Quest 3 Refresher & Issue Hotel Singgahsana, PJ ( 10 September 2013,Tuesday) Prepared by: Eva Senior Assistant Director, NPCB WHO Collaborating Centre for Regulatory Control of Pharmaceuticals Member of Pharmaceutical Inspection Cooperation Scheme MS ISO 9001:2008 Certified 1
Topic Discuss : Introduction for Quest 3 Steps-by-steps login into Quest 3 System Understand function for each submenu in Cosmetic Module Issues / problems that may encounter during notification of cosmetic products & how to overcome it
Introduction for Quest 3 System Quest 3 Application is an Online Submission System which enables Product License Holder, Manufacturer, Importers, Re-packers or Resellers to conduct secured online transactions (eg. Product registration, cosmetic notification, change request, market sampling, renewal etc.) System Quest 3 is best viewed in Internet Explorer version 8 Try no to use IE 9 or IE 10 PC Specification - O/S : Window XP Pro
Login to Quest 3 System http://portal.bpfk.gov.my BPFK Portal Users need to insert the USB Token then click on Product Registration & Cosmetic Notification menu from BPFK website
Login to Quest 3 System Cont.
Login to Quest 3 System Cont. Quest3 Front-page Users need to insert the USB Token then click on Registered User? Please Click Here. What if? BPFK website is down or under maintenance? http://quest3.bpfk.gov.my/quest3
Login to Quest 3 System Cont. Screen Displayed System identified user s identity. What if? The authorized person s name is not displayed? Call customer care at Digicert Sdn Bhd at : 03-8992 8888 / 8800 / 8903 / 8807 User need to key-in PIN code (8 digit alphanumeric provided by Digicert.) PIN CODE PASSWORD
Login to Quest 3 System Cont. What if? I have tried for 3 attempts but still fail to login? USB Token Locked! Call customer care at Digicert Sdn Bhd at : 03-8992 8888 / 8800 / 8903 / 8807 Send back Token to Digicert for PIN code re-set
Login to Quest 3 System Cont. User is required to key-in Username and Password then click Login Example:- Login ID Username : EvaBPFK (same as Quest 2) Password : ****** Password for 1 st time login into Quest 3 : Quest3
Login to Quest 3 System Cont. What if? I forgot my username or password? Contact BPFK Helpdesk at 03-7883 5560 / 61 / 62 if you see this error page : Can try many times; no password lock.
Notification of Cosmetic Products Main Menu User need to click on Menu Cosmetic for new product notification.
Notification of Cosmetic Products..Cont. Function for Each Submenu Application Form for New Cosmetic Notification / Variance Form not submitted will be stored in SAVE FORM / editable List of products submitted for payment / form editable List of products submitted but not paid / form NOT editable Printing of Notification Note Pending Payment / Notified / Under Review / Withdrawal/ Expired Notification Renewal (only applicable for product with validity > 3 months List of Notified Products Product withdrawal To change product details (refer to Annex l, Part 4 for types of changes) To re-print payment voucher Search for substance(s) from Annex ll - lv To apply approval for new substance(s) To apply / check status for CFS approval To apply / check status for MS approval To apply / check status for IHE approval
Issues / problems that may encounter during notification of cosmetic products & how to overcome it
Q1. I couldn t login into Quest 3 and keep getting error page, what shall I do? 1 st check token validity 2 nd check intermediate root certificate 3 rd check Internet Browser 4 th check whether has entered PIN code > 3 times
1 st Check Token Validity On desktop, double click on ST3 icon ST3 Certificate Manager Window will be prompted At the left menu bar, click on Certificate
1 st Check Token Validity Cont Column to fill in PIN code will be prompted Key-in 8 digit PIN code OK Select Certificate then click View
1 st Check Token Validity Cont
2 nd Check Intermediate Root Certificate At IE browser, click on Tools Internet Option Click at tab button Content Certificate
2 nd Check Intermediate Root Certificate.Cont What if? The name of authorized person is not seen? Download Intermediate Root Certificate at (http://www.digicert.com.my/download/digicert RootCertificatesInstaller2.0.msi) OR visit to below link for more information : http://portal.bpfk.gov.my/index.cfm?&menuid=12 7&parentid=68&highlightid=48 Name of the authorized person must be seen under the Personal tab menu Still cannot see the name? contact Customer Care from Digicert Sdn Bhd at 03-899208903 / 8807/ 8888/ 8800
2 nd Check Intermediate Root Certificate.Cont What if? The expiration date is not 20 May 2016? Download Intermediate Root Certificate as stated in previous slide. Under the Intermediate Certificate Authorities tab menu, the expiration date of the Digisign ID (Basic) certificate must be on 20 May 2016
3 rd Check Internet Browser At your Internet browser, click on Help tab button About Internet Explorer
4 th Check Whether has entered PIN code > 3 attempts User need to key-in 8 digit alphanumeric PIN code What if? I have tried for 3 attempts but still fail to login? USB Token is Locked! Have to bring back to Digicert to re-set PIN code
Q2. How to apply for Token Renewal? Scenario 1 : If the Token still valid. Login into Quest 3 account Click on Company Membership
Q2. How to apply for Token Renewal?...Cont Alert! 1 2 Remember to surrender your exiting token to Digicert for Renewal 3 Package A : token misplace/missi ng RM 280 Package B : valid token RM 100
Q2. How to apply for Token Renewal?...Cont Scenario 2 : If the Token already expired. - Call BPFK Helpdesk at 03-7883 5560 / 61 / 62 for further assistance. - BPKF Helpdesk officers will assist to apply for renewal & print out the Membership Slip and email back to applicant. - Documentation for renewal that should submit to DC: (a) Your payment (b) Photocopy of Authorized Person IC Alert! (c) Copy of Company s Authorization Letter (d) Copy of company registration certificate (e) authorized person signature on the Membership Slip
