France

0 Agence nationale de sécurité du médicament et des produits de santé
FRENCH EXPERIENCE WITH NDS
EIGHTH NDS USERS’ GROUP MEETING
MEXICO 7-9 OCTOBER 2013
Aldine Fabreguettes
The French National Agency for Medicines and
Health Products Safety
Narcotics and Psychotropics Department

1 Agence nationale de sécurité du médicament et des produits de santé
CURRENT SITUATION IN FRANCE : NDS 6
March 2004 : implementation and production use of NDS 5.1
February 2006 + May 2007 + September 2009 : participation to the NDS user
Meeting in Mexico
September 2006 : Implementation and Production of NDS 6.0
October 2013 : NDS 6.0 = Current version
2011 : participation to expert group meetings on an international electronic
import and export authorization system for controlled substances
2013-2014 :
the budget proposal and the provisional schedule for the installation of
the new applications of the NDS Program (NDS WEB and NDS SPA) are
under discussion with the general management
Change of network server + update our NDS current version

2 Agence nationale de sécurité du médicament et des produits de santé
CURRENT SITUATION IN FRANCE : NDS 6.0
Transactions on international level : Import/export authorizations
≈ 12 000 per year
Increase since 2007
2007 2008 2009 2010 2011
Narcotic import 1073 1282 1453 1927 1895
Narcotic export 1839 1861 2165 2267 2167
Psychotropic
import 1669 2187 2001 1718 1749
Psychotropic
export 6618 7376 6993 6886 6495
Total 11199 12706 12612 12798 12306

3 Agence nationale de sécurité du médicament et des produits de santé
CURRENT SITUATION IN FRANCE : NDS 6.0
Transactions on Domestic level : Domestic licences
≈ 1 800 per year
Increase and stabilisation
2007 2008 2009 2010 2011
Manufacturers 133 95 115 109 146
Wholesalers 209 262 259 189 196
Scientific use 1445 1702 1490 1453 1372
Custom agent 110 40 44 48 57
Total 1897 2099 1908 1799 1771

4 Agence nationale de sécurité du médicament et des produits de santé
CURRENT SITUATION IN FRANCE : NDS 6.0
Report :
Quarterly and annual statistics :
Form A, AP, B, C et P
Number of laboratories : 150-200
Master :
Pure Substance Master = 741 Pure substance codes
Substance Master = 1481 substance codes
Preparation Master = 3741 préparations codes
Establishment Master = 7704 establishment codes
⇒ Will and need to simplify these activities
- To cope with the increasing workload
- To improve processing time and maintain the same control
- To improve the quality of datas for statistics and the respect of the deadlines
⇒ With NDS WEB and SPA
⇒ Symplifying French regulation (in progress)