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OTC new medicines registration process

27 August 2020

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Step 5 - Ensuring valid GMP evidence

You will need valid evidence that the manufacturers of your OTC registrable medicines 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 7).

Evidence we accept

We accept:

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

Duration of GMP clearance for overseas manufacturers

We cannot finalise your application without current and valid GMP (issued by the TGA) 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 7:

  • 3 months for N1 applications
  • 4 months for N2 applications
  • 6 months for N3, N4, and N5 applications.

GMP clearance that is due to expire

If the GMP clearance is due to expire within the minimum timeframe (see previous section) 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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