How to Access Other in QUEST3+ System ? 

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

 

Ingredients of Human or Animal Origin (Active Ingredient, Excipient and/or Capsule Shell 

Select YES if your product contains any ingredients of human or animal origin.

5.1 Origin

• Specify whether the origin is porcine/ bovine/ ovine/ human/avian/marine or others.

Manufacturer

• Select the manufacturer of the finished product from the database list. If the manufacturer is not listed, 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
• Address must be inline with GMP certificate.

Is there any Contract Manufacturer Involved?

• Status as to whether the declared manufacturer is a contract manufacturer or otherwise. Click the appropriate button ‘Yes’ or ‘No’.
• Address must be inline with GMP certificate.

Is this Product a Second Source Product?

• Select YES or NO if the product application is second source or otherwise. 
• If the product is second source, a declaration letter stating that the product is second source, along with justification for second source must be provided.
• Applicant must also state the first source product by selecting from the database.

Is there any Repacker/Packer Involved?

• Select YES or NO if the manufacturing of the product involves any repacker/packer.

NOTE: Repacker/packer must have a valid GMP Certificate to perform such activity.

Is the Product under Patent Protection?

*If Yes,

• Patent Number
• Filing Date
• Grant Date
• Patent Statement

Does this product has any Data Exclusivity (DE)?

• This is only applicable to Product Category: Veterinary (Innovator/NCE)

  *If Yes, 

  • DCA Reference Country (for DE)
  • Date of Approval in Reference Country
  • Duration of DE Granted in Reference Country
  • Letter of Intent

Does this product contain any premix?

If Yes,
       
         12.1 State your Premix Form

         12.2 Manufacturer Name

         12.3 Manufacturer Address

         12.4 GMP Certificate

         12.5 Formulation Process

         12.6 Manufacturing Process

         12.7 Specification of Analysis

         12.8 Certificate of Analysis

Is this a replacement product? 

*If Yes,

13.1 Declaration Letter

13.2 Product(s) to be replaced

Is this an imported product?

*If Yes,

12.1 Section E Type

• Type A (CPP)
• Type B (CFS & GMP)