1. TEST OF THE NATIONAL DRUG-CONTROL SYSTEM (NDS) Version 5.0.4 5 th Users Group Meeting 10-12 March 2003 Ottawa, Canada Swiss Agency for Therapeutic Products (swissmedic) Narcotics Division, Bern, Switzerland Ms. Verena AllenbachMr. Christian Stamm

2. Today‘s situation (I) Team of 3 assistants Processing of 300‘000 notifications on domestic traffic 8000 import and export authorizations per year Annual data collection and analysis for stat. purposes

3. Today‘s situation (II) 3 Different Databases in Use! JASTAannual statistics, data collection narcotics, psychotropics, precursor Microsoft Access database BEKOdomestic traffic narcotics only Oracle database SEAWINimport and export narcotics, psychotropics, precursor dBase database

4. Why did swissmedic test NDS?... we expect NDS to help us saving resources and time Because...... we largely depend on individual IT specialists (risks)... the three databases are not connected (efficiency)... NDS allows electronic data interchange (electr. requests)... the IT system of Swissmedic is also based on Oracle

5. NDS General impressions of NDS 5.0.4 Modular structure is easy to understand and to use Some screens appear user un-friendly at first sight Expert knowledge on Oracle required for installation Modern and efficient tool for national and international control NDS can set standards in international drug control

6. NDS What we like about NDS (I) Modern and efficient Oracle database All-in-one approach (national, international, licenses) Easy data processing and analysis (Excel) Possibilities for electronic data interchange, requests... Quarterly and annual statistics automatically International harmonization (NDS language, codes etc.)

7. NDS What we like about NDS (II) Excellent module „User Preferences“ Excellent module „Custom Numbering“

8. NDS What we are not happy about Fields and information not necessary for daily business Rather complex layout of some screens Default data not uniform Substances in database which are not controlled by Conv.

9. What are the next steps in Switzerland? Decision on introduction of NDS for statistical purposes Installation of NDS 5.1 and in-depth tests of all functions Evaluation of specific needs and special modules Decision on introduction of NDS for international control

11. PROPOSALS FOR CHANGES AND AMENDMENTS 5 th Users Group Meeting 10-12 March 2003 Ottawa, Canada Swiss Agency for Therapeutic Products (swissmedic) Narcotics Division, Bern, Switzerland Ms. Verena AllenbachMr. Christian Stamm

12. PROPOSALS FOR CHANGES AND AMENDMENTS (I) Identification of each package size with EAN number Simplification of the layout of the import/export module Rename of flags to „Pre Import Notification“ and „Pre Export Notification“ In the endorsement module: „As Approved“ button

13. Calendar window automatically closed when date chosen Free data entry in „Point of Entry“, „Point of Exit“... Simplification of the Competent Authority Master PROPOSALS FOR CHANGES AND AMENDMENTS (II) Possibility to set a default system language TAB stops in chronological order