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."