Guidelines for dossier submissions in Cambodia

 

TABLE OF CONTENTS

 

Product Name: .......................................

No.	Document	Pages
	Part I: Administrative and Product Information
1	Application Form For Market Authorization
2	GMP Certificate
3	Certificate of Pharmaceutical Product
4	Summary of Product Characteristics
	Part II : Quality
6	Section A : Table of Contents
7	Section B: Quality Overall Summary (QOS)
	S- Drug Substance
	P- Drug Product
8	Section C: Body Data
	S- Drug Substance -          General information -          Manufacturer -          Characterization -          Control of drug substance -          Reference standard or materials -          Container closure system -          Stability
	P- Drug Product -          Description and composition -          Pharmaceutical development -          Manufacturer -          Control of excipients -          Control of finished product -          Reference standard or materials -          Container closure system -          Stability -          Product interchangeability
9	Section D: Key Literature Reference
	Part III: Non-Clinical
10	Section A: Table of Contents
11	Section B: Non-clinical Overview
12	Section C: Non-clinical Written and Tabulated Summaries
13	Section D: Non-clinical Study Report
	Part IV: Clinical Data
14	Section A: Table of contents
15	Section B: Clinical Overview
16	Section C: Clinical Summary
17	Section D: Tabular Listing of All Clinical Studies
18	Section E: Clinical Study Reports
19	Section F: List of Key Literature References

 

 

 

 

 

 

 

 APPLICATION FORM FOR MARKETING AUTHORIZATION 

 

                                                                                              KINGDOM OF CAMBODIA

MINISTRY OF HEALTH                                                       NATION RELIGION KING

DIRECTORATE GENERAL FOR HEALTH                                 

DEPARTMENT OF DRUGS AND  FOOD

No.151-153 Avenue Kampuchea Krom,

Phnom Penh , Cambodia.

Phone  : ( 855-23 ) 722 933

Fax      : ( 855-23 ) 426 034 / 426 841

APPLICATION FORM FOR MARKETING AUTHORIZATION 

A-    DETAILS OF APPLICANT  AND  MANUFACTURER  :

1- Applicant’s       :

      - Name :

      - Address         :

      - Phone            :

- Fax                :          

- E-mail            :

2-      Manufacturer’s*  :

       - Name :

      - Address         :

      - Phone            :

- Fax                :                                  

- E-mail            :         

* = Manufacturer responsible for final batch release.

Other manufacturers

Name & address	Role**

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

B- DETAILS OF PRODUCT:

1- Product Name        :

-          Commercial name  :

-          INN  or Generic Name :

-          Dosage  form  and Strength         :

Each tablet contains:

2- Product Description:

            Example: White, round, Plate, with engraved ‘WH” on one side and plain on the  other

3- Qualitative & Quantity formula:

            Active ingredient:

            Other ingredients:

C- REQUESTED PHARMACEUTICAL CATEGORY:

-          Prescription                                  :           €                                                                     

-          Without  prescription                   :           €        

D- INDICATION, POSOLOGY AND ROUTE OF ADMINISTRATION:

-          Requested indication  :

-          Recommended  posology:

-          Recommended  route  of  administration  :

E- ATTACHED INFORMATION:

-          GMP  Certificate                                                                                      R

-          Certificate of a Pharmaceutical  Product                                                R

-          Registration Certificate in other countries ( if available )          €

-          Summary of product characteristics                                           R

-          Technical documents  :                            

1-      Quality                                                                                    R

2-      Safety                                                                                      €

3-      Efficacy                                                                                   €

-          Samples  :

-          2 Commercial boxes for registration purpose.                            R

-    Registration fee                                                                             R 

F- PACKING SIZE   :

-          Commercial packing        :

-          Hospital  packing 

G- SHELF LIFE:

                                   

Date                :          

                                                                        Title                 :          

                                                                        Name               :          

                                                                        Signature        :

 

 

APPLICATION FOR ANALYSIS OF PHARMACEUTICAL PRODUCTS

                                                           KINGDOM OF CAMBODIA

MINISTRY OF HEALTH                                                NATION RELIGION KING

NATIONAL HEALTH PRODUCT                                                                        *************

 QUALITY CONTROL CENTER

151-153, Kampuchea Krom Blvd.,

Phnom Penh , Cambodia.

