Following the entry into force of the new Regulation (EU) 2019/6, few changes were submitted in the first half of 2022 that did not require assessment. This is because marketing authorisation holders had to familiarise themselves with the new Union Product Database (UPD) and the new submission system. This system had a difficult start and was regularly unavailable. In the third quarter of 2022, we saw a sharp increase in the number of files submitted. This trend continued in the fourth quarter of 2022. The number of files submitted on a monthly basis increased fivefold compared to the corresponding months in 2021 and the corresponding type of changes (Type IA and IB changes). The number of changes to be assessed has tripled compared to 2021 and the corresponding type of changes (type II-changes). The change in regulation and the increase in the number of files submitted lead to an increase in processing time.