Drug Registration in Bangladesh

MoH

Ministry of Health and Family Welfare, Government of the People’s Republic of Bangladesh

Directorate General of Drug Administration

Yes

Yes

The Drug Act – 1940

5 years.

Every 5 years.

BDT 63,250 per product.

Common Technical Document (CTD)

Application by the local nominated representative in Bangladesh. (Original)
Completed Form DA-1/88. (Original)
Evaluation fee of Recipe through Treasury Challan. (Through Bangladesh Bank/Sonali Bank)
Organization’s Profile.
Product Profile
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)
In case of medicine for human being: FSC/CPP of Country of Origin (if Australia, France, Germany, Switzerland, Japan, UK, USA)
In case of veterinary Medicine Registration:
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)
FSC/CPP from one of the 24 countries (if the country is none of the above mentioned then Country of Origin)
Packet sample in English/Bengali and Brochure.

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

Approval of Registration