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Annual performance statistics report: July 2018 to June 2019

21 October 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.

Table 46 Approval times for export only medicines
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%
Table 47 Applications for new and variations to export only medicines
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.

Table 48 Export certification applications and processing times
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.

Table 49 Medical device applications and processing times for export certification assessments
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.

Figure 7 Permits for the export of human substances
Permits issued for bone and tissue products: 79 in 2017-18, 48 in 2018-19; Permits issued for blood fraction products: 128 in 2017-18, 150 in 2018-19; Annual permits issued: 25 in 2017-18, 47 in 2018-19.
Figure 7 Permits for the export of human substances
Permit type 2017-18 2018-19
Permits issued for bone and tissue products 79 48
Permits issued for blood fraction products 128 150
Annual permits issued 25 47

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