Tables on assessment times for national variations

Updated 02 April 2014

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 2012 42 20  22  772  319  41 
2nd quarter 2012 41 20 21 418 138 33
3rd quarter 2012 43 20 23 820 351 43
4th quarter 2012 86 20 66 987 258 26
1st quarter 2013 72 20 52 1190 180 15
2nd quarter 2013 62 20 42 944 180 19
3rd quarter 2013 27 20 7 1104 659 60
4th quarter 2013 29 20 9 633 418 66


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 2012 43  20  23  665  286  43 
2nd quarter 2012 38 20 18 353 136 39
3rd quarter 2012 44 20 24 734 296 40
4th quarter 2012 90 20 70 909 207 23
1st quarter 2013 70 20 50 1085 155 14
2nd quarter 2013 62 20 42 885 161 18
3rd quarter 2013
 26 20 6 1022 611 60
4th quarter 2013 29 20 9 607 399 66

 

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 2012 31 20  11  107  64  31 
2nd quarter 2012 55 20 35 65 2 3
3rd quarter 2012 35 20 15 86 55 64
4th quarter 2012 40 20 20 78 51 65
1st quarter 2013 91 20 71 105 25 24
2nd quarter 2013 67 20 47 59 19 32
3rd quarter 2013
 30 20 10 82 48 59
4th quarter 2013 37 20 17 26 19 73

 

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 2012 79  95  -16 544  323  60 
2nd quarter 2012 97 95 2 640 334 52
3rd quarter 2012 79 95 -16 743 403 54
4th quarter 2012 71 95 -24 648 468 72
1st quarter 2013 80 95 -15 422 288 68
2nd quarter 2013 106 95 11 343 209 61
3rd quarter 2013
 143 95 48 670 294 44
4th quarter 2013 103 95 8 640 395 62

 

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 2012 77  95  -18  509  308  61 
2nd quarter 2012 94 95 -1 594 315 53
3rd quarter 2012 78 95 -17 711 390 55
4th quarter 2012 74 95 -21 580 412 71
1st quarter 2013 86 95 -9 375 245 65
2nd quarter 2013 108 95 13 316 191 60
3rd quarter 2013
 143 95 48 640 281 44
4th quarter 2013 105 95 10 569 349 61

 

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 2012 115  95  20  35 17  49 
2nd quarter 2012 126 95 31 46 19 41
3rd quarter 2012 97 95 2 32 13 1
4th quarter 2012 44 95 -51 68 56 82
1st quarter 2013 34 95 -61 47 43 91
2nd quarter 2013 80 95 -15 27 18 67
3rd quarter 2013 136 95 41 30 13 43
4th quarter 2013 93 95 -2 71 46 65

 

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 2012 121  185  -64  204  162  79 
2nd quarter 2012 147 185 -38 208 151 73
3rd quarter 2012 148 185 -37 327 217 66
4th quarter 2012 132 185 -53 218 155 71
1st quarter 2013 119 185 -66 245 196 80
2nd quarter 2013 155 185 -30 277 189 68
3rd quarter 2013 253 185 68 425 107 25
4th quarter 2013 187 185 2 249 152 61

 

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 2012 111  185  -74  176  147  84 
2nd quarter 2012 140 185 -45 188 142 76
3rd quarter 2012 137 185 -48 291 203 70
4th quarter 2012 120 185 -65 199 151 76
1st quarter 2013 115 185 -70 235 190 81
2nd quarter 2013 149 185 -36 256 180 70
3rd quarter 2013 254 185 69 409 102 25
4th quarter 2013 172 185 -13 229 151 66

 

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 2012 185  185  0  28  15  54 
2nd quarter 2012 216 185 31 20 9 45
3rd quarter 2012 237 185 52 36 14 39
4th quarter 2012 257 185 72 19 4 21
1st quarter 2013 213 185 28 10 6 60
2nd quarter 2013 223 185 38 21 9 43
3rd quarter 2013 232 185 47 16 5 31
4th quarter 2013 358 185 173 20 1 5

Contact

Send an email