Circular No. 06/2011/TT-BYT on cosmetic management

CIRCULAR

Regulations on cosmetic management

Pursuant to Decree No. 188/2007/NĐ-CP dated December 27, 2007 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

Pursuant to Decree No. 132/2008/NĐ-CP dated December 31, 2008 of the Government detailing a number of provisions of the Law on Product Quality;

Pursuant to Decree No. 24/2003/NĐ-CP dated March 13, 2003 of the Government detailing the implementation of the Advertising Ordinance;

Pursuant to Decree No. 89/2006/NĐ-CP dated August 30, 2006 of the Government stipulating product labeling;

Pursuant to Decree No. 12/2006/NĐ-CP dated January 23, 2006 of the Government detailing the implementation of the Law on Trade regarding international trade activities and agency buying, selling, processing, and transiting goods with foreign countries;

Pursuant to Decision No. 10/2010/QĐ-TTg dated February 10, 2010 of the Prime Minister stipulating the Free Circulation Certificate for products and goods for export and import;

To implement the Agreement on Harmonization in Cosmetic Management signed by the member states of the Association of Southeast Asian Nations on September 2, 2003 (referred to as the ASEAN Cosmetic Agreement), the Ministry of Health hereby stipulates regulations on cosmetic management as follows:

PART I
GENERAL PROVISIONS

Article 1. Scope of Regulation and Applicability

1. These Circulars regulate the management of cosmetics produced domestically and imported for circulation within the territory of Vietnam, including: product announcement; product information files; safety requirements for products; cosmetic labeling; cosmetic advertising; export and import of cosmetics; sampling of cosmetics for quality testing; inspection, supervision, and handling of violations; responsibilities of organizations and individuals producing, trading, and importing cosmetics, and rights of consumers.

2. These Circulars apply to state management agencies for cosmetics, organizations and individuals conducting activities related to product announcements, information, advertising, export, import, production, and trading of cosmetics in Vietnam.

Article 2. Explanation of terms

In this Circular, the following terms shall be understood as follows:

1. A cosmetic product is a substance or preparation intended to be applied to external parts of the human body (skin, hair system, nails, lips, and external genital organs) or teeth and oral mucosa with the primary purpose of cleansing, perfuming, altering appearance, adjusting odor, protecting the body, or maintaining the body in good condition.

2. The name of a cosmetic product is the name assigned to a cosmetic product, which may be a newly created name together with a brand or the manufacturer's name. Characters constituting the product name must be based on Latin letters.

3. The organization or individual responsible for bringing the product to market is the organization or individual named on the product announcement file and is responsible for that cosmetic product on the market.

4. The receipt number of the cosmetic product announcement form is the number issued by the competent state management agency upon receipt of the cosmetic product announcement file. The receipt number of the announcement form confirms that the cosmetic product has been declared by the organization or individual responsible for bringing the product to market to the competent state management agency about its circulation on the market but does not confirm that the product meets all the requirements of the ASEAN Cosmetic Agreement and its annexes (Annexes).

5. The owner of a cosmetic product is the organization or individual holding the formula, production process, and quality standards of the product.

The stability of a product is the ability of the product to maintain its initial characteristics when stored under appropriate conditions, particularly ensuring safety requirements.

7. The quantity of goods is the amount of cosmetic expressed by net weight or actual volume according to the metric system or both the metric and imperial systems.

8. Cosmetic labeling is the written, printed, drawn, or photographed text, images affixed, printed, attached, cast, engraved, or carved directly onto the goods, commercial packaging of the goods, or other materials attached to the goods, commercial packaging of the goods.

9. Cosmetic labeling is the representation of essential information about cosmetics on the label for users to recognize, choose, and use correctly; for manufacturers and traders to promote their products; and for competent authorities to conduct inspections and controls.

10. Primary labelc is the label first affixed to the commercial packaging of cosmetics.

11. Secondary label is the label displaying mandatory information translated from the original label of cosmetics from a foreign language into Vietnamese and supplementing mandatory information in Vietnamese as prescribed by these Circulars that are missing from the original label of cosmetics.

12. Commercial packaging of cosmetics is the packaging containing cosmetics and circulating with them. Commercial packaging of cosmetics includes two types: Direct packaging and outer packaging.

a) Direct packaging is the packaging containing goods, coming into direct contact with the goods, forming a shape or wrapping tightly around the shape of the goods.

b) Outer packaging is the packaging used to package one or more units of goods with direct packaging.

13. Circulation of cosmetics is the activity of displaying, transporting, and storing goods during the trading process, except for transportation of goods by organizations and individuals importing goods from the customs gate to storage warehouses.

14. The production batch number of cosmetics is a symbol consisting of numbers or letters, or a combination of both, used to identify a batch of products and allow tracing the entire history of a batch of products, including all stages of the production process, quality control, and distribution of that batch.

15. The production date of cosmetics is the time mark indicating the completion of manufacturing, processing, packaging, or other final steps of a batch of products.

16. The expiration date of cosmetics (use-by date) is the time limit set for a batch of cosmetics beyond which it is not allowed to circulate or use.

17. Best before date is the time recommended by the manufacturer for use when the product quality is at its optimal level.

18. The country of origin of cosmetics is the country or region where the entire cosmetic product is manufactured or where the final basic processing stage is carried out in cases where multiple countries or regions are involved in the production process of the cosmetic product.

19. Free Sale Certificate (CFS - Certificate of Free Sale) is a certificate issued by the competent authority of the exporting country to the exporter of cosmetics listed on the CFS, certifying that such cosmetics have been manufactured and are permitted to circulate freely in the exporting country.

20. Usage instructions are necessary information to guide users on how to safely and reasonably use cosmetics. Usage instructions may be printed directly on the packaging or provided as accompanying documentation with the cosmetic product packaging, including usage instructions and other contents as prescribed.

