Wednesday, June 28, 2017

Cosmetic registration vietnam

All cosmetic products (the list in accordance with the Ministry of Health) circulating in the market must comply with registration procedures circulated or published quality standards prescribed by the law of Vietnam.

1. Legal basic

- Agreement on Asean harmorized system in management of cosmetic products;

- Decision no 48/2007/QD-BYT dated December 31st 2007 of the Minister of the Ministry of Health promulgating Regulation on management of cosmetic products;

- Decision no 59/2008/QD-BTC dated July 21st 2008 amending and supplementing Decision no 44/2005/QD-BTC dated July 12th 2005 of the Minister of the Ministry of Finance stipulating regime on collection, payment, management and use of the fees for appraising conditional business activities in the health care sector, fees for appraising standards and conditions for medical pharmaceutical practice, fees for granting export-import licenses and medical and pharmaceutical practice certificates.

2. Duty of notification of cosmetic products

Under the current regulations, organizations and individuals responsible for placing cosmetic products in the market are responsible for notifying cosmetic products at the Drug Administration of Vietnam before circulating products on the market. These organizations and individuals may only place products in the market after making such notification and having it accepted by the Drug Administration of Vietnam (obtaining a cosmetic product notification number) and shall take full responsibility for the safety and effectiveness of marketed cosmetic products and comply with the provisions of Vietnamese law.

Organization or individual responsible for placing a product on the market means a manufacturer, importer or registered agent responsible for the imported goods or distributing that cosmetic product in the Vietnamese market, specifically:

a) For domestically manufactured cosmetics, it is the organization or individual manufacturing that cosmetic product.

b) For cosmetics imported for circulation in Vietnam, it is the organization or individual notifying the cosmetic product it/he/she directly imports or authorizing another organization or individual to import that cosmetic product.

c) For cosmetics directly imported into Vietnam by an organization or individual acting as a direct sale agent for a foreign trader, it is the organization or individual acting as a sale agent for that cosmetic

3. Dossier for notiffication of cosmetic prodcuts

Dossier for notiffication of cosmetic products includes the following documents:

- Template for notification of cosmetic product;

- List of notified cosmetic products;

- Business registration certificate (notarized copy);

- Power of authority;

- Notified data in softcopy.

4. Time-limit for implementation of procedure for notification of cosmetic product

Time-limit for implementation of procedure for notification of cosmetic product is 03 working days from the date of receipt of valid dossier.

5. Official fee

Official fee for each dossier of notification of cosmetic product is: 500.000 VND/ one dossier.

6. Some notes

6.1. When changing contents notified, organization, individual must notify again at the Drug Administration of Vietnam and must pay fee in accordance with regulations.

Specifically:

Change type

Notification

Change in label of cosmetic prodcut

New notification

Change in company because of change in distribution right

New notification

Change in product type

New notification

Change in intended use

New notification

Change in product name

New notification

Change in product ingredient list

New notification

Change in manufacturer/assembler (name and/or address)

 

New notification

Change in packaging format

Supplementation

Change in name and/or address of company, but not change in distribution right

Supplementation

Change in representative person of company

Supplementation

Change in packing size, packing material, product label

Supplementation, but does not apply if necessary information was not mentioned in Notification template.

6.2. An approved template for notification of cosmetic product is valid for three years. Organizations and individuals shall make a re-notification at least 01 month before the template for notification of cosmetic product expires and pay a fee as prescribed.

6.3. Organizations or individuals responsible for placing products in the market shall ensure that their products are not harmful to human health when used under normal conditions or instructed appropriate conditions suitable to the form of preparation, label information, use instructions, special caution and other information supplied by the manufacturer or an authorized place or the person responsible for circulating products in the market.

Manufacturers shall evaluate the safety of each cosmetic product under the ASEAN cosmetic safety evaluation guidance.

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