Assessment times for national variations 2018

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 Q4 2018, we make the following observations:

Type IA variations: In 2018, the share of variations assessed within the target time has been 98 %, while in 2017 was 95 %.

Type IB variations: In 2018, the share of variations assessed within the target time has been 96 %, while in 2017 was 93 %.

Type II variations: In 2018, the share of variations assessed within the target time has been 98 %, while in 2017 was 57 %.

Type IA variations

Assessment time in 2018 for type IA variations as at end-December 2018: 98 % of the cases finished within the performance requirement's maximum of 30 days (10 days on average):

• Human medicines: 98 % of the cases finished within the performance requirement's maximum of 30 days (11 days on average).
• Veterinary medicines: 100 % of the cases finished within the performance requirement's maximum of 30 days (6 days on average).

Chart 1. Assessment times for type IA variations

See table 1-3 for type IA variations

Type IB variations

Assessment time in 2018 for type IB variations as at end-December 2018: 96 % of the cases finished within the performance requirement's maximum of 60 days (27 days on average):

• Human medicines: 96 % of the cases finished within the performance requirement's maximum of 60 days (27 days on average)
• Veterinary medicines: 96 % of the cases finished within the performance requirement's maximum of 60 days (22 days on average)

Chart 2. Assessment times for type IB variations 

See table 4-6 for type IB variations

Type II variations

Assessment time in 2018 for type II variations as at end-December2018: 98 % of the cases finished within the performance requirement's maximum of 150 days (97 days on average).

• Human medicines: 98 % of the cases finished within the performance requirement's maximum of 150 days (98 days on average).
• Veterinary medicines: 100 % of the cases finished within the performance requirement's maximum of 150 days (73 days on average). 

Chart 3. Assessment times for type II variations in the start-up phase 

See table 7-9 for type II variations