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Half yearly performance report - January to June 2015

16 December 2015

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4. Biologicals

The Australian regulatory guidelines for biologicals defines the different Biological classes.

4.1 Inclusion of biologicals

Table 22: Applications for biologicals received and on hand
2014 2015
Jan-Jun Jul-Dec Jan-Jun
Applications received
Technical Master File (TMF) new 0 0 0
TMF annual updates 1 5 3
TMF variations 8 5 2
TMF notifications 4 5 3
Plasma Master File annual updates 12 6 10
Biological Class 2 - new applications 1 1 0
Biological Class 3 - new applications 0 0 0
Biological Class 2 - variations 0 2 3
Biological Class 3 - variations 4 1 1
Total received 30 25 22
Applications on hand
Technical Master File (TMF) new 2 2 1
TMF annual updates 4 4 2
TMF variations 7 0 0
TMF notifications 3 2 0
Plasma Master File annual updates 6 7 8
Biological Class 2 - new applications 20 11 3
Biological Class 3 - new applications 2 2 2
Biological Class 2 - variations 0 1 0
Biological Class 3 - variations 1 1 4
Total on hand 45 30 20
Table 23: Completed applications for Biologicals
2014 2015
Jan-Jun Jul-Dec Jan-Jun
Technical Master File (TMF) new 0 0 1
TMF annual updates 0 2 2
TMF variations 1 6 0
TMF notifications 1 5 0
Plasma Master File annual updates 6 9 8
Biological Class 2 - new applications 0 9 3
Biological Class 3 - new applications 0 4 2
Biological Class 2 - variations 0 1 0
Biological Class 3 - variations 3 0 4
Total completed 11 36 20

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