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Annual performance statistics report: July 2018 to June 2019
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8. Exports
8.1. Export only medicines
Export only medicines are listed under section 26 of the Act. The purpose of export only listings is to ensure that products exported from Australia comply with standards that are similar to the standards applied to products supplied in Australia.
In previous years the application number included all variations to existing export only listings as well as new listing applications. Starting from the 2018-19 financial year, new listing applications and variations to existing listings were separated to provide further data.
The target timeframe for processing export only listing applications is 30 working days.
| 2017-18 | 2018-19 | |
|---|---|---|
| July to June | ||
| New applications | ||
| Mean TGA processing time (days) | 25 | 22 |
| Percentage processed within target processing time | 70% | 87% |
| Variations | ||
| Mean TGA processing time (days) | 19 | 19 |
| Percentage processed within target processing time | 91% | 85% |
| 2017-18 | 2018-19 | |
|---|---|---|
| July to June | ||
| Export only applications | ||
| Applications received | 254 (95%) | 256 |
| Applications approved | 14 (5%) | 210 |
| Grouping and variation applications | ||
| Applications received | Included with applications above | 154 |
| Applications approved | 103 | |
8.2. Export certifications for medicines
The TGA provides Certificates of Pharmaceutical Product (CPP) for medicines. The CPP is based on the World Health Organisation (WHO) scheme on the quality of pharmaceutical products moving in international commerce. This is an internationally harmonised template that provides assurance about the quality of pharmaceutical products moving in international commerce. The TGA also issues Certificates of Listed Product (CLP) and Certificates of Exempt Product (CEP) that are not formally issued under the WHO scheme.
The target processing time for applications for an export certificate for a medicine is 15 working days.
| 2017-18 | 2018-19 | |
|---|---|---|
| July to June | ||
| Applications received | 1799 | 1610 |
| Export certificate issued | 1849 | 1635 |
| Processing times | ||
| Mean TGA processing time (days) | 14 | 12 |
| Percentage processed within target time | 69% | 96% |
8.3. Export certification assessment for medical devices
Certificates of free sale and export certificates are documents supplied by the TGA outlining that the relevant medical device(s) are included on the ARTG and are either able to be freely supplied and sold within Australia or are able to be exported from Australia.
In September 2018, the TGA updated the process for export certification for medical devices. This resulted in the removal of country specific certificates and the introduction of an electronic certificate for medical devices. There is now less requirement to submit multiple applications, decreasing the number of export certifications provided for medical devices.
The target processing time for applications for an export certificate for a medical device is 10 working days.
| 2017-18 | 2018-19 | |
|---|---|---|
| July to June | ||
| Applications received | 625 | 401 |
| Export certificates issued | 617 | 410 |
| Processing time | ||
| Mean TGA processing time (days) | 8 | 4 |
| Percentage processed within target time | 80% | 96% |
8.4. Permits for the export of human substances
The TGA issues permits for the export of human substances under regulation 8 of the Customs (Prohibited Exports) Regulations 1958. There are two types of permits issued, a single-use permit generally for an individual traveling overseas and an annual permit for organisations exporting multiple times throughout the year.