Tel/Fax: 023 88 07 32

Tel : 023 88 29 45

APPLICATION FOR ANALYSIS OF PHARMACEUTICAL PRODUCTS

Applicant's last name & first name:

Address:           

City: ……City code ……….Country……………..

Name of product         :    ………………   Dosage form: …………….         

INN:                 

Manufacturer's name:……………

Address: …..City: ………City code ………………Country…………….

Tel N^o:………….         Fax N^o:            …………..

E-mail:………….....................................................................................................................

 

Quality control manager's last name first name:......................................................................

Tel N^o:               Fax N^o :        

E-mail:              

 

Person to contact (first name & last name) ............................................................................

Address:

City:                   City code ..... Country..................................

Tel N^o:               Fax N^o:.........

E-mail:            

Certification required

For contract manufacturing

- License of Pharmaceutical industries and contract manufacturer

-Contract manufacturing agreement

-GMP  certificate of contract manufacturer

For manufacturing  “ under-license “

 -License of Pharmaceutical industries

-GMP certificate of the manufacturer

 -Copy of “under-license” agreement

For locally manufactured products

 - License of pharmaceutical industries

 - GMP certificate

For imported products 

-License of pharmaceutical industries / importer / wholesaler

-Certificate of a Pharmaceutical Product issued by the competent authority in the country of origin according to W.H.O. format( original copy, valid, duly signed, dated and authenticated 

-Site master file of manufacturer ( unless previously submitted within  the last 2 years

For countries not issuing CoPP

GMP Certificate

Free Sale Certificate

MODEL of  Certificate of a Pharmaceutical Product

 

This certificate conforms to the format recommended by the WHO (general instructions and explanatory notes attached)

Certificate No                                        :           _________________________

Exporting (Certifying) country  :          

Importing (Requesting) country            :          

1.         Name and dosage form of product:

                                                                                                                                     

1.1        Active ingredient(s)² and amount(s)³ per unit dose:

                                                                                                                                     

                                                                                                                                     

                                                                                                                                      

For complete qualitative composition including excipients, see attached⁴.

1.2        Is this product licensed to be placed on the market for use in the exporting country?⁵

                        Yes                              No

1.3          Is the product actually on the market in the exporting country?

                        Yes                              No                                Unknown

If the answer to 1.2 is yes, continue with section 2A and omit section 2B.

If the answer to 1.2 is no, omit section 2A and continue with section 2B⁶.

2A.1     Number of product licence⁷ and date of issue:

                                                                                                                 

2A.2     Product license holder (name and address):

                        Name                :                                                                                                          

                        Address            :                                                                      

2A.3     Status of product-license holder:⁸

                        a                      b                    c

2A.3.1   For categories b and c the name and address of the manufacturer producing the dosage form are:⁹

                        Name                :                                                                                                          

                        Address            :                                                                                                          

2A.4     Is Summary Basis of Approval appended?       

                        Yes                              No

2A.5     Is the attached, officially approved product information complete and consonant with the licence?¹¹

                        Yes                              No                                Not provided

2A.6     Applicant for the certificate (name and address):¹²

            Name                :                                                                                                          

            Address            :                                                                                                         

2B.1     Applicant for certificate (name and address):

            Name                :                                                                                                          

            Address            :                                                                       

2B.2     Status of applicant:⁸

                        a                      b                      

2B.2.1   For categories b and c, the name and address of the manufacturer producing the dosage form is:

            Name                :                                                                                                          

            Address            :                                                                      

2B.3     Why is marketing authorization lacking?

                        not required                  under consideration

                        not requested                refused

2B.4     Remarks:¹³

                                                                                                                                              

3.         Does the certifying authority arrange for periodic inspection of the manufacturing plant in which the dosage form is produced?¹⁴

                        Yes                              No                                N/A

       If no or not applicable proceed to question 4

3.1          Periodicity of routine inspection (years)  :                                 

3.2        Has the manufacture of this type of dosage form been inspected?

                        Yes                              No

3.3        Does the facilities and operations conform to GMP as recommended by the WHO?¹⁵

                        Yes                              No                                N/

4.         Does the information submitted by the applicant satisfy the certifying authority on all aspects of the manufacture of the product?¹⁶

                        If no explain                                          :                                                                                  

                        Address of the certifying authority         :                                                          

                        Telephone number                                 :                                                                      

Fax number                                           :           _________________________    

Name of authorized person                    :                                                                                  

Signature of authorized person              :                                                                                  

            Stamp and date                                                :