Public Consultation - Fees and charges proposal 2022-23

Overview

The Therapeutic Goods Administration (TGA) is conducting a public consultation to provide industry and other interested stakeholders with an opportunity to comment on options for the TGA’s proposed fees and charges for the 2022-23 financial year. Specifically, we are seeking feedback on the potential impact/s of the proposed options, prior to seeking approval from the Government for any changes.

The Therapeutic Goods Administration (TGA) within the Department of Health is responsible for the supply, import, export, manufacturing and advertising of therapeutic goods. In order to meet these responsibilities, the TGA recovers its costs from industry in accordance with Australian Government cost recovery arrangements. The Therapeutic Goods Act 1989 (the Act) provides the legal authority for the TGA to charge for its regulatory activities. The Therapeutic Goods (Charges) Act 1989 provides the legal authority to levy annual charges on sponsors and manufacturers of medicines, biologicals and medical devices.

Response to the public consultation

The consultation is open from Tuesday, 25 January 2022 to Monday, 7 March 2022. Submissions in response to the consultation paper can be made through the link below during this time period. You can right click on the link to the consultation paper and open in a new tab to access the paper while going through the online survey.

Members of peak industry bodies that the TGA held bilateral meetings with (listed in the consultation paper) are encouraged to present their comments through the respective peak body so that the industry body can present a consolidated industry feedback to the TGA.

Enquiries

Any questions relating to submissions should be emailed to TGAFeesAndCharges@health.gov.au

Why your views matter

The TGA has a long standing practice of targeted consultation with the industry bodies in relation to proposed changes to fees and charges for the next financial year. The TGA requests the peak bodies to bring any proposals for fees and charges to the attention of their members. In addition, the TGA also publishes a public consultation paper on fees and charges to provide an opportunity for organisations who are not members of industry bodies that the TGA meet with, other stakeholders and the wider community to comment on the proposed fees and charges.