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Cerificates

 Apply for COPP With WHO GMP

Apply for COPP With State GMP

 Apply for COPP Non GMP

Apply for Performance

Apply for Performance Tender

Apply for State GMP-Own

Apply for State GMP-Loan

Apply for WHO GMP-Own

Apply for WHO GMP-Loan

Apply for Non-Conviction

Apply for Non-Prosecution

Apply for Licence Validity

Apply for Not of Standard Quality

Apply for Extension of Validity of State GMP

Apply for Extension of Validity of WHO GMP

Apply for Manufacturing & Marketing

Apply for Free Sale

 






 

 

 

Click on Cerificates on home page of IDMLA website

 

 


Then click apply for copp with WHO GMP/STATE GMP/NON GMP

 

 


window shown below will open

 

 

  

 

Sr.No.

Registration No

Registration Date

Last Date

P-I

P-II

P-III

P-IV

Registered

Delete

Cover Letter

Application

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Then click on ADD button given on the left upper side

 

 

Screen shown below will open

OPP With WHO GMP

 

 

 

  

 

Sr.No.

Registration No

Registration Date

Last Date

P-I

P-II

P-III

P-IV

Registered

Delete

Cover Letter

Application

1

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Now click on yellow button which is numbered as P-I given in the above screen

 

 


Sceen shown below will open

 

 

 

 

 COPP PART-I Details

 

*To :

 

Sub: Application for COPP With WHO GMP

 

*Draft  (2000 charcters maximum allowed) – add details of covering letter here 

 

*Licenses – select licence no. in the check box given here

Select

Form No.

Licence No.

Issue Date

From Date

To Date

Districts

25

163

14-Jun-2007

16-Apr-2007

15-Apr-2012

Ahmedabad City

28

54

14-Jun-2007

16-Apr-2007

15-Apr-2012

Ahmedabad City

 

 

 

 

 

 

 

 

*Applicant : add the name of applicant here

 

*Status:       select the status of applicant here

*No of Copies :  add the no. of original copies of copp required here

Click on the submit button given below.

 

*Denotes Mandatory Fields 

 

Now click on yellow button which is numbered as P-II given in the above screen

 

 


Sceen shown below will open

 

 


Select the name of importing country in the table given as below

Application for COPP PART -II

 

 

 COPP PART-II Details

 

*1. Exporting(Certifying) Country

:

 

 

 

 

*2. Importing(Requesting) Country

:

All Countries

Other Countries

Afghanistan

Taiwan

Albania

Algeria

American Samoa

Andorra

Angola

Antigua and Barbuda

Argentina

Armenia

Aruba

Australia

Austria

Azerbaijan

Bahamas, The

Bahrain

Bangladesh

Barbados

Belarus

Belgium

Belize

Benin

Bermuda

Bhutan

Bolivia

Bosnia and Herzegovina

Botswana

Brazil

Brunei Darussalam

Bulgaria

Burkina Faso

Burundi

Cambodia

Cameroon

Canada

Cape Verde

Cayman Islands

Central African Republic

Chad

Channel Islands

Chile

China

Colombia

Comoros

Congo, Dem. Rep.

Congo, Rep.

Costa Rica

Côte d'Ivoire

Croatia

Cuba

Cyprus

Czech Republic

Denmark

Djibouti

Dominica

Dominican Republic

Ecuador

Egypt, Arab Rep.

El Salvador

Equatorial Guinea

Eritrea

Estonia

Ethiopia

Faeroe Islands

Fiji

Finland

France

French Polynesia

Gabon

Gambia, The

Georgia

Germany

Ghana

Greece

Greenland

Grenada

Guam

Guatemala

Guinea

Guinea-Bissau

Guyana

Haiti

Honduras

Hong Kong, China

Hungary

Iceland

India

Indonesia

Iran, Islamic Rep.

Iraq

Ireland

Isle of Man

Israel

Italy

Jamaica

Japan

Jordan

Kazakhstan

Kenya

Kiribati

Korea, Dem. Rep.

Korea, Rep.

Kuwait

Kyrgyz Republic

Lao PDR

Latvia

Lebanon

Lesotho

Liberia

Libya

Liechtenstein

Lithuania

Luxembourg

Macao, China

Macedonia, FYR

Madagascar

Malawi

Malaysia

Maldives

Mali

Malta

Marshall Islands

Mauritania

Mauritius

Mayotte

Mexico

Micronesia, Fed. Sts.