Q3. What is the possible cause(s) when click on Not Listed or Search button but nothing appear? Problem : Might be due to pop-up blocker function is activated in your browser. Solution : Go to Tools tab menu Pop-up Blocker Click on Turn Off Pop-up Blocker once is done, the submenu will change to
Q4. Can a COMPANY have more than one(1) Security USB Token? YES. A company can apply many supplementary USB Token under different authorized person s name. Q5. Can a PERSON apply more than one(1) Security USB Token? NO. A person is not allow to apply > one(1) USB Token. One IC = One USB Token
Q6. What should I do if one of my staff / colleague resigned? Scenario 1 : If the USB Token is still with the company. - Company appoint new staff Login into Quest 3 account apply Change of Authorized Person - Advise : settle exiting transaction first before proceed to CAP - Remember to surrender your exiting token to Digicert for Renewal - Fees : RM 100 Alert! Scenario 2 : If the USB Token is NOT returned or missing. - Company has to write-in officially to BPFK to inform about the resignation of the former staff & state down the new appointed authorized person. - Request Helpdesk officer to generate new Membership Slip for Change of Authorized Person - Fees : RM 280
Q7. Who should I speak to if my product notification status is Under Review? Cosmetic Unit - Pn. Hirza ext. 5534 - Cik. Bintul Huda ext. 5537
Q8. If my product notification is about to expire, when should I apply for the renewal? 3 months in advance Q9. What if the notification expiry is < 3 months, and is not listed in notification renewal tray? Contact BPFK Helpdesk to help generate payment voucher for renewal product(s). PV mail to applicant. Q10. What if the product validity already expired? BAD NEWS! You will have to re-notify as NEW product starting from the beginning!
Q11. If I renew product 3 months in advance, will the remaining 3 months of validity forfeited? Not to worry! Product Name NOT. No. : Facial Mask Strawberry Flavor : NOT11063785K Ref. No. : 2011060001885-P Validity Period : 27/6/2011 27/6/2013 If apply renewal on 28/3/2013, the new validity will be: 28/3/2013 28/3/2015 27/6/2013 27/6/2015
Q12. What should I do if I couldn t find my formula substance(s) in the search database? On the left menu bar, click on New Substance Application and follow the instruction to apply Check your email regularly for feedback from Cosmetic Officer
Q13. What is the fastest way to check the compliance and prohibition of an active substance? Search Substance by - Substance Name - CAS No. - Technical Name
Q14. Notification Changes..Cont All the notification changes can be done through Notification Changes submenu except item 9.
Q14. Notification Changes Adopted from Annex I, Part 4 No. Types of Change Product Notification 1. Brand Name New Notification 2. Change of Cosmetic Holder due to change of distribution rights New Notification 3. Product Type (exp. Lotion, New Notification 4. Intended Use New Notification 5. Product Name New Notification 6. Formulation New Notification 7. Manufacturer and or assembler (name and/or address) 8. Product presentation (single product, palettes in a range, etc) 9. Company Name and/ or address for Cosmetic Holder (without change in Company Reg. No.) New Notification Amendment Amendment 10. Additional Importer Amendment
Q14. Notification Changes..Cont Scenario 1 : Change of Importer name and/or address or add additional Importer - No payment is needed. - If the new importer is not listed in search database, applicant need to apply the approval of new importer via Not Listed button - Re-print Notification Note after the change is done. BPFK Sdn Bhd Lot 36, Jln University, 46200 PJ
Q14. Notification Changes..Cont Scenario 2 : Change of Manufacturer name and /or address or add additional Manufacturer - Apply under Change of Others - Payment of RM 50 is needed. - If the new Manufacturer is not listed in search database, applicant need to apply the approval of new Manufacturer via Not Listed button - Re-print Notification Note after the change is approved.
Q14. Notification Changes..Cont Scenario 3 : Change of company name and/or address of Cosmetic Holder Application shall be done via formal letter BUT not through system If the holder carries only cosmetic product(s) : Formal Letter + previous SSM + current SSM shall be forwarded to Pusat Pembangunan Organisasi (PPO) If the holder carries both pharmaceutical & cosmetic product(s) : Formal Letter + previous SSM + current SSM shall be forwarded to Seksyen Koordinasi Regulatori (SKR)
Q15. For Notification Renewal, both Notification Number & Notification expiry date will be changed? NO! Only Notification expiry date will be changed. Notification Number will remain unchanged. Q16. For Notification Changes, both Notification Number & Notification expiry date will be changed? YES!
Q17. Can I apply CFS & Notification Changes concurrently? NO! REASON : Notification Changes involve change in NOT No. This change will affect application of CFS whereby the new NOT No. will not be detected in CFS application. ADVISE : must complete either one application first than only follow by another one!
Q18. I have withdrawn my product, but when I try to renotify again, system rejected due to reason product name has already used by your company? Problem : System not able to allow re-notification of product using the same name. Solution : add a dot after the product name exp. Facial Mask Mango Flavor.
Change in Format for Notification Note i) Year for CDCR : 2007 1984 ii) Regulation 29 A 18 A(2) iii) Telephone Number is displayed iv) Extra phrase right under Name & Address of Authorized Importer v) Amendments for existing phrase for Disclaimer