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Cost recovery implementation statement: Complementary medicines, From 1 July 2015
Version 1.0, July 2015
2 July 2015
Attachments
1. Schedule of fees and charges from 1 July 2015
| Registration of complementary medicines | Fee $ |
|---|---|
| Application fee | 1,475 |
| Additional / concurrent application fee | 650 |
| Processing fee (variation to an existing registration) | 1,475 |
| Annual charge | 1,380 |
| Listing of complementary medicines | Fee $ |
|---|---|
| Application fee | 775 |
| Processing fee (variation to an existing listing) | 390 |
| Annual Charge | 985 |
| Evaluation fees if the documentation does not contain Clinical or Toxicological data - per submission | Fee $ |
|---|---|
| New registered medicine | 9,870 |
| Variation | 3,565 |
| New substance: such as sunscreen excipients and complementary medicine substances | 9,870 |
| Evaluation Fees based on total page count(s) of Clinical or Toxicological data per submission | Pages | Fee $ |
|---|---|---|
| New Listable Medicine Substance | 1 - 50 | 9,870 |
| 51 - 250 | 12,700 | |
| 251 - 500 | 17,400 | |
| 501 - 1000 | 23,000 | |
| 1001 - 2000 | 34,500 | |
| 2001 - 3000 | 46,100 | |
| > 3000 | 69,000 | |
| Assessment of safety information or documents submitted pursuant to Section 31 of the Therapeutic Goods Act 1989 | n/a | 7,505 |
| Evaluation Fees based on total page count(s) of Clinical or Toxicological data per submission | Pages | Fee $ |
|---|---|---|
| Variations | 1 - 50 | 3,565 |
| 51 - 250 | 12,700 | |
| 251 - 500 | 17,400 | |
| 501 - 1000 | 23,000 | |
| 1001 - 2000 | 34,500 | |
| 2001 - 3000 | 46,100 | |
| > 3000 | 69,000 |
| Listed medicines - Export only | Fee $ |
|---|---|
| Application fee | 775 |
| Processing fee (variation to an existing listing) | 390 |
| Listed medicines - Export certificates | Fee $ |
|---|---|
| Certificate of Pharmaceutical Product | 160 |
| Certificate of Listed Product | 160 |
| Certificate of Exempt Product | 160 |