Medicine GMP - Revised Fees and Charges Effective 1 July 2018

From 1 July 2018, the revised fees and charges model for domestic medicine manufacturers will commence. The revised fees for Good Manufacturing Practice (GMP) clearance applications will be implemented July 2019. The revised fees and charges model is being implemented as a result of the Proposal to change the current GMP fees and charges public...

From 1 July 2018, the revised fees and charges model for domestic medicine manufacturers will commence. The revised fees for Good Manufacturing Practice (GMP) clearance applications will be implemented July 2019. The revised fees and charges model is being implemented as a result of the Proposal to change the current GMP fees and charges public consultation carried out early 2018.

Summary of changes - fees related to domestic medicine manufactures

Effective 1 July 2018

Implementation of:

  • a single annual licence charge, with no further accrual of 'free hours';
  • increased domestic inspection hourly rates; and
  • licence variation fee (for variations made under s.40B of the Therapeutic Goods Act 1989).

The TGA will continue to honour existing 'free hours' for current licence holders until 30 June 2020, or until expended by inspections, whichever occurs first.

The full outcome summary of the revised GMP fees and charges is on the TGA website.

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;
  • Obtaining Evidence from Overseal Regulatory Authority; 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 and 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. 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 : GMP@health.gov.au

Source: www.tga.gov.au