Required documents

Remarks

Good manufacturing Practice (GMP) Certificate:

1. An Application in Company Letter Head
2. Manufacturing license of medicine
3. Company profile

A copy of the original duly attested by a First Class gazetted officer

Certificate for Pharmaceuticals Products (CPP) and the Free Sale Certificate (FSC):

1. An application in company letter head
2. Annexure copy¹ of expiry date of the selected medicines for export.
3. Approval for the brand name.
4. Fill up the CPP and FSC², according to WHO format³

If the brand name is changed; otherwise not required

FSC is needed only if Drug Administration asks for it

To get the license for Export:

1. A completed Application on Form 8, 9A and 10A⁴
2. LC/Purchase order

A copy of the original

Step 1

Applicant drafts a formal Application in Company letter head addressing the Director General of Drug Administration to get GMP Certificate

Step 2

Applicant submits the application with all the required documents to get GMP certificate at the Drug Administration

Step 3

Drug Control Committee (DCC) verifies all the documents

Step 4

DCC gives the decision for the certificate after the verification.

Step 5

After receiving the GMP certificate, the applicant submits the Application for the CPP and the FSC (if needed) with all the required documents.

Step 6

Applicant receives the CPP and the FSC

Step 7

Applicant then applies for the License in the prescribed Application Forms (8, 9A, 10A) with the copy of LC or Purchase order.

Step 8

Applicant receives the confirmation letter for the License to Export.