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GMP clearance guidance

Version 18.1, January 2019

4 January 2019

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Step 10 - Making a determination and assigning expiry dates

Once your application and supporting evidence have been assessed and the due dates provided in the request for information have passed, we will determine whether a GMP clearance can be:

GMP clearances that are issued or issued with a condition usually expire after three years plus six months from the date of the site inspection. The additional six months allows us time to process a renewal application or to schedule an on-site inspection, as required.

We may shorten the expiry date of your GMP clearance depending on the level of compliance assessed or due to any restrictions identified in the evidence provided.

Once we make the determination on your application, the status will change to "finalised". Please note that your application may appear like this for several days whilst we complete the GMP clearance process.

Issued

If the evidence you have provided to support your GMP clearance application is acceptable, we will issue the GMP clearance and update your application status to 'approved'. You will be able to view this status and your expiry date via your TGA Business Services portal.

We will notify you by email that your GMP clearance has been issued.

We may issue your GMP clearance with a reduced scope based on the assessment of the supporting evidence you have provided.

For example, where the:

  • dosage form selected in the application is a group term which contains several other dosage forms that are not supported by the supplied evidence, the scope will be changed to the dosage forms specifically supported by the evidence
  • manufacturing step selected in the application is a group term which contains several steps of manufacture that are not supported by the evidence, the scope will be changed to the manufacturing steps that are specifically supported by the evidence.

Issued with a condition

Depending on the information identified during assessment, we may issue a conditional GMP clearance. The conditions applied can vary and may relate to the scope or the expiry date of the GMP clearance. Existing restrictions or clarifying remarks from the overseas regulatory authority will also be placed on the clearance where applicable.

We may apply a condition which stipulates that the next GMP clearance will only be issued following a successful on-site TGA inspection.

If this condition is applied to your GMP clearance, you should submit a certification application at least 6 months prior to your GMP clearance expiry date.

  • We will not grant an extension to your GMP clearance where you have failed to submit a certification application in sufficient time.

We will update your application status to ‘approved’ and you will be able to view this status, along with the expiry date and condition placed on your clearance, via your TGA Business Services portal.

We will notify you by email that your GMP clearance has been issued and what condition has been applied.

Not issued

For both the MRA and CV pathways, the following provides general circumstances in which we are not able to issue you a GMP clearance. Where:

  • you have not provided the required supporting evidence for your application type
  • the evidence provided does not:
    • adequately demonstrate compliance to the required level or equivalent GMP standard
    • support the scope of the application
  • you have not responded to the request for information/proposal to not issue sent during the assessment by the specified due date
  • your response does not specifically detail how it addresses the deficiencies raised
  • your response to the deficiencies raised is insufficient to support issuing a GMP clearance.

MRA pathway only

For the MRA pathway, to ensure we maintain consistent processing times and do not disadvantage applicants who provide the correct information, we will make a determination on the information provided and will not seek clarification from you in specific circumstances.

For example, where the GMP certificate:

  • is not provided
  • has expired (i.e. >3years since the inspection)
  • is for the wrong manufacturing site
  • is issued using an inequivalent GMP standard
  • does not cover the scope of your application

Once the determination has been made to not issue the GMP clearance, your application will no longer be visible from your TGA Business Portal. You will be notified by email along with the reason for not issuing.

This notification will contain information about the options available to you after your GMP clearance is not issued, for example, how to submit a certification application.

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