Australian Capital Territory
Medicines, Poisons and Therapeutic Goods (Fees) Determination 2015 (No 1)
Disallowable instrument DI2015-295
made under the  
Medicines, Poisons and Therapeutic Goods Act 2008, s 197 (Determination of Fees)

1	Name of instrument
This instrument is the Medicines, Poisons and Therapeutic Goods (Fees) Determination 2015 (No 1).
2	Commencement 
This instrument commences on 1 January 2016.
3	Determination of fees
The fee payable in respect of each matter listed in column 3 of Schedule 1 is 	the amount listed for that item in column 4.  
4	Payment of fees
A fee listed in Schedule 1 is payable to the Territory by the person identified in column 6.

The fees are exempt from Goods and Services Tax under Division 81 of A New Tax System (Goods and Services Tax) Act 1999 (Cwlth).
5	Refunding of fees 
Column 5 of Schedule 1 specifies what amount, if any, of a fee paid is non‑refundable.  

A non‑refundable amount is included to cover the costs associated with the processing and administration of an application. As such, the non-refundable amount paid for a licence does not vary, regardless of the term of the licence.

6	Licence terms
The amounts listed in column 4 are based on a 1 year licence.  

Subject to some limitations, licences can also be issued for longer terms, up to a maximum duration of three years.  Where a longer term is granted, the applicable fee in column 4 is multiplied to correspond with the term of the licence.  

For example, the fee payable for a two year licence is twice the fee specified in column 4.  

7	Revocation 
This instrument revokes DI2014-300 effective on 1 January 2016.

Simon Corbell MLA
Minister for Health
 
 Date: 27 October 2015

Schedule 1

Column 1	Column 2	Column 3	Column 4	Column 5	Column 6	
Item No.	Section – Act & (Regulation)	Description	Fee Payable	Non‑refundable portion of fee	Payable By	
1	84
(625)	Application for licence ~ pharmacy medicines rural communities licence	$125	$36	Applicant for the licence	
2	84
(610)	Application for licence ~ first‑aid kit licence	$222	$36		
3	84
(615)	Application for licence ~ medicines wholesalers licence	$370	$36		
4	84
(620)	Application for licence ~ opioid dependency treatment licence	Nil	Nil		
5	84
(705)	Application for licence ~ dangerous poisons manufacturers licence	$370	$36		
6	84
(715)	Application for licence ~ dangerous poisons suppliers licence	$370	$36		
7	84
(605)	Application for licence ~ controlled medicines research and education program licence	$36	$36	Applicant for research and education program
	
8	84
(710)	Application for licence ~ dangerous poisons research and education program licence	$36	$36		
9	84
(765)	Application for licence ~ prohibited substances research and education program licence	$36	$36	Applicant for research and education program
	
10	92	Amendment of a licence	$36	$36	Licence‑holder seeking amendment	
11	95	Replacement of licence lost, stolen or destroyed. 	$36	$36	Licence‑holder seeking replacement of licence	

The fees determined are based on a 1 year licence. Subject to some limitations, licences can also be issued for longer terms, up to a maximum duration of three years.  Where a longer term is granted, the determined fee is multiplied to correspond with the term of the licence.  For example, the fee payable for a two year licence is twice the fee specified in column 4.  

For every licence for which a fee is payable, there is a non‑refundable amount that has been included to cover the costs associated with the processing and administration of the application. Such costs are incurred by the regulator irrespective of whether a licence is granted or refused.  The non-refundable portion of the fee is not affected by the term of the licence.  Accordingly, the fee to be paid for a three year licence will have the same non-refundable amount as a one year licence.