Bangladesh - Apply for Grant or Renewal of License to Manufacture Biological and Other Special Products

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Procedure

Apply In Person

1. To Apply for a Grant or Renewal of License to Manufacture Biological and Other Special Products, the applicant has to approach the Directorate General of Drug Administration (DGDA) link
2. The applicant has to visit the office, an application form will be provided to the applicant by the concerned officer. or it can be downloaded from the following link
3. The applicant has to fill in all the necessary details in the application form. (Incomplete applications are not accepted)
4. Make sure that the applicant has attached all the necessary documents that are mentioned in the “Required Documents” section of this page.
5. The applicant has to attach the photocopies of the required documents along with the application form while submitting.
6. Submit all the documents with the completed form to the concerned officer.
7. The applicant has to pay the prescribed fee as requested by the authority.
8. After receiving the application, the concerned authority will check the submitted application and document set. If all are in place, the application will be accepted.
9. An acknowledgment receipt will be provided. Please save it for future reference.
10. Then the application will be processed further. All the updates on the application status will be sent via SMS to the applicant’s mobile number.
11. Once the process gets completed, the applicant gets a call from the office regarding the application.
12. The officer will come for a site inspection to check the product.
13. This entire process can be completed within 2 weeks or as per the timeline advised by the respective department authority.

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Required Documents

• Application form link
• Product list
• ID proof
• Old license (for renewal)
• Any other documents (if required)

Office Locations & Contacts

Directorate General of Drug Administration (DGDA)
Aushad Bhavan
Beside NIPSOM
Adjacent To IPH & NIPSOM, Mohakhali Bazar Rd, 1212
Phone Number: 02222-280803
Contact link

Eligibility

• Any biological technician who intends to Apply for a Grant or Renewal of License to Manufacture Biological and Other Special Products is eligible to make this application.

Fees

• The applicant has to pay the prescribed fee as requested by the authority.

Validity

Explain the time until which the certificate/document is valid.
e.g. Birth Certificate Valid Forever

Documents to Use

• Application form link

Sample Documents

Please attach sample completed documents that would help other people.

Processing Time

• This entire process can be completed within 2 weeks or as per the timeline advised by the respective department authority.

Related Videos

Videos explaining the procedure or to fill the applications.
Attach videos using the following tag <&video type='website'>video ID|width|height<&/video&> from external websites.
Please remove the '&' inside the tags during implementation.
Website = allocine, blip, dailymotion, facebook, gametrailers, googlevideo, html5, metacafe, myspace, revver,
sevenload, viddler, vimeo, youku, youtube
width = 560, height = 340, Video ID = Can be obtained from the URL of webpage where the video is displayed.
e.gIn the following url 'http://www.youtube.com/watch?v=Y0US7oR_t3M' Video ID is 'Y0US7oR_t3M'.

Instructions

• Applicants must complete the application form before submitting it. Incomplete applications will not be accepted.
• Applicants must provide genuine information while applying for this procedure.

Required Information

• Name
• Nationality
• Gender
• Mailing address
• Mobile No
• Email Address
• Date
• Signature
• Product details
• Contact details
• Date
• Declaration
• Signature

Need for the Document

• Biomanufacturing is the production of biological products from living cells. Companies use the process to make biological drugs such as antibodies and enzyme replacement therapies. Small molecule drugs can be synthesized chemically. As their name suggests, biologics require living cells.
• The applicant has to get a legal license to manufacture biological drugs. Also, to continue the manufacturing license the applicant has to get the legal license.

Information which might help

• For more information link

Other uses of the Document/Certificate

Please explain what are other uses of obtaining this document/certificate.
e.g. Birth Certificate can be used as proof of identity.

External Links

Link

Others

More information which might help people.