CONDITION FOR BUSINESS OF COSMETIC PRODUCTS

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04Jul

CONDITION FOR BUSINESS OF COSMETIC PRODUCTS

I. THE COSMETIC PRODUCT PROCLAMATION REGULATION

  • The cosmetic product on the market just permitted selling cosmetic when be issued the number of cosmetic product proclamation receiving by the authority agencies.
  • Cosmetic product proclamation fee is implemented.
  • Must have the function of cosmetic business in Vietnam.
  • Must satisfy the ASEAN’s instruction of the cosmetic product feature proclamation (Appendix No 3-MP).

1.1 The cosmetic proclamation dossier

1.1.1. Cosmetic product proclamation report (02 coppies)

1.1.2. Copy of business registration certificate. In case the cosmetic domestic produced, but organizations, individuals who be responsible for putting products on the market are not the manufacturer must have a copy of business registration certificate of the producer (have legal notarized);

1.1.3. Original or notarized copy of letter of attorney.

1.1.4. Certificate of free sale (CFS) is only applied for import cosmetic product proclamation.

1.2 The manner to establish the cosmetic product proclamation report and the proclamation data

1.2.1. The proclamation report

a) To follow the form in appendix No 01-MP, the manner to write contents in the cosmetic product report shall followed the instruction in the appendix No 02-MP. The proclamation report must be signed by the representative under laws.

b) Every cosmetic product proclaimed in a proclamation report. The cases below may joint make a proclamation report:

  • Products are packed with a joint name and sold out in form of a product set.
  • Products have same name, same product line with similar formulas but different in color or smell. For products of hair dye, perfume, must be separate proclaimed with each color, each smell.
  • Other kinds will be decided by the Drug Administration of Vietnam – The Ministry of Health based on the ASEAN Cosmetic Association’s decision.

c) The manner to write component of formula which are composed in the cosmetic product:

Components in the product formula must be efficiently listed in descending order of content. Components with less than 1% content can be listed in whatever order after components with more than 1%.

d) The language in the proclamation report may be in Vietnamese or English, exception these contents below must be written in Vietnamese or in Vietnamese and English:

  • Section 3 (the usage purpose),
  • Section 7 (the information of organization, individual who are responsible for putting products on the market),
  • Section 8 (information of enterprise’s representative under the law),
  • Section 9 (information of import company).

1.2.2. The proclamation data (the soft version of the proclamation report):

a) Direct declaration: Organizations or individuals, who signed on the cosmetic product proclamation, must send the text to the Drug Administration of Vietnam under the Ministry of Health to be issued an entry account to access the cosmetic management database, and fill in forms in the database directly. The proclamation report which is submitted to the competent state management agency must be printed out from that database.

b) Access the Drug Administration of Vietnam’s electronic information page (website), download the database of the cosmetic product report (Appendix 01-MP), fill all the information into the database according to the law regulation, save to the electronic device (USB, CD-ROM, etc.). The proclamation report which is to be submitted to the Government’s Management Office must be printed from that database.

1.3 Procedure of receiving and solving proclamation dossier

1.3.1. 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:

a) Regarding to the export cosmetic: to apply the cosmetic product proclamation dossier at the Drug Administration of Vietnam – the Ministry of Health.

b) Regarding to the cosmetic produced by domestic organizations, individuals: to 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.

1.3.2. Handling the cosmetic product proclamation dossier:

a) 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.

b) In case the proclamation dossier which still does not satisfy provisions of Circular 06/2011/TT-BYT, 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, the 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.

c) Within 03 months since the announcement document is issued as provided at point b of this clause; 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.

1.4 The effect time of the receipt number of cosmetic product proclamation report

The receipt number of cosmetic product proclamation report shall be valid for 05 years since issuing day. When out of the expiration date, 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.

II. COSMETIC PRODUCTS INFORMATION DOSIER

Every cosmetic product must get a Product Information File (PIF) when delivered to the market in accordance with ASEAN’s instruction which is saved at the address of organizations or individuals who are responsible for putting the product on the market.

The Product Information File involves of the following 04 parts:

a) Part 1: Administrative documents and a summary of product             

b) Part 2: Material quality

c) Part 3: Product quality

d) Part 4: Safety and efficiency

III. EXPORT OR IMPORT COSMETIC

3.1 Export cosmetic

Export of cosmetic must be implemented at the Customs agency in accordance with the current law regulation and the import country’s requirements.

3.2 The file, procedure of issuing the Certificate of Free Sale (CFS) in regard to the cosmetic which has been domestic produced for export

3.2.1. The CFS issuing request file includes

a) The CFS issuing request applying (Appendix IV of the February 10, 2010 Decision No 10/2010/QD-TTg of the Prime Minister, on providing the certificate of free sale for the export or import commodities, products) must be fully regularly enumerated.

b) The copy of the cosmetic product proclamation report has been issued the receipt No (the copy sealed by trader who suggest for the CFS granting).

