Tables on assessment times for national variations in 2023
Updated 05 March 2024
Table 1. Type 1A notifications
| Total assessment time for type IA variations - HUM | Average assessment time | Target days | Difference between assessment time 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 2022 | 30 | 30 | 0 | 267 | 246 | 92 |
| 2nd quarter 2022 | 11 | 30 | -19 | 292 | 285 | 98 |
| 3rd quarter 2022 | 37 | 30 | 7 | 259 | 236 | 91 |
| 4th quarter 2022 | 84 | 30 | 54 | 536 | 230 | 43 |
| 1st quarter 2023 | 58 | 30 | 28 | 342 | 262 | 77 |
| 2nd quarter 2023 | 31 | 30 | 1 | 253 | 210 | 83 |
| 3rd quarter 2023 | 270 | 30 | 240 | 834 | 246 | 29 |
| 4th quarter 2023 | 34 | 30 | 4 | 234 | 188 | 80 |
Table 2. Type 1A notifications - Human medicines
| Total assessment time for type IA/VNRA variations - VET | Average assessment time | Target days | Difference between assessment time 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 2022 | 19 | 30 | -11 | 56 | 54 | 96 |
| 2nd quarter 2022 | 21 | 30 | -9 | 54 | 48 | 89 |
| 3rd quarter 2022 | 99 | 30 | 69 | 24 | 18 | 75 |
| 4th quarter 2022 | 29 | 30 | -1 | 21 | 16 | 76 |
| 1st quarter 2023 | 21 | 30 | -9 | 92 | 89 | 97 |
| 2nd quarter 2023 | 21 | 30 | -9 | 68 | 68 | 100 |
| 3rd quarter 2023 | 72 | 30 | 42 | 77 | 46 | 60 |
| 4th quarter 2023 | 33 | 30 | 3 | 72 | 62 | 86 |
Table 3. Type 1A notifications - Veterinary medicines
| Total assessment time for type IB variations - HUM | Average assessment time | Target days | Difference between assessment time 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 2022 | 85 | 60 | 25 | 288 | 164 | 57 |
| 2nd quarter 2022 | 36 | 60 | -24 | 360 | 323 | 90 |
| 3rd quarter 2022 | 68 | 60 | 8 | 315 | 224 | 71 |
| 4th quarter 2022 | 77 | 60 | 17 | 401 | 267 | 67 |
| 1st quarter 2023 | 60 | 60 | 0 | 486 | 347 | 71 |
| 2nd quarter 2023 | 54 | 60 | -6 | 297 | 201 | 68 |
| 3rd quarter 2023 | 69 | 60 | 9 | 396 | 278 | 70 |
| 4th quarter 2023 | 59 | 60 | -1 | 477 | 353 | 74 |
Table 4. Type IB notifications
| Total assessment time for type IB/VRA reduced variations - VET | Average assessment time | Target days | Difference between assessment time 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 2022 | 77 | 60 | 17 | 47 | 28 | 60 |
| 2nd quarter 2022 | 82 | 60 | 22 | 46 | 28 | 61 |
| 3rd quarter 2022 | 84 | 60 | 24 | 17 | 11 | 65 |
| 4th quarter 2022 | 19 | 60 | -41 | 118 | 111 | 94 |
| 1st quarter 2023 | 28 | 60 | -32 | 35 | 33 | 94 |
| 2nd quarter 2023 | 94 | 60 | 34 | 19 | 10 | 53 |
| 3rd quarter 2023 | 24 | 60 | -36 | 9 | 8 | 89 |
| 4th quarter 2023 | 17 | 60 | -43 | 12 | 11 | 92 |
Table 5. Type IB notifications - Human medicines
| Total assessment time for type II variations - HUM | Average assessment time | Target days | Difference between assessment time 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 2022 | 192 | 150 | 42 | 31 | 8 | 26 |
| 2nd quarter 2022 | 167 | 150 | 17 | 84 | 53 | 63 |
| 3rd quarter 2022 | 199 | 150 | 49 | 80 | 42 | 53 |
| 4th quarter 2022 | 180 | 150 | 30 | 79 | 40 | 51 |
| 1st quarter 2023 | 239 | 150 | 89 | 140 | 56 | 40 |
| 2nd quarter 2023 | 325 | 150 | 175 | 106 | 32 | 30 |
| 3rd quarter 2023 | 274 | 150 | 124 | 132 | 48 | 36 |
| 4th quarter 2023 | 285 | 150 | 135 | 206 | 53 | 26 |
Table 6. Type IB notifications - Veterinary medicines
| Total assessment time for type II/VRA standard variations - VET | Average assessment time | Target days | Difference between assessment time 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 2022 | 156 | 150 | 6 | 5 | 1 | 20 |
| 2nd quarter 2022 | 86 | 150 | -64 | 3 | 3 | 100 |
| 3rd quarter 2022 | 196 | 150 | 46 | 19 | 2 | 11 |
| 4th quarter 2022 | 147 | 150 | -3 | 4 | 3 | 75 |
| 1st quarter 2023 | 322 | 150 | 172 | 4 | 2 | 50 |
| 2nd quarter 2023 | 346 | 150 | 196 | 10 | 1 | 10 |
| 3rd quarter 2023 | 158 | 150 | 8 | 5 | 4 | 80 |
| 4th quarter 2023 | 201 | 150 | 51 | 7 | 2 | 29 |