Drug Registration in Bangladesh

Documents Required for Registration of Pharmaceuticals / Registration for Foreign Medicine in Bangladesh

1. Application by the local nominated representative in Bangladesh. (Original)
2. Completed Form DA-1/88. (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)/Free sale certificate (FSC)6 Signed by the producing country’s health authority. (A copy duly attested by the Bangladesh Embassy of that concern county)
7. In case of medicine for human being: FSC/CPP of Country of Origin (if Australia, France, Germany, Switzerland, Japan, UK, USA)
8. In case of veterinary Medicine Registration:
9. 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)
10. FSC/CPP from one of the 24 countries (if the country is none of the above mentioned then Country of Origin)
11. Packet sample in English/Bengali and Brochure.

Drug Registration Procedure

1. Collecting information form the Drug Administration Office
2. Deposits by Treasury Challan and collects the Money Receipt from the Bank
3. Submits the filled- in Application From along with supporting documents, Treasury Challan or Money Receipt
4. The Drug Control Committee (DCC) evaluates the Application and Recipe.
5. DCC will decides whether to provide with the Registration for Foreign Medicine
6. Issues an approval letter if the decision is positive.
7. Applicant deposits and submits the Registration Fee, Analysis Fee, CPP/FSC and Packet of the Product (according to the issued letter)

Approval of Registration