NIS Considerations
CHCUK NewsletterFebruary 2012
In this Month's Issue
EU: Introduction of New PV Legislation
France: New NIS Requirements
EU: GCP app for iPhone and Android




Welcome to the first edition of NIS Considerations of 2012.  The transposition of the PV Directive into national law in 2012 means that we are likely to see man changes in the regulations and guidelines that impact on the conduct of non-interventional studies.

We're also pleased to annouce, on a different topic, that we have released a 'GCP Basics' app that is available for the iPhone and Android platforms.  This year we'll be focusing on developing a similar tool (mobile app) for non-interventional studies.


Best wishes,

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

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The ABPI have Published the 2012 version of their Code of Practice

ABPI Code of Practice for the Pharmaceutical Industry 2012


The code regulates the advertising of medicines for prescription to health professionals and administrative staff. It also covers information about prescription only medicines made available to the general public.

The 2012 code will come into effect on 1 January 2012 with a transitional period between 1 January 2012 and 30 April 2012. During this time no promotional material or activity will be regarded as being in breach of the code if it fails to comply with its provisions only because of newly introduced requirements.

There are different transitional provisions for Clauses 17.2 and 23.8. Details are given in the supplementary information for those clauses.

Non-interventional Studies (Clause 13)
According to Clause 13.2, Companies must publish the summary details and
results of non-interventional studies of marketed medicines in a manner consistent with their parallel obligations with respect to clinical trials.

This requirement applies to non-interventional studies completed on and after 1 May 2011 with which a UK company has had any involvement. Companies are, however, encouraged to publish details and results of such studies completed prior to that date.

Attention is also drawn to the EU Guidelines on Pharmacovigilance for Medicinal Products for Human Use

For further information refer to:



EU: Introduction of New PV Legislation
EMA Counts Down to Introduction of New Pharmacovigilance Legislation










Better protection of public health: European Medicines Agency counts down to introduction of new pharmacovigilance legislation

The European Medicines Agency, together with the European Member States and the European Commission, is preparing for the introduction of the new pharmacovigilance legislation in July this year, which will bring the biggest change to the legal framework since the establishment of the Agency in 1995. Over the next five months, the Agency will finalise its preparations for the inaugural meeting of the new Pharmacovigilance Risk Assessment Committee (PRAC), planned for 19 July 2012.


The implementation/enforcement into national legislation in 2012 will have a direct impact on Post-Approval Safety and Efficacy Studies (PASS/PAES)  


For further information refer to:

France: New NIS Requirements
The French Parliament has adopted a bill of law which may modify the French Public Health Code on non-interventional studies
Flag of France
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: Paule Drouault-Gardrat of PDG Avocats 

EU: GCP app for iPhone and Android
CHCUK have published a GCP Basics (Europe) mobile app for the iPhone and Android Markets

GCP BasicsGCP Basics (Europe), is a comprehensive app developed by CHCUK that guides you through the requirements for conducting clinical trials in Europe in accordance with the Clinical Trial Directive (2001/20/EC) and the GCP Directive (2005/28/EC).  The UK has been used as an example of how these European Directives have been implemented at the 'Member State' level.
'GCP Basics' includes a step-wise guide of GCP considerations from the history of GCP through to implementation, conduct, completion and archiving of clinical trials conducted in Europe.

For further information and to download, refer to: