Cosmetics (Medicated) under the jurisdiction of DGDA-Bangladesh
Guideline for Medicated Cosmetics by DGDA (after the Drug & Cosmetics act, 2023)
Required documents for import registration of cosmeceuticals under the jurisdiction of DGDA:
- Application to the Director General, Directorate General of Drug Administration
- Letter of Authorization – reflecting the product names – duly signed by the manufacturer.
- Free sale certificate issued the Regulatory authority of the Country of Origin – online verifiable.
- GMP certificate or, ISO 22716 – online verifiable.
- For OEM products, Agreement between the Actual Manufacturer and Brand owner is required.
- A complete quantitative and qualitative ingredient list using International Nomenclature Cosmetic Ingredient (INCI) names with percentages.
- A safety declaration from the manufacturer confirming the product is free from banned or harmful substances, such as hydroquinone, specific steroids, heavy metals, or EU-banned ingredients.
- Certificate of Analysis (COA).
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Submission of physical samples. Products from Japan, Singapore, the USA, and EU countries will be registered on a “reliance” basis through a review of their existing test reports. Products from all other countries must undergo testing at the DGDA laboratory or a DGDA-accredited facility.
- Packaging materials/empty box/label – original
- Government fees: BDT 57,500 per product. All Variants will be registered separately.
- Trade license, IRC, Income tax return proof, TIN and BIN Certificate of the importer/distributor/Local agent/registration holder.
Packaging Materials (Product label/sticker/box/container) must reflect the following information:
- Trade name/brand name and specific intended use.
- Full ingredient list as per the INCI format.
- Batch number, Net weight, Date of manufacturing & Date of expiry.
- Name & address of the manufacturer and the importer/local agent.
- Instruction for use, precautions and warnings.
Packaged foods, Cosmetics, Chemical products, Engineering, Electronics, Electrical product regulation and registration in Bangladesh
Bangladesh Standards and Testing Institution (BSTI) is a government agency under the Ministry of Industries (MoI) constituted for the purpose of controlling the standard of service and quality of the goods. BSTI is responsible for the quality control of the products which are ensured as per specific national standards made by the technical committees formed by BSTI. Cosmetics and consumer goods must be registered in BSTI for import and manufacture.
BSTI brought 328 Products under Mandatory Certification Marks Wing. Local manufacturers require product-to-product CM license, while importers require to apply and collect a Clearance certificate from the BSTI once the shipment arrives on a Bangladeshi port (i.e., Benapole land port, Dhaka Airport, Chittagong Sea Port etc.). BSTI issue Clearance certificate for the imported goods after the lab test report done by BSTI labs, if the products comply with a specific BDS.
Governing Legislations:
- Bangladesh Standards and Testing Institution Ordinance, 1985
- Bangladesh Standards and Testing Institution Act, 2018
- Packaging & Commodities Rules, 2007
How can Pharma DRA team help you in BSTI?
- Identifying the products under the BSTI jurisdiction before import.
- Regulatory intelligence report on BSTI products.
- PCR (Packaging, commodity rules) compliance report before shipment to Bangladesh.
- CM (Certification mark) license application and issuance service for mandatory products.
- Clearance certificate/license application once the shipment arrives on the Bangladeshi port.
- Clearance certificate/license issue service for the applied products/shipment.
- Metrology Certificate issue by BSTI for weight/volume confirmation.
- MSC (Managment system certificate) issue service.
- Halal certification service for foods and cosmetics.
Connect us for identifying your products under the jurisdiction of BSTI or DGDA Bangladesh.
