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French experience with NDS NDS User meeting Mexico : 1-3 september 2009

French experience with NDS NDS User meeting Mexico : 1-3 september 2009. Stéphane LUCAS French Health Products Safety Agency Narcotics and Psychotropics Department. Current situation in France : NDS 6. March 2004 : implementation and production of NDS 5.1 : Licences

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French experience with NDS NDS User meeting Mexico : 1-3 september 2009

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  1. French experience with NDSNDS User meetingMexico : 1-3 september 2009 Stéphane LUCAS French Health Products Safety Agency Narcotics and Psychotropics Department

  2. 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) 15/10/2014 - Titre de la présentation

  3. Curent situation in France : NDS 6 15/10/2014 - Titre de la présentation

  4. 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 15/10/2014 - Titre de la présentation

  5. 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 15/10/2014 - Titre de la présentation

  6. 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 15/10/2014 - Titre de la présentation

  7. 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). 15/10/2014 - Titre de la présentation

  8. 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 ?) 15/10/2014 - Titre de la présentation

  9. 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. 15/10/2014 - Titre de la présentation

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