Assessment times for national variations 2026

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 28th of January 2022 are also divided into Type IA / IB / II, while the variations applied for after 28th 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.

For Q2 2026, we make the following observations for variations for human medicinal products:

Type IA variations: In 2026, the share of variations assessed within the target time has been 91 %, while in 2025 was 96 %.

Type IB variations: In 2026, the share of variations assessed within the target time has been 87 %, while in 2025 was 84 %.

Type II variations: In 2026, the share of variations assessed within the target time has been 38 %, while in 2025 was 68 %.

For Q2 2026, we make the following observations for variations for veterinary medicinal products:

Type IA and VNRA variations: In 2026, the share of variations assessed within the target time has been 72 %, while in 2025 was 62 %.

Type IB and VRA reduced variations: In 2026, the share of variations assessed within the target time has been 100 %, while in 2025 was 60 %.

Type II and VRA standard/extended variations: In 2026, the share of variations assessed within the target time has been 76 %, while in 2025 was 39 %.

The low compliance for Type II variations is due to the completion of older cases. We expect to reach 95% compliance in 2027.

Type IA and VNRA variations

Assessment time for human medicinal products in 2026 for type IA variations as at end-June 2025: 91 % of the cases finished within the performance requirement's maximum of 30 days (24 days on average).

Assessment time for veterinary medicinal products in 2026 for type IA and VNRA variations as at end-June 2026: 72 % of the cases finished within the performance requirement's maximum of 30 days (48 days on average).

Chart 1. Assessment times for type IA and VNRA variations

See table 1-2 for type IA variations

Type IB and VRA reduced variations

Assessment time for human medicinal products in 2026 for type IB variations as at end-June 2026: 87 % of the cases finished within the performance requirement's maximum of 60 days (36 days on average):

Assessment time for veterinary medicinal products in 2026 for type IB and VRA reduced variations as at end-June 2026: 100 % of the cases finished within the performance requirement's maximum of 60 days (22 days on average):

Chart 2. Assessment times for type IB and VRA reduced variations

See table 3-4 for type IB variations

Type II and VRA standard/extended variations

Assessment time for human medicinal products in 2026 for type II variations as at end-June 2026: 38 % of the cases finished within the performance requirement's maximum of 150 days (196 days on average).

Assessment time for veterinary medicinal products in 2026 for type II variations as at end-June 2026: 76 % of the cases finished within the performance requirement's maximum of 150 days (135 days on average).

Chart 3. Assessment times for type II and VRA standard/extended variations

See table 5-6 for type II variations

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