GMP clearance process – Fees for compliance verification GMP clearance applications

21 June 2017

The TGA is required to recover its costs through fees and charges for all activities that fall within the scope of the Therapeutic Goods Act 1989, including the TGA's public health responsibilities.

GMP clearance fees are detailed in Schedule 9 of the Therapeutic Goods Regulations 1990 and TGA Schedule of Fees & Charges document.

The compliance verification (CV) fee has not been applied to non-sterile Active Pharmaceutical Ingredients (API) CV GMP clearance applications. This has resulted in under recovery of our regulatory activities.

We will be applying this fee to all CV GMP clearance applications, including non-sterile API applications, that are submitted from 1 July 2017.

Please note

  • Fees and charges are reviewed and updated periodically
  • The information provided here does not replace the current Schedule of Fees & Charges document