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NIS Considerations
CHCUK NewsletterDecember 2012 - ERRATUM
In this Month's Issue
ERRATUM - Germany: New Notification Requirements for All Non-Interventional Studies

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Greetings!

Firstly, I want to wish you a very happy and prosperous new year.

I appreciate that this is a very busy time, trying to catch-up with the build-up of work so I'll keep this quick.  We're issuing a short erratum to out Dec 2012 Issue.

In the Article entitled "Germany: New Notification Requirements for All Non-Interventional Studies", we stated that:

"Recent changes to the German Drug Law ( 67 Abs. 6 AMG and 63f. AMG), mean that from October 2012 sponsors of non-interventional safety studies and other non-interventional studies must now also notify the "Verband der Privaten Krankenversicherung e.V"  (PKV - the association of nearly all private health insurance companys, who earn their money in Germany with the private substitutive health insurance), as well as BfArM/PEI, BFDI, KBV and GKV."

Please that this is an error on our part.  There is currently no requirement to notify the BFDI for these types of studies.

The article below has been updated to reflect this.
 

Oops
Best wishes,

Stuart McCully
CHCUK
 
Tel: +44 (0) 1997 42 33 11
Mobile: +44 (0) 7909 111 510
email: stuart.mccully@chcuk.co.uk

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ERRATUM - Germany: New Notification Requirements for All Non-Interventional Studies
New Requirements for the Conduct of Non-Interventional  Studies as of 26 October 2012
Germany-map

In the November Issue of NIS Considerations we explored the impact
of the recent updates to the German Drug Law (AMG) on non-interventional safety studies.

This week we focus on the new requirements for all non-interventional studies in Germany.

New Notification Requirements in Germany

Recent changes to the German Drug Law ( 67 Abs. 6 AMG and 63f. AMG), mean that from October 2012 sponsors of non-interventional safety studies and other non-interventional studies must now also notify the "Verband der Privaten Krankenversicherung e.V"  (PKV - the association of nearly all private health insurance companys, who earn their money in Germany with the private substitutive health insurance), as well as BfArM/PEI, KBV and GKV.
 
We have contacted the PKV to determine whether this also applies to non-interventional studies that had already started in Germany before October 2012.  The PKV response is below:
 
 
"the answer depends on the interpretation of the law. Unfortunately, the law is not very precise.
 
Actually, we think, that you are hundred percent on the safe side, if you notify also the studies, which started before October, but still are lasting.
 
But this ist only one possibillty of interpretation of he rule. We won`t force you to notify also the older studies. It is your choice and your decision."




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