21. Cosmetics advertising refers to activities introducing and promoting cosmetics aimed at promoting the production, sale, and use of cosmetics.

22. Seminars and events to introduce cosmetics are conferences for introducing or discussing specialized topics with consumers regarding issues deeply related to cosmetics.

23. Advertiser is an organization or individual who has the need to advertise about cosmetics produced or distributed by themselves.

24. Advertising publisher is an organization or individual delivering cosmetic advertisements to consumers, including news agencies, radio stations, television stations, publishers, organizations managing computer network information, organizers of cultural, sports, trade fair, exhibition programs, and organizations or individuals using other advertising means.

25. The ASEAN Cosmetics Council is the representative body of ASEAN member countries responsible for monitoring, deciding, and resolving disputes related to the implementation of the ASEAN Cosmetics Agreement.

Chapter II
REGISTRATION OF COSMETIC PRODUCTS

Article 3. Provisions on the registration of cosmetic products

1. Organizations and individuals responsible for bringing cosmetic products to the market are only allowed to circulate cosmetics when they have received from the competent state management agency the acceptance number of the Cosmetic Product Registration Form and must fully bear responsibility for the safety, efficacy, and quality of the product. The competent state agency will conduct post-market inspections when the product is circulating on the market.

2. Fees for registering cosmetic products shall be implemented according to current regulations.

3. Organizations and individuals responsible for circulating products on the market must have the function of operating cosmetics in Vietnam.

4. The declaration of the characteristics of cosmetic products (the purpose of use of the product) must comply with ASEAN's guidelines on declaring the characteristics of cosmetic products (Annex No. 03-MP).

Article 4. Documents for registering cosmetic products

Documents for registering cosmetic products include the following:

2. A copy of the Business Registration Certificate of the organization or individual responsible for bringing the product to the market (signed and stamped by the enterprise). In cases where domestic cosmetics are produced and the organization or individual responsible for bringing the product to the market is not the manufacturer, a copy of the Business Registration Certificate of the manufacturer (with valid certification) must be provided;

3. Original or certified true copy of the Power of Attorney from the manufacturer or owner of the product authorizing the organization or individual responsible for bringing the product to the market to distribute cosmetic products in Vietnam (applicable to imported cosmetics and domestically produced cosmetics where the organization or individual responsible for bringing the product to the market is not the manufacturer). For imported products, the Power of Attorney must be a certified true copy with apostille authentication according to the law, except in cases exempted from apostille authentication under international treaties to which Vietnam is a party. The Power of Attorney must meet the requirements stipulated in Article 6 of this Circular.

4. Free Sale Certificate (CFS): Only applicable to the registration of imported cosmetic products and must meet the following requirements:

a) The CFS issued by the local authority must be the original or a certified true copy, still valid. If the CFS does not specify a validity period, it must be issued within 24 months from the date of issuance.

b) The CFS must be authenticated according to the law, except in cases exempted from apostille authentication under international treaties to which Vietnam is a party.

1. Product Notification Form for Cosmetics:

a) The Product Notification Form for Cosmetics shall be established according to Model Appendix No. 01-MP. The Notification Form must be signed by the legal representative and stamped with the seal of the organization or individual responsible for bringing the product to market. The recording of contents in the Product Notification Form for Cosmetics shall follow the guidelines set out in Appendix No. 02-MP..

b) Each cosmetic product shall be notified on a separate Notification Form.

If a complete cosmetic product is manufactured at different production companies, each company shall notify separately. In cases where more than one company participates in the production process to produce a complete product, they shall jointly establish a single Notification Form and clearly state the name and full address of each company.

Cosmetics products under the same owner that fall into any of the following situations may be notified on a single Notification Form:

- Products packaged under a common name and sold as a set of products.

- Products with the same name, belonging to the same product line, having similar formulas but different colors or scents. For hair dye and perfume products, each color or scent shall be notified separately.

- Other cases will be decided by the Drug Administration of Vietnam based on the decision of the ASEAN Cosmetics Council.

c) Recording of ingredients in the formula of cosmetics products:

- Ingredients in the product formula must be fully recorded in descending order of concentration. Fragrance components, flavoring agents, and their raw materials can be listed as "fragrances" (perfume, fragrance, flavor, aroma). Ingredients with concentrations less than 1% may be listed in any order after those with concentrations greater than 1%. Colorants may be listed in any order after other ingredients according to the CI number or by name as specified in Annex IV of the ASEAN Cosmetics Agreement. Cosmetics products used for makeup, in various colors, may list all colorants under the heading "may contain" or "+/-".

- Fully record the percentage of ingredients subject to concentration limits as specified in the Appendices of the ASEAN Cosmetics Agreement. A comma (" , ") shall be used between the unit and decimal places.

- Ingredient names must be recorded using the International Nomenclature of Cosmetic Ingredients (INCI) as defined in the latest editions: International Cosmetic Ingredient Dictionary, British Pharmacopoeia, United States Pharmacopeia, Chemical Abstracts Service, Japanese Standard Cosmetic Ingredient, Japanese Cosmetic Ingredients Codex. Plant names and plant extracts must be written in scientific names including genus and species (genus names of plants may be abbreviated). Animal-derived ingredients must specify the scientific name of the animal species.

The following substances shall not be considered as ingredients of cosmetics:

- Impurities in raw materials.

- Auxiliary materials used for technical purposes but not present in the finished product.

- Materials used in quantities necessary as solvents or carriers for fragrance components.

d) The language used in the Notification Form shall be Vietnamese or English. Contents recorded in Item 3 (Purpose of Use), Item 7 (Information about the Organization or Individual Responsible for Bringing the Product to Market), Item 8 (Information about the Legal Representative of the Company), and Item 9 (Information about the Importing Company) in the Notification Form must be recorded in Vietnamese or Vietnamese and English.

