NIS Considerations
CHCUK NewsletterJune/July 2010
In this Month's Issue
NIS Report (Part 1): 2nd Edition
Greece: 2010 SFEE Code of Practice
Sweden: Updated LIF Code of Practice
EC Pharmaceuticals Website Updated
Austria: New NIS Ordinance
Latvia: New NIS Regulation
Norway: Updated Code of Practice

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Greetings!

Beach Ball
Welcome to the summer edition of our newsletter.  The good news is that the 2nd Edition of Part 1 of the 'NIS Europe' report will be finalised and released next month, so please keep checking your inbox.

If you haven't received your copy by the 1st September please email me.

For those who have vacations planned...enjoy!

Best wishes,

Stuart McCully
CHCUK
 
Tel: +44 (0) 1997 42 33 11
Mobile: +44 (0) 7909 111 510
email: stuart.mccully@chcuk.co.uk
NIS Report (Part 1): 2nd Edition
Part 1 of the NIS Report will be updated and re-released in August 2010
NIS Europe - Part 1 (V2)
We are now in the process of updating the first of the NIS Reports (Part 1). 

The report will be provided free of charge to all who have previoulsy purchased a copy.

ADVERTISING OPPORTUNITY

We will be adding a new 'Service Providers' section to each country after the 'Useful Links' section of the NIS Report. The intention is to provide users with convenient access to NIS-related service providers in each of the countries covered.

Fees & Format
  • Full page colour Advert in each of the Countries of your choice: 250
  • Half page colour advert in each of the countries of your choice: 125
  • Half page text advert in each of the countries of your choice: 75
The deadline for and notice of interest and/or submission of advert materials is 31st July 2010.

Further information can be found in our "Information for Advertisers " document. 

If you would like to take advantage of this advertising opportunity please contact me at stuart.mccully@chcuk.co.ukor +44 (0) 1997 42 33 11 to discuss the nominal fee, format etc.
 
Greece: Updated SFEE Code of Practice
The SFEE Code of Practice as amended by decision of the General Assembly on March 19, 2010 has been in force since May 1st 2010
Greece Flag

The SFEE Code of Practice, as amended by the decision of the General Assembly on 19th March 2010, has been in force since 1st May 2010.

There are no significant changes from the 2008 COP which impact on the conduct and management of NIS.  However, the reader should verify this.

2010 SFEE Code of Practice:
Sweden: Updated LIF COP
Readers are reminded that the LIF COP has been updated.  The latest version came in to force on the 1 July 2010

LIF Logo Readers are reminded that the LIF Ethical Rules for the Pharmaceutical Industry in Sweden (LIF COP ) has recently been updated (as featured in the Feb 2010 edition of the Newsletter).  The latest version came in to force on the 1st July 2010 (see below):


Refer to Chapter IV for "Rules on Non-interventional Studies"
 
European Commission's Pharmaceuticals Website Updated
The EC's "Pharmaceuticals in the European Union" Website has moved under the umbrella of the "EC-Public Health" Website
Eudralex
The European Commission's "Pharmaceuticals in the European Union " website has moved under the umbrella of the "EC-Public Health" website which will have broken any previous bookmarks and hyperlinks.  Readers will need to update any bookmarks or hyperlinks they had to any of documents within the previous "Pharmaceuticals in the European Union" website.

This includes:
 
Austria: New NIS Ordinance
A new Ordinance relating to Non-Interventional Studies (VO-NIS 1/2010) has been released by Pharmig 
Austrian Flag
A new Ordinance relating to Non-Interventional Studies (VO-NIS 1/2010) has been released by Pharmig .  The Ordinance entered into force on the 1 March 2010.

This comprehensive Ordinance covers:
  • Definitions
  • Purpose of NIS 
  • Distinction from Clinical Studies
  • Designing an NIS
  • Reviewing an NIS
  • Approving an NIS
According to Article 8.2 of Ordinance 1/2010 of the Pharmig Board regarding Non-Interventional Studies (VO-NIS 1/2010):
  • NIS, in which the first patient is documented after 30 June 2010, must be in compliance with the provisions of this Ordinance.
 
Latvia: New NIS Regulation
Cabinet Regulation No. 289 (Regulations on Conducting...Non-Interventional Studies) was Published in March 2010
Latvian Flag
Cabinet Regulation No.289 was published in March 2010 and came into force on the 1 April 2010.

The full title of the regulation is:

"Regulations on Conducting Clinical Trials and Non-interventional studies and Labelling ofInvestigational Medicinal Products, and Procedure for Conducting Inspections on Compliance with the Requirements of Good Clinical Practice"

Section XVI deals specifically with Non-Interventional Studies and mirrors the previous requirements stipulated in Regulation No. 172 of 28 February 2006.
 
Norway: Updated Code of Practice
LMI have recently undated their "RULES FOR MARKETING OF MEDICINAL PRODUCTS"
Norwegian Flag
The Norwegian self-regulatory body (LMI) have recently undated their "RULES FOR MARKETING OF MEDICINAL PRODUCTS".

As per Section 15, "Reference is made to separate guidelines for non-intervention trials adopted by the Association".


 

CHCUK