Assessment times for authorisation of parallel import of medicines in 2021

Status for 2021 as at end-December 2021: In 2021, the share of cases assessed within the target time has been 20 %.

The Covid-19 pandemic has meant that it has been necessary to make a different priority than usual, which is why the target fulfillment for the assessment times is lower compared with previous years. It is expected that the assessment times will not reach 95% compliance until 2023.

20 % of the cases finished within the performance requirement's maximum of 60 days (average assessment time is 197 days):

• Human medicines: 20 % of the cases finished within the performance requirement's maximum of 60 days (197 days on average).
• Veterinary medicines: 25 % of the cases finished within the performance requirement's maximum of 60 days (197 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 godkendelse@dkma.dk.