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Fees and charges: summary from 1 July 2019

Version 1.1, July 2019

25 July 2019

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Export of therapeutic goods

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.

Table 30: Medicine export certificates
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

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

Listed export-only medicines

There is an application fee and a processing fee for listed export-only medicines.

Table 31: Listed export-only medicines
Export only applications Fee Item in Schedule 9 Part 2
Application fee $840 Item 3(b)
Processing fee (variation to an existing listing) $430 Item 2A(c)

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

Device export certificates

You can apply for an export certificate for a medical device (including IVD devices) or OTG.

Table 32: Device export certificates
Certificate type Fee Schedule 9 Part 2
Certificate of free sale $180 Item 10
Export certificate $180 Item 10

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

Export-only devices

These fees apply to include a medical device, including IVD device, in the ARTG that is for export only.

Table 33: Export-only devices
Export only applications Fee Schedule 5 Part 1
Application for inclusion into the ARTG of export only devices $90 Item 1.5(f)
Application for inclusion into the ARTG of export only IVD devices $90 Item 1.5(i)

This fee is in the Therapeutic Goods (Medical Devices) Regulations 2002

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