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Process to change a registered OTC medicine

27 August 2020

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Step 5 - Ensuring GMP evidence is valid

You will need valid evidence that the manufacturers of your OTC medicine have been certified to perform each step in the manufacture of the goods. If you do not have valid evidence of GMP for each manufacturer, your application will not validate when you submit your application (Step 8).

Evidence we accept

Ensure you have:

  • for Australian manufacturers: a Licence to Manufacture (GMP licence) issued by the TGA
  • for overseas manufacturers: a GMP clearance issued by the TGA.

In both cases the evidence is valid only for the steps of manufacture and dosage forms nominated on the licence or clearance.

The duration of GMP clearance for overseas manufacturers

We cannot finalise your application without current and valid GMP clearance for each overseas manufacturer. You need to ensure that the GMP clearance will not expire during the evaluation timeframe.

Check that the GMP clearance will not expire within the following minimum timeframe from when you submit your application in Step 8:

  • 2 months for C1 applications
  • 4 months for C2 applications
  • 6 months for C3 and C4 applications.

For notification applications, GMP must be current at the time of lodgment and payment.

GMP clearance that is due to expire

If the GMP clearance is due to expire within the minimum timeframe or is likely to expire before the application is finalised, before you submit the application you need to either:

  • apply to renew the GMP clearance
  • seek an extension to the GMP clearance expiry.

Consider applying to renew the GMP clearance for applications with a target evaluation time that exceeds 6 months, rather than seeking extension of the GMP clearance. Extension to the expiry may not cover the full period to completion of the application.

If you have requested an extension or applied to renew the clearance, state this in the cover letter of your OTC medicine application.

Guidance to complete this process

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