2. Notification Data (Electronic Version of the Notification Form): Organizations and individuals may submit notification data as prescribed in Clause 1 of Article 4 of this Circular in either of the following ways:

a) Direct Declaration: The organization or individual named in the notification of the cosmetic product sends a document to the Drug Administration of Vietnam - Ministry of Health to obtain access credentials to the cosmetic management database, and directly declare on the database. The Notification Form submitted to the competent authority must be printed from that database.

b) Access the electronic information website of the Drug Administration, download the cosmetic product Notification Form database (Appendix No. 01-MP), fill in the required information according to regulations into the database, and back up to an electronic storage medium (USB, CD-ROM, etc.). The Notification Form submitted to the competent authority must be printed from that database.

The organization or individual named in the notification of the product shall bear full responsibility for the consistency of the contents of the signed and stamped Product Notification Form for Cosmetics with the declared or submitted notification data (electronic version) to the managing authority.

Article 6. Provisions on Power of Attorney

1. The language used shall be Vietnamese, English, or bilingual Vietnamese and English.

2. The power of attorney must contain the following contents:

a) Name and address of the manufacturer; in cases where the party granting the power of attorney is the owner of the product, the name and address of the product owner and the name and address of the manufacturer must be specified;

b) Name and address of the entity or individual authorized.

c) Scope of authorization (registration and distribution of cosmetic products in Vietnam);

d) Brand or name of the authorized product;

đ) Term of authorization;

e) Commitment of the manufacturer or product owner to provide complete Product Information File (PIF) to organizations or individuals responsible for bringing the product to market in Vietnam;

g) Name, position, signature of the representative of the party granting the power of attorney.

Article 7. Procedures for Acceptance and Processing of Cosmetic Product Registration Dossiers

a) For imported cosmetics: Organizations or individuals responsible for bringing the product to market submit the cosmetic product registration dossier to the Drug Administration of Vietnam under the Ministry of Health.

c) For cosmetics traded within the Moc Bai Border Economic Zone in Tay Ninh Province, the registration shall be carried out at the Management Board of the Moc Bai Border Economic Zone; for cosmetics traded within the Lao Bao Special Economic and Trade Zone in Thua Thien Hue Province, the registration shall be carried out at the Management Board of the Thua Thien Hue Province Economic Zone.

Bringing cosmetics from the Moc Bai Border Economic Zone in Tay Ninh Province into other functional zones within the Moc Bai Border Economic Zone in Tay Ninh Province or into the domestic market for trade; bringing cosmetics from the Lao Bao Special Economic and Trade Zone in Thua Thien Hue Province into the domestic market for trade must be registered with the Drug Administration of Vietnam under the Ministry of Health according to the provisions of this Circular (the organization or individual named in the cosmetic product registration must have the function of trading cosmetics in Vietnam and be outside these two zones).

2. Processing of cosmetic product registration dossiers:

a) Within three working days from the date of receipt of a valid registration dossier and registration fee as prescribed, the competent state management agency shall issue a receipt number for the cosmetic product registration form.

Supplementary documents of the unit include:

- A written explanation regarding the amendments and supplements by the organization or individual named in the registration;

- The cosmetic product registration form along with the registration data (soft copy of the registration form) or other documents that have been amended and supplemented;

Within five working days from the date of receipt of a supplementary dossier meeting the requirements of this Circular, the competent state management agency shall issue a receipt number for the cosmetic product registration form.

In cases where the amended and supplemented dossier does not meet the requirements of this Circular, within five working days from the date of receipt of the supplementary dossier, the receiving agency shall notify in writing that it will not issue a receipt number for the cosmetic product registration form for this product.

c) Within three months from the date of issuance of the notification as stipulated in point b of this clause, if the competent state management agency does not receive a supplementary dossier from the organization or individual named in the registration, the registration dossier will lose its validity. In this case, if the organization or individual wishes to continue the registration, they must submit a new dossier and pay the new registration fee as prescribed.

The Registration Number of the Cosmetic Product Notification Form shall be specified as follows: registration number + forward slash + year of issuance (last two digits) + forward slash + CBMP + hyphen + abbreviation of the name of the province, city, Economic Zone Management Board, or Drug Administration (DA) according to Appendix No. 04-MP.

Example: 135/11/CBMP-HN means that the Registration Number of the Cosmetic Product Notification Form is 135 issued by the Health Department of Hanoi in 2011.

Article 9. Changes to Published Contents

For cosmetic products that have been published and received a Registration Number of the Cosmetic Product Notification Form, when there are changes to the contents prescribed in Appendix No. 05-MP, the organizations or individuals responsible for bringing the product to market must submit a supplementary document (for contents not requiring new publication) along with relevant documentation related to the supplementary content and must obtain written approval from the competent state agency or implement new publication according to regulations (for contents requiring new publication).

Article 10. Validity of the Registration Number of the Cosmetic Product Notification Form

The Registration Number of the Cosmetic Product Notification Form is valid for five years from the date of issuance. Upon expiration of the five-year period, organizations or individuals wishing to continue circulating cosmetic products on the market must re-publish before the Registration Number of the Cosmetic Product Notification Form expires and must pay the prescribed fee.

Chapter III
COSMETIC PRODUCT INFORMATION FILE

Article 11. General Provisions on the Cosmetic Product Information File

Each cosmetic product put into circulation on the market must have a Cosmetic Product Information File (PIF - Product Information File) in accordance with ASEAN guidelines, which must be kept at the address of the organization or individual responsible for bringing the product to market.

Article 12. Contents of the Cosmetic Product Information File

1. The Cosmetic Product Information File consists of four parts as follows:

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

b) Part 2: Quality of raw materials;

c) Part 3: Quality of finished products;

d) Part 4: Safety and efficacy.

