Authorized representative is required to hold the medicine registration in Bangladesh.
Govt. fees for finished medicine import registration in Bangladesh:
Cost for medicine registration in Bangladesh is BDT 63,250 per product.
Required documents for finished medicine registration in Bangladesh:
- Letter of Authorization from the manufacturer (proof of authorization).
- Form DA 2/88 (attached herewith) – For first time molecule in Bangladesh. It is a DGDA prescribed form.
- COPP of Manufacturing country – Bangladesh Embassy attested. (COPP means Certificate of Pharmaceutical product)
- COPP from any one of the following countries: USA, UK, Japan, Australia, Switzerland, France, Germany, EMA issued CPP marketed in EU countries (Bangladesh Embassy attested, Original).
- Product profile (CTDA, module-2 only)
- Company profile
- Packaging Materials (empty): Box, Label, Direction slip, Labeling must reflect the Brand name, Manufacturer name, Country of Origin, Mfg. date, Expiry date & Lot no.
- FDA or, EMA, or, UKMHRA approval reference
*Govt. treasury fee: USD 600/product
For Veterinary medicine:
COPP from any one of the following countries:
Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Japan, Netherlands, Norway, Singapore, Sweden, Switzerland, UK, USA, Russia, Poland, Spain, South Korea, Czechoslovakia (Original copy)
