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GMP clearance fees

29 May 2019

Revised fees taking effect on 1 July 2019

On 7 June 2018, the Government approved a number of changes to our fees and charges for the 2018-19 financial year. The full outcome summary of this consultation, including a table of the revised GMP fees and charges, is available on the TGA website.

Changes to the fees and charges related to domestic medicines manufacturers became effective on 1 July 2018 whilst the revised fees for GMP clearance were postponed by a year.

As such, from 1 July 2019, the revised GMP clearance fees (per manufacturer, per site, per sponsor) will be implemented as per following:

  • Application processing fee will increase from $400 to $650
  • Compliance Verification (CV) fee will increase from $2070 to $2480

These changes will apply when an application for a GMP clearance is submitted on or after 1 July 2019.

Reinstatement of expired GMP clearance fee

It is the Sponsor's responsibility to maintain current GMP clearance for products on the Australian Register Therapeutic Goods (ARTG). We still allow Sponsors to submit variation applications up to 30 days after the expiry date of their GMP clearance.

Even with the above mechanism in place, there are still a number of applicants who allow their GMP clearance(s) to expire. Reinstating a GMP clearance involves TGA staff having to perform additional work which is currently not being cost-recovered.

Following consultation with the peak industry associations via the TGA Industry Working Group on GMP (TIWGG) from 1 July 2019, where your GMP clearance has expired beyond the 30 days allowed and you request it to be re-instated or extended, we will begin consistently charging the reinstatement of expired GMP clearance fee.

This fee (per manufacturer, per site, per sponsor) is in addition to other relevant fees associated with GMP clearance assessment as outlined in the schedule of fees and charges.

Should you have any questions about the information outlined above, please contact us.