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Registration

Traditional Medicines & Health Supplements. Registration. Seminar on Control of Quality and safety of Traditional Medicines and Health Supplements. Grand Seasons Hotel ,Kuala Lumpur 26 January 2005. National Pharmaceutical Control Bureau.

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Registration

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  1. Traditional Medicines & Health Supplements Registration Seminar on Control of Quality and safety of Traditional Medicines and Health Supplements. Grand Seasons Hotel ,Kuala Lumpur 26 January 2005 National Pharmaceutical Control Bureau

  2. On line Registration of Traditional Medicines and HealthSupplements 1 January 2004

  3. What Is ONLINE REGISTRATION Paperless submission using web-basedapplication accessible via internet connectivityProcess includes: • Filing, editing, completing and submitting registration forms • Receiving & replying to memos (inclusive of e-mail notification) • Change Requisition Processes • Approval, Certification and • Product Renewal

  4. WHY Online Registration ? • QUEST 1 – Developed in 1993 • As an administrative support to registration process. • Overruns its capacity and capabilities. • Increased workload puts pressure on personnel and system. • New system to improve delivery of services. • Capitalized on web based technology and e-government initiatives. • Proposed QUEST 2 in 2001with added features.

  5. IT intervention will improve evaluation time and information delivery systems. • Payment of fees could be electronic. Fee paid via bank draft • Much time wasted on incomplete documents. • Pre-submission guidelines need to be more user-friendly. • Online submissions with data validation checks could help solve this problem. Receipt of application • Electronic submissions of application forms for all types of application could greatly reduce manpower cost and increase efficiency. Applications checked Incomplete • Time consuming - pharmacists do data entry. • Could benefit from online submission of forms. • Additional support staff for administrative jobs. Complete Additional Data Data Entry Rejected Letter issued to applicant Source: Management Information, NPCB, E&Y Analysis

  6. FLOW CHART OF REGISTRATION PROCEDURES Applicant BPKP Obtain Smart Card LAB GMP Input data and submit BFS NPCB evaluate application Request for add. data Prepare evaluation report JKPP Request for add. data Secretariat DCA

  7. Evaluation Process- Unchanged Manual Online S1 1 mth Screening Database S2 4 mth Testing S2 S3 Evaluation Testing S3 6 mth Evaluation Approval & Licence Approval & Licence

  8. Registered User To enable user to access secured domain of on-line submission, Applicant shall execute membership registration and create Login name and password. Login Name and password are created by individual user during membership registration process

  9. www.bpfk.gov.my

  10. QUEST 2- ON LINE REGISTRATION

  11. Contains all application forms • Contains all work in progress including application forms filled up, submission awaiting payment and correspondence

  12. Step-1

  13. Step 2- Section A

  14. Section B

  15. Section C

  16. Section D

  17. Section E

  18. Section F

  19. Click confirm button to go to registration submission page Click back button to make changes before submitting Click print button to print all the details submitted

  20. PRODUCT STATUS • Unsubmitted • Submitted but not paid • Submitted paid not confirmed • Submitted and paid but not reviewed • Under assessment by Assessor • KIV • Correspondence • Approved by KPP, Under Review by JKP • Approved by JKP, Under Review by DCA • Rejected by KPP, Under Review by JKP • Rejected by JKP, Under review by DCA • Registered

  21. CONCLUSION • Change in procedure. Does not compromise QUALITY, SAFETY and EFFICACY • Web based paperless submission • Requires appropriate hardware / software • No major changes in evaluation process • Increased efficiency, accessibility and convenience

  22. CONTACTS 1. For Administrative matters and General Inquiry about the requirements regarding the Product Registration, Licensing and others, please contact:National Pharmaceutical Control Bureau (NPCB) •Tel:603 - 79573611 • Fax:603 – 79562924 • E-mail: Head and officers of relevant division/unit

  23. CONTACTS 2. For Technical Support regarding Quest2 System, please contact:Customer Service Department Technology Innovation Resources SdnBhd •Tel:1 - 300 - 88 – 1121 • Fax:603-8943 – 0395 •URL:http://www.tir.com.my • E-mail: webmaster@tir.com.my

  24. CONTACTS 3. For Technical Support regarding your Digital Certificate or Smart Card System, please contact: Customer Service DepartmentDigicert Sdn Bhd •Tel:603 - 89961600 •URLhttp://www.digicert.com.my • E-mail: customercare@digicert.com.my

  25. Training Conducted by TIR

  26. Online Status

  27. 30 April 2005

  28. 3590

  29. National Pharmaceutical Control Bureauwww.bpfk.gov.my

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