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Cost recovery impact statement: Prescription medicines, 1 July 2014 - 30 June 2015
Version 1.0, June 2014
26 June 2014
Attachment A: Fees and charges 2013-14
Fees and charges for the prescription medicine sector for 2013-14 are outlined below.
| 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 | 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 | 2013-14 Fee $ |
|---|---|
| Correction of a Register entry | 1,520 |
| Annual charges | 2013-14 Charge $ |
|---|---|
| Biological Medicines (Biologics) | 6,430 |
| Non-Biologics | 3,860 |
| Clinical trials | 2013-14 Fee $ |
|---|---|
| CTX 30 Days | 1,560 |
| CTX 50 Days | 19,400 |
| CTN | 320 |
| CTN - more than one trialing body | 320 |