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GMP clearance process improvements - Post implementation update

23 April 2018

In September 2017 we implemented a number of improvements to the GMP Clearance processes including publication of the updated GMP Clearance guidance, launching the GMP Clearance Application Assistance Tool, publishing re-designed GMP clearance application forms on TBS and clarification of the compliance verification process.

To educate and support applicants we have been gathering data about the GMP clearance applications submitted since the introduction of the improvements. Our data indicates that there are some common misinterpretations related to submitting GMP Clearance applications and the below information aims to clarify these.

A common misinterpretation is how to complete sections of the application form, specifically:

When requesting new manufacturing sites

It is important that you search the list of manufacturers registered with the TGA before requesting a new manufacturer or manufacturing site address to be added.

Incorrect selections or unnecessary new manufacturing site requests may cause delays with variations to your registered or listed products and may require updates to your ARTG entries.

The new manufacturer request form should only be completed when the manufacturer name or manufacturing site address is not already listed with the TGA. This will prevent duplicate manufacturer entries, and is very important as the Client and Site ID is included on the Australian Register of Therapeutic Goods (ARTG).

The application type selected is incorrect

In particular selections are being made for application type as a TGA GMP Certificate or Compliance Verification (CV), when in fact the application is an MRA.

Screenshot of Application Type - MRA

The table below outlines the types of GMP clearance applications:

Application type Applicable when
MRA The manufacturer is located within the borders of a MRA country and has been inspected by that country's regulatory authority
TGA Certificate The manufacturer has been inspected by the TGA and you were not using this manufacturer at the time the inspection was scheduled.
Compliance Verification (CV)

The manufacturer does not meet the criteria for the MRA pathway and has been inspected by a regulatory authority that has an agreement or arrangement with the TGA.

The type of CV application will depend on the type of manufacturer you are seeking GMP clearance for.

Incorrect application type selections may cause significant delays in obtaining your GMP clearance. You should ensure you select the correct application type as once the application is submitted this cannot be changed.

Application processing fees will not be refunded as per TGA's refund policy.

It is important that you identify the appropriate GMP clearance pathway as the documentation required to support your GMP clearance application depends on the pathway you select. Before submitting a GMP Clearance application ensure you refer to step 2 and step 3 in this guidance and utilize the GMP Clearance Application Assistance Tool (CAAT) for assistance. Once the application has been submitted this application type cannot be changed and you will be required to submit a new application if an incorrect selection of application type is made and applicable fees apply for new applications.

You should carefully review each application prior to submission to ensure that it is correct in all respects. This will avoid paying undue fees.

The evidence required is not provided

In particular where Letter of Access (LoA) is used as an evidence source, particularly for the CV pathway certain sponsor-specific evidence is still required to be provided (where applicable) in addition to the LoA.

If you do not submit the required or requested evidence, you may not be issued a GMP clearance and any fees you have paid may be forfeited.

Screenshot highlighting incorrect and correct process

If you are unsure what evidence is required, please refer to the GMP Clearance Guidance, utilise the GMP Clearance Application Assistance Tool (CAAT) or contact us prior to submitting your application.

Please note:

The information provided here does not replace the requirements specified in the GMP Clearance guidance and we strongly recommend that before submitting your application to assure yourself that your application meets all applicable requirements.