NIS Considerations
CHCUK NewsletterApril 2012
In this Month's Issue
CHCUK NIS eLearning Now Available
NIS eLearning - NIS Basics (Europe).
France: New NIS Requirements
Article Headline




Time stands still for no-one, and this is always true for the non-interventional study (NIS) regulatory environment.  In this addition of NIS Considerations we bring you news from France and the UK.

Furthermore, we're pleased to share our new elearning tool with you.  The first of many NIS eLearning courses, "NIS Basics (Europe)" is highlighted below.

Best wishes,

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

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CHCUK NIS eLearning Now Available
CHCUK's elearning tool is now online


We are pleased to announce that we now offer elearning courses for non-interventional studies. 

The first course to be uploaded in "NIS Basics (Europe)" and is priced at £35 per person.

Over the coming weeks and months we will be uploading country-specific NIS modules with a view to capturing all of the countries currently in our portfolio (<50 countries).  Each of the country-specific modules will cost £50

For further information refer to:
NIS eLearning - NIS Basics (Europe)
CHCUK have released the first of their online NIS training courses 
NIS Basics (Europe) explains what a non-interventional study is, and explores the practical considerations and challenges when conducting NIS in Europe

NIS Basics has been setup in video format in order to make the learning process as painless as possible.

The course is split into 4 modules and includes a certificate of completion.  It is estimated that  the course will take one hour to complete.

The five course modules are as follows:
  1. Module 1: The Ethical Standards for NIS
  2. Module 2: What is a Clinical Trial?
  3. Module 3: What is a NIS?
  4. Module 4: Course Summary
Cost: £35

The course is applicable to:
  • Post-approval non-interventional studies that are NOT safety-related

This course doesn't cover:
  • Post-approval safety studies (PASS)
The course aims to:
  • Provide you with an overview of the ethical considerations applicable to all biomedical research
  • Explore the similarities and key differences between clinical trials and NIS
  • Explain the practical aspects and challenges of conducting non-interventional studies in Europe
  • Familiarise you with common NIS terminology

Course Content

Module 1: Looks at the ethical and scientific standards which should be considered when conducting non-interventional studies

Module 2: Explores the similarities and differences between interventional clinical trials and non-interventional studies.  In order to explain what NIS are, we first need to explain whet they aren't

Module 3: Explains what NIS are and explores the practical aspects and challenges when conducting non-interventional studies in Europe

Module 4: Course Summary

Course Resources
We provide you with:
  • Course handouts: so no note-taking is required!
  • PDFs of related documents
  • A course resources booklet which includes hyperlinks to all of the cited materials


Access NIS Basics (Europe) at: 


France: New NIS Requirements (Update)
The French Parliament has adopted a bill of law which may modify the French Public Health Code on non-interventional studies
Flag of France
NOTE - "Law No.2012-300 of 5 March relating to research involving humans" was published on the 5th March 2012.  This law mandates the need to obtain ethics committee approvall (CPP) prior to comencing non-interventional studies

The French Parliament has adopted on 26 January 2012  a bill of law relating to the researches on human beings which may modify the French Public Health Code on non-interventional studies.
The bill of law distinguishes now between three types of studies (Article L.1121-1):
  1. interventional studies which include an intervention on the person which is not justified by usual care ;
  2. interventional studies which do not relate to medicinal products and include only minimal risks and constraints, for which a list will be fixed by Ordinance by the Ministry of Health after advice of the French Agency,
  3. non-interventional studies in which every act is practised and every product is used in a usual manner, without additional or unusual  diagnostic, treatment or monitoring procedures.

According to the bill of law, the conduct of non-interventional studies will need to obtain the prior opinion of the CPP. The Sponsor will have to send a copy of the opinion of the CPP and a summary of the study to the French Agency.

The patient will receive a preliminary information by the investigator and can refuse to be included in the study.

For non-interventional studies relating to the observance of a treatment which respond to a request of the French Agency, the Haute Autorité de Santé (HAS) or the EMA, a short information on the objective, methodology and length of the study is enough.

Agence nationale de sécurité du médicament et des produits de santé (ANSM)

Afssaps (French Food Safety Agency of Health Products), much criticized for its passivity towards the Servier in the case of the Mediator, is replaced by the National Security Agency of Medicines and Health Products (ANSM) , with increased powers (refer to Lemonde Article - in French).


Law No. 2011-2012 of 29 December 2011creates the « Agence nationale de sécurité du médicament et des produits de santé » (ANSM). Law No. 2011-2012 will enter into force at the date of publication of the corresponding Decree of application and by the latest on 1st August 2012. Until this date, AFSSAPS is still competent.


Acknowledgement: Cristina Lozano, Aurelie Vivet of Outcome and Paule Drouault-Gardrat of PDG Avocats  


For further information, refer to:


UK: Draft Blue Guide Published
A Draft of the 3rd Edition of the MHRA Blue Guide Published 
A draft of the Third Edition of the MHRA Blue Guide, Advertising and Promotion of Medicines in the UK, has been published today (3 April 2012). This new edition updates our guidance on advertising medicines in a number of areas, including providing information before the grant of a marketing authorisation and using digital communications. We have extended the introductory chapter to provide more background on the licensing system, collected existing and new advice on providing non-promotional material for the public on Prescription Only Medicines into a new chapter and added the individual guidance notes we have prepared on specific areas such as traditional herbal medicines and homeopathic remedies into an appendix.

The legal references in this draft reflect the draft Human Medicines Regulations published in MLX 375. Once the final regulations are published these references will be updated.  

Interested parties are invited to send comments on the draft Blue Guide to the Advertising Standards Unit at by Friday 8 June 2012.  A final version will be published in early July when the new regulations come into force.

The Blue Guide: Advertising and Promotion of Medicines in the UK

For further information refer to: Draft Blue Guide Third Edition published