Procedure for filling online application
:: Fresh WHO-GMP Certificate with Annexure
|
|
Select Fresh WHO-GMP application from the drop down list given of Certificate type. |
|
|
All Approved Products list will appear on selection of Fresh WHO-GMP application. |
|
|
If OWN,
Upload Site Master File and Acknowledge Copy for the application
If LOAN,
Upload PDF of Technical agreement copy between OWN licensee and him and Undertaking of OWN licensee..
|
|
|
Click on Proceed to apply, application will not proceed unless manufacturer agrees with the
proforma.
|
|
|
After Applying, Click on ‘Make Payment’ from the application list generated below.
If Reverted, Click on ‘Make Payment’ to view reverted remarks. |
|
|
Manufacturer must check all the details for the products selected by him from the list given
below.
|
|
|
Payment Option: There are two options for manufacturer to pay their fees for the application.
Deposit at relevant district FDA office : if the manufacturer selects to pay by cash or DD at respective district FDA office, Manufacturer must generate the challan from this system and pay the fees as applicable.
Online Payment through Net Banking
|
|
|
After payment of fees, Manufacturer must enter his payment details as asked. |
|
|
Manufacturer must CONFIRM his application after providing all the details above. |
|
|
After confirming, Manufacturer will not be able to make any changes and application will be
forwarded to respective district.
|
::Copy of WHO-GMP certificate with/ without Annexure
|
|
Select Copy of WHO-GMP application from the drop down list given of Certificate type. |
|
|
Select previously issued valid WHO-GMP certificate number from the drop down list, select
the products for which certificate required.
|
|
|
Click on Proceed to apply, application will not proceed unless manufacturer agrees with the
proforma.
|
|
|
After Applying, Click on ‘Make Payment’ from the application list generated below. |
|
|
Manufacturer must check all the details for the products selected by him from the list given
below.
|
|
|
Payment Option: There are two options for manufacturer to pay their fees for the application.
Deposit at relevant district FDA office : if the manufacturer selects to pay by cash or DD at respective district FDA office, Manufacturer must generate the challan from this system and pay the fees as applicable.
Online Payment through Net Banking
|
|
|
After payment of fees, Manufacturer must enter his payment details as asked. |
|
|
Manufacturer must CONFIRM his application after providing all the details above. |
|
|
After confirming, Manufacturer will not be able to make any changes and application will be
forwarded to respective district.
|
::1st Extension / Further Extension of WHO-GMP Certificate
Before applying for 1st extension of WHO-GMP, manufacturer must first apply Fresh for WHO-GMP
certificate.
|
|
Select 1st Extension of WHO-GMP from the drop down list given of Certificate type. |
|
|
Select previously issued valid or expired WHO-GMP certificate number from the drop down
list.
|
|
|
Click on Proceed to apply, application will not proceed unless manufacturer agrees with the
proforma.
|
|
|
After Applying, Click on ‘Make Payment’ from the application list generated below. |
|
|
Manufacturer must check all the details for the products selected by him from the list given
below.
|
|
|
Payment Option: There are two options for manufacturer to pay their fees for the application.
Deposit at relevant district FDA office : if the manufacturer selects to pay by cash or DD at respective district FDA office, Manufacturer must generate the challan from this system and pay the fees as applicable.
Online Payment through Net Banking
|
|
|
After payment of fees, Manufacturer must enter his payment details as asked. |
|
|
Manufacturer must CONFIRM his application after providing all the details above. |
|
|
After confirming, Manufacturer will not be able to make any changes and application will be
forwarded to respective district.
|
::New Certificate of Pharmaceutical Products with PVSS or Brand Change.
|
|
Select Certificate of Pharmaceutical Products ( COPP ) with PVSS from the drop down list
given of Certificate type.
|
|
|
Click on Proceed, to apply
|
|
|
After applying, click on Add Details to enter products within that application
|
|
|
Select certificate type from the dropdown list as applicable. |
|
|
Select product from the list, list will contain products which is not appearing in the product
Annexure for previously issued WO-GMP certificate.
|
|
|
If the selected product is for Brand change.
Manufacturer must select the similar product from the product list that appear under select
product dropdown
If the selected product is for new COPP
Manufacturer must upload PDF of PVSS copy.
|
|
|
Select exporting country from the list. |
|
|
Click on ‘ADD to add details , manufacturer can apply for multiple COPPs under single
application.
|
|
|
Manufacturer must check all the details for the products selected by him from the list given
below.
|
|
|
Payment Option: There are two options for manufacturer to pay their fees for the application.
Deposit at relevant district FDA office : if the manufacturer selects to pay by cash or DD at respective district FDA office, Manufacturer must generate the challan from this system and pay the fees as applicable.
Online Payment through Net Banking
|
|
|
After payment of fees, Manufacturer must enter his payment details as asked. |
|
|
Manufacturer must CONFIRM his application after providing all the details above. |
|
|
After confirming, Manufacturer will not be able to make any changes and application will be
forwarded to respective district.
|
::Copy of Certificate of Pharmaceutical Products
|
|
Select copy of Certificate of Pharmaceutical Products ( COPP ) from the drop down
list given of Certificate type.
|
|
|
Click on Proceed, to apply
|
|
|
After applying, click on Add Details to enter products within that application
|
|
|
Select certificate type from the dropdown list as applicable. |
|
|
Select product from the list, list will contain products which is appearing in the product
Annexure or previously issued WHO-GMP certificate.
|
|
|
Select exporting country from the list. |
|
|
Click on ‘ADD to add details , manufacturer can apply for multiple COPPs under single
application.
|
|
|
Manufacturer must check all the details for the products selected by him from the list given
below.
|
|
|
Payment Option: There are two options for manufacturer to pay their fees for the application.
Deposit at relevant district FDA office : if the manufacturer selects to pay by cash or DD at respective district FDA office, Manufacturer must generate the challan from this system and pay the fees as applicable.
Online Payment through Net Banking
|
|
|
After payment of fees, Manufacturer must enter his payment details as asked. |
|
|
Manufacturer must CONFIRM his application after providing all the details above. |
|
|
After confirming, Manufacturer will not be able to make any changes and application will be
forwarded to respective district.
|