Step 1: Ensure the compliance of cosmetics
As a member state of ASEAN, Vietnam fully implemented the ASEAN Cosmetic Directive (ACD) by the release of Circular 06/2011/TT-BYT Providing Cosmetic Management on January 25th, 2011. The precondition of exporting cosmetics to Vietnam is that cosmetic companies must ensure the products comply with related regulations concerning ingredients, manufacturing, labeling, claim, safety, etc.
Step 2: Notify authorities of cosmetics to be imported
Before exporting cosmetics, companies shall notify the Drug Administration of Vietnam (DAV) to gain approval in the form of a notification receipt number. The notification receipt number is also required by the Customs. There are three steps to notify the products:
1. Designate a local company as the notification applicant
According to the Vietnam cosmetic regulations, only a company in the territory of Vietnam can apply for notification with the DAV and place the products in the market. In such a case, exporters can choose to set up a subsidiary, find a reliable and experienced local distributor or a third-party consulting company. Generally, around one month is required to set up a subsidiary.
2. Prepare notification dossiers
There are three documents requiring submission to the DAV for notification, shown in the table below:
|1||Cosmetic notification report with the notification data|
|2||Original or notarized copy of letter of attorney from the producers or the owners of products authorizing organizations or individuals to put products on the market in Vietnam|
1. Apply to imported cosmetics or domestically produced cosmetics in which the organization or individual responsible for bringing the product to the market is not a manufacturer;
2. For imported cosmetics, the letter of attorney must be a notarized copy and legalized by the consulate.
Certificate of free sale (CFS) which should have at least the following information:
1. Apply to imported cosmetics;
2. CFS which is issued by the current territory must have been original or legally notarized and still in the day of validity. In case CFS is not provided of the expiry day, it must be a certificate which has just been issued within 24 months;
3. Except for some special circumstances, CFS must be consul legalized;
4. The following three cosmetics can be exempted from CFS submission:
The annex 02-MP of Circular 06/2011/TT-BYT Providing Cosmetic Management details the notes for each document.
3. Submit the dossiers online
The applicant shall submit the dossiers online via http://vnsw.gov.vn and pay the notification fee: about 21 USD for each product.
Within one working day from the date of receipt of the cosmetic notification dossier, DAV is responsible for receiving the dossier and sending the collection notice if the dossier is complete and valid. In case the dossier is incomplete or invalid, DAV shall send a notice stating incomplete or invalid contents to the applicant.
Within three working days as of receipt of the valid notification dossiers and notification fee, the DAV will issue the notification receipt number. The notification receipt number is delivered in PDF format rather than a hard copy. The applicant can check the issuance of receipt number on the online notification platform.
If the dossier is unqualified, within five working days from the date of receipt, the DAV shall notify the applicant electronically. There is one chance to supplement the dossier. Within five working days as of receipt of the supplementary documents, the receipt number will be issued.
The receipt number is valid for five years. The applicant shall apply for notification and pay the notification fee again before the expiration date if he wants to continue marketing cosmetics.
Step 3: Exporting cosmetics to Vietnam
After obtaining the notification receipt number cosmetics are permitted to be exported to Vietnam and placed in the market.
Customs clearance requires submission of the following documents:
Notification receipt number
Customs declaration (original)
Sales contract (copy)
A commercial invoice (copy)
Certificate of Origin (original)
Taxes are also mandatory for customs clearance. In Vietnam, the general taxes for imported cosmetics include:
Value-added Tax (VAT)
Special Consumption Tax (SCT)
Environment Protection Tax (EPT)
However, the specific rate varies in the origin of cosmetics.
In addition, a Product Information File (PIF) shall be prepared for each cosmetic, which includes four parts:
Administrative documents and a summary of product
A copy of cosmetic notification report with the receipt number
Power of attorney
Certificate of Free Sale (for imported cosmetics)
Other relevant administrative documents (Business Registration Certificateor Investment license)
Ingredients and percentage of all ingredients in the formula
Labels and product information
Instructions for use
Announcement on production
Commitment of compliance
Lot number/product code recording system
Safety declaration (with conclusion conclusions, signatures and namesQualifications certificates of auditors)
Summary of adverse effects on humans (if any)
Report on evaluating the function and efficacy of cosmetics based on its ingredients and testing results
Quality standards and testing methods of ingredients
Ingredient safety data
Finished product quality
Detailed information about the manufacturer
Summary of production process
More detailed information about the production process, quality management and records
Standards and testing methods of finished products
The criteria used to test microbiological limits in the final product
Testing methods corresponding to quality standards
Summary report on product stability (for products with a shelf life of less than 30 months)
Safety and efficacy
Safety assessment report
Introduction of the assessor on product safety
Latest report on adverse effects (if any)
Documents explaining function and efficacy of the product announced on the product packaging
The PIF must be kept at the address of the notification applicant for future post-market inspections. Among the above four parts, administrative documents and a summary of the product must immediately be presented to the inspection authority when required, while the other three parts shall be presented within 15-60 days after the inspection day.