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