THE DEVELOPMENT AND TESTING OF NDS
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THE DEVELOPMENT AND TESTING OF NDS IRELAND’ S EXPERIENCE TO DATE Dr Lorraine Nolan - PowerPoint PPT Presentation


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

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  • 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.



  • NDS Installation and Testing the

  • 1. Hardware and Software Installation.

  • 2. Development of Master files.

  • 3. Testing of Functionality Aspects.

  • 4. Import Licence/Certificate and Export Licence Templates.


  • NDS Installation and Testing the

  • 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.


  • NDS Installation and Testing the

  • 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


  • NDS Installation and Testing the

  • 2. Development of Master Files Continued (ii)

  • Entry of information for international companies.

  • Entry of national and international estimates and assessments.


  • NDS Installation and Testing the

  • 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.


  • NDS Installation and Testing the

  • 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.


  • NDS Installation and Testing the

  • 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.


  • NDS Installation and Testing the

  • 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.


NDS Installation and Testing the

  • 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 the

  • 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.


  • 3. Testing of Functionality Aspects Continued (ii). the

  • 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.


  • 3. Testing of Functionality Aspects Continued. (iii) the

  • 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.


  • 4. Import Licence/Certificate and Export Licence Templates the

  • 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.


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