We – SBLAW are grateful to present client our legal procedure on cosmetic product notification in Vietnam as follows:
1. relevant information and documents
An importer who would like to notify cosmetic products in Vietnam should submit to Ministry of Health (MoH) following documents:
– 03 templates for notification of cosmetic product (the form of template shall be provided later);
– Power of Attorney of the manufacturer clearly indicate that the Client in Vietnam is authorized to carry out all necessary procedures to notify the cosmetic products at Drug Administration – Ministry of Health, in which all cosmetic products to be notified should be listed. This Power of Attorney must be legalized by the Consulate of Vietnam in the host country.
– A notarized copy of Business Registration Certificate of the Client in Vietnam. Please be noted that in the Business Registration Certificate, the “cosmetic trade” must be available.
– Certificate of Free Sale (or Permit of Circulation) issued by the competent authority of the country of origin certifying that the product is permitted to be freely sold in domestic and overseas markets and/or is currently circulated in accordance with the law and regulations of the country of origin.
– Softcopy (Memory stick or CD) of Templates for notification of cosmetic product.
Ingredients of the cosmetic products
According to the regulation of Ministry of Health, Ingredients of the cosmetic product must be in compliance with the regulations stipulated in the Annexes of the ASEAN Cosmetic Directive, namely:
– Not contain any prohibited substances in cosmetic product listed in the Annex II;
– Compliance with the restrictions and conditions stipulated in the Annex III;
– List of Coloring Agents Allowed for Use in Cosmetic Products in the Annex IV;
– List of Preservatives Which Cosmetic Products May Contain in the Annex VI;
– List of UV Filters Which Cosmetic Products May Contain in the Annex VII.
According to the notice of the ASEAN Cosmetics Association, Inc., these Annexes are adjusted from time to time. We will continuously update these adjustments to guarantee the precision in checking the ingredients of the cosmetic products of the Client.
2 TIME SCHEDULE
– To check ingredients of the cosmetic products: 05-10 working days from the date of receipt of dossier.
– To complete checklist of application dossier(s): 02 working days from the date of receipt of dossier from client.
Following up the examinationprocess:
In the smooth case, the time for getting the Template for Notification having the Notification Number of MoH is about 15 working days counted from the date the Drug Administration received the payment of official fee from the Client.
– The above timing schedule is in the smooth case. It may be longer depending on the quantity of application dossier;
– Only when receiving all required documents (sufficient dossier) as mentioned in the above list, do we submit application dossier to the competent of authority and following up examination process.
3.OFFICIAl Fee, SERVICES FEE
The official fee for notification of 01 cosmetic product is VND 500,000 (Five hundred thousand Vietnam Dong). This fee shall be paid by the Client to the Drug Administration – MoH right after the applications are submitted to the Drug Administration.
The total package service fee for advising and proceeding with the procedure for notification of 01 cosmetic product is in the region of US$300 (Three hundred United States Dollars).
If there are more than 10 products to be registered in one time, the total fee might be in the region of US$200 (Two hundred United States Dollars).
If there are more than 30 products to be registered in one time, the total fee might be in the region of US$150 (One hundred fifty United States Dollars)
4. Scope of works
Generally, with regard to cosmetic product notification in Vietnam, our scope of work shall be as follows:
Preparation of the application documents:
- Notifying application documents required in accordance with Vietnamese law;
- Checking ingredients of the cosmetic products and application documents;
- Providing templates for notification of cosmetic product;
- Reviewing and amending the filled templates provided by the client via email;
Providing the final amended templates for the client to sign and seal.
- Submitting the application dossier to the licensing authority on behalf of the client;
- Monitoring and following up with the relevant authorities on the approval process;
- Keeping the client updated on the developments and additional requirements, if any; and
- Assisting the client in obtaining the final result
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