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What did documents include in the declaration of imported cosmetics in Vietnam?

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My company specializes in the pharmaceutical and cosmetic business. This July, we have just imported a new shipment of water serum from Korea. The manager told me to make a declaration of imported cosmetics and wait for approval before I can sell them. But I don’t know much about this. So, my lawyer asked me, What documents are included in the declaration of imported cosmetics?? Is there anything to note?

Thank you for sending your questions to Lawyer X. So, we answer your questions through the article :What documents are included in the declaration of imported cosmetics?

Legal grounds

Circular 06/2011/TT-BYT

Circular 29/2020/TT-BYT

Regulations on imported cosmetics

Conditions for business registration of imported cosmetics include having a legal business registration license and cosmetics that are legally imported into Vietnam. Specifically:

– Subjects are registered to trade in imported cosmetics
All individuals and organizations not specified in Article 13 of the Enterprise Law are allowed to establish companies operating in the field of imported cosmetics.

– Register the establishment of a business before conducting business activities. Cosmetics is not a conditional business field, so the company needs to carry out business registration procedures before conducting business.

The company name must not overlap or cause confusion with other enterprises in accordance with the Law on Enterprises.

Business license with industry code 4649 with detailed content: Wholesale of cosmetics and industry code 4772 with content: Retail of cosmetics.

The company’s address is not located in an apartment building, a group house or a prescribed location that cannot be used as the company’s headquarters, for example: Houses built on agricultural land, project land that has not been converted for purposes, etc.

Directors and legal representatives are not subject to business registration restrictions or business registration bans. For example: The person who worked as a director of a business ran away,…

In case the warehouse is not concurrently the head office of the company, the company must add the warehouse location to the business license after completing the procedures for establishing the company.

– Business cosmetics are legally imported and eligible for circulation in Vietnam.

The company must make cosmetic announcement at the Drug Administration of Vietnam – Ministry of Health before importing cosmetics.

The company must meet the legal requirements for management and backup of the cosmetic product quality and publication records at the company.

The cosmetic trademark must not be confused with the trademark that has been protected exclusively in Vietnam.

Circulating cosmetics must be properly labeled as announced by the Ministry of Health and must not be extracted or changed.

Regulations of the law on the cosmetic announcement

What is the declaration of imported cosmetics?

Announcement of imported cosmetics means that an organization or individual importing cosmetics carries out procedures at a competent State management agency to be granted a receipt number for the cosmetic product proclamation slip and must be completely responsible for the safety, effectiveness, and quality of the product.

Announcement of imported cosmetics for what?

In terms of legal aspects

According to Clause 1, Article 3 of Circular 06/2011/TT-BYT:

Article 3: Regulations on cosmetic product announcement

1. Organizations and individuals responsible for bringing cosmetic products to the market are only allowed to put cosmetics into circulation when they have been granted a receipt number by the competent state management agency to receive the cosmetic product announcement slip. product and is solely responsible for the safety, effectiveness, and quality of the product. Competent state agencies will conduct post-sale inspections when the product is circulated on the market.

Thus, the law stipulates that before circulating on the market, the company will have to carry out procedures for the cosmetic announcements, to prevent acts of bringing fake, imitation, poor quality goods to the market and have reasonable grounds. grounds to handle violations on import.

In terms of the market

+ For businesses: strictly comply with the State’s regulations on cosmetic circulation announcement; affirming the quality of cosmetics imported by them and finally creating a competitive advantage compared to other enterprises that have not yet carried out this procedure, the trust and impression of customers.

+ For consumers: it will be easy to find reputable and quality cosmetic products by checking the cosmetic announcement number usually written on the product packaging.

Dossier of declaration of imported cosmetics include what?

Pursuant to Article 4 of Circular 06/2011/TT-BYT, amending and supplementing Circular 29/2020/TT-BYT:

A cosmetic product announcement dossier includes the following documents:

1. Cosmetic product announcement sheet (02 copies) enclosed with announced data (soft copy of Announcement slip);

2. The original or a duly authenticated copy of the power of attorney of the manufacturer or the product owner authorizing the organization or individual responsible for bringing the product to market to distribute cosmetic products in Vietnam (applicable to imported cosmetics and domestically produced cosmetics that the organization or individual responsible for bringing the product to the market is not the manufacturer). For imported products, the Power of Attorney must be a certified copy of the signature and consular legalized according to the provisions of law, except for cases exempted from consular legalization under international treaties to which Vietnam is a member. Nam is a member. The power of attorney must satisfy the requirements specified in Article 6 of this Circular.

3. Certificate of free sale (CFS) for imported cosmetic products.

Some notes on the declaration of imported cosmetics

– Regarding the language shown is Vietnamese, English, or bilingual Vietnamese and English;

– Regarding the content, it must contain the following contents: Name and address of the manufacturer; Name and address of the authorized organization or individual; authorized scope, authorized brand, or product name; authorization period; besides, the commitment of the manufacturer or the product owner to provide complete product information and records; name, title, and signature of the representative of the authorizing party;

– Thirdly, the power of attorney of imported cosmetics must consular legalize, except for cases exempted from legalization under international treaties to which Vietnam is a member.

