France

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
Agence nationale de sécurité du médicament et des produits de santé
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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
Agence nationale de sécurité du médicament et des produits de santé
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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
Agence nationale de sécurité du médicament et des produits de santé
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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
1897
2099
1908
1799
1771
Total
Agence nationale de sécurité du médicament et des produits de santé
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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 :
741 Pure substance codes
Substance Master = 1481 substance codes
Preparation Master = 3741 préparations codes
Establishment Master = 7704 establishment codes
 Pure Substance Master =



⇒ 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)
Agence nationale de sécurité du médicament et des produits de santé
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CURRENT SITUATION IN FRANCE : NDS 6

Possibility to make several types of requests and to export to excel :
⇒ Quick and easy
 Quarterly and Annual statistics :
 Identification of non endorsed permit
 Inspection :
 To give a chronological account of domestic licences and
import/export authorizations of one establishment
 To give a cartography of authorised establishment according to type
of activities in France (manufacturer / wholesaler / raw materiel/
medicine …)
 Our activity report (monthly and annually)
 Number of domestic licenses and import/export authorizations
Agence nationale de sécurité du médicament et des produits de santé
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CURRENT SITUATION IN FRANCE : NDS 6

Developement of an additional application related to NDS : « Assistant »
 Recording the estimates, the current approved and endorsed quantities
for each country ⇒ checking of estimates before issuing a permit

Developement of an electronic data exchange with the Customs = « Gun
Project »
 Project is in progress
 Not limited to narcotics and psychotropics substances / for all medicines
Agence nationale de sécurité du médicament et des produits de santé
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PROJECTS

NDS WEB, SPA and IIES seem to take into account the main suggested
improvements proposed in 2009
 electronic submissions = NDS WEB and SPA
 import/export authorizations = IIES
 checking estimate before issuing authorization
 Identification of import for reexport shipment

Master Preparation Substances :
 Inactivate some preparation codes to clean up the application (3741
preparation codes)
 Mistakes
 Duplications
 These measures are particularly important with the implementation of NDS
WEB
 to control the data entered by laboratories
Agence nationale de sécurité du médicament et des produits de santé
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CONCLUSION : NDS WEB / SPA and I2ES

Simplification policy in French Agency +++

Data cleaning in NDS (preparation codes, establishment…)

Change of network server + Update our NDS current version
Implementation of NDS WEB and SPA
 Training of 2 pharmacists and 3 database administrators of
ANSM
 Training of different companies
 Pilot phase
 Roll out
 IIES :
 France renew its interest in participating in the development of
such a project

Agence nationale de sécurité du médicament et des produits de santé
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