Product Validation

Applicants need to complete all the required fields in Product Validation before proceeding to other Sections.

PV 1 : Full Product Name

PV 2.0 : Dosage Form

2.1 Dosage Form
2.2 Dosage Form Description
2.3 Source of Capsule Shell (if applicable)
2.4 Certificate to Verify the Source of Capsule Shell (if applicable)
2.5 Colouring Agent Used in Capsule Shell (if applicable)
2.6 Certificate of Analysis of Capsule Shell (if applicable)

PV 3.0 : Active Ingredient(s)

3.1 Active Ingredient Name
3.2 Salt Form
3.3 Strength of Active Ingredient (Quantity unit/ dose)
3.4 Strength of Active Ingredient (Salt-Free Equivalent)
3.5 Source of Active Ingredient (Animal – e.g. Bovine, Porcine, Ovine or Others/ Plant/ Others)
3.6 Remarks (if any)
3.7 Status

PV 4.0 : Excipient(s)

4.1 Excipient name
4.2 Strength of excipient (Quantity unit/ dose)
4.3 Function of excipient (e.g. absorbent, diluents, bulking agent, coating agent, anti-caking agent, etc.)
4.4 Source of excipient
4.5 Remarks (if any)

PV 5 - PV 14 : Other Information

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?
10. Is the Product Under Patent Production? 
11. Does this product has Any Data Exclusivity (DE)?
12. Does this product contain any premix?
13. Is this a replacement product?
14. Is this an imported product?

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

DISCLAIMER

The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

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  • Last Modified: Thursday 18 April 2019, 12:45:08.
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