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Cambodia Requiement Application Form

This document is an application form for marketing authorization from the Ministry of Health of Cambodia. It requests details on the applicant, manufacturer, product name and description, formula, requested pharmaceutical category, indications, posology, administration route, attached documents including GMP certificates and product samples, packing size, and shelf life. The applicant must provide these details for evaluation and potential approval of marketing authorization for their product.

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Afaz Uddin
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771 views3 pages

Cambodia Requiement Application Form

This document is an application form for marketing authorization from the Ministry of Health of Cambodia. It requests details on the applicant, manufacturer, product name and description, formula, requested pharmaceutical category, indications, posology, administration route, attached documents including GMP certificates and product samples, packing size, and shelf life. The applicant must provide these details for evaluation and potential approval of marketing authorization for their product.

Uploaded by

Afaz Uddin
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOC, PDF, TXT or read online on Scribd

KINGDOM OF CAMBODIA

MINISTRY OF HEALTH NATION – RELIGION – KING


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- 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 .

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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 :

2- Product Description :

3- Qualitative & Quantity formula :

Active ingredient :

Other ingredients :

C- REQUESTED PHARMACEUTICAL CATEGORY :

- Prescription : €

- Without prescription : €

D- INDICATION , POSOLOGY AND ROUTE OF ADMINISTRATION :

- Requested indication :

…………………………………..

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- Recommended posology :

…………………………………..

- Recommended route of administration :

……………………………………………

E- ATTACHED INFORMATION :

- GMP Certificate €

- Certificate of a Pharmaceutical Product €

- Registration Certificate in other countries ( if available ) €

- Summary of product characteristics €

- Technical documents :

1- Quality €

2- Safety €

3- Efficacy €

- Samples :

2 Commercial boxes for registration purpose. €

- Registration fee €

F- PACKING SIZE :

- Commercial packing :
……………………………….

- Hospital packing
……………………………….

G- SHELF LIFE :
……………………..
Date :
Title :
Name :
Signature :

Page 3 of 3

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