Applying for NEW WHO GMP Certificate online

You can apply for new WHO GMP Certificate 60 days prior to expiry of already granted WHO GMP Certificate or can make an application for WHO GMP Certificate for the first time. Please ensure that you have entered the licence, approved product details correctly and completely.

1.       Go to "New Application" and Select and click on "WHO-GMP Application". New screen will open.

2.       Again click on "New Application". Select certificate type from the drop down list given of Certificate type.

3.       If application is for fresh WHO GMP Certificate with annexure, then list of products will appear. The product can be selected for which the said certificate is required.

4.       Upload the pdf file of the site master file. For a application by a LOAN Licensee, Upload PDF of Technical agreement between applicant and the OWN licensee and Undertaking of OWN licensee. (Draft formats can be downloaded)

5.       Read the undertaking and declaration. If agreed then only you can proceed further with the application.

6.       Click on "Proceed". Your application is ready for submission and for further payment of fee.

7.       You can preview the draft copy of WHO GMP Certificate which may be issued. This can be previewed for verifying the details. If anything has to be corrected, it can be done here itself, by deleting the application and redrafting (preparing).

8.       For making Payment click on "+". The amount will be calculated by the system as per the fee structure notified by FDA and amount will be displayed. You have two options for paying the displayed fees for the application.

a.       Deposit at FDA office convenient to you. If the manufacturer selects to pay by cash or DD at convenient FDA office, select "Deposit at FDA office. You can select the convenient FDA office from the drop down list of the FDA offices. Then Click on "Generate Challan" to generate challan in duplicate to be submitted to the selected FDA office. Pay the fees at the Selected FDA office. Obtain receipt.

b.         Online Payment through Net Banking: You can pay the fee by internet banking only. Select "Online Payment". Again click on "Online Payment" tab. New window will take you to "Government Receipt Accounting System". Click "Pay Without Registration".New screen will open. Select Department from drop down "FOOD AND DRUG ADMINISTRATION". Select Payment type from drop down as "DRUG MANUFACTURING CERTIFICATE". Select District from drop down as "MUMBAI". Select Office Name from drop down as "COMMISSIONER FOOD DRUG ADMIN". Keep Period (Year) as "2012-2013". Then select "ONE TIME/ ADHOC" from the drop down besides "period". Then select Form ID from drop down as "WHO GMP Certificate" or "COPP" or "SLSPP", as the case may be. Enter amount to be paid. Enter the details as asked in the right block. Then select the bank through which you will be paying. At present the banks through which you can pay are – State Bank of India, State Bank of Hyderabad, Union Bank of India, Indian Overseas Bank, IDBI Bank, Dena Bank, Punjab National Bank, Bank of India, Bank of Baroda, Bank of Maharashtra, Canara Bank only. Submit for payment.

 9.       After making payment Click on "PAY & CONFIRM". New window will open.enter the details of payment made such as Receipt no / GRN No., date of payment. Upload the pdf copy of the receipt obtained from FDA office (Both sides of receipt) or generated by online payment.

10.    Agree with the responsibility statement and then confirm the application by clicking on "CONFIRM". Now your application has been freezed and submitted to the FDA office.

11.    Status of the application can be viewed by logging in and going to the new application.