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Cost recovery impact statement - Prescription medicines, 1 July 2013 - 30 June 2014

28 June 2013

Book pagination

8. Fees and charges 2012-13

Prescription medicines registration fees

Registration Fees 2012-13
Application Fee $
2012-13
Evaluation Fee $
New Chemical Entity 42,000 168,100
New Chemical Entity of a medicine used as an ancillary medical component of a device (item 4(aa)(i) and 4(aa)(ii)) 14,000 56,100
New Chemical Entity of a medicine used as an ancillary medical component of a device (item 4(aa)(iii)) 28,000 112,000
Extension of indications 25,000 99,900
Extension of indicators of a medicine used as an ancillary medical component of a device – chemistry, quality control and manufacturing or pre-clinical studies 8,330 33,300
Extension of indicators of a medicine used as an ancillary medical component of a device – documentation mentioned in subparagraphs (i) and (ii) 16,700 66,600
Major variations 16,300 65,000
Major variation of a medicine used as an ancillary medical component of a device – chemistry, quality control and manufacturing or pre-clinical studies 5,430 21,600
Major variation of a medicine used as an ancillary medical component of a device – documentation mentioned in subparagraphs (i) and (ii) 10,900 43,400
New generic product 16,100 64,100
Additional trade name 2,640 10,600
Minor variations (Change in formulation, composition, design specifications, type of container or change of trade name). 960 3,830
Fees for the evaluation of the quality and/or the non-clinical data of a new chemical entity incorporated as an ancillary component of a medical device of therapeutic device. various various

Prescription medicines variation fees

Variation Fees 2012-13
Application Fee $
2012-13
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. 960 3,830

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.

4,790
Variations to a Register entry (requiring changes to Product Information) with no evaluation of data 'minor editorial changes' 1,480
Testing and provision of advice, requested from Pharmaceutical Benefits Program, prior to listing on Pharmaceutical Benefits Listing Program (*this item is inclusive of GST) 1,930
(2,123*)

Prescription medicines administrative charges

Administrative Charges 2012-13
Fee $
Correction of a Register entry 1,480

Prescription medicines annual charges

Annual Charges 2012-13
Charge $
Biological Medicines (Biologics) 6,250
Non-Biologics 3,750

Prescription medicines clinical trials

Clinical Trials 2012-13
Fee $
CTX 30 Days 1,520
CTX 50 Days 18,900
CTN 310
CTN - more than one trialing body 310

Book pagination