Detailed contents of the Cosmetic Product Information File are prescribed in Appendix No. 07-MP.

2. Part 1 of the Cosmetic Product Information File must be immediately presented to the inspection or supervisory authority upon request; other parts, if incomplete, must be presented within 15-60 days from the date of inspection as required by the competent authority.

Chapter IV
REQUIREMENTS FOR THE SAFETY OF COSMETIC PRODUCTS

Article 13. Requirements for the Safety of Cosmetic Products

Organizations and individuals responsible for bringing cosmetic products to market must ensure that their products are harmless to human health when used under normal conditions or suitable conditions as directed, consistent with the form of preparation, information on the label, usage instructions, special precautions, as well as other information provided by the manufacturer or product owner.

Manufacturers and product owners must assess the safety of each cosmetic product according to the ASEAN Guidelines for Safety Assessment of Cosmetics. Limits for heavy metals and microorganisms in cosmetics must meet the requirements of ASEAN as prescribed in Appendix No. 06-MP. The formula components of cosmetics must comply with the latest Annexes of the ASEAN Cosmetics Agreement (access addresses: www.dav.gov.vn send a text message www.aseansec.org).

Article 14. Prohibited components, components with specified concentration limits, content levels, and conditions for use in cosmetic product formulas

Organizations and individuals shall not bring to market cosmetic products containing:

1. Prohibited substances listed in Annex II for use in cosmetics, subject to accompanying conditions.

2. Components listed in Part I of Annex III, at concentrations or contents exceeding the prescribed limits or outside permitted conditions.

3. Coloring agents other than those listed in Part I of Annex IV, except when such coloring agents are used solely for hair dyeing purposes.

4. Coloring agents listed in Part I of Annex IV used outside the stated conditions.

5. Preservatives not included in the list in Part I of Annex VI.

6. Preservatives listed in Part I of Annex VI, at contents exceeding the prescribed limits or outside permitted conditions, except when these substances are used for specific purposes unrelated to their preservative function.

7. Ultraviolet filters not included in the list in Part I of Annex VII.

8. Ultraviolet filters listed in Part I of Annex VII but at contents exceeding the prescribed limits or outside permitted conditions.

The presence of substances listed in Annex II at trace levels is acceptable if unavoidable due to "Good Manufacturing Practices" for cosmetics and still meet the safety requirements for cosmetics as stipulated in Article 13 of this Circular.

Article 15. Cosmetic products containing the following components may still be circulated on the market

1. Components or raw materials listed in Part II of Annex III within the limits and under the conditions specified, until the date indicated in column (g) of this Annex.

2. Coloring agents listed in Part II of Annex IV within the permitted limits and under accepted conditions, until the date indicated in this Annex.

3. Preservatives listed in Part II of Annex VI within the permitted limits and under accepted conditions, until the date indicated in column (f) of this Annex. However, some of these components may be used at different concentrations for specific purposes clearly indicated in the product presentation.

4. Ultraviolet filters specified in Part II of Annex VII within the permitted limits and under the conditions specified, until the date indicated in column (f) of this Annex.

Regulations concerning the use of substances listed in the above Annexes may change according to decisions of the ASEAN Cosmetics Council. These regulations will automatically be updated and effective in Vietnam.

Chapter V
LABELING OF COSMETICS

Article 16. Position of cosmetic labels

1. Cosmetic labels must be affixed to goods or commercial packaging in a position where all required label information can be easily and fully observed without disassembling parts of the goods.

2. In cases where outer packaging cannot be opened, the outer packaging must bear a label that fully displays all mandatory information.

Article 17. Size, form, and content of the label

1. Organizations and individuals responsible for bringing cosmetic products to the market shall determine the size of the cosmetic product label themselves but must ensure that the information on the label is easily readable with the naked eye. The content of the label and the supplementary label (if any) must be truthful, clear, accurate, and reflect the true characteristics of the product.

2. The color of letters, numerals, drawings, images, symbols, and signs presented on the cosmetic product label must be clear. The color of letters and numerals must contrast with the background of the label.

Article 18. Mandatory information to be marked on the label

1. The cosmetic product label must comply with the ASEAN cosmetic labeling requirements. The following information must be displayed on the product label:

a) The name of the product and its function, except when the presentation form of the product clearly shows the function of the product;

b) Usage instructions, except when the presentation form clearly shows the usage method of the product;

c) Full formula ingredients: All ingredients must be listed according to the international nomenclature specified in the latest publications referred to in Point c Clause 1 Article 5 of this Circular (percentage ratios of the ingredients do not need to be indicated);

d) Name of the country of production;

đ) Name and address of the organization or individual responsible for bringing the product to the market (fully recorded in Vietnamese according to the Business Registration Certificate or Investment License);

e) Net quantity expressed in mass or volume, according to the metric system or both the metric and imperial systems;

g) Production batch number;

h) Manufacturing date or expiration date must be clearly stated (for example: day/month/year). The date format must clearly include month and year or day, month, and year in the correct order. The term "expiration date" or "best before date" may be used if necessary, and additional conditions specifying compliance requirements to ensure product stability may be added.

For products with a shelf life of less than 30 months, the expiration date must be clearly marked.

i) Safety warnings during use, especially those listed in the column "Usage Conditions and Mandatory Warnings to be Printed on Product Labels" mentioned in the appendices of the ASEAN Cosmetic Agreement, these precautions must be reflected on the product label.

2. In cases where the size, form, or packaging material cannot accommodate all the required information stipulated in Clause 1 of this Article on the original label, such mandatory contents must be marked on a supplementary label attached to the cosmetic product, and the cosmetic product label must indicate where such information is recorded.

