Tables on assessment times for national variations 2018
Updated 06 February 2019
Table 1. Type 1A notifications
| Total assessment time for type IA variations | Average assessment time | Target days | Difference between assessment times and target days | No. of cases measured No. of drug IDs |
No. of cases within target | Share of cases within target in per cent |
| 1st quarter 2017 | 17 | 30 | -13 | 578 | 517 | 89 |
| 2nd quarter 2017 | 34 | 30 | 4 | 551 | 488 | 89 |
| 3rd quarter 2017 | 12 | 30 | -18 | 344 | 324 | 94 |
| 4th quarter 2017 |
16 | 30 | -14 | 2125 | 2101 | 99 |
| 1st quarter 2018 | 10 | 30 | -20 | 405 | 399 | 99 |
| 2nd quarter 2018 | 11 | 30 | -19 | 661 | 647 | 98 |
| 3rd quarter 2018 | 11 | 30 | -19 | 367 | 365 | 99 |
| 4th quarter 2018 | 10 | 30 | -20 | 602 | 591 | 98 |
Table 2. Type 1A notifications - Human medicines
| Total assessment time for type IA variations | Average assessment time | Target days | Difference between assessment times and target days | No. of cases measured No. of drug IDs |
No. of cases within target | Share of cases within target in per cent |
| 1st quarter 2017 | 18 | 30 | -12 | 520 | 461 | 89 |
| 2nd quarter 2017 | 35 | 30 | 5 | 527 | 467 | 89 |
| 3rd quarter 2017 | 12 | 30 | -18 | 326 | 306 | 94 |
| 4th quarter 2017 | 16 | 30 | -14 | 1945 | 1924 | 99 |
| 1st quarter 2018 | 10 | 30 | -20 | 371 | 365 | 98 |
| 2nd quarter 2018 | 11 | 30 | -19 | 570 | 556 | 98 |
| 3rd quarter 2018 |
11 | 30 | -19 | 340 | 339 | 100 |
| 4th quarter 2018 |
10 | 30 | -20 | 536 | 525 |
Table 3. Type 1A notifications - Veterinary medicines
| Total assessment time for type IA variations | Average assessment time | Target days | Difference between assessment times and target days | No. of cases measured No. of drug IDs |
No. of cases within target | Share of cases within target in per cent |
| 1st quarter 2017 | 14 | 30 | -16 | 58 | 56 | 97 |
| 2nd quarter 2017 | 13 | 30 | -17 | 24 | 21 | 88 |
| 3rd quarter 2017 | 8 | 30 | -22 | 18 | 18 | 100 |
| 4th quarter 2017 | 14 | 30 | -16 | 180 | 177 | 98 |
| 1st quarter 2018 | 4 | 30 | -26 | 34 | 34 | 100 |
| 2nd quarter 2018 | 5 | 30 | -25 | 91 | 91 | 100 |
| 3rd quarter 2018 |
11 | 30 | -19 | 27 | 26 | 96 |
| 4th quarter 2018 |
5 | 30 | -25 | 66 | 66 | 100 |
Table 4. Type IB notifications
| Total assessment time for type IB variations | Average assessment time | Target days | Difference between assessment times and target days | No. of cases measured No. of drug IDs |
No. of cases within target | Share of cases within target in per cent |
| 1st quarter 2017 | 35 | 60 | -25 | 567 | 489 | 86 |
| 2nd quarter 2017 | 27 | 60 | -33 | 560 | 526 | 94 |
| 3rd quarter 2017 | 42 | 60 | -18 | 650 | 611 | 94 |
| 4th quarter 2017 | 22 | 60 | -38 | 767 | 740 | 96 |
| 1st quarter 2018 | 29 | 60 | -31 | 407 | 385 | 95 |
| 2nd quarter 2018 | 25 | 60 | -35 | 736 | 718 | 98 |
| 3rd quarter 2018 |
24 | 60 | -36 | 643 | 626 | 97 |
| 4th quarter 2018 |
30 | 60 | -30 | 643 | 608 | 95 |
Table 5. Type IB notifications - Human medicines
| Total assessment time for type IB variations | Average assessment time | Target days | Difference between assessment times and target days | No. of cases measured No. of drug IDs |
No. of cases within target | Share of cases within target in per cent |
| 1st quarter 2017 | 36 | 60 | -24 | 538 | 460 | 86 |
