Assessment times for national variations 2016

Updated 16 June 2017

The assessment times are divided respectively in human and veterinary medicines. We calculate the total assessment time for the three types of variations:

Type IA variations
Type IB variations
Type II variations

The assessment times reported are broken down by type IA, IB and II variations and calculated in the following way:

Assessment times for type IA variations: The assessment time is measured against the target time of 30 days from the date on which we receive the application until the date of determination (grant or refusal).

Assessment times for type IB variations: The assessment time is measured against the target time of 60 days from the start of procedure until the date of determination (grant or refusal), excluding any clock-stop days.

Assessment times for type II variations: The assessment time is measured against the target time of 150 days from the date on which we receive the application until the date of determination (grant or refusal), excluding any clock-stop days.

For Q2 2016, we make the following observations:

Type IA variations: In 2016, the share of variations assessed within the target time has been 81 %, while in 2015 was 77 %.

Type IB variations: In 2016, the share of variations assessed within the target time has been 84 %, while in 2015 was 52 %.

Type II variations: In 2016, the share of variations assessed within the target time has been 44 %, while in 2015 61 %.

We are working on removing the accumulated amount of type II variations, and since the beginning of 2015, we have reduced the amount of months that the oldest type II variations have to wait before start of procedure, from 23 months to 6 months.

Type IA variations

Assessment time in 2016 for type IA variations as at end-December 2016: 81 % of the cases finished within the performance requirement's maximum of 30 days (20 days on average):

  • Human medicines: 80 % of the cases finished within the performance requirement's maximum of 30 days (22 days on average).
  • Veterinary medicines: 91 % of the cases finished within the performance requirement's maximum of 30 days (12 days on average).

Chart 1. Assessment times for type IA variations
Chart 1. Assessment times for type IA variations   
See table 1-3 for type IA variations

Type IB variations

Assessment time in 2016 for type IB variations as at end-December 2016: 84 % of the cases finished within the performance requirement's maximum of 60 days (39 days on average):

  • Human medicines: 83 % of the cases finished within the performance requirement's maximum of 60 days (40 days on average)
  • Veterinary medicines: 93 % of the cases finished within the performance requirement's maximum of 60 days (32 days on average)

Chart 2. Assessment times for type IB variations
Chart 2. Assessment times for type IB variations   
See table 4-6 for type IB variations

Type II variations

Assessment time in 2016 for type II variations as at end-December 2016: 44 % of the cases finished within the performance requirement's maximum of 150 days (179 days on average).

  • Human medicines: 48 % of the cases finished within the performance requirement's maximum of 150 days (198 days on average).
  • Veterinary medicines: 34 % of the cases finished within the performance requirement's maximum of 150 days (204 days on average). 

Chart 3. Assessment times for type II variations in the start-up phase
Chart 3. Assessment times for type II variations in the start-up phase   
See table 7-9 for type II variations

For further information, please contact Send an email.