GRS Blog

Australia: Revised TGA fees & charges

29/6/2011

Advance notice published by the TGA as follows:

The amendment regulations for amending the Therapeutic Goods Regulations 1990, the Therapeutic Goods (Charges) Regulations 1990 and the Therapeutic Goods (Medical Devices) Regulations 2002 have been approved by the Executive Council in its meeting on 16 June 2011 in order to increase most TGA fees and charges by 3.4%.

In applying the 3.4% increase, fees and charges have been rounded to the nearest $10 for items under $10,000 and to the nearest $100 for items $10,000 or more. Due to rounding, certain items, which are currently $140 or below will remain unchanged.

In addition, the Therapeutic Goods Regulations 1990 have been amended to split evaluation fees for registration of prescription medicines in to application fees and evaluation fees. The total amount of these two fees will remain the same as the current evaluation fees, subject to the 3.4% increase from 1 July 2011.

The revised fees and charges will take effect from 1 July 2011 and will apply to all TGA fees and charges for the 2011-12 financial year.

The revised fees and charges schedule will be published soon on the TGA website: www.tga.gov.au

Author: Greer Deal, Director of Global Regulatory Services (GRS)