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GMP clearance guidance

Version 18.1, January 2019

4 January 2019

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Step 6 - Providing your evidence

In the Evidence tab, you need to answer some questions about the GMP clearance prior to providing the required evidence. The information you provide will assist us in processing your applications efficiently.

  1. Inform us if the GMP clearance application is related to a submission to list or register a product or vary an existing ARTG entry.
    • Selecting 'Yes' will require you to choose the submission type from the drop down menu (mandatory) and submission number (if known)

      Screenshot highlighting the 'Evidence' tab

  2. Choose whether the application is for the Compliance Verification pathway.
  3. Choose whether you intend to use a Letter of Access (LoA) to Clearance or Evidence as part of your evidence. If you select yes then you will need to provide the GMP clearance number in instruction 43 or instruction 44.

    There are Yes and No radio buttons for the question 'In the Evidence to be provided are you using a Letter of Access to Clearance or Evidence?'

Choosing your evidence and delivery method

  1. Save your application before proceeding.

    The Save button is the first button under the title 'TGA eBusiness Services Clerance Application'

    You will be required to select a delivery method for each piece of evidence you provide.

    Based on the Application Type selected, this section will display:

    Ensure you have read the relevant information contained within this guidance regarding identifying the appropriate GMP clearance pathway and identifying what documentation is required prior to proceeding.

Mandatory certificates or letters

  1. In the mandatory certificates or letters section, select whether you intend to provide a current GMP certificate or a Letter of Access (to clearance or evidence).

    There is a drop down menu to choose from for the type of Evidence

    Letters of Access - If you choose to use a letter of access, you must upload the letter here and select the equivalent delivery method in the mandatory evidence section for the evidence to be covered by the LoA.

    USFDA evidence - If you are using USFDA evidence, you must select TGA to obtain GMP certificate as your delivery method. Do not provide the cover letter from the USFDA EIR.

  2. Select the required delivery method from the drop down menu.

    Select delivery method from the drop down list.

Delivery methods

There are multiple delivery methods available depending on each type of evidence. Additional information specific to the delivery method chosen will be required once selected. These are:

TGA to obtain GMP certificate
  1. If you have selected this delivery method, in the resulting dialog box select:
    • the regulatory authority the TGA are to liaise with from the drop down menu
    • the inspection date of the GMP Certificate required

    Fill out thet wo mandatory fields and select the OK button at the bottom.

    For MRA applications, we can only liaise for GMP certificates with regulatory authorities with whom we have a MRA or equivalent agreement with.

    For CV applications, if you are submitting evidence from a US FDA inspection you must select TGA to obtain GMP certificate to ask TGA to confirm the current GMP compliance status from the US FDA COMSTAT database.

    You may receive alerts if the inspection date is ≥3 years identifying that the GMP clearance may:

    • result in a short expiry date (if approved)
    • OR
    • not be issued if the evidence is > 3years from date of inspection.
Manufacturer to provide
  1. If you have selected this delivery method, in the resulting dialog box select the expected date the evidence will be provided to us. The delivery date cannot be earlier than the GMP application submission date and should not be later than one month past the date you submit the application.

    Enter the expected delivery date and select the 'OK' button

    You should liaise with your manufacturer to ensure the date selected is achievable prior to submitting your GMP clearance application.

    Evidence should be provided no later than 1 month from the submission of the GMP clearance application.

    If we have not received the evidence by the time we perform application receipt, your application will progress to assessment as incomplete. This will result in extended processing times and your GMP clearance may not be issued.

Submit paper copy
  1. If you have selected this delivery method, in the resulting dialog box select the expected date the evidence will be delivered to TGA.

    Enter the expected delivery date and select the 'OK' button.

    We prefer to receive electronic copies of documents. A file size of 100MB is available and files may be zipped. Paper copies are accepted if they cannot be submitted electronically.

    You should liaise with your manufacturer to ensure that the date selected is achievable prior to submitting your GMP clearance application.

