Part I, Section A: Product Particulars

References:

1)    New Product Development Requisition (NPDR)

2)    Innovator’s immediate label, outer carton & package insert

3)   Product Development Report (PDR)

4)   Martindale/AHFS/electronic Medicines Compendium (eMC) – www.medicines.org.uk


A1 - A3

A1 Active Ingredient

A1.1 Active Ingredient Name

A1.2 Salt Form

A1.3 Strength of Active Ingredient (Quantity unit/ dose)

A1.4 Strength Salt-Free

A1.5 Source of Active Ingredient (Animal – e.g. Bovine, Porcine, Ovine   or Others/ Plant/ Others)

A1.6 Form of Substance

A1.7 Remarks (if any)

A1.8 Status

 

·   Please refer to Part 1 : Product Validation (3) Active Ingredients

A2 Excipients

A2.1 Excipient name

A2.2 Strength of Excipient (Quantity unit/ dose)

A2.3 Function of excipient (e.g. absorbent, diluents, bulking agent,

         coating agent, anti-caking agent etc.)

A2.4 Source of excipient

A2.5 Remarks (if any)

 

·   Please refer to Part 1 : Product Validation (4) Excipients

A3 Dosage

A3.1 Dosage Form

A3.2 Dosage Form Description

A3.3 Source of Capsule Shell

A3.4 Certificate to verify the Source of Capsule Shell

A3.5 Colouring Agent used in capsule shell

A3.6 Certificate of Analysis of Capsule Shell

 

·   Please specify the form of product dosing such as: tablet, capsule, suspension, cream, ointment, granule or other dose form.
·   Please state the source of gelatin coating capsules used, for example: Porcine, Bovine or vegi cap.
·   Please submit certificate of analysis (COA) for capsule coating that state the source of gelatin.
·   Sources of bovine should be declared free from 'BSE / Mad cow disease & TSE'.
·   Please ensure the type of coloring agent used should be stated and is the only one allowed not prohibited.
·   Please refer to Appendix 8.3 Lists of Permitted and Restricted Colouring Agents in the DRGD for information change from time to time.
A4 : Product Description
A5 : Pharmacodynamic
A6 : Pharmacokinetics
A7 : Indication
A8 : Recommended Dose
A9 : Route of Administration
A10 : Contraindication
A11 : Warning and Precautions
A12 : Interaction with Other Medicaments
A13 : Pregnancy and Lactation
A14 : Side Effects
A15 : Symptoms & Treatment of Overdose
A16 : Effect on Ability to Drive and Use Machine
A17 : Preclinical Safety Data
A18 : Instructions For Use
A19 : Storage Condition
A20 : Shelf life
A21 : Therapeutical Code/ATC Code (If any)
A22 : Herbal Code (If any)

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