Assessment times for authorisation of parallel import of medicines 2018

27 September 2018, Updated 23 January 2019

Status for 2018 as at end-December2018: In 2018, the share of cases assessed within the target time has been 87 %, while in 2017 was 85 %.

87 % of the cases finished within the performance requirement's maximum of 60 days (average assessment time is 51 days):

  • Human medicines: 87 % of the cases finished within the performance requirement's maximum of 60 days (51 days on average).
  • Veterinary medicines: 100 % of the cases finished within the performance requirement's maximum of 60 days (54 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.