Cosmetic publication

Product proclamation procedures for cosmetics

Before putting cosmetics on the market, businesses, organizations and individuals will have to make a product announcement. This is a mandatory procedure in accordance with the current law. So, the profile needed to make the number of cosmetic products include? Application procedure like? Invite your members to follow the article below.

I. Some definitions to learn

1. Cosmetic product  is a substance or preparation used to come into contact with the external parts of the human body (skin, hair system, nails, toenails, lips and external genitals). or teeth and oral mucosa whose main purpose is to clean, aroma, change the appearance, appearance, correct body odor, protect the body or keep the body in good condition.

2. Cosmetic publication also known as cosmetic circulation announcement : is the individual or organization filing dossier at the competent state agency to apply for the publication number for cosmetic products before circulating on. market.

Organizations and individuals responsible for putting cosmetic products on the market are only allowed to put cosmetics into circulation when they have been issued the receipt number of cosmetic product proclamation receipt by the competent state management agency and be solely responsible for the safety, effectiveness and quality of the product. The competent state agency will conduct post-sale inspection when the product is circulating in the market.

3. Organization, individual responsible for bringing the product to market : is the organization, individual whose name is on the cosmetic product proclamation file and is responsible for that cosmetic product on the market.

Organizations and individuals responsible for putting products into circulation on the market must have a cosmetic business function in Vietnam.

II. Profile published cosmetic products

The cosmetic product proclamation dossier includes:

1. The cosmetic product proclamation report (02 copies) together with the proclamation data (the soft version of the proclamation report);

2. The original or a valid certified copy of the authorization of the manufacturer or the product owner authorizes the organization or individual to be responsible for bringing the product to the market where cosmetic products are distributed at Vietnam (applicable to imported cosmetics and domestically produced cosmetics in which the organization or individual responsible for bringing the product to the market is not a manufacturer). For imported products, the Power of Attorney must be authenticated by signature and consularly legalized according to the provisions of law, except for cases exempt from consular legalization under international treaties to which Vietnam Male is a member.

Note:  The power of attorney must have the presentation language of Vietnamese, English or bilingual Vietnamese and English. Includes:

- Name and address of manufacturer; in case the principal is the product owner, it is necessary to state clearly the name and address of the product owner and the name and address of the manufacturer;

- Name and address of authorized organization or individual;

- Scope of authorization (in the name of publication and distribution of cosmetic products in Vietnam);

- Authorized brand or product name;

- Authorization term;

- Commitment of the manufacturer or product owner to provide a complete product information file (PIF) for the organization or individual responsible for bringing the product to market in Vietnam;

- Name, title, signature of the authorized representative.

3. Certificate of Free Sale (CFS): Only applicable to the case of declaring imported cosmetic products and meeting the following requirements:

- CFS issued by the host country is the original or a valid and valid certified copy. In case the CFS does not specify a deadline, it must be issued within 24 months from the date of issue.

- CFS must be consular legalized in accordance with the law, except for cases exempted from consular legalization under international treaties to which Vietnam is a member.

III. Application procedure

1. Place of submission : submit in person or by post to:

- Pharmaceutical Management Department - Ministry of Health for imported cosmetics.

- The Department of Health where the factory is located for domestically produced cosmetics. Cosmetic products manufactured and packaged from imported semi-finished products are considered domestically produced products.

- The Management Board of Moc Bai border-gate economic zone for cosmetics trading within the industrial trade zone of Moc Bai border-gate economic zone, Tay Ninh province.

- Quang Tri Economic Zone Authority for cosmetics trading within the Lao Bao Special Economic - Commercial Area, Quang Tri Province.

- The introduction of cosmetics from the industrial trade zone of Moc Bai border-gate economic zone, Tay Ninh province into other functional areas in Moc Bai border-gate economic zone, Tay Ninh province or into the domestic market for business purposes. joint; bringing cosmetics from Lao Bao Special Economic - Commercial Area, Quang Tri province into the domestic market for business must be announced at the Drug Administration of Vietnam - Ministry of Health in accordance with  Circular 06/2011 / TT-BYT  organizations, individuals that announce cosmetic products must have a cosmetic business function in Vietnam and located outside of these 2 zones).

2. Time limit for processing cosmetic product proclamation records:

- Within 03 working days from the date of receipt of a valid publication record and publication fee as prescribed, the competent state management agency is responsible for issuing the receipt number of the cosmetic product proclamation report. Products.

- If the published dossier does not meet the regulations, within 05 working days from the date of receiving the dossier, the dossier-receiving agency shall notify in writing the publishing organization or individual. The content has not yet met to amend and supplement the profile (specify unsatisfactory content).

Supplementary documents of the unit include:

+ Written explanation about the amendment and supplement of the organization or individual whose name is announced;

+ The cosmetic product proclamation report with the proclamation data (soft version of the proclamation report) or other modified and supplemented documents;

- Within 05 working days from the date of receipt of additional records to meet the regulations, the competent state management agency is responsible for issuing the receipt number of the cosmetic product proclamation report.

If a dossier of modification or supplementation does not meet regulations, within 05 working days from the date of receipt of the supplemented dossier, the dossier-receiving agency shall notify in writing not to issue the receipt number of the report. announced cosmetic products for this product.

Within 3 months from the date of issuance of the written notice according to the above-mentioned supplementation, if the competent state management agency does not receive the supplementary dossier of the organization or individual whose name is announced, the dossier published profiles are no longer valid. In this case, if the organization or individual wants to continue the publication, they must submit a new dossier and pay a new fee as prescribed.

Legal basis:  Circular 06/2011 / TT-BYT .