Stepwise procedure for Online submissions

A.       Guidance for uploading the data in pdf format

At the time of registration, data updation and making online applications be ready with the data to be uploaded in pdf formats as below

a.       After scanning preferably name the files so as to identify it any time after.

b.       Scan the licence granted for a respective location / site e.g. Form 25. If it has been renewed then add latest renewal certificate in the same file. i.e. the file will have two pages, one licence and second its renewal certificate. (File size shall not exceed 1 MB)

c.       Follow the same procedure for the different licences granted at the same location / site. i.e. for Form 28, 28D, 28F, etc. (File size shall not exceed 1 MB)

d.       For adding the products approved under the respective licences, scan the respective page(s) of approved list of products granted for the first time, then its amendment, if any, (such as change in specification, name, colour, etc.) and its latest renewal. Please make sure that the said pages have the date of grant, sign, stamp, product details, etc. All the pages should be scanned in one single file and upload the same. (File size shall not exceed 1 MB)

e.       For the entering WHO GMP Certificate, scan the first page of the valid WHO GMP certificate only. (File size shall not exceed 1 MB)

f.         For the addition of the products for which the WHO GMP Certificate has been granted in form of Annexure to WHO GMP Certificate or Certificate of the Pharmaceutical Products (COPP), scan the relevant COPP or the respective page of the Annexure to WHO GMP Certificate. (File size shall not exceed 1 MB)

g.       While applying for the fresh WHO GMP Certificate, scan the Site Master File in a single pdf file only. (File size shall not exceed 4 MB)

h.       While applying for COPP for new product, scan the validation and stability study data records in one pdf file. (File size shall not exceed 4 MB)

 

B.      Registration

a.       Please enter name of Licensee as that is written on the licence granted and without using any prefix as ‘M/S’.

b.       Write the address with pin code and select the district in which it is located as written on the licence.

c.       Write Licence number (numerical or alphanumeric) without space and without using special characters.

d.       Select date of grant and validity.

e.       Upload the copy of licence and its latest renewal in form of single file in pdf format as stated above A.

f.         Specify the correct name, mobile number and email ID of the contact person.

g.       Enter the password of your choice.

h.       Click on proceed to generate and display the unique user ID.

i.         Please note down the user id and remember the password.

 

C.      Addition of Product details

It is required for the manufacturer to add the details of the products approved, under the respective licence granted (Form 25 or Form 28, etc). This is necessary while making an application for WHO GMP Certificate or COPP.

1.       Login through the “Manufacturer Login”

2.       Click “Approved Product” from the menu

3.       New Screen will appear. Click on the “Add Product”

4.       Enter the details by a. Selecting the Licences from the options in “Licence Nos.”, b. Select the date of first approval of the product, c. Upload the file of the respective product approval granted by the Licensing Authority. D. Enter the brand name as in the Approved product list. E. Enter the generic name, if any. F. select the dosage form, category and the activity.

5.       At the option “Composition” Please enter between “Each” and “contains” the description as per the approved list of products. E.g. Each “uncoated tablet” contains or “film coated tablet” or “gram” or “capsule” or “vial” or “ampoule” or “lyophilised injection” or “5ml” or “15ml”, etc.

6.       If the manufacturer wants the excipients to be part of COPP, then upload the scanned pdf copy of proof of the excipients used in the said product, such as relevant page of Batch Manufacturing Record having the details of the raw materials / ingredients used for manufacture of the said product. Manufacturer can also upload the pdf of certified copy of summary of the same.

7.       Then click on “ADD”. The summary / list of the products entered will be displayed.

8.       To add the detailed composition and excipients click “+” under composition / excipient. New window will appear. Select from drop down against “Select” as composition or Excipient. Enter the details against “Ingredients”. Select specification as “IP” or “BP”, etc. from the drop down. You can even select “IH” or blank. Qty shall be a numeric value only. Units can be selected from the drop down which includes “qs” also. Click “ADD” after adding each ingredient. If you come across any mistake, you can enter the correct ingredient newly after deleting the respective ingredient.

D.      Updating the existing already granted WHO GMP Certificate and COPPs.

If manufacturer is already a WHO GMP Certificate holder and/or COPPs have been granted or otherwise, he has to upload such details.

1.       Click “GMP Certificates Details” from the menu

2.       New Screen will appear. Enter the details a. Certificate No. appearing on the certificate granted. b. Select the date of approval and validity of the certificate, c. Upload the pdf file of the WHO GMP Certificate granted.

3.       The certificate details will be displayed.

4.       Click “+” for adding the products for which the WHO GMP Certificate has been granted by way of Annexure or COPP. New screen will be displayed. Select the product from the drop down. Upload the pdf file of the relevant page of the annexure where the said product is appearing, alternatively the pdf copy of the COPP granted for same can also be uploaded.

 

E.       Applying for WHO GMP Certificate

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.
If Reverted, Click on ‘Make Payment’ to view reverted remarks.

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

F.       Applying for Certificate of Pharmaceutical Products (COPP)

You can apply for new COPP if you have already granted WHO GMP Certificate. Please ensure that you have entered the licence, approved product details correctly and completely.

1.       Go to “New Application” and Select and click on “COPP Application”. New screen will open.

2.       Select certificate type from the drop down list given of “Application for”. Then click on “Proceed”. Summary will be displayed down.

3.       Click “+” for adding the details. If application is for COPP with PVSS, then upload the pdf file of the Product Validation and Stability Study records.

4.       Click on “Proceed”. Your application is ready for submission and for further payment of fee.

5.       You can preview the draft copy of COPP 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).

6.       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.

 

G.      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.

H.      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.

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

Click here :PROCEDURE For filling online application.