    Evidence should be provided no later than 1 month from the submission of the GMP clearance application.

    If we have not received the evidence by the time we perform application receipt, your application will progress to assessment as incomplete. This will result in extended processing times and your GMP clearance may not be issued.

Upload evidence
  1. If you have selected this delivery method, in the resulting dialog box select 'Browse' and select the file to upload. When uploading GMP certificates or inspection reports, you will also need to enter the inspection date relevant to the evidence provided.

    You may receive alerts if the inspection date is ≥3 years identifying that the GMP clearance may:

    • result in a short expiry date (if issued)
    • OR
    • not be issued if the evidence is > 3years from date of inspection.

    You can Browse your files to select a file to upload. Enter the Last Inspection Date. Select the OK button.

    Ensure the document has the correct naming convention.

    The maximum file size is 100MB per piece of evidence. If supplying multiple documents in response to a single item of evidence (for example a SMF and separate appendices) please provide a single zip file.

  2. If the document does not have the correct naming convention, an error message will be displayed. Update the document name as per the naming convention and upload it again.

    Exclamation: Upload file name does not conform to agreed format. Please refer Help for instructions. Select the 'OK' button.

Letter of access to clearance
  1. If you have selected this delivery method, in the resulting dialog box enter a valid GMP clearance tracking number.

    Screenshot - Letters of Acces to Clearance. Enter a valid GMP tracking number. Select 'OK' button.

    To avoid unnecessary delays and unforeseen outcomes that may impact your regulatory submissions, we strongly recommend you to only use LoA to clearance to access already issued GMP clearances.

Letter of access to evidence
  1. If you have selected this delivery method, in the resulting dialog box enter a valid GMP clearance tracking number that contains this piece of evidence you wish to access.

    Screenshot - Letter of Access to Evidence. Enter a vaild GMP tracking number. Select the 'OK' button.

    If choosing either letter of access delivery methods, the letter must be uploaded in the Mandatory certificates or letters section.

    A valid GMP Clearance tracking number is a GMP clearance that is currently under review or has been issued.

    • Expired or not issued GMP clearances cannot be accessed using either type of LoA.

    Ensure you have read the relevant information contained within this guidance regarding Letters of Access.

Mandatory evidence

  1. If you are submitting a Compliance Verification application, there is a Mandatory Evidence section.

    Identify the evidence that is required (step 3) for your application type:

    • Select N/A for the evidence that is not required and
    • Check the box next to the evidence that is required

    If you or your manufacturer do not provide all required evidence, you will experience significant delays in processing times and your GMP Clearance may not be issued.

    Screenshot - Mandatory Evidence. There is a column of N/A tick boxes and a column of tick boxes next to each type of evidence. If you select N/A there will be a green tick on the right of the row. If you select a piece of evidence, there will be a red cross until you have selected a delivery method for that evidence.

  2. For each piece of evidence, choose the delivery method and complete the dialog box that appears.

    Screenshot - Mandatory Evidence. When you select a type of evidence and a delivery method, a green tick will appear at the end of the row.

  3. To update the information that you previously entered into a dialog box (for example the delivery date of evidence), click once on the dropdown list and the dialog box will be displayed again to update.

    Screenshot - Mandatory Evidence. Click the delivery method once to update details that you have already entered.

  4. To change the type of delivery method selected (for example to change from Post paper version to Upload Evidence), click & hold the drop down menu and select the new delivery method and complete the required information in the resulting dialog box.

    Screenshot - Mandatory Evidence. To change the type of delivery method, click and hold then scroll to the new delivery method.

Optional evidence

  1. If you wish to supply additional evidence, select the relevant check box in the Optional Evidence section and select the delivery methods as per instructions 37-42.

    Screenshot - Optional evidence. For the Optional Evidence window there is a list of evidence types and delivery methods as with the MAndatory Evidence, but no N/A option or ticks or crosses.

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