Marketing/manufacturing authorization holders = Application License Holder.
Its the License holder's ultimate responsibility to risk assess the excipient, although they may assign this task to a CMO or any service provider!
Hope this helps!
Note: Same in the US
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Original Message:
Sent: 11-Oct-2021 20:18
From: Anonymous Member
Subject: "manufacturing authorization holder" & "marketing authorization holder"
This message was posted by a user wishing to remain anonymous
Hello RAPS community,
Does anyone have any feedback they could provide?
Original Message:
Sent: 01-Oct-2021 18:44
From: Anonymous Member
Subject: "manufacturing authorization holder" & "marketing authorization holder"
This message was posted by a user wishing to remain anonymous
Hello Everyone,
In 2015 the European Union (EU) published Guideline 2015/C 95/02 on the formalized risk assessment of excipients. This EU Guideline requires "manufacturing authorization holders" (MAHs) to assess the risk of each excipient.
- Is a "manufacturing authorization holder" the same as a "marketing authorization holder", i.e., the license holder of a product?
- Are these descriptions used interchangeably to describe the same entity?
- Also if a Contract Manufacturing Organization is not the license holder for a finished drug product, is that CMO responsible for implementing this guidance or is it only the responsibility of the license holder?"
Thank you for the help!