1. NDS : Ireland’s Experience 5th NDS USER GROUP MEETING,OTTAWA, CANADA 10-12 March 2003 1 THE DEVELOPMENT AND TESTING OF NDS IRELAND’ S EXPERIENCE TO DATE Dr Lorraine Nolan

2. NDS : Ireland’s Experience 5th NDS USER GROUP MEETING,OTTAWA, CANADA 10-12 March 2003 2 Requirement for IT Technologies to Manage the following:- Various Controlled Drug Licence Application and Issue Processes.Various Controlled Drug Licence Application and Issue Processes. Client Files and Information.Client Files and Information. UN Reporting Functions.UN Reporting Functions. Frequently Asked Questions.Frequently Asked Questions.

3. NDS : Ireland’s Experience 5th NDS USER GROUP MEETING,OTTAWA, CANADA 10-12 March 2003 3 The Purpose of Introducing IT Based Technologies is to make the the various business processes more efficient. Specific Aims Are:- To decrease the turn around time for the licence issue processTo decrease the turn around time for the licence issue process particularly for import and export licences. To provide information for FAQ in an manner that is convenientTo provide information for FAQ in an manner that is convenient and readily accessible. To provide electronic methods of generating the statistical reports for the INCB and decrease the turn around time for this process.To provide electronic methods of generating the statistical reports for the INCB and decrease the turn around time for this process. To provide better client file management.To provide better client file management.

4. NDS : Ireland’s Experience 5th NDS USER GROUP MEETING,OTTAWA, CANADA 10-12 March 2003 4 The Development of IT Technologies has two Main focuses:- The testing introduction and of the NDS System developed by UNDCP.The testing introduction and of the NDS System developed by UNDCP. The development and introduction of a functionally based Website Application.The development and introduction of a functionally based Website Application.

5. NDS : Ireland’s Experience 5th NDS USER GROUP MEETING,OTTAWA, CANADA 10-12 March 2003 5 NDS Installation and Testing 1.Hardware and Software Installation. 2.Development of Master files. 3.Testing of Functionality Aspects. 4.Import Licence/Certificate and Export Licence Templates.

6. NDS : Ireland’s Experience 5th NDS USER GROUP MEETING,OTTAWA, CANADA 10-12 March 2003 6 NDS Installation and Testing 1.Hardware and Software Installation. Installation of NDS version 4.01 was completed December 2001.Installation of NDS version 4.01 was completed December 2001. Upgrade to NDS version 4.05 was completed in September 2002.Upgrade to NDS version 4.05 was completed in September 2002.

7. NDS : Ireland’s Experience 5th NDS USER GROUP MEETING,OTTAWA, CANADA 10-12 March 2003 7 NDS Installation and Testing 2.Development of Master Files (i) Entry of information from all nationally based company files.Entry of information from all nationally based company files.Coding Additional Definitions Contact Details Licensing/ Registration Details Coding EAN Coding Type of organisation Type of organisation

8. NDS : Ireland’s Experience 5th NDS USER GROUP MEETING,OTTAWA, CANADA 10-12 March 2003 8 NDS Installation and Testing 2.Development of Master Files Continued (ii) Entry of information for international companies.Entry of information for international companies. Entry of national and international estimates and assessments.Entry of national and international estimates and assessments.

9. NDS : Ireland’s Experience 5th NDS USER GROUP MEETING,OTTAWA, CANADA 10-12 March 2003 9 NDS Installation and Testing 2.Development of Master Files Continued (iii) Entry of Substances e.g. raw drugEntry of Substances e.g. raw drug Those under international control were included as part of the installation. Those under national control were entered into the system.

10. NDS : Ireland’s Experience 5th NDS USER GROUP MEETING,OTTAWA, CANADA 10-12 March 2003 10 NDS Installation and Testing 2.Development of Master Files Continued (iv) Entry of Preparations: Medicinal Products, Chemical Preparations.Entry of Preparations: Medicinal Products, Chemical Preparations. Every product imported or exported must be entered. Products are assigned a unique code. Product definitions.

