Tables on assessment times for national variations
Updated 13 February 2018
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 2016 | 27 | 30 | -3 | 648 | 402 | 62 |
| 2nd quarter 2016 | 23 | 30 | -7 | 888 | 750 | 84 |
| 3rd quarter 2016 | 10 | 30 | -20 | 522 | 470 | 90 |
| 4th quarter 2016 | 19 | 30 | -11 | 455 | 421 | 93 |
| 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 |
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 2016 | 27 | 30 | -3 | 608 | 365 | 60 |
| 2nd quarter 2016 | 23 | 30 | -7 | 848 | 714 | 84 |
| 3rd quarter 2016 | 11 | 30 | -19 | 332 | 298 | 90 |
| 4th quarter 2016 | 20 | 30 | -10 | 416 | 382 | 92 |
| 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 |
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 2016 | 19 | 30 | -11 | 42 | 37 | 88 |
| 2nd quarter 2016 | 21 | 30 | -9 | 40 | 36 | 90 |
| 3rd quarter 2016 | 8 | 30 | -22 | 190 | 172 | 91 |
| 4th quarter 2016 | 12 | 30 | -18 | 39 | 39 | 100 |
| 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 |
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 2016 | 46 | 60 | -14 | 502 | 407 | 81 |
| 2nd quarter 2016 | 44 | 60 | -16 | 558 | 436 | 78 |
| 3rd quarter 2016 | 32 | 60 | -28 | 419 | 373 | 89 |
| 4th quarter 2016 | 35 | 60 | -25 | 704 | 621 | 88 |
| 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 |
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 2016 | 47 | 60 | -13 | 409 | 316 | 77 |
| 2nd quarter 2016 | 45 | 60 | -15 | 517 | 402 | 78 |
| 3rd quarter 2016 | 34 | 60 | -26 | 353 | 314 | 89 |
| 4th quarter 2016 | 35 | 60 | -25 | 667 | 584 | 88 |
| 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 |
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 2016 | 40 | 60 | -20 | 93 | 91 | 98 |
| 2nd quarter 2016 | 30 | 60 | -30 | 41 | 34 | 83 |
| 3rd quarter 2016 | 21 | 60 | -39 | 66 | 59 | 89 |
| 4th quarter 2016 | 36 | 60 | -24 | 37 | 37 | 100 |
| 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 |
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 2016 | 205 | 150 | 55 | 251 | 110 | 44 |
| 2nd quarter 2016 | 193 | 150 | 43 | 272 | 134 | 49 |
| 3rd quarter 2016 | 154 | 150 | 4 | 256 | 98 | 38 |
| 4th quarter 2016 | 165 | 150 | 15 | 186 | 78 | 42 |
| 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 |
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 2016 | 210 | 150 | 60 | 243 | 104 | 43 |
| 2nd quarter 2016 | 189 | 150 | 39 | 257 | 134 | 52 |
| 3rd quarter 2016 | 153 | 150 | 3 | 253 | 96 | 38 |
| 4th quarter 2016 | 162 | 150 | 12 | 174 | 73 | 42 |
| 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 |
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 2016 | 63 | 150 | -87 | 8 | 6 | 75 |
| 2nd quarter 2016 | 271 | 150 | 121 | 15 | 0 | 0 |
| 3rd quarter 2016 | 201 | 150 | 51 | 3 | 2 | 67 |
| 4th quarter 2016 | 215 | 150 | 65 | 12 | 5 | 42 |
| 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 |