Assessment times for authorisation of parallel import of medicines
Status for 2025 as at end-September 2025: In 2025, the share of cases assessed within the target time has been 97%, while in 2024 it was 84%.
97 % of the cases finished within the performance requirement's maximum of 60 days (average assessment time is 53 days):
- Human medicines: 97 % of the cases finished within the performance requirement's maximum of 60 days (52 days on average).
- Veterinary medicines: 60 % of the cases finished within the performance requirement's maximum of 60 days (104 days on average).
Chart 1: Average assessment times for parallel import
See table 1-3 for parallel import
|
Table 1. Average assessment times for parallel import |
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|
|
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 percent |
|
Parallel import |
||||||
|
4th quarter 2023 |
73 |
60 |
13 |
150 |
123 |
82 |
|
1st quarter 2024 |
61 |
60 |
1 |
135 |
118 |
87 |
|
2nd quarter 2024 |
58 |
60 |
-2 |
118 |
96 |
81 |
|
3rd quarter 2024 |
75 |
60 |
15 |
119 |
97 |
82 |
|
4th quarter 2024 |
81 |
60 |
21 |
181 |
153 |
85 |
|
1st quarter 2025 |
48 |
60 |
-12 |
110 |
107 |
97 |
|
2nd quarter 2025 |
56 |
60 |
-4 |
182 |
176 |
97 |
|
3rd quarter 2025 |
53 |
60 |
-7 |
177 |
170 |
96 |
|
Table 2. Average assessment times for parallel import – Human medicines |
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|
|
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 percent |
|
Parallel import |
||||||
|
4th quarter 2023 |
73 |
60 |
13 |
146 |
121 |
83 |
|
1st quarter 2024 |
58 |
60 |
-2 |
130 |
115 |
88 |
|
2nd quarter 2024 |
58 |
60 |
-2 |
118 |
96 |
81 |
|
3rd quarter 2024 |
75 |
60 |
15 |
118 |
97 |
82 |
|
4th quarter 2024 |
67 |
60 |
7 |
173 |
153 |
88 |
|
1st quarter 2025 |
48 |
60 |
-12 |
110 |
107 |
97 |
|
2nd quarter 2025 |
54 |
60 |
-6 |
178 |
174 |
98 |
|
3rd quarter 2025 |
53 |
60 |
-7 |
176 |
169 |
96 |
|
Table 3. Average assessment times for parallel import – Veterinary medicines |
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|
|
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 percent |
|
Parallel import |
||||||
|
4th quarter 2023 |
100 |
60 |
40 |
4 |
2 |
50 |
|
1st quarter 2024 |
125 |
60 |
65 |
5 |
3 |
60 |
|
2nd quarter 2024 |
|
60 |
|
0 |
|
|
|
3rd quarter 2024 |
132 |
60 |
72 |
1 |
0 |
0 |
|
4th quarter 2024 |
374 |
60 |
314 |
8 |
0 |
0 |
|
1st quarter 2025 |
|
60 |
|
0 |
|
|
|
2nd quarter 2025 |
128 |
60 |
68 |
4 |
2 |
50 |
|
3rd quarter 2025 |
10 |
60 |
-50 |
1 |
1 |
100 |
The assessment times are measured against the target time of 60 days, i.e. from the date when we start reviewing the application until we issue the marketing authorisation. The assessment times are net times, which means that they do not include any time periods during which we await a reply from the applicant or the export country.
For further information, please contact Send an email.