French experience with NDS

NDS User meeting

Mexico : 1-3 september 2009

Stéphane LUCAS

French Health Products Safety Agency

Narcotics and Psychotropics Department

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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)

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Curent situation in France : NDS 6

National

licences

2007 2008

Manufacturers 133 95

Wholesalers 209 262

Scientific use 1 445 1 702

Custom agent 110 40

Total 1 897 2 099

Import/export

authorizations

2007 2008

Narcotic import 1 073 1 282

Narcotic export 1 839 1 861

Psycotropic

import

1 669 2 187

Psychotropic

export

6 618 7 376

Total 11 199 12 706

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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

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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

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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

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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).

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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 ?)

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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.