Medicine GMP - revised fees and charges effective 1 July 2018

25 June 2018

On 7 June 2018 the Government approved a number of changes to TGA fees and charges for 2018-19.

In addition to a 1.9 % indexation increase to most TGA fees and charges (subject to rounding and a minimum increase of $10 to the low fee items) and a small number of other updates, a number of changes will apply to Good Manufacturing Practices (GMP) fees and charges.

The proposed changes were discussed with peak therapeutic bodies at bilateral meetings held in December 2017 and February/March 2018. Additionally, these peak bodies were consulted during the April meeting of the TGA - Industry Working Group on GMP (TIWGG).

A public consultation to seek stakeholders' view on options to change the GMP fees and charges was also undertaken early this year. The full outcome summary of this consultation, including a table of the revised GMP fees and charges, is available on the TGA website.

From 1 July 2018, the revised fees and charges model for domestic medicine manufacturers will commence. The revised fees for GMP clearance applications will take effect from 1 July 2019.

Summary of changes - fees related to domestic medicine manufactures

Effective 1 July 2018

Implementation of:

  • a single annual licence charge will replace the previous two-tier (high/low) structure, providing an overall reduction in annual licence charges - with no 'free inspection hours'[1];
  • reduced GMP licence application fee;
  • increased domestic inspection hourly rates; and
  • licence variation fee (for variations made under s.40B of the Therapeutic Goods Act 1989).

Summary of changes - fees related to GMP clearances

Effective 1 July 2019

Implementation of revised fees (per manufacturer, per site, per sponsor) for:

  • GMP Clearance application processing; and
  • Compliance Verification.

Who do the changes apply to?

The changes to the medicine GMP fees and charges effective 1 July 2018, applies to you if you:

  • hold an existing domestic manufacturer's licence;
  • are applying for a new licence; or
  • are varying your licence under s.40B of the Therapeutic Goods Act 1989.

The changes to the medicine GMP fees & charges that relate to GMP clearances will not become effective until 1 July 2019. These changes will apply when you submit an application for a GMP clearance or Compliance Verification (CV) on or after 1 July 2019.

Please note that the other TGA fees and charges, not mentioned above, will increase by 1.9% as a result of the annual indexation from 1 July 2018. The complete TGA fees and charges schedule is available on the TGA website.

What are the key dates?

Date Description
1 July 2018

New Fees and Charges for Australian manufacturing activities become effective.

No more 'free' inspection hours will be accrued.

Existing 'free' hours will be honored by TGA.

1 July 2019

Existing 'free' hours continue to be honored by TGA.

Introduction of increased GMP Clearance application processing fee.

Introduction of increased Compliance Verification fees.

1 July 2020 Full implementation. Any residual 'free inspection hours' will expire.

Will there be changes to TGA Business Services (TBS)?

In implementing the revised GMP fees and charges model, we are making updates to TGA Business Services (TBS). Automated invoicing will be temporarily disabled during the application process, however an invoice will be raised by TGA staff once an application is submitted. Once an invoice is paid, we will progress the application as usual. Should you have any questions during this transition process, please contact the Manufacturing Quality Branch :


Footnote

  1. The existing 'free hours', if any, can be used by the current licence holders until 30 June 2020, or until expended by inspections, whichever occurs first.