Category : License
Renewal Frequency of the License : Renewal is not required
Issuing Ministry : Ministry of Health and Family Welfare
Incumbent Office : Name: Directorate General of Drug Administration
Address: 105-106, Motijheel C/A, Dhaka-1000, Bangladesh
Issuance of license for Drugs (Medicine) Export
Required documents
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Remarks
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Good manufacturing Practice (GMP) Certificate:
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An Application in Company Letter Head
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Manufacturing license of medicine
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Company profile
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A copy of the original duly attested by a First Class gazetted officer
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Certificate for Pharmaceuticals Products (CPP) and the Free Sale Certificate (FSC):
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An application in company letter head
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Annexure copy1 of expiry date of the selected medicines for export.
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Approval for the brand name.
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Fill up the CPP and FSC2, according to WHO format3
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If the brand name is changed; otherwise not required
FSC is needed only if Drug Administration asks for it
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To get the license for Export:
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A completed Application on Form 8, 9A and 10A4
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LC/Purchase order
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A copy of the original
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Process Steps
Step 1
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Applicant drafts a formal Application in Company letter head addressing the Director General of Drug Administration to get GMP Certificate
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Step 2
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Applicant submits the application with all the required documents to get GMP certificate at the Drug Administration
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Step 3
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Drug Control Committee (DCC) verifies all the documents
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Step 4
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DCC gives the decision for the certificate after the verification.
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Step 5
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After receiving the GMP certificate, the applicant submits the Application for the CPP and the FSC (if needed) with all the required documents.
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Step 6
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Applicant receives the CPP and the FSC
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Step 7
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Applicant then applies for the License in the prescribed Application Forms (8, 9A, 10A) with the copy of LC or Purchase order.
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Step 8
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Applicant receives the confirmation letter for the License to Export.
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Process Map

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
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Written procedures are accessible at the office of Drug administration
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Forms are available online
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There is no Help Desk in the agency
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