Assessment times for authorisation of parallel import of medicines 2014

Status for 2014 as at end-December 2014: The assessment time has significantly improved since Q1 2014, although the performance requirement cannot be complied based on the previously announced temporary decline in the resources assigned within this field. However, the assessment times has significantly improved since Q1 2014. The average assessment time has been reduced from 138 days in Q1 2014 to 107 days in Q4 2014. In addition, it should be mentioned that the average number of completed cases per quarter has increased from 120 cases in 2013 to 190 cases in 2014.

41 % of the cases finished within the performance requirement's maximum of 60 days (average assessment time is 117 days):

• Human medicines: 42 % of the cases finished within the performance requirement's maximum of 60 days (118 days on average).
• Veterinary medicines: 26 % of the cases finished within the performance requirement's maximum of 60 days (95 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.