How to Access Other in QUEST3+ System ? 

Product Registration >> New Application Form >> Product Validation >> Other Information

• 5.1 Origin
• 5.2 Function 
• 5.3 In the Manufacturing Process
• 5.4 In the Final Product 

• Please select YES if there is any active ingredient, excipient and/or capsule shell derived from human or animal.
• Please specify whether the origin is porcine/ bovine/ ovine or others.
• If OTHERS is selected, please specify the source.

• Please select the manufacturer of the finished product from the database list. If the manufacturer is not listed, please click the ‘Not Listed’ button; upon which, the particulars of the manufacturer should be provided by applicant, along with the manufacturer’s GMP Certificate/ Status
• Please take note that the manufacturer must be listed in the database before applicant may proceed with product registration application. 
• Please ensure the name and address of manufacturer is the same with the GMP certificate attached.

• Status as to whether the declared manufacturer is a contract manufacturer or otherwise, has to be entered. Click the appropriate button ‘Yes’ or ‘No’.

8.1 Declaration Letter

8.2 Product(s) from First Source

An application for a second source may be considered where deemed necessary. This second source product shall be the same as the first product in all respects except for the site of manufacture.

If Yes, please state

1. Manufacturer (repacker/packer) name
2. Manufacturer (repacker/packer) address
3. Certificate of Good Manufacturing Practice (GMP)
4. Packaging Process

Please select YES or NO if the manufacturing of the product involves any repacker/packer. If a repacker is involved, please be advised that the repacker/packer must have a valid GMP Certificate to perform such activity.

11.1 Patent Protection

11.2 Filling Date

11.3 Grant Date

11.4 Patent Statement

Please select YES or NO if the product has any patent protection or otherwise.  If there is any patent protection, applicant should click YES, and provide the Patent Number, Filing Date, Grant Date and attach the patent statement as supporting document.

• *If Yes, 
• 12.1 Section E Type

• Please select YES or NO, depending whether this is an imported product or otherwise. If imported product, please select Section E Type either Type A (CPP) or Type B (CFS & GMP).

*If Yes, 

• 13.1 State your Premix Form
• 13.2 Manufacturer Name
• 13.3 Manufacturer Address
• 13.4 GMP Certificate
• 13.5 Formulation Process
• 13.6 Manufacturing Process
• 13.7 Specification of Analysis
• 13.8 Certification of Analysis

Please select YES or NO, depending whether this product contains any premix or not. If it does, applicant should state the premix form, manufacturer name and address, and provide its GMP Certificate, Formulation Process, Specification of Analysis and Certificate of Analysis.

Note: Process Validation (Protocol & Report) for API Premix (in Section P3.4)

*If Yes, 

• 14.1 Declaration Letter
• 14.2 Product(s) to be replaced

A product registration holder is not allowed to register/ hold two or more products with similar formulation (same active ingredient of raw material, strength and dosage form) at any one time unless product variant.

Note: Letter of justification for replacement by product holder is required.

*If Yes, 

• 15.1 Application Letter 
• 15.2 Priority Review Status 
• 15.3 Date of Grant 

Please select YES or NO, depending if the product has priority review or otherwise. If there is priority review granted, applicant should click YES, and provide the Application Letter to NPRA, Approval Letter for Priority Review from NPRA, Priority Review Status and Grant Date. 

*If Yes, 

16.1 DCA Reference Country (for DE)

16.2 Date of Approval in Reference Country

16.3 Duration of DE Granted in Reference Country

16.4 Letter of Intent

Please select YES or NO for data exclusivity, and applicant need to provide/ state DCA Reference Country (for DE), Date of Approval in Reference Country, Duration of DE Granted in Reference Country as well as attach the Letter of Intent.

Please refer:

1. Data Exclusivity Directive
2. Data Exclusivity Letter of Intent

*If Yes, 

• 17.1 Halal Certificate 
• 17.2 Certificate No.

*If Yes,

• 18.1 Medical Device
• Please select YES or NO, depending whether this product contain medical device component or not. If YES, applicant should attach the medical device component document.

Please refer :

• Directive No. 4 Year 2017, Ref. (9) dlm.BPFK/PPP/07/25 Jld. 1 : DIREKTIF KUATKUASA PEMAKAIAN GUIDELINE FOR REGISTRATION OF DRUG-MEDICAL DEVICE AND MEDICAL DEVICE-DRUG COMBINATION PRODUCTS
• Guideline For Registration Of Drug-Medical Device and Medical Device-Drug Combination Products