The following information must be marked on the original label of the direct packaging of the product:

a) The name of the product;

b) Production batch number.

Article 19. Language on the cosmetic product label

The contents prescribed in Article 18 of this Circular must be presented in English or Vietnamese; specifically, the information at Points b, đ, i Clause 1 Article 18 must be recorded in Vietnamese.

Article 20. Other contents displayed on the cosmetic product label

Organizations and individuals are permitted to record other contents on the cosmetic product label. Additional contents must not contravene legal regulations and must ensure truthfulness, accuracy, and reflection of the true nature of the goods, without obscuring or distorting the mandatory contents marked on the cosmetic product label.

Chapter VI
COSMETIC ADVERTISING

Article 21. Provisions on cosmetic advertising

1. Cosmetic advertising may be conducted through mass media such as television, radio, electronic information websites (Internet, Websites), books, newspapers, magazines, flyers, billboards, posters, airborne objects, underwater objects, or other advertising means implemented or sponsored by cosmetic business units, or authorized to other units to implement, and activities organizing seminars, providing information, and introducing cosmetic products.

2. Units are only permitted to advertise, organize seminars, and events to introduce cosmetic products when they have received a Registration Form for Advertising, Seminar, and Event Introduction of Cosmetics in accordance with the provisions of the law.

3. The content of cosmetic advertising must be consistent with the documentation proving the safety and efficacy of cosmetics and must comply with the ASEAN guidelines on product claims.

Article 22. Content of cosmetic advertising, seminars, and events introducing cosmetics

The content of cosmetic advertising, seminars, and events introducing cosmetics must include the following information:

1. Name of the cosmetic product;

2. Features and functions (stating the main features and functions of the cosmetic product if not already reflected in the product name);

3. Name and address of the organization or individual responsible for bringing the cosmetic product to market;

4. Usage precautions (if applicable).

Article 23. Cosmetic advertising on television and radio

When advertising cosmetics on television and radio, Clauses 1, 3, and 4 of Article 22 must be read out clearly and loudly. In cases where these contents are displayed on screen in text form, the display speed must be appropriate, and the size of the advertisement text must be large enough to ensure clarity and readability.

Article 24. Advertising in newspapers and flyers

For advertising in newspapers and flyers, the first page of the cosmetic advertising material must print: (a) the number of the Registration Form for Advertising received by the Health Department; (b) the date... month... year... when the valid application was received as recorded on the Registration Form.

Article 25. Application dossier for cosmetic advertising, seminar, and event introduction

1. The application dossier for cosmetic advertising, seminar, and event introduction includes the following documents:

a) Registration Form for Advertising, Seminar, and Event Introduction of Cosmetics (Annex No. 10-MP);

b) A copy of the Product Announcement Certificate that has been issued (stamped by the registering entity or individual);

c) A copy of the Business Registration Certificate of the registering entity or individual (stamped by the registering entity or individual);

d) Power of Attorney from the entity or individual announcing the cosmetic product to the entity or individual registering for advertising, seminar, or event introduction (in cases where the entity or individual registering for advertising, seminar, or event introduction is not the entity or individual who announced the product);

đ) Documentation explaining the features and functions of the product in cases where the advertising content or content presented at the seminar or event introduces product features and functions outside the scope stated in the Product Announcement Certificate;

e) Two advertising scripts (the script must describe the visual elements, dialogue, and music planned for the advertisement) or two sample advertisements intended for release (applicable to the application dossier for advertising cosmetics) or materials intended to be displayed or distributed at the seminar or event introducing cosmetics (applicable to the application dossier for organizing seminars or events introducing cosmetics). The dossier must bear the counterfoil stamp of the registering entity or individual for advertising, seminar, or event introduction.

2. Method of preparing the application dossier for cosmetic advertising, seminar, and event introduction:

a) The application dossier for cosmetic advertising can be prepared for one or more products, advertised on one or more different mass media channels.

Sample advertisements and advertising scripts for cosmetics can be prepared for one or more different products.

b) The application dossier for organizing seminars and events introducing cosmetics can be prepared for one or more products held at one or more locations within the province or city.

Article 26. Competence to Accept and Process Applications for Cosmetic Advertising Registration, Organizing Seminars, and Product Introduction Events

1. Organizations and individuals must submit one set of application files for cosmetic advertising registration in accordance with current regulations to the Department of Health at the location where the organization or individual has its main office before engaging in cosmetic advertising. The envelope containing the application file must clearly state "Cosmetic Advertising Registration Application File."

2. Organizations and individuals must submit one set of application files in accordance with current regulations to the local Department of Health where the seminar or product introduction event will be held before organizing such events. The envelope containing the application file must clearly state "Application File for Organizing Seminars and Product Introduction Events."

3. Departments of Health of provinces and centrally-administered cities (excluding advertising forms implemented according to Circular Joint No. 06/2007/TTLT/BVHTT-BYT-BNN-BXD dated February 28, 2007 of the Ministry of Culture, Sports and Tourism, the Ministry of Health, the Ministry of Agriculture and Rural Development, and the Ministry of Construction on guiding procedures for issuing one-stop-shop advertising permits) shall accept and process applications for cosmetic advertising registration, organizing seminars, and product introduction events.

Article 27. Procedure and Formalities for Issuing Receipts for Acceptance of Applications for Cosmetic Advertising Registration, Organizing Seminars, and Product Introduction Events

1. After receiving valid application files for cosmetic advertising registration, organizing seminars, and product introduction events in compliance with this Circular and the prescribed fees, the Department of Health shall send the applicant a receipt for acceptance of the application file (Annex No. 11-MP) along with a sample or script of the advertisement that meets the requirements (applicable to application files for advertising registration). The date recorded on the receipt for acceptance of the application file is the date when the Department of Health receives all valid application files. Within ten working days from the date of receipt of the application file, if the Department of Health does not issue a document requesting amendments or supplements, the applicant may advertise or organize seminars and product introduction events in accordance with the registered content.

