quest 3 refresher & issue - ctfa...

Quest 3 Refresher & Issue

WHO Collaborating Centre

for Regulatory Control of

Pharmaceuticals

Member of Pharmaceutical

Inspection Cooperation

Scheme

MS ISO 9001:2008

Certified 1

Hotel Singgahsana, PJ ( 10 September 2013,Tuesday)

Prepared by: Eva Senior Assistant Director, NPCB

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

BPFK Portal

Users need to insert the USB Token then click on ‘Product Registration & Cosmetic Notification’ menu from BPFK website

http://portal.bpfk.gov.my

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

System identified user’s identity.

User need to key-in PIN code (8 digit alphanumeric provided by Digicert.) PIN CODE PASSWORD

Screen Displayed


The authorized person’s name is not displayed?

Call customer care at Digicert Sdn Bhd at :

03-8992 8888 / 8800 / 8903 / 8807

What if ?


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

User is required to key-in Username and Password then click ‘Login’

Example:-

Username : EvaBPFK (same as

Quest 2)

Password : ******

Password for 1st time login into Quest 3 :

Quest3

Login ID


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.

Function for Each Submenu

Notification of Cosmetic Products……..Cont.

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?

1st – check token validity

2nd –check intermediate root certificate

3rd – check Internet Browser

4th – check whether has entered PIN code > 3 times

1st 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’

1st 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’

1st Check Token Validity………Cont

2nd Check Intermediate Root Certificate

At IE browser, click on ‘Tools’ ‘Internet Option’

Click at tab button ‘Content’ ‘Certificate’

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

2nd Check Intermediate Root Certificate….Cont

The name of authorized person is not seen ?

Download Intermediate Root Certificate at (http://www.digicert.com.my/download/DigicertRootCertificatesInstaller2.0.msi)

OR visit to below link for more information :

http://portal.bpfk.gov.my/index.cfm?&menuid=127&parentid=68&highlightid=48

What if ?

2nd Check Intermediate Root Certificate….Cont

Under the ‘Intermediate Certificate Authorities’ tab menu, the expiration date of the Digisign ID (Basic) certificate must be on 20 May 2016

The expiration date is not 20 May 2016 ?

Download Intermediate Root Certificate as stated in previous slide.

What if ?

3rd Check Internet Browser

At your Internet browser, click on ‘Help’ tab button ‘About Internet Explorer’

4th Check Whether has entered PIN code > 3 attempts

User need to key-in 8 digit alphanumeric PIN code

I have tried for 3 attempts but still fail to login ? What if ?

USB Token is Locked ! Have to bring back to Digicert to re-set PIN code

Scenario 1 : If the Token still valid.

Q2. How to apply for Token Renewal ?

Login into Quest 3 account

Click on ‘Company Membership’

Q2. How to apply for Token Renewal ?.....Cont

1

Package A : token misplace/missing RM 280

Remember to surrender your exiting token to Digicert for Renewal

Alert !

2

3

Package B : valid token RM 100

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

(c) Copy of Company’s Authorization Letter

(d) Copy of company registration certificate

(e) authorized person signature on the Membership Slip

Q2. How to apply for Token Renewal ?.....Cont

Alert !

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

YES. A company can apply many supplementary USB Token under different authorized person’s name.

Q4. Can a COMPANY have more than one(1) Security USB Token ?

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

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 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

Q6. What should I do if one of my staff / colleague resigned ?

Alert !

Cosmetic Unit

- Pn. Hirza – ext. 5534

- Cik. Bintul Huda – ext. 5537

Q7. Who should I speak to if my product notification status is ‘Under Review’ ?

3 months in advance

Q8. If my product notification is about to expire, when should I apply for the renewal ?

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 !

Not to worry !

Product Name : Facial Mask Strawberry Flavor

NOT. No. : 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

Q11. If I renew product 3 months in advance, will the remaining 3 months of validity forfeited?

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

Q12. What should I do if I couldn’t find my formula substance(s) in the search database?

Search Substance by

- Substance Name

- CAS No.

- Technical Name

Q13. What is the fastest way to check the compliance and prohibition of an active substance ?

All the notification changes can be done through ‘Notification Changes’ submenu except item 9.

Q14. Notification Changes………..Cont

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)

New Notification

8. Product presentation (single product, palettes in a range, etc)

Amendment

9. Company Name and/ or address for Cosmetic Holder (without change in Company Reg. No.)

Amendment

10. Additional Importer Amendment

Q14. Notification Changes Adopted from Annex I, Part 4

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


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.


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)

NO!

Only Notification expiry date will be changed.

Notification Number will remain unchanged.

Q15. For Notification Renewal, both Notification Number & Notification expiry date will be changed ?

Q16. For Notification Changes, both Notification Number & Notification expiry date will be changed ? YES!

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!

Q17. Can I apply CFS & Notification Changes concurrently?

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.

Q18. I have withdrawn my product, but when I try to re-notify again, system rejected due to reason product name has already used by your company?

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’

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