Assessment times for national variations
Variations for human medicinal products are divided in three types of variations:
Type IB and VRA reduceret: 60 days
Type II and VRA standard/extended: 150 days
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 daysType 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 Q3 2024, we make the following observations for variations for human medicinal products:
Type IA variations: In 2024, the share of variations assessed within the target time has been 96 %, while in 2023 was 54 %.
Type IB variations: In 2024, the share of variations assessed within the target time has been 84 %, while in 2023 was 71 %.
Type II variations: In 2024, the share of variations assessed within the target time has been 62 %, while in 2023 was 32 %.For Q3 2024, we make the following observations for variations for veterinary medicinal products:
Type IA and VNRA variations: In 2024, the share of variations assessed within the target time has been 74 %, while in 2023 was 86 %.
Type IB and VRA reduced variations: In 2024, the share of variations assessed within the target time has been 91 %, while in 2023 was 83 %.
Type II and VRA standard/extended variations: In 2024, the share of variations assessed within the target time has been 67 %, while in 2023 was 35 %.Due to the Covid-19 pandemic, the Danish Medicines Agency did not prioritize the assessments times. We therefore built up a backlog of cases which were completed in 2023. 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
It is expected to reach 95% compliance in 2024 for type IA variations, Q2 2025 for type IB variations and Q4 2024 for type II variations.
2 parallelimport variations covering many medicinal products (respectively 478 and 68 products) are to blame for the high assessment time for type IA variations in Q3 2023. The 2 variations where time-consuming due to updates in manufacturer data for all medicinal products.
Type IA and VNRA
Assessment time for human medicinal products in 2024 for type IA variations as at end-September 2024: 96 % of the cases finished within the performance requirement's maximum of 30 days (20 days on average).
Assessment time for veterinary medicinal products in 2024 for type IA and VNRA variations as at end-September 2024: 74 % of the cases finished within the performance requirement's maximum of 30 days (39 days on average).
Chart 1. Assessment times for type IA and VNRA variations
See table 1-3 for type IA variations
Type IB and VRA reduced variations
Assessment time for human medicinal products in 2024 for type IB variations as at end-September 2024: 84 % of the cases finished within the performance requirement's maximum of 60 days (49 days on average):
Assessment time for veterinary medicinal products in 2024 for type IB and VRA reduced variations as at end-September 2024: 91 % of the cases finished within the performance requirement's maximum of 60 days (28 days on average):
Chart 2. Assessment times for type IB and VRA reduced variations
See table 4-6 for type IB variations
Type II and VRA standard/extended variations
Assessment time for human medicinal products in 2024 for type II variations as at end-September 2024: 62 % of the cases finished within the performance requirement's maximum of 150 days (186 days on average).
Assessment time for veterinary medicinal products in 2024 for type II variations as at end-September 2024: 67 % of the cases finished within the performance requirement's maximum of 150 days (147 days on average).
Chart 3. Assessment times for type II and VRA standard/extended variations
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