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

Any source from animal origin must be declared and to specify the type of animal.

Manufacturer (Name and Address)

Contract manufacturer is applicable when product owner is not the product manufacturer.

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.

*If Yes,

11.1 Patent Protection

11.2 Filling Date

11.3 Grant Date

11.4 Patent Statement

*If Yes,

12.1 Section E Type

*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

Note: Certificate of GMP for manufacturer/ supplier is required for the premixed ingredient(s) in formulation

*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

*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

*If Yes,

17.1 Halal Certificate

17.2 Certificate No.

*If Yes,

18.1 Medical Device