Hi Tom,
To get this thread rolling, I suggest reviewing this (http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000327.jsp) and (http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000632.jsp&mid=WC0b01ac058089682b).
I recently reviewed these as they pertain to my situation -- we the sponsor footed fees applicable as we were the MAH. Fees can vary depending on if your company qualifies as a micro/small/medium size enterprise. If you qualify for said enterprise sizes, then you can get a number of the fees deferred/reduced.
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Samuel Christopher Bonilla
Los Angeles CA
United States
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Original Message:
Sent: 14-Nov-2017 14:50
From: Tom Stothoff
Subject: User Fees for EU
My experience with User Fees is limited to US/FDA for applications, efficacy supplements and the new Program fees. I'm wondering if other health authorities issue similar fees - specifically in the EU? Also, in US it is the applicant/sponsor's responsibility to pay the fees while contract manufacturing organizations are not responsible for these fees. Would CMO's be responsible for EU fees? I would think not but would appreciate confirmation. Thank you.
Tom
Chicago