Status for 2024 as at end-September 2024: In 2024, the share of cases assessed within the target time has been 84%, while in 2023 it was 69%.

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 reduced in 2023. It is expected that the assessment times will reach 95% compliance in the 2^nd half of 2025

84 % of the cases finished within the performance requirement's maximum of 60 days (average assessment time is 65 days):

• Human medicines: 84 % of the cases finished within the performance requirement's maximum of 60 days (64 days on average).
• Veterinary medicines: 50 % of the cases finished within the performance requirement's maximum of 60 days (126 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.

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