The approval of packing materials is a crucial part of pharmaceutical product registration, governed by The Drug & Cosmetic Act, 2023. This legislation ensures that packaging materials meet strict standards to maintain product safety and efficacy. The following process outlines the essential steps for obtaining this approval.
Issuing Authirity
Name : Directorate General of Drug Administration
Address : Aushad Bhaban, Mohakhali, Dhaka-1212
Email : dgda.gov@gmail.com
Website : www.dgda.gov.bd
Required list of all documents
- Application letter (In the letterhead of the company)
- Recipe Approval Certificate (Copy)
- Treasury Challan (Product including & testing fee)
- Draft Text for Packing materials (2 copies)
Step by step all process
Step 1 Collect and Submit the Application Form: The applicant collects the prescribed Application Form or Application template from the Directorate General of Drug Administration (DGDA). After filling out the form, the applicant submits it to the Dispatch section along with all necessary supporting documents. These documents might include identification, qualifications, and other relevant certifications that support the application. This step initiates the approval process and ensures that all required fields and documents are properly provided.
Step 2 Dispatch Forwards Application to Dealing Assistant: After receiving the completed application and supporting documents, the Dispatch section forwards the application to the Dealing Assistant (DA). The DA is responsible for the initial review and organization of the application materials.
Step 3 Review and Approval by Dealing Assistant and Medical Officer: The Dealing Assistant (DA) first reviews the application file to ensure that all required documents are present and correctly filled out. Once the review is complete, the DA forwards the file to the Medical Officer (MO). The MO then examines the application, focusing specifically on the packing materials to ensure they meet the necessary standards and regulations. After a thorough check, the MO sends the approval to the Assistant Director (AD) for further processing.
Step 4 Approval Process through Administrative Hierarchy: From the Assistant Director, the application file moves through the administrative hierarchy. It is reviewed sequentially by the Deputy Director (DD) and the Director. Each official ensures compliance with regulations and standards before passing the file along.
Step 5 Final Approval and Issuance: The Director General (DG) reviews the application and, upon satisfaction with the compliance and thoroughness of the review process, signs the approval. The DG then sends the signed document back to the Medical Officer (MO). Finally, the applicant is notified of the approval and can collect the signed and approved document from the MO, completing the application process.
Fee schedule
No fee
Official timeline
7-10 days
Actual timeline
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