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Procedure NameRegistration for Foreign Medicine
Description

Category

: Registration

Renewal Frequency of the Registration 

: Every Five Years

Issuing Ministry 

: The Ministry of Health & Family Welfare

Incumbent Office

Name: Directorate General of Drugs Administration (DGDA)

 

Address: 105-106, Motijheel Commercial Area, Dhaka-1000

 

Email: drugs@citech.net

 

Website: www.dgda.gov.bd

 

Issuance of Registration for Foreign Medicine

Required Documents

Remarks

  1. Application by the local nominated representative in Bangladesh

Original

  1. Completed Form DA-1/88

Original

  1. Evaluation fee of Recipe through Treasury Challan

Through Bangladesh Bank/Sonali Bank

  1. Organization’s Profile  

 

  1. Product Profile 

 

  1. 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

  1. In case of medicine for human being:
  1. FSC/CPP of Country of Origin (if Australia, France, Germany, Switzerland, Japan, UK, USA )

 

  1. 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)

 

  1. Packet sample in English/Bengali and Brochure

 

 

Process Steps

Step 1

Collects information form the Drug Administration Office

Step 2

Deposits by Treasury Challan and collects the Money Receipt from the Bank

Step 3

Submits the filled- in Application From along with supporting documents, Treasury Challan/Money Receipt

Step 4

Drug Control Committee (DCC) evaluates the Application and Recipe

Step 5

DCC decides whether to provide with the Registration for Foreign Medicine

Step 6

Issues an approval letter if the decision is positive

Step 7

Applicant deposits and submits the Registration Fee, Analysis Fee, CPP/FSC and Packet of the Product (according to the issued letter)

Step 8

Approval of Registration

 

 

Process Map:

         

 

Renewal of registration for Foreign Medicine

Required Documents

Remarks

  1. Certificate of Pharmaceuticals Products (CPP)/Free Sale Certificate (FSC) signed by the producing country’s Health Authority 

 

  1. Packet Sample in English/Bengali and Brochure

Original

 

Process Steps

  1. Deposits the renewal and other fees and collects the Money receipt from the bank 
  1. Submits Application along with the supporting documents and Money Receipt
  1. Completion of the renewal of the Registration

 

 

General Information

Legal Basis of the Registration

The Drug Act – 1940

Drug Control Ordinance – 1982, Section 5

The nature of the Registration

Sector specific (Pharmaceutics)

The purpose of the Registration

Operational

Territorial Scope of the Registration

National

Eligibility Criteria to obtain the registration

Trade License/Business Entity 

Information availability

  • Written Procedures are easily accessible by the public from Directorate General of Drug Administration (DGDA)
  • Forms are available online
  • There is no Help Desk in the office

 

CategoryDirectorate General of Drug Administration (DGDA)

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