License for Drugs (Medicine) Export ড্রাগস (মেডিসিন) রফতানির জন্য লাইসেন্স

License for Drugs (Medicine) Export ড্রাগস (মেডিসিন) রফতানির জন্য লাইসেন্স

License for Drugs (Medicine) Export

Good manufacturing Practice (GMP) Certificate:

An Application in Company Letter Head

Manufacturing license of medicine

Company profile

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

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

An application in company letter head

Annexure copy1 of expiry date of the selected medicines for export.

Approval for the brand name.

Fill up the CPP and FSC2, according to WHO format3

Remarks: If the brand name is changed; otherwise not required

Remarks: FSC is needed only if Drug Administration asks for it

To get the license for Export:

A completed Application on Form 8, 9A and 10A4

LC/Purchase order

Remarks: A copy of the original

Process Steps

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.

General Information

Legal Basis of the License: The Drugs Act, 1940, [Section -18(C);]

The Nature of the License: The Drug Rules 1945

The purpose of the license: Pharmaceutical Sector

Territorial Scope of the License: Operational License

Eligibility Criteria to Obtain the License:  National

Information Availability:     Holder of Manufacturing License of Medicine

Written procedures are accessible at the office of Drug administration

Forms are available online

There is no Help Desk in the agency

Category        Directorate General of Drug Administration (DGDA)

You Can Read Also: Application for a Licence to sell, stock and exhibit for sale and distribute drugs