– Then, a certificate of Free Sale (CFS for short): Only applicable to the case of declaration of imported cosmetics, must meet the requirements on time limit and consular legalization.

Regulations on the certificate of free sale (CFS) in the declaration of imported cosmetic products

Exemption from CFS

– Cosmetic products manufactured in a member country of the Comprehensive and Progressive Agreement for Trans-Pacific Partnership, whose accession to this Agreement has been ratified and entered into force by the competent authority of that country (after hereinafter referred to as CPTPP member country);

– Cosmetic products circulated and exported from CPTPP member countries: Enterprises responsible for bringing products to the market must submit documents proving that the products circulated in CPTPP member countries by the competent authority issued by a CPTPP member country (a cosmetic product marketing license or a cosmetic product announcement card that granted a reception number or other legal document certifying that the product circulated in a CPTPP member country) approved by the CPTPP member country consular legalization as prescribed by law, except for legal papers in one of the following cases:

+ Be exempted from consular legalization under international treaties to which the Socialist Republic of Vietnam (hereinafter referred to as Vietnam) is a contracting party or on the principle of reciprocity between Vietnam and the issuing country. ;

+ Have documents certified by a foreign diplomatic agency or a competent cosmetic state management agency or a legal document-issuing agency of a CPTPP member country. juridical;

+ Enterprises responsible for bringing products to the market send the results of self-searching of legal documents from the website (English website) of the legal document-issuing agency of the CPTPP member country with the stamp of certification. receipt from the enterprise together with a document providing information on the search link to the Drug Administration of Vietnam. Enterprises must take responsibility before the law for the legality and accuracy of these papers and information and the results of the self-search of enterprises;

– Besides, cosmetic products that issued with the receipt number of the cosmetic product proclamation slip in the country of the Association of Southeast Asian Nations (ASEAN): The enterprise responsible for bringing the product to market must submit the product announcement slip. Cosmetic products that granted a reception number in an ASEAN country consular legalize by the law, except for the cosmetic product announcement slip in one of the following cases:

+ Be exempt from consular legalization under international treaties to which the Socialist Republic of Vietnam is a contracting party or on the principle of reciprocity between Vietnam and the granting country;

+ On the other hand, to be sent by a foreign diplomatic agency or a competent cosmetic state management agency or by an agency that issues a cosmetic product announcement form of an ASEAN member country to send a text or email to the Drug Administration of Vietnam. receive the cosmetic product announcement slip;

+ Enterprises responsible for bringing products to the market send the results of self-searching of the cosmetic product announcement form from the English website of the competent management agency of the ASEAN member country that issues the product announcement receipt number. cosmetic products with the enterprise’s seal of certification along with a document providing information on the search link to the Drug Administration of Vietnam. Enterprises must take responsibility before the law for the legality and accuracy of these papers and information and the results of the self-search of enterprises;

Requirements for CFS records

In addition to the cases of CFS exemption specified at Point 1 of this Clause, the application for a declaration of imported cosmetic products must have a CFS that meets the following requirements:

– CFS issued by the competent authority of the country of manufacture or the country of cosmetic export to Vietnam with the validity period (original or certified copy). If the CFS does not specify a time limit, it must be issued within 24 months from the date of issue;

– CFS must consular legalize by the law unless the CFS meets one of the following regulations:

+ Be exempt from consular legalization under international treaties to which Vietnam is a contracting party or on the principle of reciprocity between Vietnam and the granting country;

+ There is a document or email sent by the CFS-issuing authority or a foreign diplomatic mission to the Drug Administration of Vietnam with the content confirming the information of the CFS;

– The CFS must have at least the information specified in Article 36 of the Law on Foreign Trade Management and Clause 3, Article 10 of Decree No. 69/2018/ND-CP dated May 15, 2018, of the Government detailing a number of articles. of the Law on Foreign Trade Management (hereinafter referred to as Decree No. 69/2018/ND-CP).”

Please see more:

Frequently asked questions

Where can I apply for a license to publish imported cosmetics?

For imported cosmetic products, the application shall be submitted to the Drug Administration of the Ministry of Health.

What is the penalty for not announcing imported cosmetics?

According to the Decree No. 117/2020/ND-CP stipulating penalties for administrative violations in the medical field, a number of acts in cosmetic announcement procedures are as follows:
– Untruthful declaration of the contents of the cosmetic product announcement sheet;
– Do not conduct announcements of domestically produced cosmetics or imported cosmetics before being put on the market for consumption.
For the above two acts, the subject will be fined from VND 20,000,000 to VND 30,000,000.
Besides, with these acts, the subject is also forced to destroy cosmetics. Particularly for the act of dishonest declaration, it will be recommended to the competent state agency to revoke the receipt number of the cosmetic announcement slip.

What is the process of declaring imported cosmetics?

Step 1: Register for an online cosmetic publication account.
Step 2: Organizations and individuals prepare dossiers, including:
Stage 3: Organizations and individuals are responsible for submitting dossiers to the following agencies:
Step 4: The receiving agency processes the application and returns the results.

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