a. A valid WHO/State GMP Certificate should exist in Manufacturer’s profile. Check the validity in certificate entry. ( Go My ProfileàCertificate Issued)
b. For product which are not in WHO certificate but are similar to any of WHO products and wanted to apply for COPP, they must be declared as a Similar Product to WHO product first. For this Go (My ProfileàWHO Similar Product)
c. Licenses to be included in it. License status must be active and Valid
d. Product section for each Licenses to be specified
e. Products are included for each license & product section wise.
2. We have provided the facility to enter multiple products in multiple countries.
3. User can add extra excipients in product composition while including product in COPP application. This will not update the product profile.
4. User can delete the composition of products applied in COPP, if they wish. This will not reflect in product master profile.
Quick Steps to apply COPP with WHO GMP Certificate
Step:-1 Login into iDMLA porta
Step:-2 Click Menu item “Apply For Certificates”
Step:-3 Click on COPP with WHO GMP
Step:-4 Add draft. Here Licenses are selected
Step:-5 Add products
Step:-6 Specify Country for each product
Stap:-7 Fill up the Format
Step:-8 Enter the Fees Details
Step:-9 Attach the PDF/JPEG Files
Step: 10 Register the Application
Step:-1 Login to iDMLA site
After the successful login you will get the home page of IDMLA. Click on ‘Apply for Certificates’ button provided on the left menu. It will list out sub-items within the menu for various type of application for certificates.
Step:-2 Click COPP with WHO GMP
Following screen will appear.
NOTE: If you have any application that is pending to register yet ( RegID=0) then you cannot add new application until and unless you either register first one or delete.
Step:-3 Clicking ADD or Clicking on Draft , the following screen will appear.
Step:-4 Enter Products
Once you have saved the Draft of an application then only you can specify the products for COPP.
Click the Button under the Product Column. It will allow including the products for which COPP is being apply.
Clicking on the product button will allow entering the product in application.
The below screen will show you the included products and allow to add another products also in the application
Please provide License, Product section and/ search text then click the GO button. It will list all available WHO products or products which are similar.
(Note: WHO products must be entred in WHO certificates. WHO similar product must be specified in WHO Similar product. To specify the WHO similar product a option is given in My Profile Menu.)
Step:-5 Specify country for each product(s)
On clicking ADD button it will allow to add country against the product exist in that row.
Finally it will look like below
Step:-6 Clicking Format Button
Step:-7 Enter Fees as usual
Step:-8 Enter Attachment
The name of the file to be uploaded should be valid, like TEST.PDF. There should be only one dot in the file name. No space is allowed. Some invalid file names are
TEST FILE.PDF ( space is not allowed)
TESTFILE..PDF ( double dots found)
TEST\PDF ( not a valid file name)
Step:9 Once the data is final , register the application
A registration id will be generated. Once the application is registered it cant be edited further.