THE DEVELOPMENT AND TESTING OF NDS IRELAND’ S EXPERIENCE TO DATE Dr Lorraine Nolan

1. THE DEVELOPMENT AND TESTING OF NDS • IRELAND’ S EXPERIENCE TO DATE • Dr Lorraine Nolan

2. Requirement for IT Technologies to Manage the following:- • Various Controlled Drug Licence Application and Issue Processes. • Client Files and Information. • UN Reporting Functions. • Frequently Asked Questions.

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 process • particularly for import and export licences. • To 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 better client file management.

4. The Development of IT Technologies has two Main • focuses:- • The testing introduction and of the NDS System developed by UNDCP. • The development and introduction of a functionally based Website Application.

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 Installation and Testing • 1. Hardware and Software Installation. • Installation of NDS version 4.01 was completed December 2001. • Upgrade to NDS version 4.05 was completed in September 2002.

7. NDS Installation and Testing • 2. Development of Master Files (i) • Entry of information from all nationally based company files. • Coding • Additional Definitions • Contact Details • Licensing/ Registration Details EAN Coding Type of organisation

8. NDS Installation and Testing • 2. Development of Master Files Continued (ii) • Entry of information for international companies. • Entry of national and international estimates and assessments.

9. NDS Installation and Testing • 2. Development of Master Files Continued (iii) • Entry 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 Installation and Testing • 2. Development of Master Files Continued (iv) • 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 Installation and Testing • 2. Development of Master Files Continued (v) • Entry of Preparations: Medicinal Products, Chemical Preparations • 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 Installation and Testing • 2. Development of Master Files Continued (vi) • Entry of Preparations: Medicinal Products, Chemical Preparations • Product Definitions • EAN Number. • Country of Export. • Content: Identification of the active and expression of its content as anhydrous base per unit.

13. NDS Installation and Testing • 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”.

14. 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.

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 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 the information in the Master Files is correct.

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.

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 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.