Fees and charges: summary - from 1 July 2018

Version 1.1, October 2018

12 October 2018

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Export

The Therapeutic Goods Act 1989 applies to both the supply of therapeutic goods in Australia and the export of therapeutic goods from Australia.

Medicine export certificates

You can apply for an export certificate for any medicine. These fees are in Schedule 9, Therapeutic Goods Regulations 1990.

Certificate type Fee Item in Schedule 9 Part 2
Certificate of pharmaceutical product $180 Item 10
Certificate of listed product $180 Item 10
Certificate of exempt product $180 Item 10

Listed export-only medicines

These fees are in Schedule 9, Therapeutic Goods Regulations 1990.

Export only applications Fee Item in Schedule 9 Part 2
Application fee $820 Item 3(b)
Processing fee (variation to an existing listing) $420 Item 2A(c)

Device export certificates

You can apply for an export certificate for a medical device (including IVD devices) or OTG. These fees are in Schedule 9, Therapeutic Goods Regulations 1990.

Certificate type Fee Item in Schedule 9 Part 2
Certificate of free sale $180 Item 10
Export certificate $180 Item 10

Export-only devices

This fee applies to include a medical device in the ARTG that is for export only. This fee does not apply to IVD devices. These fees are in the Therapeutic Goods (Medical Devices) Regulations 2002.

Export only applications Fee Item in Schedule 5 Part 1
Application for inclusion into the ARTG of export only devices (excluding IVDs) $90 Item 1.5(f)

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