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Annual performance statistics report: July 2018 to June 2019

21 October 2019

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5. Biologicals and blood components

5.1. Inclusion of biologicals

Table 29 Applications for biologicals[a] received and on hand
2017-18 2018-19
July to June
Number (% of Total)
Applications received
Technical Master File (TMF)[b] new 0 0
TMF annual updates 3 (5%) 3 (4%)
TMF variations 14 (22%) 18 (23%)
TMF notifications 8 (12%) 12 (16%)
Plasma Master File[c] annual updates 10 (15%) 12 (16%)
Biological Class 2 - new applications 1 (1%) 1 (1%)
Biological Class 3 - new applications 0 0
Biological Class 4 - new applications 2 (3%) 1 (1%)
Biological Class 2 - variations 22 (34%) 23 (30%)
Biological Class 3 - variations 5 (8%) 3 (4%)
Biological Class 4 - variations 0 4 (6%)
Total received 65 (100%) 77 (100%)
Applications on hand
TMF new 0 0
TMF annual updates 2 (10%) 1 (7%)
TMF variations 4 (19%) 5 (33%)
TMF notifications 0 0
Plasma Master File annual updates 7 (33%) 4 (27%)
Biological Class 2 - new applications 2 (10%) 1 (7%)
Biological Class 3 - new applications 1 (5%) 1 (7%)
Biological Class 4 - new applications 2 (10%) 1 (7%)
Biological Class 2 - variations 3 (14%) 2 (13%)
Biological Class 3 - variations 0 0
Biological Class 4 - variations 0 0
Total on hand 21 (100%) 15 (100%)

Footnotes


Table 30 Completed applications for biologicals
2017-18 2018-19
July to June
Number (% of Total)
Biologicals applications
Technical Master File (TMF) new 1 (2%) 0
TMF annual updates 2 (4%) 3 (4%)
TMF variations 8 (14%) 13 (19%)
TMF notifications 8 (14%) 12 (17%)
Plasma Master File annual updates 8 (14%) 9 (13%)
Biological Class 2 - new applications 3 (5%) 2 (3%)
Biological Class 3 - new applications 0 0
Biological Class 4 - new applications 0 1 (1%)
Biological Class 2 - variations 22 (39%) 23 (33%)
Biological Class 3 - variations 5 (9%) 3 (4%)
Biological Class 4 - variations 0 4 (6%)
Total completed 57 (100%) 70 (100%)

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