2. In cases where the application file does not comply with the provisions of this Circular, the Department of Health shall notify the applicant to supplement and complete the application file.

a) The document must specifically and in detail list the documents and contents that need to be amended or supplemented.

b) The applicant must amend or supplement the application file in accordance with the contents specified in the document requesting amendments or supplements and resubmit it to the Department of Health. When the Department of Health receives a complete and validly supplemented application file, it shall issue a receipt for acceptance of the application file, with the date recorded on the receipt being the date when the Department of Health receives the supplemented application file. Within ten working days from the date of receipt of the amended and supplemented advertisement content, if the Department of Health does not issue a document requesting further amendments or supplements, the applicant may advertise or organize seminars and product introduction events based on the amended content.

c) If the supplemented application file does not meet the requirements specified in the document requesting amendments or supplements, the Department of Health will notify the applicant that they cannot advertise or organize seminars and product introduction events based on the registered content. In this case, if the applicant wishes to continue advertising or organizing seminars and product introduction events, they must resubmit the application file; the application and review procedures will start anew, and the prescribed fee must be paid again.

d) Within two months from the date the Department of Health sends the applicant a document detailing the required supplements, if the Department of Health does not receive a document accompanied by a supplemented application file, the submitted application for cosmetic advertising registration, organizing seminars, and product introduction events will lose its validity.

Article 28. Fees for reviewing the content of information and advertisements

1. The fee for reviewing the content of cosmetic advertisement applications, carried out according to current regulations, shall be calculated based on the corresponding product with 01 Cosmetic Product Notification Form that has been issued a registration number (irrespective of the means of mass communication used for advertising).

2. The fee for reviewing the organization of seminars and events introducing cosmetics (Fees for reviewing the content of information and advertisements) carried out according to current regulations shall be calculated based on the corresponding product with 01 Cosmetic Product Notification Form that has been issued a registration number (irrespective of the number of times the seminar or event is organized and the location of the seminar or event).

Article 29. Advertising cosmetics in other localities

After receiving the Application Acceptance Receipt for registering cosmetic advertisements, units wishing to advertise on promotional media belonging to localities different from where the application was submitted must submit a written notification along with a certified true copy of the Application Acceptance Receipt for registering cosmetic advertisements and all related advertisement content already registered (scripts or advertisement samples) to the Health Department of the locality where the advertisement is planned to be conducted at least 03 working days before the advertisement is implemented.

Article 30. Changes and supplements to the content of advertisements, organization of seminars, and events introducing cosmetics

1. Units registering advertisements, organizing seminars, and events introducing cosmetics must submit supplementary registration applications to the Health Department issuing the Application Acceptance Receipt when there is a change in one of the following contents:

a) The name and address of the organization or individual responsible for bringing the product to market without changing the Business Registration Certificate number or Investment Certificate number;

b) The name and address of the unit registering the advertisement, organizing the seminar, or event introducing cosmetics without changing the Business Registration Certificate number or Investment Certificate number;

c) The actual location and time of organizing the seminar or event introducing cosmetics compared to the originally registered plan.

2. Supplementary documents include: A request for changes and supplements and relevant documents concerning the changed or supplemented content.

3. Any changes or supplements outside the contents mentioned in Clause 1 of this Article, units registering advertisements, organizing seminars, or events introducing cosmetics must re-register according to the regulations.

4. The Health Department is responsible for processing supplementary applications within 10 working days from the date of receipt of complete and valid applications.

Article 31. Cases where the validity of the content of cosmetic advertisements, organization of seminars, and events introducing cosmetics expires

1. The content of cosmetic advertisements, organization of seminars, and events introducing cosmetics becomes invalid in the following cases:

a) Cosmetics have circulation registration numbers, Quality Standard Declaration Notification Forms, or Product Declaration Notification Forms that have expired.

b) Cosmetics are advised to stop using or recalled by competent state management agencies.

c) There are changes in information affecting the safety and quality of cosmetics.

2. Units with expired content of cosmetic advertisements, organization of seminars, and events introducing cosmetics are responsible for notifying relevant authorities and advertisers to immediately cease the dissemination of such information and advertisements.

Chapter VII
EXPORT AND IMPORT OF COSMETICS

Article 32. Export of cosmetics

The export of cosmetics shall be carried out at the Customs office in accordance with current laws and the requirements of the importing country.

Article 33. Documents and procedures for issuing the Free Circulation Certificate (CFS) for domestically produced cosmetics for export

1. The application dossier for the CFS includes:

a) A completed and valid Application Form for the CFS (Annex IV of Decision No. 10/2010/QĐ-TTg dated February 10, 2010 of the Government Chairman stipulating the Free Circulation Certificate for products and goods for export and import);

b) A copy of the Product Registration Notification for cosmetics that has been issued a registration number by the competent authority (a copy stamped by the applicant for the CFS).

2. Issuing the Free Circulation Certificate (CFS) for domestically produced cosmetics for export shall be conducted in accordance with Chapter II of Decision No. 10/2010/QĐ-TTg dated February 10, 2010 of the Government Chairman stipulating the Free Circulation Certificate for products and goods for export and import, in addition to:

a) Domestic cosmetics for export will be issued a CFS when the product has been granted a registration number for the Product Registration Notification for cosmetics by the competent state management authority.

b) Exporters must register their business dossier with the Health Department where the cosmetic production facility is located and complete the procedure for issuing the CFS for exported cosmetic goods.

c) Each CFS is issued for one or more products (the CFS form according to Annex 12-MP) and is valid for two years from the date of issuance.

