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%) |
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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