French experience with NDS NDS User meeting Mexico : 1-3 september 2009 Stéphane LUCAS French Health Products Safety Agency Narcotics and Psychotropics Department

2 28/10/ Titre de la présentation Current situation in France : NDS 6  March 2004 : implementation and production of NDS 5.1 : - Licences - Import Export Authorizations - Narcotics and Psychotropics : quaterly statistics  2005 : Convention UNODC/Afssaps for NDS support  May 2006 : participation in the NDS user meeting in Mexico  September 2006 : implementation and production of NDS 6.0 (Vladimir ZEMSKOV ) : -licences, import/export authorizations, quaterly statistics - establishment Management Module - annual Statistics (Form C and P)

3 28/10/ Titre de la présentation Curent situation in France : NDS 6 National licences Manufacturers13395 Wholesalers Scientific use Custom agent11040 Total Import/export authorizations Narcotic import Narcotic export Psycotropic import Psychotropic export Total

4 28/10/ Titre de la présentation NDS 6.0 capacities (1)  General improvements : - All modules on only one screen (Masters, import/export, EMM…) - Possibility to define a language during the installation - More precise user profile : limited access to one or several modules increases the security of the system.  Import/export : - Checking the import country estimate and approved quantity for export authorization - Possibility to copy authorization request in case of repeated requests by an establishment - User friendly updating of the estimates

5 28/10/ Titre de la présentation NDS 6.0 capacities (2)  Import/Export (2) : - Import/export report, endorsement report : possibility to make several types of requests (establishment, date, substance, preparation, pure substance, authorization endorsed, not endorsed…)  Licences : - Links between licence type and authorization number  Establishment management module : - Clear and readable screens - Better control of the establishments activities - Stock ledger : useful and clear  Quarter and annual reports : - Form A, A/P, C, P clearer

6 28/10/ Titre de la présentation NDS 6.0 : Suggested improvements (1)  Masters : - Preparation master : simplify : EAN code located in the header and package size in the contents screen - 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 - Competent authority master : simplify  Licence : - Possibility to copy a licence request in case of requests for severals pharmacists in a same establishment

7 28/10/ Titre de la présentation NDS 6.0 : Suggested improvements (2)  Import export : - Endorsement report import and export : add a field with the date located in remarks field (date of endorsement by custom) - Add a summary (in permited/restricted substances for example) with the estimates, the current approved and endorsed quantities and balance estimates for each country - Export authorization request : control of the uniqueness of import certificate number  Establishment Management Module : - Consequences on stocks when scientific use by establishment (manufacturer) which is allowed to keep stocks  Excel files : - More readable (all data on a same file).

8 28/10/ Titre de la présentation Suggested further developments (1)  Electronic submissions : Import/export requests, licences, - Endorsment by companies, - Pharmaceutical companies annual reports : closing stocks, quantities used for schedule III substances, manufactured quantities, losses… BUT the system must allow : - easy use and time saving for companies, - securised access for companies (login and password for the authorised person) - access for companies to selected data from NDS substance Master (substances, preparations used by the company) - enclosed documents (problem of original import certificate ?)

9 28/10/ Titre de la présentation Suggested further developments (2)  Data transmission between authorities : According to the INCB project (cf circular letters INCB/PSY/C.L 24/2009) - Import certificates, - Export authorizations, Example : PEN on line for precursors But the system should allow : - Securised data transmission, - possibility to load the certificates data in NDS.