NIS Considerations
CHCUK NewsletterDecember 2012
In this Month's Issue
Hungary: Overview of New NIS Regulatory Requirements
Germany: New Notification Requirements for All Non-Interventional Studies
Austria:...Updated Guidance for the Conduct of NIS
Brookwood Academy:...Practical guide to post authorisation studies - requirements and concepts



CHCUK: NIS Country-specific eLearning

CHCUK: Country-Specific NIS Reports
CHCUK: Summary of NIS Requirements for Europe
CHCUK: Free NIS Resources

We wanted to take of this unique opportunity to send the last edition of our 2012 newsletter to you on the 12/12/12. 

A big thank you to everyone for your support over the past 12 months.  We look forward to supporting you and continuing to work with many of you in 2013.

Hot Chocolate
Best wishes,

Stuart McCully
Tel: +44 (0) 1997 42 33 11
Mobile: +44 (0) 7909 111 510

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Hungary: Overview of New NIS Regulatory Requirements 

The Recent Update to Government Decree 235/2009 has impacted the Regulatory Requirements for Certain Types of NIS (as of 21 October 2012)
(as of 21 October 2012)

Government Decree 235/2009 was updated this year (effective October 2012) to reflect the new European pharmacovigilance requirements.  The table below provides an overview of the regulatory requirements for non-interventional studies (NIS).  As indicated below, the type of NIS determines the regulatory requirements.  The updates to the legislation have not impacted the requirements for 'other NIS'.


For further information refer to:


Germany: New Notification Requirements for All Non-Interventional Studies
New Requirements for the Conduct of Non-Interventional  Studies as of 26 October 2012
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, BFDI, 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."

Useful References


Austria:  Updated Guidance for the Conduct of NIS
The BASG Guidance on the Conduct of NIS in Austria was Updated in December 2012


The following sections of the BASG NIS Guidance have been updated to reflect/capture the new EU/EMA pharmacovigilance requirements:


  • Section 7: Collection and Reporting of Adverse Drug Reactions
  • Section 8: Potential Goals of Non-Interventional Studies
  • Section 11: Final Report and Abbreviated Final Report 

For further information refer to:


Brookwood Academy: Practical guide to post authorisation studies - requirements and concepts
Brookwood International Academy

For those of you finding it a challenge to interpret the impact of the new EU Pharmacoviglance Regulations on your post-authorisation studies, we recommend you attend the next Brookwood Academy workshop "A practical guide to post-authorisation studies in Europe" which will be held in Copenhagen on 16 January 2012  


Register your interest in the next course soon as places will be limited due to its interactive workshop style:


Next event: Wednesday 16 January 2013, DGI Byen, Copenhagen


Outline content

  • Types of PAS study (PASS, PAES)
  • Regulations and guidelines affecting the conduct of post authorisation studies
  • Protocol content defined by EU requirements
  • Impact of the latest EU Pharmacovigilance Directive and Regulation
  • Obligatory studies v voluntary studies
  • Impact of key Good Pharmacovigilance Practices (GVPs)
  • EFPIA guidance for post authorisation studies
  • Good Pharmacoepidemiology Practice (GPP)
  • Grace Principles
  • Interactive sessions
    - to determine if case studies are interventional or not
    - the design and practical implications of setting up three different kinds of post-authorisation study
  • Issues relating to the data management of PAS.

399 (ex VAT) for confirmed bookings before 30 November 2012, 450 (ex VAT) thereafter. Discounts for groups can be negotiated.


To register your interest for the next course contact: or telephone +44 1483 811383


For further details refer to: