Assessment times for authorisation of parallel import of medicines in 2023
Status for 2023 as at end-December 2023: In 2023, the share of cases assessed within the target time has been 69%.
Due to the Covid-19 pandemic, the Danish Medicines Agency has not prioritized the assessments times. We have therefore built up a backlog of cases which we have reduces in 2023.
It is expected that the assessments times will reach 95% compliance in the 2nd half of 2024
69 % of the cases finished within the performance requirement's maximum of 60 days (average assessment time is 102 days):
- Human medicines: 70 % of the cases finished within the performance requirement's maximum of 60 days (100 days on average).
- Veterinary medicines: 33 % of the cases finished within the performance requirement's maximum of 60 days (174 days on average).
Chart 1: Average assessment times for parallel import
See table 1-3 for parallel import
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.