The License for Drugs (Medicine) Export, mandated by the Drug & Cosmetic Act of 2023, regulates the exportation of pharmaceutical products. This legal provision requires entities to obtain a valid license, ensuring adherence to quality standards and regulatory protocols. It plays a vital role in upholding public health and ensuring the integrity of pharmaceutical exports.
Issuing Authority:
Name : Directorate General of Drug Administration
Address : Aushad Bhaban, Mohakhali, Dhaka-1212
E-mail : dgda.gov@gmail.com
Website : www.dgda.gov.bd
Required Documents
Good Manufacturing Practice (GMP) Certificate: (Original copy)
- An Application in Company Letterhead
- Manufacturing License of Medicine (Original copy duly attested by First-Class gazette officer)
- Company profile
Certificate for Pharmaceuticals Products (CPP) and the Free Sale Certificate (FSC):
- An application in company Letterhead
- Annexure copy1 of expiry date of the selected medicines for export.
- Approval for the brand name. (If the brand name is changed; otherwise not required)
- Fill up the CPP and FSC, according to WHO format (FSC is needed only if Drug Administration asks for it)
To get the License for Export:
- A completed Application Form (See 8, 9A and 10A)
- L/C Purchase Order (Original copy)
Process Steps
Step 1 Application submission: The applicant drafts a formal application on the company letterhead, addressing the Director General of Drug Administration, to request a Good Manufacturing Practice (GMP) Certificate. Subsequently, the applicant submits the formal application along with all the necessary documents to the Drug Administration to initiate the process of obtaining the GMP Certificate.
Step 2 Verification and Decision by DCC: The Drug Control Committee (DCC) verifies all the submitted documents to ensure compliance with regulatory requirements and makes a decision regarding the issuance of the GMP Certificate. #
Step 3 CPP and FSC Application & Approval: After receiving the GMP Certificate, if necessary, the applicant submits applications for the Certificate of Pharmaceutical Product (CPP) and the Free Sale Certificate (FSC), along with the required documentation. Upon approval, the applicant receives both the Certificate of Pharmaceutical Product (CPP) and the Free Sale Certificate (FSC) from the relevant authority.
Step 4 Apply for License: The applicant submits an application for the License to Export using the prescribed Application Forms (8, 9A, 10A), along with a copy of the Letter of Credit (LC) or Purchase Order.
Step 5 Confirmation of License: Upon review and approval of the application, the applicant receives a confirmation letter for the License to Export from the relevant authority, authorizing them to proceed with drug export activities.
Fee Schedule
No fee is required
Official Time Limit
30 days
Actual Time Limit
45 days