| 2nd quarter 2017 | 25 | 60 | -35 | 517 | 493 | 95 |
| 3rd quarter 2017 | 39 | 60 | -21 | 617 | 584 | 95 |
| 4th quarter 2017 | 21 | 60 | -39 | 751 | 727 | 97 |
| 1st quarter 2018 | 31 | 60 | -29 | 366 | 344 | 94 |
| 2nd quarter 2018 | 24 | 60 | -36 | 703 | 691 | 98 |
| 3rd quarter 2018 |
24 | 60 | -36 | 579 | 563 | 97 |
| 4th quarter 2018 | 31 | 60 | -29 | 614 | 579 | 94 |
Table 6. Type IB notifications - Veterinary medicines
| Total assessment time for type IB variations | Average assessment time | Target days | Difference between assessment times and target days | No. of cases measured No. of drug IDs |
No. of cases within target | Share of cases within target in per cent |
| 1st quarter 2017 | 24 | 60 | -36 | 29 | 29 | 100 |
| 2nd quarter 2017 | 54 | 60 | -6 | 43 | 33 | 77 |
| 3rd quarter 2017 | 97 | 60 | 37 | 33 | 37 | 82 |
| 4th quarter 2017 | 36 | 60 | -24 | 16 | 13 | 81 |
| 1st quarter 2018 | 11 | 60 | -49 | 41 | 41 | 100 |
| 2nd quarter 2018 | 46 | 60 | -14 | 33 | 27 | 82 |
| 3rd quarter 2018 |
22 | 60 | -38 | 64 | 63 | 98 |
| 4th quarter 2018 | 12 | 60 | -48 | 29 | 29 | 100 |
Table 7. Type II notifications
| Total assessment time for type II variations | Average assessment time | Target days | Difference between assessment times and target days | No. of cases measured No. of drug IDs |
No. of cases within target | Share of cases within target in per cent |
| 1st quarter 2017 | 224 | 150 | 74 | 195 | 58 | 30 |
| 2nd quarter 2017 | 177 | 150 | 27 | 176 | 101 | 57 |
| 3rd quarter 2017 | 159 | 150 | 9 | 172 | 110 | 64 |
| 4th quarter 2017 | 116 | 150 | -34 | 147 | 127 | 86 |
| 1st quarter 2018 | 89 | 150 | -61 | 79 | 78 | 99 |
| 2nd quarter 2018 | 109 | 150 | -41 | 116 | 112 | 97 |
| 3rd quarter 2018 |
85 | 150 | -65 | 70 | 69 | 99 |
| 4th quarter 2018 | 97 | 150 | -53 | 147 | 144 | 98 |
Table 8. Type II notifications - Human medicines
| Total assessment time for type II variations | Average assessment time | Target days | Difference between assessment times and target days | No. of cases measured No. of drug IDs |
No. of cases within target | Share of cases within target in per cent |
| 1st quarter 2017 | 239 | 150 | 88 | 179 | 45 | 25 |
| 2nd quarter 2017 | 180 | 150 | 30 | 172 | 97 | 56 |
| 3rd quarter 2017 | 156 | 150 | 6 | 156 | 100 | 64 |
| 4th quarter 2017 | 116 | 150 | -34 | 146 | 126 | 86 |
| 1st quarter 2018 | 90 | 150 | -60 | 78 | 77 | 99 |
| 2nd quarter 2018 | 111 | 150 | -39 | 113 | 109 | 96 |
| 3rd quarter 2018 |
85 | 150 | -65 | 65 | 64 | 98 |
| 4th quarter 2018 | 97 | 150 | -53 | 141 | 138 | 98 |
Table 9. Type II notifications - Veterinary medicines
| Total assessment time for type II variations | Average assessment time | Target days | Difference between assessment times and target days | No. of cases measured No. of drug IDs |
No. of cases within target | Share of cases within target in per cent |
| 1st quarter 2017 | 48 | 150 | -102 | 16 | 13 | 81 |
| 2nd quarter 2017 | 64 | 150 | -86 | 4 | 4 | 100 |
| 3rd quarter 2017 | 193 | 150 | 43 | 16 | 10 | 63 |
| 4th quarter 2017 | 99 | 150 | -51 | 1 | 1 | 100 |
| 1st quarter 2018 | 31 | 150 | -119 | 1 | 1 | 100 |
| 2nd quarter 2018 | 66 | 150 | -84 | 3 | 3 | 100 |
| 3rd quarter 2018 |
82 | 150 | -68 | 5 | 5 | 100 |
| 4th quarter 2018 | 77 | 150 | -73 | 6 | 6 | 100 |