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Half yearly performance report - January to June 2015
Processing time is defined as the number of working days from the acceptance of the application including payment until formal notification of decision. Under the Therapeutic Goods Regulations 1990, working days exclude public holidays and weekends. Processing time excludes time where the TGA was unable to progress the application until the sponsor provided additional information unless otherwise specified.
7.1 Export only medicines
The target timeframe for processing of export only medicine applications and variations is 31 working days.
|Mean TGA processing time||24||20||21|
|Percentage processed within target processing time||98%||100%||100%|
|Mean TGA processing time||22||12||13|
|Percentage processed within target processing time||98%||100%||98%|
|Applications awaiting response from sponsor||0||6||17|
- N/A - This data is not available as it was not being collected for these periods.
7.2 Export certifications for medicines
The target processing time for applications for an export certificate for a medicine is 15 working days. We aim to have 100% of applications processed within the target timeframe.
|Mean TGA processing time||12||12||13|
|Percentage processed within target time||98%||99%||97%|
7.3 Export certification assessment for medical devices
The target processing time for applications for an export certificate for a medical device is 5 working days. We aim to have at least 90% of applications processed within the target timeframe.
|Export certificates issued||198||255||327|
|Mean TGA processing time||3||3||3|
|Percentage processed within target time||98%||95%||95%|
7.4 Blood permits for export
The TGA issues permits to export human blood and its fractions (products derived from human blood) on receiving written applications from medical professionals, hospitals and bone banks. Most often these professionals or health organisations approach the Australian Red Cross who then applies for the permit on their behalf. Very rarely an individual citizen may also apply with reference to his/her requirement, for example, a patient travelling overseas with Biostate injections, which is a blood fraction and requires a permit for taking it out of Australia.
In addition to issuing individual permits, the TGA also issues annual permits. Applications for these permits are submitted by commercial (pharmaceutical companies) or government organisations (such as the Australian Defence Force). The permits cover one year's worth of anticipated export supplies for these organisations.
Figure 5: Number of blood permits processed
Text version of figure 5
- Jan-Jun 2014
- Individual permits - 50
- Blood fractions - 45
- Annual permits - 27
- Jul-Dec 2014
- Individual permits - 27
- Blood fractions - 60
- Annual permits - 4
- Jan-Jun 2015
- Individual permits - 39
- Blood fractions - 74
- Annual permits - 14
- Jan-Jun 2014