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Submissions received: Fees and charges proposal 2019-20

4 April 2019

On 21 December 2018, the Therapeutic Goods Administration (TGA) released on its website a consultation paper, Fees and charges proposal 2019-20. The purpose of this consultation was to provide industry and other stakeholders with an opportunity to comment on options for changes to fees and charges for 2019-20. The consultation period closed on 8 February 2019.

A total of 14 submissions were received, including five from peak industry bodies. We thank those individuals and organisations who lodged submissions for their valuable contribution. This feedback has been taken into consideration as part of the approval process for the 2019-20 fees and charges.

All submissions that gave permission to be published on the TGA website are available below in PDF format. Two of the individuals/organisations did not wish to publish any part of their submissions.

Submissions received

How to access a pdf document

A C F N O P S

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  • Novis Healthcare, Annie Lo, Head of Product Management

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  • OurPillsTalk

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  • Seqirus Pty Ltd, Alexandra Varanaki, Global Regulatory Intelligence Manager

Summary

The majority of submissions supported an indexation increase to the TGA fees and charges based on the Consumer Price Index (CPI) and the Wage Price Index (WPI). The indexation increase is not only consistent with the long standing practice but also provides opportunities for efficiency gains through business process improvement.

A small number of respondents opposed any increase to the application fee of $530 for inclusion of Class I medical devices in the Australian Register of Therapeutic Good (ARTG) as this fee was only introduced on 1 July 2018. However there does not seem to be a reason for excluding this fee from the standard indexation increase to other fees and charges as there has been no change to business process and the underlying cost of inclusion of such devices in the ARTG since the fee was first introduced in 2018-19.

After consideration of the submissions the Government approved an increase of 2.05% to all fees and charges, subject to rounding. In addition, a lower application fee of $90 (reduced from $1,020) for inclusion of export only in-vitro diagnostic medical devices in the ARTG and the new fee structure for variations to listed medicines under the assessed listed pathway have been approved.

The TGA will publish its updated Cost Recovery Implementation Statement prior to the commencement of the revised fees and charges on 1 July 2019.