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Tables on assessment times for national variations

Updated 16 June 2017

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 2015
 54 30 24 835 546 65
2nd quarter 2015
 30 30 0 950 782 82
3rd quarter 2015  33 30  3 805 615 76
4th quarter 2015  27 30 -3 739 634 86
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

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 2015
 56 30 26 771 492 64
2nd quarter 2015
 32 30 2 796 632 79
3rd quarter 2015  36 30  6 683 498 73
4th quarter 2015  26 30 -4 690 602 87
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

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 2015
 28 30 -2 64 54 84
2nd quarter 2015
 19 30 -11 154 150 97
3rd quarter 2015  18  30  -12  122  117  96 
4th quarter 2015  31  30 1 49 32 65
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

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 2015
 48 60 -12 771 648 84
2nd quarter 2015
 44 60 -16 469 378 81
3rd quarter 2015  49 60  -11 546 481 88
4th quarter 2015  37 60 -23 656 570 87
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

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 2015
 45 60 -15 711 601 85
2nd quarter 2015
 45 60 -15 436 346 79
3rd quarter 2015  51 60  -9  502 439 87
4th quarter 2015  37 60 -23 631 554 88
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

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 2015
 74 60 14 60 47 78
2nd quarter 2015
 25 60 -35 33 32 97
3rd quarter 2015  25  60  -35  44  42  95 
4th quarter 2015  34 60 -26 25 16 64
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

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 2015
 198 150 48 211 113 54
2nd quarter 2015
 243 150 93 206 94 46
3rd quarter 2015  153  150  3  219  133  61 
4th quarter 2015  105  150 -45 245 194 79
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

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 2015
 202 150 52 198 102 52
2nd quarter 2015
 244 150 94 200 90 45
3rd quarter 2015  149  150  -1  209  128  61 
4th quarter 2015  97  150 -53 234 193 82
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

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 2015
 140 150 -10 13 11 85
2nd quarter 2015
 196 150 46 6 4 67
3rd quarter 2015  229  150  79  10  5  50 
4th quarter 2015  282 150 132 11 1 9
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