EMA: Paper on GMP Responsibilities and MAHs in Version 2
The EMA released Version 2 of its Reflection paper on GMP and Marketing Authorisation Holders on 10 January 2022. A minor text addition to the document was performed: The section on „Serialisation Data - Uploading Responsibilities" was amended with the following paragraph regarding Contract Manufacturing Organisations:
“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
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