3. Fees for issuing the CFS shall be implemented in accordance with current regulations (Fees for issuing the CFS are calculated based on each product corresponding to one Product Registration Notification for cosmetics that has been granted a registration number).

Article 34. Documents and procedures for issuing the Certificate confirming compliance with the Good Manufacturing Practice (GMP) principles and standards of the Association of Southeast Asian Nations (ASEAN) for export purposes

1. Production units requiring the issuance of a Certificate confirming compliance with the Good Manufacturing Practice (GMP) principles and standards of the Association of Southeast Asian Nations (ASEAN) for export purposes shall submit an application dossier to the Drug Administration Department under the Ministry of Health. The dossier includes:

a) The Application Form for GMP Inspection (Annex 13-MP);

b) A copy of the Business Registration Certificate or Investment License;

c) An organizational chart and personnel list of the facility (the organizational chart must clearly show the name, position, and technical qualifications of staff members responsible for various departments), work history and experience in the assigned field of staff members responsible for various departments (production, quality control, quality assurance, warehouse);

d) Training program and evaluation results of the GMP training at the unit;

đ) Layout and design of the factory (including: overall floor plan; employee route map; raw material, packaging, semi-finished product, finished product route map; waste treatment system layout);

e) List of existing equipment in the factory (including production equipment and quality control equipment) must clearly indicate the name of the equipment, year of manufacture, country of manufacture, and condition of the equipment;

g) List of products currently being produced or planned to be produced (specify the type of product);

h) Self-inspection report on GMP (The self-inspection report must clearly indicate the inspection period, self-inspection team members, self-inspection objectives, self-inspection results, and recommendations for corrective actions and measures).

2. Authority to accept and process applications:

The Drug Administration Department under the Ministry of Health is responsible for reviewing the dossier, planning, and issuing a decision to establish an inspection team, and notifying the facility at least ten days before conducting the inspection.

3. The Certificate confirming compliance with the Good Manufacturing Practice (GMP) principles and standards is valid for three years from the date of issuance.

4. The production unit (referred to as the GMP registration facility) must pay the assessment fee for production standards and conditions in accordance with current regulations.

Article 35. Import of cosmetics

1. Cosmetic products that have been issued with a Registration Number for Product Declaration by the Drug Administration Department under the Ministry of Health and are still valid may be imported into Vietnam. The import procedures shall be carried out at customs authorities according to current regulations. When handling import procedures, enterprises must present to the customs authority the Product Declaration Form for cosmetics which has been issued with a Registration Number by the Drug Administration Department under the Ministry of Health.

2. Importation of cosmetics in certain special cases (not required to declare products according to this Circular):

The import order for cosmetics used for research and testing shall be made in three copies. After approval, two copies will be kept at the Drug Administration Department, and one copy will be sent to the entity. The copy sent to the entity will bear the stamp "Copy sent to enterprise" to be presented to the customs authority when handling clearance procedures.

Cosmetics imported for research and testing must be used for their intended purpose and may not be allowed to circulate on the market.

b) Organizations and individuals receiving cosmetics as gifts or presents must handle import procedures at the customs authority according to current regulations. The total value of each receipt must not exceed the tax-exempt limit for goods according to current regulations.

Samples of cosmetics imported as gifts or presents may not be allowed to circulate on the market.

c) Organizations and individuals importing cosmetics for display at trade fairs, exhibitions, and other temporary import and re-export cases must apply for a temporary import and re-export permit from the Ministry of Industry and Trade according to current regulations.

Chapter VIII
TAKING SAMPLES OF COSMETICS FOR QUALITY CHECK

Article 36. Principles of Sampling

1. Sampling of cosmetics for quality inspection or monitoring shall be done randomly and must be taken from different positions within the batch.

2. The amount of sample needed for analysis and storage must be sufficient based on the inspection requirements, quality standards, and testing methods but must be at least enough for three analyses or must be sufficient to perform tests ensuring accurate and reliable results.

3. Analytical samples and storage samples must be placed in containers, sealed tightly, and labeled. The label of the container must clearly state the product name, the name of the organization or individual responsible for bringing the product to the market, production batch number, expiration date, sampling location, and sampling date.

4. A record of sampling cosmetics shall be made according to the model in Annex 09-MP: The sampling record must clearly state the product name, production batch number, sampling date, sampling location, notes on any abnormalities during the sampling process, the name and signature of the sampler, representative of the sampled entity, and witness (if necessary). The record shall be made in three copies: one copy retained by the sampled entity, one copy retained by the testing authority, and one copy retained by the cosmetic quality control management authority.

Article 37. Rights and Responsibilities of the Sampler

1. Present the inspector's card or quality control officer's card or letter of introduction or decision to establish a quality inspection team signed by the head of the cosmetic quality inspection authority when performing duties.

2. Require the entity holding the sample to present relevant files and documents related to the origin, quantity, and quality of the batch of cosmetics being sampled, propose sampling plans, the number of analytical samples, and storage samples taken from the batch during the sampling process.

3. Check and take samples from any package in the batch of cosmetics if there is suspicion about the quality or safety of the product.

4. Be responsible under the law for technical operations and legal procedures during the sampling process, transportation, and handover of samples to the testing authority.

Article 38. Transport and Transfer of Samples

2. Collected cosmetic samples must be packaged in appropriate packaging and transported using suitable means to ensure that the samples are preserved according to regulations and protected from damage or breakage during transportation.

Article 39. Conclusion of Quality Inspection Results for Cosmetic Samples

1. The quality inspection results of cosmetic samples taken by state authorities with the authority to conduct quality inspections, which are representative of the entire batch of cosmetics and analyzed at recognized laboratories, have legal validity for the entire batch of cosmetics.

2. The quality inspection results of cosmetic samples submitted by organizations or individuals to the state quality inspection authority for quality determination only have legal validity for the submitted sample.

