1.      Pre-requisites

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.

 

 

 

 

 

 

 

 

 

 

 

 

 

Oval Callout: Applications for various types of 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.

 

 

Rounded Rectangular Callout: Format of the COPPRounded Rectangular Callout: To specify the countriesRounded Rectangular Callout: Products entryRounded Rectangular Callout: You can print Application & FormatRounded Rectangular Callout: Click this to view the status of an applicationRounded Rectangular Callout: This indicates that the number of Licenses included in the applicationRounded Rectangular Callout: Click this button to ADD new application

 

 

 

Step:-3 Clicking  ADD or Clicking on Draft , the following screen will appear.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Rounded Rectangular Callout: Checked License will be included in the COPPRounded Rectangular Callout: Click this to refresh the license dataRounded Rectangular Callout: Those licenses will be listed which are valid and included in WHO GMP certificates. Firm should have first entered WHO GMP certificate first. The certificates data should be completed with License, Product Sections & products, Product section and product details

 

 

 

 

Rounded Rectangular Callout: Click this button to save the dataStep:-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.

 

 

Rounded Rectangular Callout: Click this to enter COPP formatRounded Rectangular Callout: Click this to enter which product for which countryRounded Rectangular Callout: Click this to enter ProductsRounded Rectangular Callout: Two licenses are selected in Draft

 

 

 

 

 

 

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

Rounded Rectangular Callout: Select License.  If the desired license is not found here you may please check whether the product is available in WHO certificates or in WHO similar product List.
 

 


Rounded Rectangular Callout: Select the product sub sectionRounded Rectangular Callout: Select the product sectionRounded Rectangular Callout: You can add new productsRounded Rectangular Callout: List of products included. Please see the legend for color indication. You can remove the product from the application alsoRounded Rectangular Callout: Enter some text to search the product on either Generic name OR on Brand Name. And click GO button

 

 

 

 

 

 

 

 

 

 

 

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.)

 

Rounded Rectangular Callout: You can check the products and click the ADD button. The selected products will be included in the COPP application

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Rounded Rectangular Callout: You can add compositions. This will applicable to only this COPP certificate. It will not delete composition from existing master data.Rounded Rectangular Callout: You can add new excipients from here. IT WILL NOT AFFECT THE EXISTING PROFILERounded Rectangular Callout: You can delete the product from Here

 

 

 

 

Step:-5 Specify country for each product(s)

 

Rounded Rectangular Callout: Click this button to map the product with country

 

 

 

 

 

 

 

On clicking ADD button it will allow to add country against the product exist in that row.

 

 

Rounded Rectangular Callout: Select the country and specify the number of copies for this product

 

 

 

 

 

Finally it will look like below

 

Rounded Rectangular Callout: Note: Please care that the country you specify will be applicable to his product. It has come while you click the ADDRounded Rectangular Callout: You can delete the country

 

 

 

 

 

 

Step:-6 Clicking Format Button

 

 

Rounded Rectangular Callout: Click the Next buttonRounded Rectangular Callout: Country can be removed for particular product

 

 

 

 

 

 

 

 

 

 

 

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.