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Process and procedure for imported cosmetic proclamation

1. General Regulations1
  • Organizations or individuals who are responsible for bringing the cosmetic product to the market, only permitted to sell cosmetic when be issued the number of cosmetic product proclamation by the authority agencies as well as responsible for safety, effectiveness, and quality of product. The authority agencies shall carry out the inspection of after-sales service when the product has been being sold in the market;
  • Paying fee for Cosmetic product proclamation;
  • Must have the function of cosmetic business in Vietnam;
  • Cosmetic product feature proclamation (the cosmetic usage purpose) must satisfy the ASEAN’s instruction of the cosmetic product feature proclamation.
2. Imported Cosmetic Proclamation Dossier
According to circular No. 06/2011/TT-BYT, to conduct an imported cosmetic proclamation before importing to Vietnam, the organizations, individuals must prepare the following documents2:
  • Cosmetic product proclamation report (02 versions) with the proclamation data (soft version of proclamation report);
  • Original or notarized copy of power of attorney (“POA”) from the producers or the owners of products authorizing organizations, individuals who are responsible for bringing products to the market in Vietnam. The power of attorney must be a notarized and consular legalized copy in accordance with the provisions of law, except for being exempted of the consular legalization according to international treaties in which Vietnam is a member. The power of attorney must satisfy the following requirements3:
  1. The language of POA must be Vietnamese or English or bilingual Vietnamese and English;
  2. The producer’s name and address; in case the mandator  is the owner of product, must clearly state name and address of the owner of product, and name and address of the producer as well;
  3. The name and address of authorized organizations, individuals;
  4. The scope of authorization (named to proclaim and distribute the cosmetic product in Vietnam);
  5. The label or name of authorized product;
  6. The period of authorization;
  7. The commitment of the producer or the owner of product to provide sufficient product information file (PIF) for organizations or individuals who are responsible for bringing product to market;
  8. Name, position, and the signature of the representative of mandator.
  • Certificate of free sale (CFS):
a. In case of notification of a cosmetic product imported from a non-CPTPP member state, there must be a CFS meeting the following requirements 4:
  1. The CFS is an unexpired and authentic copy issued by the exporting country. If the CFS has no expiry date, it must be issued within the last 24 months;
  2. The CFS must be consular legalized according to regulations of laws, unless it is exempt from legalization under treaties to which Vietnam is a signatory;
  3. The CFS must contain the basic information prescribed in Article 36 of the Law on Foreign Trade Management and Article 10.3 of the  Decree No. 69/2018/ND-CP: “Name of CFS issuing authority; CFS number and date of issue; Goods eligible for CFS; Type or category of goods eligible for CFS; Manufacturer’s name and address; The CFS clearly indicates that the goods are produced and freely sold in the market or the country of production or the country by which the CFS is issued; Full name and signature of the CFS signatory and seal of the CFS issuing authority”.
  4. bCFSs are not required for notification of cosmetic products imported from CPTPP member states (all states and customs territories in which CPTPP has entered into force).”
3. Process and procedure of imported cosmetic proclamation5:

Step 1: Submitting the dossier

The dossiers of cosmetic product proclamation are made into one set, submitted directly or posted to Drug Administration of Vietnam - Ministry of Health (for imported products).

Step 2: Handling the cosmetic proclamation dossier:

Within 03 working days since receiving the valid proclamation dossier and proclamation fee in accordance with the provisions, Drug Administration of Vietnam - Ministry of Health are obligated to issue the receipt number of the cosmetic product proclamation report.

In case the proclamation dossier which still does not satisfy provisions of law, 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, 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 the 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 date the announcement document is issued; if 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.
 
4. The effect time of the cosmetic product proclamation report:

The receipt number of cosmetic product proclamation report shall be valid for 05 years since issuing day. After 05-year-expiry, if organizations or individuals want to continue selling product in the market, they must make a proclamation again before the expiry of the receipt number of cosmetic product proclamation report and pay a regulated cost fee.
 
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