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Procedure NameLicense for Drugs (Medicine) Export
Description

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
Website: www.dgda.gov.bd

 

Issuance of license for Drugs (Medicine) Export

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

 

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.

                                                    

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

  • Written procedures are accessible at the office of Drug administration
  • Forms are available online
  • There is no Help Desk in the agency
CategoryDirectorate General of Drug Administration (DGDA)

The following form/s are used in this procedure
TitleDescriptionCreated DateUpdated DateIssued By
The form is known as FORM 1O-A. An applicant needs to submit the form to the Directorate General of Drug Administration office to get the Drugs Export License. Please click the PDF mark to view or download the form in English.05-10-201509-10-2017Ministry of Health and Family WelfareThis is Dowload File
This procedure applies to the following measures
NameMeasure TypeAgencyDescriptionCommentsLegal DocumentValidity ToMeasure Class
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