Assessment times for national variations in 2021

Updated 16 February 2022

The assessment times are divided respectively in human and veterinary medicines. We calculate the total assessment time for the three types of variations:

Type IA variations
Type IB variations
Type II variations

The assessment times reported are broken down by type IA, IB and II variations and calculated in the following way:

Assessment times for type IA 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 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 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 Q4 2021, we make the following observations:

Type IA variations: In 2021, the share of variations assessed within the target time has been 90 %, while in 2020 was 87 %.

Type IB variations: In 2021, the share of variations assessed within the target time has been 88 %, while in 2020 was 94 %.

Type II variations: In 2021, the share of variations assessed within the target time has been 59 %, while in 2020 was 80 %.

Due to the Covid-19 pandemic, the Danish Medicines Agency has not prioritized the assessments times in 2021. Only in 2022 is it expected that the assessments times will reach the approx. 95% compliance for type IA variations, and in 2023 for type IB and type II variations.

Type IA variations

Assessment time in 2021 for type IA variations as at end-December 2021: 87 % of the cases finished within the performance requirement's maximum of 30 days (20 days on average):

  • Human medicines: 86 % of the cases finished within the performance requirement's maximum of 30 days (20 days on average).
  • Veterinary medicines: 95 % of the cases finished within the performance requirement's maximum of 30 days (13 days on average).

Chart 1. Assessment times for type IA variations

Assessment times for national variations IA in 2020 and 2021 

See table 1-3 for type IA variations

Type IB variations

Assessment time in 2021 for type IB variations as at end-December 2021: 82 % of the cases finished within the performance requirement's maximum of 60 days (41 days on average):

  • Human medicines: 82 % of the cases finished within the performance requirement's maximum of 60 days (43 days on average)
  • Veterinary medicines: 89 % of the cases finished within the performance requirement's maximum of 60 days (30 days on average)

Chart 2. Assessment times for type IB variations 

Assessment times for national variations IB in 2020 and 2021
  

See table 4-6 for type IB variations

Type II variations

Assessment time in 2021 for type II variations as at end-December 2021: 57 % of the cases finished within the performance requirement's maximum of 150 days (165 days on average).

  • Human medicines: 57 % of the cases finished within the performance requirement's maximum of 150 days (163 days on average).
  • Veterinary medicines: 58 % of the cases finished within the performance requirement's maximum of 150 days (182 days on average). 

Chart 3. Assessment times for type II variations

Assessment times for national variations II in 2020 and 2021 

See table 7-9 for type II variations

For further information, please contact godkendelse@dkma.dk.