Corporate User Manual

Form Submission

Form 40

1.Applicant can apply for “FORM 40” by choosing select department and select form from the drop down list ,as shown in Figure 1.1.

Figure 1.1.

Note:-

Form40 is applied for the issue of “Registration Certificate (RC)” for import of drugs.

2.After clicking on Proceed a new window will open ,as shown in Figure 1.2.

Figure 1.2.

Note:-

Applicant can apply form for Corporate (Self) or on behalf of Manufacturing Unit.

3. After clicking on proceed a new window will open ,as shown in Figure 1.3.

Case 1: Type of Application: Fresh

Figure 1.3.

Note:-

Type of application can be Fresh or Endorsement or Re-Registration.

4.After clicking on Save and Continue a new window will open i.e. Drug Details ,as shown in Figure 1.4.

Figure 1.4.

Note:-

Application can be applied by applicant for Bulk Drug or Finished Formulation.
On clicking Save, Drug Details will be added.
If user change the option Application applied for in Drug Details part ,then all drugs of either Bulk drug case or Finished Formulation case will be deleted.

5.Click on Next ,a new window will open i.e. Manufacturer Unit Details ,as shown in Figure 1.5.

Figure 1.5.

On Clicking "Add" Button, new record will be added and Next button will become visible to proceed further ,as shown in Figure 1.6.

Figure 1.6.

Note:-

Manufacturing Unit will be that Unit where Manufacturing will be carried on.
Applicant can Delete the manufacturing unit details.
Applicant can add new site details by selecting other sites option from the drop down.

Case2: Type of Application :- Endorsement

Figure 1.7.

Note:-

In case of Endorsement new drugs can be added ,but premises will remain same.

On Clicking Continue , a new window will open as shown in Figure 1.8.

Figure 1.8.

On clicking Next ,a new window will open as shown in Figure 1.9.

Figure 1.9.

Case3: Type of Application :- Re-registration

Figure 1.10.

Note:-

In case of Re-registration drugs can be deleted which are not be renewed ,but premises will remain same.

On Clicking Continue , a new window will open as shown in Figure 1.11

Figure 1.11.

On Clicking Continue , a new window will open as shown in Figure 1.12.

Figure 1.12.

Note:-

After applying for all the three cases i.e. Fresh ,Endorsement,Re-registration a new window will open and it will remain common for all the three cases.

6. Click on "Next" button for Fresh Case / "Continue" button for Endorsement and Re-Registration Case, a new window will open and it will remain common for all the three cases ,as shown in Figure 1.14.

Figure 1.13.

On clicking "Save and Continue", a new window will open, as shown in Figure 1.14.

Figure 1.14.

7.After clicking on OK a new window will open ,as shown in Figure 1.15..

Figure 1.15.

Note:-

Checklist points will vary for Endorsement case and Re-registration case.

7.1.When applicant will click on first point in checklist a new window will pop up ,as shown in Figure 1.16.

Figure 1.16.

7.2. To Change or Replace the document ,tick the check box “Click to change file” , as shown in Figure 1.18.

Figure 1.17.

7.3.When applicant will click on submit a tick will come before that point ,as shown in Figure 1.18.

Figure 1.18.

Note:-

Applicant should fill the complete checklist otherwise applicant will not be able to proceed further.

8.After clicking on submit a new window will open as shown in Figure 1.19.

Figure 1.19.

9.After clicking on Submit a new window will open ,as shown in Figure 1.20.

Figure 1.20.

Note:-

Applicant can click on Download PDF to download the file.

10.After clicking on Continue a new window will open ,as shown in Figure 1.21.

Figure 1.21.

11.After clicking on Submit a new window will open ,as shown in Figure 1.22.

Figure 1.22.

Note:-

A file number will be generated for future correspondence purpose.
Applicant has successfully applied for Form 40.