Moldova

Monaco

Mongolia

Montenegro

Morocco

Mozambique

Myanmar

Namibia

Nepal

Netherlands

Netherlands Antilles

New Caledonia

New Zealand

Nicaragua

Niger

Nigeria

Northern Mariana Islands

Norway

Oman

Pakistan

Palau

Panama

Papua New Guinea

Paraguay

Peru

Philippines

Poland

Portugal

Puerto Rico

Qatar

Romania

Russian Federation

Rwanda

Samoa

San Marino

São Tomé and Principe

Saudi Arabia

Senegal

Serbia

Seychelles

Sierra Leone

Singapore

Slovak Republic

Slovenia

Solomon Islands

Somalia

South Africa

Spain

Sri Lanka

St. Kitts and Nevis

St. Lucia

St. Vincent and the Grenadines

Sudan

Suriname

Swaziland

Sweden

Switzerland

Syrian Arab Republic

Tajikistan

Tanzania

Thailand

Timor-Leste

Togo

Tonga

Trinidad and Tobago

Tunisia

Turkey

Turkmenistan

Uganda

Ukraine

United Arab Emirates

United Kingdom

United States

Uruguay

Uzbekistan

Vanuatu

Venezuela, RB

Vietnam

Virgin Islands (U.S.)

West Bank and Gaza

Yemen, Rep.

Zambia

Zimbabwe

 

 

Click on the next button after completing the selection

 

 


Additional screen shown as below will open in the same screen which includes list of products covered under WHO GMP or STATE GMP. Select the product from the list given in the screen for which COPP is required by scrolling. Selection of product will be as per the amount of challan paid.

 

COPP PART-II Details Continue

Product for Which COPP with WHO GMP is applied

Your details has been successfully saved.

*3. Product(s) included in WHO GMP Certificate(Select for COPP)

Select

License No.

Brand Name

Generic Name

Product Permission No.

Issue Date

Renwal Date

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

click on the next button when selection of product is complete.

 

 


Below shown Screen will open

 

COPP PART-II Details Continue

 

Your details has been successfully saved.

Product for Which COPP with WHO GMP is applied With Composition Detail

Sr.No.

Brand Name

Generic Name

License No.

Issue Date

Renwal Date

Product Composition

Excipients

Delete

1

METAZOLE

METRONIDAZOLE GEL USP

MFG/WESTCOAST/J1/43441/B1

16-Apr-2007

 

Ingerdiants

Spec(Std)

Each Contains

Delete

METRONIDAZOLE

IP

Milligram

Others

--

QS

 

 

 

 

2

MIZOL GEL

MICONAZOLE OROMUCOSAL GEL BP 2%

MFG/WESTCOAST/J1/43441/B1

16-Apr-2007

 

Ingerdiants

Spec(Std)

Each Contains

Delete

MICONAZOLE NITRATE

BP

%w/w (Per weight/weight)

Others

--

QS

 

 

 

 

 

 

 

 

 

 

 

 

 

 Give proper selection in point-4 and 5 in below options (yes – if product is available in local mrket & no – if product is not available in local market)

 

*4. Is Product Licensed to placed on the market for use in Exporting Country?

:

 

*5. Is this product actually in the market in the exporting country?

:

 

then click on the next button. Screen shown below will open.

 

 

COPP PART-II Details Continue

 Is Product Licensed to placed on the market for use in Exporting Country Yes then

 

Your details has been successfully saved.

*6.1. Number of product License and date of issue

Sr.No.

License No.

Brand Name

Generic Name

Product Permission No.

Issue Date

1

GUJ/25/163

METAZOLE

METRONIDAZOLE GEL USP

MFG/WESTCOAST/J1/43441/B1

16-Apr-2007

2

GUJ/25/163

MIZOL GEL

MICONAZOLE OROMUCOSAL GEL BP 2%

MFG/WESTCOAST/J1/43441/B1

16-Apr-2007

 

 

 

 

 

 

 

*6.2. Product License Holder Name & Address

:

*6.3. Status of of product License Holder

:

A

B

C

If B & C is Selected then display name & address of parent firm

:

Name

:

Address -1

:

Address - 2

:

Address - 3

:

City

:

Pin Code

:

State

:

District

:

Taluka

:

 

*6.4. Is summary basis of approval appended?

