Update On Electronic Licensing System For The Import
Update On Electronic Licensing System For The Import
Update On Electronic Licensing System For The Import
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Sample and Flow of Licences<strong>For</strong>m 3<strong>Import</strong> LicenceOriginal CopyDH<strong>For</strong>m 6Export Licence<strong>Import</strong>erCargo/ShippingCompanyTIDC&EDSpotCheck
New <strong>Electronic</strong> <strong>Licensing</strong> <strong>System</strong>TraderRegistrationDatabaseSubmit inpersonGet licence inpersone-CertCompanyDatabaseI/E LicenceApplicationProductRegistrationDatabaseEnlistingProductApplicationReport ActualShipmentInformation
Benefits of New <strong>System</strong>• Full automation of the licence applicationand approval process• Print of approved licence online bytraders for customs clearance• Licence details kept in system for easyretrieval and updating• Counter checking of licence informationonline by other relevant departmentsusing access code specified to eachlicence
Application of New <strong>System</strong>• Centralized adminstration - licence holdersunder the PPO set up a single login account• Sign-in using HK Post e-certificate(Organisational)• <strong>Import</strong>ers/exporters enlist products prior toapplication of import or export licences• Bar code generated on licence for customsclearance• New <strong>Licensing</strong> conditions on licences
New <strong>Licensing</strong> Conditions• Each licence is valid for one shipment only• Traders must re-export unregistered drugswithin ONE year after importation• Each licence must be produced, at the time ofimport/export, to an officer of the Customs andExcise Department for certification ofimport/dispatch (phase approach)• <strong>Import</strong> licence is valid for 8 weeks from thedate of issue
Added Features of New <strong>System</strong>• Actual shipment date captured by scanning barcodes by C&ED officer• Traders input actual shipment quantity ofunregistered drugs within 14 days aftershipment• <strong>System</strong> monitors the balance of unregistereddrugs for re-export• Alert applicant to re-export any remainingunregistered drugs 9 months after importation• Traders submit Disposal Plan for theoutstanding drugs
Flowchart of Licence ApplicationTraderApply <strong>Import</strong>/Export LicenceDH <strong>Licensing</strong> <strong>System</strong>C&ED ConsignmentCheckApproval /RejectionData Profilingbased on risksPrint LicenceLicenceInformation<strong>Import</strong>er’sWarehouseC&ED CustomsClearanceExport
Progress of the <strong>System</strong>• Enhanced feature of the central administrationfor traders– <strong>On</strong>e registration for DH Drug Office– Access to different modules in different units, i.e.• Application of <strong>Import</strong> and Export Licence• Application of Certificate of Registration• Reports of recall, etc.
Progress of the <strong>System</strong>• Digital Signature authentication under the <strong>Electronic</strong>Transactions Ordinance (Cap. 553)(6). An electronic record given, presented or served under astatutory provision must be signed with a digital signature if:-(a) the provision expressly requires the signature of a person: or(b) the provision requires the submission to be made in a specifiedform and the specified form has a signature requirement(7). A digital signature shall be attached to an electronicrecord in accordance with the Secure Multipurpose InternetMail Extension (S/MINE) standard, the Public-KeyCryptography Standards (PKCS#7) or PDF v1.5/1.6/1/7(ISO32000-1)
E-Cert. vs Security Token
Workflow of Centralized Administration(Create Primary User)
Workflow of Centralized Administration(Account Maintenance by Trader/Cert. Holder)Organisational eCert. +PasswordDH <strong>Licensing</strong> <strong>System</strong>LoginPharmaceuticalsRegistration<strong>System</strong>•Application of <strong>Import</strong> andExport Licence•Reports of recallPharmaceuticalsLicense Applicationand MovementMonitoring <strong>System</strong>•Application of Certificate ofRegistration
Digital Signature
Prototype
Prototype
Prototype
Prototype
Prototype
Tentative Schedule for PilotWorkshops to traders on themodules of “centraladministration” and “enlisting”Test run of the modules forselected tradersStart registration of selectedtraders (traders for re-export ofunregistered drugs)Commence registration of alltradersAll unregistered products for reexportbe enlisted onlineMarch 2012March 2012March to April2012July 2012Aug to Sep 2012
Tentative Schedule of full systemWorkshops to traders on thepilot systemTest run of the pilot system forselected tradersReview workshop with selectedtradersParallel submission (paperlicences or e-licences)Mandatory e-submission for allunregistered products declaredfor re-export purposeAug 2012Oct-Dec 2012Dec 2012Feb-Apr 2013May 2013
Pilot of the system• Expected to roll out in March –April 2012– Modules of central administration and enlisting ofunregistered pharmaceutical products declared tobe re-exported– Traders enlist all unregistered pharmaceuticalproducts on-line; an identifier be assigned for eachproduct– To enhance the monitoring and tracing of theunregistered products
.Thank You !
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