Dossier to apply pharma product in Cambodia

APPLICATION FOR

REGISTRATION

OF PHARMACEUTICAL PRODUCT

IN CAMBODIA

 (Brand and generic name)

PART –I

1.       TABLE OF CONTENTS,

2.       ADMINISTRATIVE DATA

3.       &

4.       PRODUCT  INFORMATION

TABLE OF CONTENT(Part-1)

S/N	Description	Page No.
1.	Administrative information  and prescribing information
2.	Introduction
3.	Information of applicant
4.	Information of manufacturer
5.	Information of product
6.	Asean common Technical Documents Table of contents

ADMINISTRATIVE INFORMATION

AND

PRESCRIBING INFORMATION

TABLE OF CONTENTS

S.NO.	DOCUMENTS	PAGE NO.
APPENDIX-I	APPLICATION FORM
APPENDIX-II	LETTER OF AUTHORIZATION
APPENDIX-III	CERTIFICATION 1- Manufacturing Licence 2- Registration certificate of Product in Pakistan 3- cGMP 4-Certificate of Pharmaceutical Product 5- Free Sale Certificate
APPENDIX-IV	LABELLING
APPENDIX-V	PRODUCT INFORMATION
APPENDIX-VI	SUMMARY OF PRODUCT CHARACTERISTICS
APPENDIX-VII	PACKAGE INSERT

 APPLICATION FORM

KINGDOM OF CAMBODIA

NATION-RELIGION-KING

MINISTRY OF HEALTH

DIRECTORATE GENERAL FOR HEALTH

DEPARTMENT OF DRUGS AND FOOD

8,Ung Pokun Street, Phnom Penh, Cambodia

Phone : (855-23)880247-48 Fax:     : (855-23)880247

                       

APPLICATION FORM FOR MARKETING AUTHORIZATION

A.           DETAIL OF APPLICANT AND MANUFACTURER

1.           Applicant’s:

Name:        

Address:

Phone:                                             Fax:

2.           Manufacturer’s*:

Name	:
Address	:
Phone	:
Fax	:
E-mail	:

*= Manufacturer responsible for final batch release

Other manufacturer:

Name & Address	Role**
N/A	N/A
N/A	N/A
N/A	N/A

**= e.g. “prepares semi-finished product” , “packaging” , “granulation”, “manufactures bulk finished dosage form” , “contract research organization”, etc.

B.          DETAIL OF PRODUCT:

1.           Product Name:

	Commercial Name	:
	INN or Generic Name	:
	Dosage form	:	Capsule
	Composition	:	Each capsule Contains
2.   Product Description		:
3.   Qualitative & Quantitative Formula			Each Capsule Contains
Active Ingredient			i.
In-Active Ingredients			ii.

C.   REQUESTED PHARMACEUTICAL CATEGORY:

1. Prescription                       ☑
2. Without prescription           ☒

C.   INDICATION, POSOLOGY AND ROUTE OF ADMINISTRATION:

Indication

Posology

Rout of Administration                            

E.  ATTACHED INFORMATION

GMP Certificate                                                                                 ☑

Certificate of a Pharmaceutical Product                                        ☑

Registration Certificate in other countries (if available)                    ☐

Summary of Product Charecteristic                                                       ☑

Technical Documents

1.     Quality                                                                                 ☑

2.    Safety                                                                                   ☐

3.    Efficacy                                                                                 ☐

Samples

4.    Commercial boxes for registration purpose                                 ☑

Registration fee                                                                                        ☑

F. Pack Size

A.                            Commercial Packing                                                    Hospital Packing                                                                     ☒

G. Shelf Life                                                                                                            

Date:

Title:

Name:

Signature:

Part II

QUALITY DOCUMENT

SECTION A:

TABLE OF CONTENTS

TABLE OF CONTENT (Part-II)

	Section A : Table of content	41-42
	Section B : Quality overall summary	45
	a)      Drug substance of Active Pharmaceutical Ingredient b)     Drug Product
a-Drug Substance of Active Pharmaceutical Ingredient                                          46
	S1: General information       S1.1 : Nomenclature       S1.2 : Structural Formula       S1.3 : General Properties	DMF of Drug Substance
	S2: Manufacture        S2.1 : Manufacturer(s) S2.2 : Description of manufacturing    process and process control       S2.3 : Control of Materials            S2.4 : Control of Critical steps & Intermediates       S2.5 : Process Validation/or Evaluation       S2.6 : Manufacturing Process Development
	S3: Characterization S3.1 : Elucidation of structure & characteristic S3.2 : Impurities
	S4: Control of drug Substance S4.1 : Specifications S4.2 : Analytical Procedures S4.3 : Validation of analytical Procedure S4.4 : Batch Analyses S4.5 : Justification of Specification
	S5: Reference Standards or materials
	S6: Container Closure System
	S7: Stability
b-Drug Product                                                                                                              47
	P1:   Description and composition	48
	P2:   Pharmaceutical development P2.1 : Information on development studies P2.2 : Component of drug product          P2.2.1 Active Ingredient          P2.2.2 In-active Ingredient P2.3 : Finished Product          P2.3.1 Formulation Development          P2.3.2 Overages          P2.3.3 Physiochemical  Biological  properties P2.4 : Manufacturing Process Development P2.5 : Container Closure System P2.6 : Microbial Attributes P2.7 : Compatibility	49
	P3:   Manufacturer P3.1 : Batch Formula P3.2 : Manufacturing process and process control P3.3 : Control of Critical steps & Intermediates P3.4 : Process Validation/or Evaluation	73
	P4 :  Control of Excipients P4.1 : Specifications P4.2 : Analytical Procedures P4.3 : Excipients of Human and Animal origin P4.4 : Novel Excipients	88
	P5 :  Control of Drug (Finished) Product P5.1 : Specifications P5.2 : Analytical Procedures P5.3 : Control of Analytical Procedures P5.4 : Batch Analyses P5.5 : Characterization of Impurities P5.6 : Justification of Specification	133
	P6: Reference Standards or materials	143
	P7: Container Closure System	145
	P8: Product Stability	165
	P9: Product Interchangeability	169

SECTION B

QUALITY OVERALL SUMMARY

a)      Drug substance of Active Pharmaceutical Ingredient b)     Drug Product

PART III:

NON CLINICAL DOCUMENT

NON-CLINICAL SAFETY DATA

Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction.

PART IV:

CLINICAL DOCUMENT

SECTION D

KEY LITERATURE REFERENCE

·               BP

·               USP

·               Pharmaceutical Excipients

·               Martindale The Extra Pharmacopoeia

·               Online data collection