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Cost recovery impact statement: Prescription medicines, 1 July 2014 - 30 June 2015

Version 1.0, June 2014

26 June 2014

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Attachment A: Fees and charges 2013-14

Fees and charges for the prescription medicine sector for 2013-14 are outlined below.

Registration fees
Registration fees 2013-14
Application Fee
$
2013-14
Evaluation Fee
$
New Chemical Entity 43,200 173,000
New Chemical Entity of a medicine used as an ancillary medical component of a device (item 4(aa)(i) and 4(aa)(ii)) 14,400 57,700
New Chemical Entity of a medicine used as an ancillary medical component of a device (item 4(aa)(iii)) 28,800 115,200
Extension of indications 25,700 102,800
Extension of indicators of a medicine used as an ancillary medical component of a device - chemistry, quality control and manufacturing or pre-clinical studies 8,570 34,300
Extension of indicators of a medicine used as an ancillary medical component of a device - documentation mentioned in subparagraphs (i) and (ii) 17,200 68,500
Major variations 16,800 66,900
Major variation of a medicine used as an ancillary medical component of a device - chemistry, quality control and manufacturing or pre-clinical studies 5,590 22,200
Major variation of a medicine used as an ancillary medical component of a device - documentation mentioned in subparagraphs (i) and (ii) 11,200 44,700
New generic product 16,600 66,000
Additional trade name 2,720 10,900
Minor variations (Change in formulation, composition, design specifications, type of container or change of trade name) 990 3,940
Variation fees
Variation fees 2013-14
Application Fee
$
2013-14
Evaluation Fee
$
Variations to a Register entry involving the evaluation of clinical, pre-clinical or bio-equivalence data, but not included in another fee category. Includes applications for changes to Product Information involving the evaluation of clinical, pre-clinical or bio-equivalence data. 990 3,940

Variations to a Register entry involving the evaluation of only chemistry, quality control or manufacturing data.

Includes applications for changes to Product Information involving the evaluation of only chemistry, quality control or manufacturing information.

4,930
Variations to a Register entry (requiring changes to Product Information) with no evaluation of data 'minor editorial changes' 1,520
Testing and provision of advice, requested from Pharmaceutical Benefits Program, prior to listing on Pharmaceutical Benefits Listing Program (*this item is inclusive of GST)

1,990

(2,189*)

Administrative charges
Administrative charges 2013-14 Fee
$
Correction of a Register entry 1,520
Annual charges
Annual charges 2013-14 Charge
$
Biological Medicines (Biologics) 6,430
Non-Biologics 3,860
Clinical trials
Clinical trials 2013-14 Fee
$
CTX 30 Days 1,560
CTX 50 Days 19,400
CTN 320
CTN - more than one trialing body 320

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