Product Validation

  • All fields are compulsory to be entered.
  • Option is given either to accept the validation result and submit; or override and manually select.
  • Once validation is verified and submitted, the related application form under Step 2 will be displayed.
  • Information entered in Step 1 will be captured in the database and need not be re-entered at Step 2.

PV 1.0 Product Name

1.1 Brand Name
1.2 Generic Name
1.3 Full Product Name

PV 2.0 Dosage Form

2.1 Dosage Form
2.2 Dosage Form Description
2.3 Source of Capsule Shell
2.4 Certificate to verify the Source of Capsule Shell (attachment)
2.5 Colouring Agent used in Capsule Shell
2.6 Certificate of Analysis of Capsule Shell

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 Salt-Free
3.5 Source of Active Ingredient (Animal – e.g. Bovine, Porcine, Ovine or Others/ Plant/ Others)
3.6 Form of Substance
3.7 Remarks (if any)
3.8 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 18 : Other Information

5. Ingredients of Human or Animal Origin (Active Ingredient, Excipient and / or Capsule Shell)
6.Manufacturer (Name and Address)
7. Is there any Contract Manufacturer involved? (Yes or No)
8.Is this product a Second Source Product? (Yes or No)
9. Is there any repacker involved? (Yes or No)
10. Is the Product Manufactured for Export Only? (Yes or No)
11. Is the Product Under Patent Protection? (Yes or No)
12. Is this an Imported Product? (Yes or No)
13. Does this product contain any premix? (Yes or No)
14. Is this a replacement product? (Yes or No)
15. Does this product need Priority Review? (Yes/No)
16. Request for Data Exclusivity (DE)? (Yes/No)
17. Is this product Certified Halal? (Yes/No)
18. Does this product contain a medical device component?  (Yes/No)

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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Site Last Modified

  • Last Modified: Friday 06 December 2019, 11:24:27.
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