Assessment times for national variations

Variations for human medicinal products are divided in three types of variations:

Type IA variations
Type IB variations
Type II variations

Variations for the veterinary medicinal products applied for before 28^th of January 2022 are also divided into Type IA / IB / II, while the variations applied for after 28^th of January 2022 are divided into VNRA, VRA reduced, VRA standard and VRA extended, according to the new regulation for veterinary medicinal products . Types IA / IB / II and VNRA / VRA for the veterinary medicinal products are broken down according to the target assessment times:

Type IA and VNRA variations: 30 days

Type IB and VRA reduced: 60 days

Type II and VRA standard/extended: 150 days

The assessment times reported are calculated in the following way:

Assessment times for type IA and VNRA variations: The assessment time is measured against the target time of 30 days from the date on which we receive the application until the date of determination (grant or refusal).

Assessment times for type IB and VRA reduced variations: The assessment time is measured against the target time of 60 days from the start of procedure until the date of determination (grant or refusal), excluding any clock-stop days.

Assessment times for type II VRA standard/extended variations: The assessment time is measured against the target time of 150 days from the date on which we receive the application until the date of determination (grant or refusal), excluding any clock-stop days.

As announced on the website here on the 24^th of January 2024 [Link], we consider our backlog of delayed cases to be over and all delayed cases are either closed or in the process of being processed. These last cases affect and will continue to affect the assessment times until they are completely closed. To illustrate this, the following table shows the assessment times for human and veterinary cases combined and for comparison, it can be stated that the percentage of compliance with the assessment times for cases received after the 1^st of  January 2024 is as follows: Type IB = 84% and type II 71%. There is still need for improvements, but there are not many older unprocessed cases lying around.

For Q3 2025, we make the following observations for variations for human medicinal products:

Type IA variations: In 2025, the share of variations assessed within the target time has been 94 %, while in 2024 was 96 %.

Type IB variations: In 2025, the share of variations assessed within the target time has been 81 %, while in 2024 was 85 %.

Type II variations: In 2025, the share of variations assessed within the target time has been 68 %, while in 2024 was 57 %.

For Q3 2025, we make the following observations for variations for veterinary medicinal products:

Type IA and VNRA variations: In 2025, the share of variations assessed within the target time has been 58 %, while in 2024 was 65 %.

Type IB and VRA reduced variations: In 2025, the share of variations assessed within the target time has been 51 %, while in 2024 was 85 %.

Type II and VRA standard/extended variations: In 2025, the share of variations assessed within the target time has been 37 %, while in 2024 was 59 %.

It should be noted in particular that the completion of backlog of cases were defined as starting the case and not ending the case. Therefore, assessment times will continue to be affected by the delayed cases until they are completely settled. We expect to reach 95% compliance in the second half of 2026.