Vietnam: Procedure of receiving and solving proclamation dossier

According to Article 7 of Circular No. 06/2011/TT-BYT of the Ministry of Health of Vietnam, the procedure of receiving and solving proclamation dossier is as follows:

1. Cosmetic product proclamation dossier

The collecting and solving cosmetic product proclamation dossier is packed up into one set, submitted directly or posted to the following competent state management agency:

- Regarding the export cosmetic: organizations or individuals who are responsible for bringing product into the market apply the cosmetic product proclamation dossier at the Medicine Management Bureau – the Ministry of Health.

- Regarding the cosmetics produced by domestic organizations, individuals: organizations or individuals who are responsible for putting product on market apply the cosmetic product proclamation dossier at the Department of Health in which have production factory. The cosmetic products which are produced, packed from the import semi finished products shall be considered domestic produced products.

- Regarding to the cosmetic trading in the scope of industrial trading area of Moc Bai border gate economic area in Tay Ninh province implement of the proclamation at the Moc Bai border gate Economical Area Management Board; the cosmetic trading in the scope of Lao Bao special economic -trade area in Quang Tri province implement of the proclamation at the Economic Area Management Board of Quang Tri province.

The transporting cosmetic from the industrial trade area of Moc Bai border gate economic area in Tay Ninh province into other function areas in Moc Bai border gate economic area of Tay Ninh province or into the domestic market for trading; transporting cosmetic from the Lao Bao special economic -trade area in Quang Tri province into the domestic market for trading must implement of the proclamation at the Medicine Management Department– the Health Ministry in accordance with regulations of this Circular (organizations or individuals, who undersign on the cosmetic proclamation, must have function to trade on cosmetic in Vietnam, and not located in two these areas).

2. Handling the cosmetic product proclamation dossier:

Within 03 working days since receiving the regular proclamation dossier and proclamation fee as provided competent state management agencies are obligated to issue the number of receiving the cosmetic product proclamation report.

In case the proclamation dossier which still does not satisfy provisions of this Circular, within 05 working days since receiving dossier, the dossier receiving agency must announce in writing for organizations or individuals of contents, which having not satisfied yet, to fix, amend dossier (figuring out unsatisfied contents in details).

The amending dossier includes:

- A document explains amending and supplementing of the organization or the individual whose name is on the cosmetic proclamation;

- The cosmetic product proclamation report with the proclamation data (soft copy of the proclamation report) or other amended and supplemented documents;

Within 05 working days since receiving the supplementing dossier satisfying the regulations in this circular, competent state management agencies are obligated to issue the receipt number of the product proclamation report.

In case the amending and supplementing dossier does not satisfy this circular’s regulation, within 05 working days since receiving the supplementing dossier, the dossier receiving agency must announce organizations or individuals in a text document of not issuing the receipt number of the product proclamation report.

Within 03 months since the announcement document is issued as provided at point b of this clause; if the competent state management agency still does not receive any supplementing dossier  from organizations or individuals whose name are on the cosmetic proclamation, the proclamation dossier shall be invalid. In this case, if organizations or individuals want to continue the proclamation, they must submit a new dossier and pay a new fee according to the regulations.

View details at Circular No. 06/2011/TT-BYT of the Ministry of Health of Vietnam, effective from April 01, 2011.

Thuy Tram

>> CLICK HERE TO READ THIS ARTICLE IN VIETNAMESE