11. NDS : Ireland’s Experience 5th NDS USER GROUP MEETING,OTTAWA, CANADA 10-12 March 2003 11 NDS Installation and Testing 2.Development of Master Files Continued (v) Entry of Preparations: Medicinal Products, Chemical Preparations Preparation Coding.Preparation Coding. Medicinal Products are coded where appropriate in terms of the market authorisation number. Chemical Products are coded in terms of the Manufacturers Product Number.

12. NDS : Ireland’s Experience 5th NDS USER GROUP MEETING,OTTAWA, CANADA 10-12 March 2003 12 NDS Installation and Testing 2.Development of Master Files Continued (vi) Entry of Preparations: Medicinal Products, Chemical Preparations Product DefinitionsProduct Definitions EAN Number. Country of Export. Content:Identification of the active and expression of its content as anhydrous base per unit.

13. NDS : Ireland’s Experience 5th NDS USER GROUP MEETING,OTTAWA, CANADA 10-12 March 2003 13 2.Development of Master Files Continued (vii) Entry of Preparations: Medicinal Products, Chemical Preparations Description: Should be adequate to identify the product to its labelling including details of strength/concentration and pack size/unit quantity e.g. in the case of the following medical preparation “Morstel SR Tablets (60mg) x 60”. NDS Installation and Testing

14. NDS : Ireland’s Experience 5th NDS USER GROUP MEETING,OTTAWA, CANADA 10-12 March 2003 14 NDS Installation and Testing NDS Installation and Testing 3.Testing of Functionality Aspects (i) As part of the development process every import and export licence issued during 2002 has been systematically entered into NDS in conjunction with the current system. Through this the following key issues have been examined. That the system is capable of assembling and correctly presenting all of the information required for the generation of an import licence, import certificate and an export licence.That the system is capable of assembling and correctly presenting all of the information required for the generation of an import licence, import certificate and an export licence.

15. NDS : Ireland’s Experience 5th NDS USER GROUP MEETING,OTTAWA, CANADA 10-12 March 2003 15 3.Testing of Functionality Aspects Continued (ii). The ability of the NDS to collectively compile and control the quantities of controlled drug (expressed in terms anhydrous base) imported and exported by Ireland during 2002.The ability of the NDS to collectively compile and control the quantities of controlled drug (expressed in terms anhydrous base) imported and exported by Ireland during 2002. The ability of the NDS to manage the national and international estimates and assessments for controlled drugs.The ability of the NDS to manage the national and international estimates and assessments for controlled drugs. That preparations and substances have been correctly entered into system in terms of coding, description and content.That preparations and substances have been correctly entered into system in terms of coding, description and content. That the information in the Master Files is correct.That the information in the Master Files is correct.

16. NDS : Ireland’s Experience 5th NDS USER GROUP MEETING,OTTAWA, CANADA 10-12 March 2003 16 3.Testing of Functionality Aspects Continued. (iii) The endorsement information received in respect of the import and export licences issued during 2002 has also been entered into the system. The Quarterly Statistical Reports for the INCB have been automatically generated by NDS through this endorsement process and examined. This has verified that NDS is capable of accurately generating such statistical reports, through a more efficient process which does not require additional manual entry and transfer of data.This has verified that NDS is capable of accurately generating such statistical reports, through a more efficient process which does not require additional manual entry and transfer of data.

17. NDS : Ireland’s Experience 5th NDS USER GROUP MEETING,OTTAWA, CANADA 10-12 March 2003 17 4.Import Licence/Certificate and Export Licence Templates Templates have to be integrated into NDS so that it is capable of generating actual licences and certificates comparable with those issued by current systems. The UNDCP are progressing the development of the templates.The UNDCP are progressing the development of the templates. The current templates are to be integrated into NDS by May 2003 at which point NDS can be used to generate our Import Licence/Certificate and Export Licences.The current templates are to be integrated into NDS by May 2003 at which point NDS can be used to generate our Import Licence/Certificate and Export Licences. Launch of our use of NDS is anticipated in mid 2003.Launch of our use of NDS is anticipated in mid 2003.