Sr. No.

Appendix 1
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b)
2.
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b)
3.
Appendix 2
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b)
c)
2.
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ii.
b)
3.
4.
5.
6.
Appendix 3
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i.
ii.
2.
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iii.
Appendix 4
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2.

Particulars
Packaging Specifications and Product Composition
Specifications of the Packaging Material
Primary (inner) Container(s)
Outer Packing
Product Composition
Active Ingredients
Inactive Ingredients
Additional Raw materials
Chemistry and Pharmaceuticals Aspects
Raw Material Specifications and Analytical Control Methods used:
Crude Plant/Non-Plant Material (Source of Active Ingredients)
Processed Plant / Non-Plant Material (Active Ingredients)
Inactive Ingredients
Details of Manufacturing Procedures (incl. Packaging) and Summary of equipment used:
Summary of Manufacturing Process:
Preparation of Processed Raw Material from Crude Plant / Non-Plant Material
Preparation of Finished Product From Processed Raw material
Summary of Equipment Used
Details of In-Process Control Procedures
Finished product Specifications and Analytical Tests
Stability Studies on Finished Product (Based On Two Batches)
Complete, Filled Batch Manufacturing Records For One Commercial Batch
Safety and Efficacy
Safety
Evidence of Safety in Use
Side Effects, Contra-Indications, Precautions etc.
Efficacy
Main Pharmacological and clinical Effects
Evidence Of Efficacy in use for Proposed Indications
Justifications for Combinations Products
Supporting Documents and Samples
Two Samples per pack size, as intended for Marketing (i.e. Including patient and prescriber
information leaflets)
Copy of Marketing Authorisation in Country of manufacture