your files to attache supporting documentation. Select the Send buttom at the bottom when you have finished.

    Once TGA Business Services have registered the manufacturer or 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.

Book pagination