“In relation to Contract Manufacturing Organisations (CMOs), these will not be permitted to on-board to the EU-Hub, and it is considered that the relevant MAH needs to ensure that appropriate arrangements are put in place in this regard, in order to ensure the secure upload of the serialisation data.”
To learn more about this informative reflection paper, please click here. We reported in detail on Version 1 in August 2021.
Source:
EMA: Reflection paper
Write a comment on this news.