The manner to establish the cosmetic product proclamation report and the proclamation data in Vietnam

The manner to establish the cosmetic product proclamation report and the proclamation data in Vietnam (Image from Internet)

1. The manner to establish the cosmetic product proclamation report and the proclamation data in Vietnam

The manner to establish the cosmetic product proclamation report and the proclamation data in Vietnam is outlined in Article 5 of Circular 06/2011/TT-BYT as follows:

* Cosmetic Product Notification Form:

- The Cosmetic Product Notification Form is prepared according to the template in Appendix No. 01-MP. The notification form must be signed by the legal representative, stamped with the seal of the organization or individual responsible for bringing the product to market. The content in the Cosmetic Product Notification Form must be filled out according to the instructions in Appendix No. 02-MP.

- Each cosmetic product is declared in one notification form.

For cosmetic products fully manufactured at different manufacturing companies, separate declarations are required. In cases where more than one company participates in various production stages to produce a complete product, the form is consolidated into one notification form, specifying the full name and address of each company.

Products owned by the same owner that fall into the following cases are allowed to be declared in one notification form:

+ Products packaged under the same name and sold as a set of products.

+ Products with the same name and product line having similar formulas but different colors or scents. For hair dyes and perfumes, separate notifications are required for each color or scent.

+ Other cases will be decided by the Drug Administration of the Ministry of Health based on the decision of the ASEAN Cosmetic Committee.

- How to list the formulation ingredients in the cosmetic product:

+ The ingredients in the product formulation must be fully listed in descending order of concentration. Fragrance and flavoring ingredients can be written as "perfume", "fragrance", "flavor", or "aroma." Ingredients with less than 1% concentration may be listed in any order after those with higher than 1%. Coloring agents can be listed in any order after other ingredients, according to color index (CI) or names as in Annex IV of the ASEAN Cosmetic Directive. Cosmetic products used for makeup that come in different colors can list all colors in the "may contain" or "+/-" section.

+ Indicate the full percentage of ingredients regulated about concentration limits as specified in the Annexes of the ASEAN Cosmetic Directive. The separation between units and decimals must be indicated with a comma (",").

+ Ingredient names must be listed using international nomenclature (International Nomenclature of Cosmetic Ingredients - INCI) as specified in the latest publications: International Cosmetic Ingredient Dictionary, British Pharmacopoeia, United States Pharmacopoeia, Chemical Abstract Services, Japanese Standard Cosmetic Ingredient, and publications of Japanese Cosmetic Ingredients Codex. Botanical names and extracts must be written with the scientific names including genus and species (the genus name may be abbreviated). Ingredients of animal origin must specify the precise scientific name of the animal.

The following substances are not considered cosmetic ingredients:

+ Impurities in raw materials.

+ Auxiliary materials used for technical purposes but are not present in the final product.

+ Materials used in necessary quantities as solvents or carriers of fragrance ingredients.

- The language for presenting in the Notification Form is Vietnamese or English. Sections 3 (Intended Use), 7 (Information on the Organization/Individual Responsible for Marketing the Product), 8 (Information on the Legal Representative), 9 (Information on the Importing Company) must be in Vietnamese or both Vietnamese and English.

* Disclosure Data (electronic copy of the Notification Form): Organizations or individuals can submit disclosure data in accordance with Clause 1, Article 4 of Circular 06/2011/TT-BYT using one of the following methods:

- Direct declaration: The organization/individual declaring the cosmetic product sends a written request to the Drug Administration of the Ministry of Health to obtain an access account to the cosmetic management database for direct declaration. The Notification Form submitted to the competent state management agency must be printed from the database.

- Access the Drug Administration's website, download the database of the Cosmetic Product Notification Form (Appendix No. 01-MP), fill out the required information according to regulations, save it on electronic storage media (USB, CD-ROM, ...). The Notification Form submitted to the competent state management agency must be printed from the database.

The organization or individual declaring the product is fully responsible for the accuracy and consistency of the contents of the Notification Form (signed and stamped) with the disclosed data (electronic copy) submitted to the management agency.

2. Procedure of receiving and solving cosmetic product proclamation dossier in Vietnam

The Procedure of receiving and solving cosmetic product proclamation dossier in Vietnam is stipulated in Article 7 of Circular 06/2011/TT-BYT as follows:

- The notification dossier for a cosmetic product is prepared in 01 set, submitted directly or via postal service to the competent state management agency as follows:

+ For imported cosmetics: The organization/individual responsible for marketing the product submits the notification dossier to the Drug Administration of the Ministry of Health.

+ For domestically manufactured cosmetics: The organization/individual responsible for marketing the product submits the notification dossier to the Department of Health where the manufacturing plant is located. Cosmetic products manufactured and packaged from imported semi-finished products are considered as domestically manufactured products.

+ For cosmetics traded within the Industrial Trade Zone under the Moc Bai Border Economic Zone, Tay Ninh Province, the notification is performed at the Management Board of the Moc Bai Border Economic Zone; for cosmetics traded within the Special Economic-Commercial Zone of Lao Bao, Quang Tri Province, the notification is performed at the Management Board of the Quang Tri Economic Zone.

Bringing cosmetics from the Industrial Trade Zone under the Moc Bai Border Economic Zone into functional areas within the Moc Bai Border Economic Zone or into the domestic market for trading; bringing cosmetics from the Special Economic-Commercial Zone of Lao Bao into the domestic market for trading must be declared at the Drug Administration of the Ministry of Health according to the regulations of Circular 06/2011/TT-BYT (the organization/individual declaring the cosmetic product must have a business function in cosmetics in Vietnam and outside these two zones).

- Processing of the cosmetic product notification dossier:

+ Within 03 working days from the date of receiving a valid notification dossier and the prescribed disclosure fee, the competent state management agency is responsible for issuing the reception number of the Cosmetic Product Notification Form.

+ In cases where the notification dossier does not comply with the regulations of this Circular, within 05 working days from the date of receiving the dossier, the receiving agency shall notify in writing the organization/individual declaring the areas that do not meet the requirements to amend and supplement the dossier (specifically stating the areas that do not meet the requirements).

The supplementary dossier includes:

++ An explanatory document on the amendments and supplements by the organization/individual declaring;

++ A Cosmetic Product Notification Form accompanied by disclosure data (electronic copy of the Notification Form) or other amended and supplemented documents;

Within 05 working days from the date of receiving the supplementary dossier that meets the regulations of Circular 06/2011/TT-BYT, the competent state management agency is responsible for issuing the reception number of the Cosmetic Product Notification Form.

In cases where the amended and supplemented dossier does not comply with the regulations of Circular 06/2011/TT-BYT, within 05 working days from the date of receiving the supplementary dossier, the receiving agency shall notify in writing that the reception number of the Cosmetic Product Notification Form shall not be issued for this product.

- Within 03 months from the date of issuing the notification according to point b, clause 3, Article 7 of Circular 06/2011/TT-BYT, if the competent state management agency does not receive the supplementary dossier from the organization/individual declaring, the notification dossier will no longer be valid. In this case, if the organization/individual wishes to continue the notification, they must submit a new dossier and pay the new fee according to the regulations.

>> CLICK HERE TO READ THIS ARTICLE IN VIETNAMESE