You are here

Fees and charges: summary from 1 July 2020

Version 1.3, November 2020

6 November 2020

Book pagination

Export of therapeutic goods

This section references the fees and charges associated with export only therapeutic goods and export certification for therapeutic goods.

Export only medicines

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

Table 30: Export only listed medicines
Export only applications Fee Schedule 9 Part 2
New export only medicine listing $860 Item 3(b)
Grouping application for an existing export only medicine listing $860 Item 3(b)
Variation application for an existing export only medicine listing $440 Item 2A(b)
Grouping application to add an export name to a registered product $860 Item 3(b)

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

Export certification for medicines

Export certification is provided for medicines that are registered or listed in the Australian Register of Therapeutic Goods (ARTG).

Table 31: Export certification for medicines
Certificate type Fee Schedule 9 Part 2
Certificate of Pharmaceutical Product (CPP) $180 Item 10
Certificate of Listed Product (CLP) $180 Item 10

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

Medical device export certification

Export certification is provided for medical devices, including in-vitro diagnostic medical devices (IVDs) and Other Therapeutic Goods (OTGs).

Table 32: Export certification for medical devices
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

Export only devices

This fee applies 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

Book pagination