Assessment times for authorisation of parallel import of medicines 2016

Updated 16 June 2017

Status for 2016 as at end-December 2016: In 2016, the share of cases assessed within the target time has been 94 %, while in 2015 was 76 %.

94 % of the cases finished within the performance requirement's maximum of 60 days (average assessment time is 48 days):

  • Human medicines: 94 % of the cases finished within the performance requirement's maximum of 60 days (48 days on average).
  • Veterinary medicines: 100 % of the cases finished within the performance requirement's maximum of 60 days (49 days on average).

Chart 1: Average assessment times for parallel import
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.