What does a cosmetic declaration dossier in Vietnam include?

The declaration of cosmetics in Vietnam is a mandatory legal process to ensure the safety and quality of cosmetic products circulated on the market. This not only protects consumers but also helps maintain the reputation of cosmetic manufacturing and trading businesses. Medgate will provide detailed answers about the ingredients in the cosmetic declaration dossier in Vietnam.

Legal basis for cosmetic declaration documents

For cosmetic declaration dossiers , there are separate regulations posted on management agency pages, including:

  • Circular 06/2011/TT-BYT issued on January 25, 2011.
  • Circular 29/2020/TT-BYT issued on December 31, 2020.
  • Circular No. 277/2016/TT-BTC issued on November 14, 2016.

What is cosmetic declaration for circulation in Vietnam?

Announcing the circulation of cosmetic products is a legal procedure that individuals, organizations and businesses carry out before putting cosmetics into circulation in the Vietnamese market, and this procedure is mandatory.

When completing the above procedures, the management agency will issue a cosmetic product announcement receipt number and this form proves that the individual, organization or business is allowed to circulate cosmetic products produced by themselves and business.

What are the regulations for announcing the circulation of cosmetic products?

According to Article 3 of Circular 06/2011/TT-BYT, announcement of cosmetic circulation is guided according to the following regulations:

– Imported cosmetics and domestically produced cosmetics both require a cosmetic product announcement receipt number before being put on the market for business.

– Cosmetics already circulating on the market may undergo post-inspection by state authorities.

– Organizations, individuals, and businesses must take full responsibility for the effectiveness, safety, and quality of drugs when bringing cosmetic products to the market.

– Requires one of the following documents: business registration certificate, establishment decision, or submit investment registration certificate and business code registration, trading or import/export of cosmetics when registering. Sign the announcement of product circulation.

– Must meet ASEAN guidelines on declaring cosmetic properties when declaring the intended use of the product.

– The cosmetic announcement fee is set at 500,000 VND according to Circular No. 277/2016/TT-BTC.

– Cosmetic products must be in the list of cosmetics published according to current provisions of law.

– Ingredients announced to create cosmetics must meet standards and not be harmful to users.

Cosmetic product declaration dossier

According to Article 4, Circular 06/2011/TT-BYT stipulates dossiers for announcing the circulation of cosmetic products as follows:

1. Cosmetic business registration certificate of the enterprise

First, businesses must have a cosmetic business registration certificate. This legal document confirms that the business is legally registered to operate in the field of cosmetic manufacturing or trading. Information on the business registration certificate of organizations and individuals includes:

– Business name
– Business code
– Business lines
– Head office address

Providing a business registration certificate helps management agencies check and authenticate the legality of the business and this is a necessary condition for cosmetic products to be announced.

2. Authorization letter from the manufacturer

If the business is not a direct manufacturer but a distributor or importer, a letter of authorization from the manufacturer is required. This authorization letter proves that the business is allowed to represent the manufacturer to announce and distribute cosmetic products in the Vietnamese market. The content of the power of attorney usually includes:

– Name and address of the manufacturer
– Name and address of the authorized enterprise
– List of authorized products
– Authorization period
– Signature and seal of the manufacturer

Note that the authorization letter from the foreign manufacturer requires consular legalization according to regulations.

3. Cosmetic announcement form includes 2 copies

The cosmetic product announcement form includes all information related to the cosmetic products announced by the enterprise such as:

– The section for the cosmetic management agency to stamp the confirmation and write the publication number and the name of the form.
– The name of the cosmetic product is announced, the product form along with the intended use and product presentation format.
– Information about manufacturers, importers and distributors (including name, address, exporting country name, business license number,…).
– Information about the legal representative of the company under whose name the announcement is made.
– Commitment to product compliance with legal and ASEAN regulations.
– Name, signature, stamp and date of preparation of the proclamation form

The announcement form must be filled out completely and accurately according to the form prescribed by the Ministry of Health, and submit 2 copies with the announcement data as soft copies.

4. Certificate of Free Sale (CFS) for imported cosmetic products.

– CFS needs to be issued by a competent authority in the country of manufacture or export of cosmetic products and is valid at the time of submission.
– CFS needs to be consularly legalized according to the provisions of law

Procedure for submitting application for declaration of cosmetic products

After fully preparing the above documents, cosmetic businesses proceed to submit cosmetic declaration documents to the management agency. The procedure for submitting cosmetic product declaration documents includes the following steps:

1. Submit application: Enterprises submit applications directly to the management agency or via the online system if available.
2. Check documents: Management agencies check the completeness and validity of product announcement documents. If the cosmetic declaration dossier is missing or invalid, the business will be asked to supplement or edit.
3. Appraisal of dossiers: Cosmetic proclamation dossiers are appraised for the accuracy and science of the accompanying information and documents.
4. Granting a publication number: If the application meets the requirements, the management agency will issue a publication number for the cosmetic product. Businesses are allowed to bring products to market with this cosmetic declaration number.

Thus, declaring cosmetics is not only a legal requirement but also the responsibility of cosmetic manufacturing, distribution and trading businesses to consumers. A complete and accurate cosmetic product declaration file helps ensure that the products reaching consumers are safe, of good quality and comply with legal regulations. To learn more about cosmetic announcement documents and cosmetic product announcement services , please contact Medgate via Hotline: 098.546.1894 or Email: medgatevn@gmail.com for advice.

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