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 0
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 1
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 Narcotic export Psychotropic import Psychotropic export 1073 1282 1453 1927 1895 1839 1861 2165 2267 2167 1669 2187 2001 1718 1749 6618 7376 6993 6886 6495 Total 11199 12706 12612 12798 12306 2
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 Wholesalers Scientific use 133 95 115 109 146 209 262 259 189 196 1445 1702 1490 1453 1372 Custom agent 110 40 44 48 57 Total 1897 2099 1908 1799 1771 3
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) 4
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 5
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 6
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 7
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 8