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 of Active Ingredient (Salt-Free Equivalent)
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
7. Is there any Contract Manufacturer Involved?
8. Is this Product a Second Source Product?
9. Is there any Repacker/Packer Involved?
11. Is the Product Under Patent Protection?
12. Is this an Imported Product?
13. Does this product contain any premix?
15. Does this product need Priority Review?
16. Request for Data Exclusivity (DE)?
18. Does this product contain a medical device component?
