REGISTRATION FOR FOREIGN MEDICINE

The registration of foreign medicines is governed by a specific legal framework to ensure their safety, efficacy, and quality. This process is primarily regulated under the Drug & Cosmetics Act, 2023, and the Drug Control Ordinance, 1982, particularly Section 5. These laws outline the necessary requirements and procedures for the approval and monitoring of imported pharmaceutical products.

Issuing Authority:

Name : Directorate General of Drug Administration (DGDA)

Address : Aushad Bhaban, Mohakhali, Dhaka-1212

E-mail : dgda.gov@gmail.com

Website : www.dgda.gov.bd

Required Documents

1. Application by the local nominated representative in Bangladesh [Original]
2. Completed Form DA-1/1881. [Original]
3. Evaluation fee of Recipe through Treasury Challan [Through Bangladesh Bank/ Sonali Bank]
4. Organization’s Profile
5. Product Profile
6. Certificate of Pharmaceuticals Products (CPP)2 /Free Sale Certificate (FSC)3 signed by the producing country’s health authority [A copy duly attested by the Bangladesh Embassy of that concern country]
7. In case of medicine for human being:
   1. FSC/CPP of Country of Origin (if Australia, France, Germany, Switzerland, Japan, UK, USA)
   2. FSC/CPP from any of the above seven countries (for countries other than the above country of origin
8. In case of Veterinary Medicine Registration:
   1. CPP of Country of origin (Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Japan, The Netherlands, Norway, Singapore, Sweden, Switzerland, UK, USA, Russia, Poland, Spain and South Korea)
   2. FSC/CPP from one of the 24 countries (if the country is none of the above mentioned then Country of Origin)
9. Packet sample in English/ Bengali and Brochure [Original]

Process Steps

Step 1 Application form submission:

The process for registering foreign medicine begins with the collection of information and payment of fees. First, the applicant must gather detailed information from the Drug Admission Office about the requirements and procedures for registering foreign medicine. Then, the necessary fees must be deposited via Treasury Challan, and the Money Receipt must be collected from the bank. Following this, the applicant needs to fill out the Application Form and gather all the supporting documents. The completed Application Form, along with the supporting documents and the Treasury Challan/Money Receipt, is then submitted to the relevant authorities.

Step 3 Evaluation and Decision by DCCL:

The Drug Control Committee (DCC) evaluates the submitted Application and Recipe for compliance and completeness. The DCC then decides whether to grant Registration for the Foreign Medicine.

Step 4: Issuance of Approval Letter and Final Payment

If the decision is positive, an approval letter is issued to the applicant. The applicant then deposits and submits the Registration fee, Analysis fee, Certificate of Pharmaceutical Product (CPP)/Free Sale Certificate (FSC), and a sample packet of the product as specified in the approval letter.

Step 5: Registration Approval

The final approval of the Registration is granted upon successful submission of all required fees and documents.

Fee Schedule

Official Time Limit

5-6 working days**

Actual Time Limit

6 months-2 years

Renewal Process

Required Documents

1. Certificate of Pharmaceuticals Products (CPP)/Free Sale Certificate (FSC) signed by the Producing country’s Health Authority
2. Packet Sample in English/ Bengali and Brochure. [Original]

Process Steps

Step 1: Deposit Fees and Collect Money Receipt

First, visit the designated bank to deposit the renewal fee along with any other required fees. Ensure you have all necessary details, such as the account number and fee structure, to complete the transaction smoothly. Once the deposit is made, collect the Money Receipt from the bank, which will serve as proof of payment.

Step 2: Submit Application with Supporting Documents

Next, prepare your application for renewal by gathering all required supporting documents, such as identification proof, previous registration certificates, and any other relevant paperwork. Attach the Money Receipt obtained from the bank to your application. Submit the complete application package to the appropriate office or authority responsible for processing renewals.

Step 3: Completion of Registration Renewal

After submission, the relevant authority will review your application and supporting documents. Upon successful verification and approval, your registration renewal will be processed. You will receive a confirmation or updated registration certificate, marking the completion of the renewal process.

Fee Schedule

Per Item of Medicine BDT 10,000.00

Official Time Limit

1-2 month**

Actual Time Limit

Time may vary