:

*6.5. Is the attached, officially approved product information complete and consonant with the license ?

:

*6.6. Applicant for certificate ( if different from License holder )

:



Name

:

Address -1

:

Address - 2

:

Address - 3

:

City

:

Pin Code

:

Mobile

:

State

:

District

:

Taluka

:

 

 

 

 

Give proper selection in above point no- 6.2 to 6.6 as per the std COPP format.

 

 

Click on the next button after completion of selections

 

 

Screen shown below will open.

COPP PART-II Details Continue

 

Your details has been successfully saved.

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

:

8. Periodicity of routine inspection

:

 

*9. has the manufacturer of this dosage form been inspected ?

:

 

*10. Do the facilities and operation conform to GMP as recommended by the World Health Organization?

:

 

 

Give proper selection in above point no- 7 to 10 as per the std COPP format.

 

 

Click on the submit button after completion of selections.

 

 


Screen shown below will open

 

COPP With WHO GMP

 

 

 

  

 

Sr.No.

Registration No

Registration Date

Last Date

P-I

P-II

P-III

P-IV

Registered

Delete

Cover Letter

Application

1

0

 

 

 

Click on the orange button which is numbered as P-III given in the above screen

 

 


Sceen shown below will open

 

COPP PART-II Details Continue

 

 

Fess Details

 

Your details has been successfully saved.

 

11. Fess Details

 

      Fees per Country per Product per Copy:

400

 

 

 

 

 

Sr.No.

Challan Amount

Challan Date

Bank

Branch

Bank Challan No

Delete

 

 

Click on the ADD button in above screen

 

 


Sceen shown below will open

 

 

COPP PART-II Details Continue

Add Fess Details

 

 

*Challan Amount

:

*Challan Date

:

*Bank

:

*Branch

:

*Bank Challan No.

:

 

 

Fill the details of challan fees in the above selection area and then click on the submit button.

 


Sceen shown below will open

 

COPP PART-II Details Continue

 

 

Fess Details

 

Your details has been successfully saved.

 

11. Fess Details

 

      Fees per Country per Product per Copy:

400

 

 

 

 

 

Sr.No.

Challan Amount

Challan Date

Bank

Branch

Bank Challan No

Delete

1

400.00

01-Jan-2009

State Bank of India

1355

123

 

 

 

 

 

 

 

 

 

click on the back button.

 

 


Sceen shown below will open

 

 

 

 

  

 

Sr.No.

Registration No

Registration Date

Last Date

P-I

P-II

P-III

P-IV

Registered

Delete

Cover Letter

Application

1

0

 

 

 

Click on the brown button which is labeled as part-4 in this screen.

 

 


Below screen will open

 

COPP PART-II Details Continue

Attachment Detalis

 

12. Attachment Detalis

 

 

 

Select the documents you want to attaché separately in you application file in the selection box given against each document list item.

 

 

 


Click on the ADD EXTRA button if you want to attaché any additional document which is not included in the above list.

 

 


click on the back button.

 

 


Sceen shown below will open

 

 

 

 

  

 

Sr.No.

Registration No

Registration Date

Last Date

P-I

P-II

P-III

P-IV

Registered

Delete

Cover Letter

Application

1

0

 

 

 

Click on the REGISTERED button when all the above steps are completed.

 

 


Sceen shown below will open which will show registration no., registration date and last date before which you have to submit your hard file of COPP application to the FOOD And DRUG CONTROL ADMINISTRATION, GANDHINAGAR.COPP

 

Sr.No.

Registration No

Registration Date

Last Date

P-I

P-II

P-III

P-IV

Registered

Delete

Cover Letter

Application

2

146

07-Jan-2009

22-Jan-2009

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


 

IMPORTANT POINTS

 

1.   Before clicking REGISTER button you can edit your file any time.

2.   Application can be done by part wise. i.e. you can submit all the 4 parts at different time. It is not necessary to submit whole file at a time.

3.   Application file must be registered by the admin password and user ID.

4.   Hard file of COPP application to the FOOD And DRUG CONTROL ADMINISTRATION, GANDHINAGAR.

5.   Application file must include no. of products as per the amount of challan paid to bank. in case of less amount file will be rejected.