 3.2.2.The issuing of the Certificate of Free Sale (CFS) for cosmetics which are domestic produced for export must be implemented according to regulations in Chapter II of the February 10, 2010 Decision No 10/2010/QD-TTg of the Prime Minister, providing the certificate of free sale for export or import commodities, products; moreover:

a) The domestic cosmetic for export purpose is issued the CFS when it is issued the cosmetic product proclamation receipt number by competent state management agency.

b) The export trader must register the trader file at the Health department where have cosmetic manufacturing plant and  make CFS issuing procedure for export cosmetic goods.

c) Every CFS is issued for 01 or many products (CFS pattern in regard to Appendix 12-MP) and become effective in next 02 years since issued day.

3.2.3. The cost or the fee for the CFS issuing is implemented according to the current regulation (The cost or the fee for the CFS issuing is calculated on product in 01 cosmetic product proclamation report with issued receipt number).

3.2.4. The Department of Health in central-affiliated cities and provinces are competent agencies in issuing and managing CFS of export cosmetics which are manufactured in that area (where the manufacturing plant is placed).

3.3 The file, the procedure of issuing the certificate of organization satisfying principles and norms of the “Cosmetic good manufacturing Practice” of the ASEAN Association (CGMP- ASEAN), which serves for the export demand

3.3.1. The manufacturing organization which has demand to be issued the certificate of organization satisfying principles and standard of the “Cosmetic Good Manufacturing Practice” of the ASEAN Association (CGMP- ASEAN), which serves for the export demand, sends the consideration registration file to the Drug Administration of Vietnam – The Ministry of Health. The file is inclusive of:

a) The consideration registration applying of “Cosmetic Good Manufacturing Practice” (Appendix No 13-MP);

b) The copy of Business Registration Certificate or the Investment license;

c) The organization chart and human of organization (the organization chart must clearly presents the  name, job title, technical, professional level of officers who are in charge of parts), the working process and experiences in the assigned fields of the officers who are in charge of parts (production, quality control, quality asurance, warehouse);

d) The training program, assessment results of training the “Cosmetic Good Manufacturing Practice” at organization;

đ) The location chart and design of factory (includes: site master file; personnel flow; material, packaging, semi-finished product, finished product flow; waste-treatment system layout);

e) The list of factory’s current equipments (involves process equipments and cosmetic quality testing equipments) has to clearly states name, manufacture year, manufacture country and situation of equipment);

g) The list of goods which are being manufactured or estimated produced (state clearly the product form);

h) The self-inspection report of “Cosmetic Good Manufacturing Practice” (in there must clearly states inspection time, inspector team members, self-inspection purpose, self-inspection results and timeline proposals and corrective action of findings).

3.3.2. The authority of receiving and handling file

The Drug Administration of Vietnam – The Ministry of Health is obligated to consider files, plan and make decision to establish auditor team, inform to organization at least 10 days before implementing audit.

3.3.3. The certificate of organization satisfying principles and guideline of “Cosmetic Good Manufacturing Practice” is valid in 03 years since the issuing day.

3.3.4. The manufacture organization (the GMP registration organization for short) must pay the fee for evaluating of cosmetic manufacture standards and conditions, in accordance with the current regulations.

3.4 Import of cosmetic

3.4.1. Cosmetic products which have been issued the valid cosmetic product proclamation receipt number by the Drug Administration of Vietnam – The Ministry of Health, permitted to import in Vietnam. The import procedure is implemented at the Customs agency according to the current regulations. When implementing the import procedure, enterprise presents to the Customs agency the cosmetic product proclamation report which has been issued the receipt number by the Drug Administration of Vietnam – The Ministry of Health.

3.4.2. Import of cosmetic in some special situations (not obligated to implement the cosmetic product proclamation according to this Circular’s regulation);

a) Organization or individual who imports cosmetic in order to study and testing must send the cosmetic import order used for studying and testing to the Drug Administration of Vietnam – The Ministry of Health (Appendix No 14-MP). The maximum amount for each product is 10 patterns.

The cosmetic import order which is used for studying and testing is made into 03 copies. After approved, 02 copies are saved at the Drug Administration of Vietnam, 01 version is sent back to the organization. The copy which is sent back to the organization shall be sealed with “The copy for sending to enterprise” in order to show to the customs agency when make customs procedure.

The cosmetic products which are imported for studying, testing have to be used in the right purpose and not to permit to put on the market.

b) The organizations, individuals who receive cosmetic as gifts must implement the import procedure at the customs agency as the regulations. The overall value of each gift receiving time is not to exceed the cargo quantum which is exempted of the imposed tax in the current regulations.

The import cosmetic patterns such as gifts shall be not permitted to put on the market. c) The organizations, individuals who imports cosmetic for displaying at fair, gallery and other temporary import for re-export situations must implement procedure of applying for temporary import for re-export license of the Ministry of Industry and Trade in accordance with the current regulations