Product Validation PV5 - PV18 : Other Information


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


6 Manufacturer


7. Is there any Contract Manufacturer Involved?


8. Is this Product a Second Source Product?


9. Is there any Repacker/Packer Involved?

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.


10. Is the Product Manufactured for Export Only?


11. Is the Product Under Patent Protection?


12. Is this an Imported Product?


 13. Does this product contain any premix?

*If Yes, 

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)


14. Is this A Replacement Product?

*If Yes, 

Please select YES or NO, depending whether this is a replacement product or not. If it is, applicant must attach a declaration letter and state the product(s) to be replaced with justification. 


15. Does this product need Priority Review?

*If Yes, 

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. 


16. Request for Data Exclusivity (DE)? 

Not applicable to generic product.

*If Yes, 


17. Is this product Certified Halal? (Yes/No)

*If Yes, 

Not applicable to generic product.


18. Does this product contain a medical device component?

*If Yes,

Please refer :



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