French experience with NDS NDS User meeting Mexico : 7-9 May 2007 Stéphane LUCAS French Health Products Safety Agency Narcotics and Psychotropics Department

Curent situation in France : NDS 5.1 March 2004 : implementation and production use of NDS 5.1 : Masters Establishment Management Module : Licences Import Export Authorizations Narcotics : Form A Psychotropics : Form A/P, Form P (Import/export only) February 2006 : participation to the NDS user meeting September 2006 : implementation of NDS 6.0 test data base in Afssaps by UNODC (Vladimir ZEMSKOV ) 13/11/2018 - Titre de la présentation

Curent situation in France : NDS 5.1 National licences 2005 2006 Manufacturers 225 124 Wholesalers 191 250 Scientific use 1474 1244 Custom agent 53 16 Total 1943 1634 Import/export authorizations 2005 2006 Narcotic import 856 995 Narcotic export 1615 1689 Psycotropic import 1450 1500 Psychotropic export 6333 6720 Total 10254 10904 13/11/2018 - Titre de la présentation

NDS 6.0 : improvements General improvements : All modules in only one screen (Masters, import/export, EMM…) Possibility to define a language during the installation Users profiles more precise : limited access to one or several modules increases the security of the system. Import export : Schecking the import country estimate and approved quantity for export authorization Possibility to copy authorization request in case of several same requests by establishment Easier updating of the estimates Import export of poppy straw concentrate with details of alcaloïds 13/11/2018 - Titre de la présentation

NDS 6.0 : improvements (2) Import Export (2) : Import-export report, endorsement report : possibility to make several type of requests (establishment, date, substance, preparation, pure substance, authorization endorsed, not endorsed…) Excel files : very readable, possibility to save requests Licences : Links between licence type and authorization number Establishment management module : Screens very clear and readable Better control of the establishments activities Stock movement : addition of closing stocks Stock ledger : very useful and clear 13/11/2018 - Titre de la présentation

NDS 6.0 : improvements (3) Quarter and annual reports : Form A, A/P, C, P clearer 13/11/2018 - Titre de la présentation

NDS 6.0 : Suggested improvements (1) Masters : Preparation master : EAN code located in the header and package in the contents Substance master : Permitted restricted substance : add a flag for substances under stricter control by importing country (psychotropic substances schedule III or IV) Impossibility to cancel a substance, in case of mistake Signature master : extend the field size Competent autority master : simplify Licence : Possibility to make request on the field « contact person » or list of authorised person for one establishment 13/11/2018 - Titre de la présentation

NDS 6.0 : Suggested improvements (2) Import export (2) : Endorsement report import and export : add a field with the date located in remarks field (date of endorsement by custom) Add a schedule with the estimate quantity, approved quantity, balance estimate, endorsed quantity for all countries Export authorization request : control of the uniqueness of import certificate number Establishment Management Module : Consequences on stocks when scientific use by establishment (manufacturer) allowed to keep stocks 13/11/2018 - Titre de la présentation

Conclusion Compare to NDS 5.1, NDS 6.0 is an application : More friendly-use, More readable, Easy for the users, Allow a better control of establishments activities (national and international trade) Allow time-saving, Afssaps will be used NDS 6.0 in production in May 2007 for narcotics and psychotropics control. Current study to use NDS 6.0 by Ministry of Industry for precursors control. 13/11/2018 - Titre de la présentation