Tables on assessment times for national variations 2019

Updated 05 March 2021

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 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
1st quarter 2019 12 30 -18 530 521 98
2nd quarter 2019 11 30 -19 455 449 99
3rd quarter 2019
 6 30 -24 3961 3929 99
4th quarter 2019
 12 30 -18 376 361 96

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 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 98
1st quarter 2019
 12 30 -18 441 433 98
2nd quarter 2019
 10 30 -20 389 383 98
3rd quarter 2019
 6 30 -24 3921 3889 99
4th quarter 2019
 13 30 -17 321 306 95

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 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
1st quarter 2019
 12 30 -18 89 88 99
2nd quarter 2019
 14 30 -16 66 66 100
3rd quarter 2019
 16 30 -14 40 40 100
4th quarter 2019
 7 30 -23 55 55 100

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 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
1st quarter 2019
 20 60 -40 611 593 97
2nd quarter 2019
 23 60 -37 580 563 97
3rd quarter 2019
 24 60 -36 610 575 94
4th quarter 2019
 30 60 -30 575 534 93

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 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
1st quarter 2019
 20 60 -40 559 541 97
2nd quarter 2019
 23 60 -37 564 548 97
3rd quarter 2019
 24 60 -36 577 544 94
4th quarter 2019
 31 60 -29 512 471 92

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 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
1st quarter 2019
 20 60 -40 52 52 100
2nd quarter 2019
 26 60 -34 16 15 94
3rd quarter 2019
 22 60 -38 33 31 94
4th quarter 2019
 23 60 -37 63 63 100

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 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
1st quarter 2019
 95 150 -55 188 178 95
2nd quarter 2019
 81 150 -69 79 75 95
3rd quarter 2019
 98 150 -52 100 95 95
4th quarter 2019
 86 150 -64 101 86 85

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 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
1st quarter 2019
 90 150 -60 160 156 98
2nd quarter 2019
 84 150 -66 71 67 94
3rd quarter 2019
 99 150 -51 97 92 95
4th quarter 2019
 84 150 -66 95 80 84

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 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
1st quarter 2019
 127 150 -23 28 22 79
2nd quarter 2019
 57 150 -93 8 8 100
3rd quarter 2019
 67 150 -83 3 3 100
4th quarter 2019
 116 150 -34 6 6 100