Article 40. Costs for Sampling and Testing Cosmetics for Quality Determination

1. The costs for sampling and testing cosmetic samples for quality control during production, compounding, and circulation on the market shall be borne by the quality inspection authority responsible for sampling and testing according to Circular Joint No. 28/2010/TTLT-BTC-BKHCN dated March 3, 2010, issued by the Ministry of Finance and the Ministry of Science and Technology guiding the management and use of funds for state quality inspection activities of products and goods.

2. In cases where the quality inspection authority concludes that the cosmetic samples do not meet quality standards, the organization or individual responsible for bringing the product to the market must reimburse the full cost of sampling and testing the cosmetic samples to the quality inspection authority according to Articles 10, 12, 14, 16, and 41 of the Product Quality Law 2007, Circular Joint No. 28/2010/TTLT-BTC-BKHCN dated March 3, 2010, issued by the Ministry of Finance and the Ministry of Science and Technology guiding the management and use of funds for state quality inspection activities of products and goods, and related regulatory documents.

3. In cases where cosmetics are complained about or reported regarding quality, if the quality inspection authority concludes that the complaint or report about the quality of cosmetics is incorrect, the complainant or reporter must pay back the costs of sampling and analysis/testing of cosmetic samples as stipulated in Clause 1 of this Article.

4. The costs for sampling cosmetics for quality inspection and the costs for testing cosmetic samples are allocated within the budget for the activities of the state quality inspection authority for cosmetics according to Circular Joint No. 28/2010/TTLT-BTC-BKHCN dated March 3, 2010, issued by the Ministry of Finance and the Ministry of Science and Technology guiding the management and use of funds for state quality inspection activities of products and goods.

Chapter IX
INSPECTION, AUDIT AND VIOLATION HANDLING

Article 41. State Quality Inspection of Cosmetics

1. Quality Inspection Authorities for Cosmetics:

Based on the test results of national quality inspection agencies, the Drug Administration under the Ministry of Health is the authority to conclude the quality of cosmetics nationwide.

Conclude the quality of cosmetics based on the test results of the local national quality inspection agency for cosmetics.

2. The state testing system for cosmetics includes:

a) At the central level: the Central Institute for Pharmaceutical Testing, the Ho Chi Minh City Institute for Pharmaceutical Testing;

b) At the local level: the Pharmaceutical and Cosmetic Testing Centers of provinces and centrally-administered cities.

3. The heads of quality inspection agencies for cosmetics are responsible for the conclusions of quality inspection results before the law.

Article 42. Forms of inspection and supervision

1. Regular inspection and supervision: Regular inspection and supervision shall be notified in advance by the competent authority to the inspected unit so that the unit can prepare for the inspection before the inspection activity takes place.

2. Surprise inspection and supervision: Surprise inspection and supervision shall be conducted when substandard products are discovered, which do not comply with market circulation regulations or due to customer complaints. In urgent cases, the competent authority has the right to conduct inspections without prior notice.

Article 43. Contents of Inspection and Supervision

1. Inspection and supervision of compliance with laws on the production and sale of cosmetics:

a) Compliance with the principles and standards of "Good Manufacturing Practices for Cosmetics" (CGMP-ASEAN) or equivalent standards recognized by the ASEAN Cosmetic Council;

b) Cosmetic labeling;

c) Product Information File (PIF) in accordance with ASEAN regulations;

d) Cosmetic advertising.

2. Inspection and supervision of dispute resolution, complaints, and accusations regarding cosmetic quality and other related matters (if applicable).

3. Inspection and supervision of the implementation of cosmetic recall notifications as prescribed (if applicable).

Article 44. Priority Order in Post-market Surveillance Inspection

Post-market surveillance inspection of cosmetics should focus on importers, distributors, and manufacturers. The priority order for post-market surveillance inspection of cosmetics is based on product type, origin, brand, company trademark, and product formula components according to ASEAN's guidelines on post-market surveillance (Annex 08-MP).

Article 45. Suspension of Circulation and Recall of Cosmetics

1. Cosmetics shall be suspended from circulation and recalled if any of the following situations occur:

a) Cosmetics are circulated without the competent national management agency issuing the registration number for the cosmetic product notification form;

b) Cosmetics do not meet quality standards and are unsafe for users;

c) Circulated cosmetics have formulas that do not match the declared files;

d) Circulated cosmetics contain prohibited ingredients or substances exceeding permitted limits;

đ) Circulated cosmetics have labels stating functions that do not correspond to the declared files or do not comply with the labeling requirements of this Circular, depending on the severity of the violation, they may be suspended from circulation and recalled;

e) Circulated cosmetics produced at facilities that do not meet the principles and standards of "Good Manufacturing Practices for Cosmetics" (CGMP-ASEAN) or equivalent standards recognized by the ASEAN Cosmetic Council, depending on the severity of the violation, they may be suspended from circulation and recalled;

g) Cosmetics have exceeded their expiration date or usage period as recommended by the manufacturer;

h) Counterfeit, smuggled, or untraceable source cosmetics, or cosmetics without intact packaging;

i) Cosmetics voluntarily recalled by organizations or individuals responsible for bringing products to the market.

2. Authority to issue decisions on recalling violative cosmetics:

a) The Department of Drug Management under the Ministry of Health issues decisions to recall violative cosmetics nationwide.

Article 46. Revocation of Registration Number for Cosmetic Product Notification Form

Clause 1. The registration number for the Cosmetic Product Notification Form shall be revoked in any of the following cases:

Point a) Two batches of cosmetics circulating in the market fail to meet quality standards as concluded by the competent state management agency on cosmetic quality.

Point b) Cosmetics circulating in the market have formulas that differ from those declared in the notification form.

Point c) Cosmetics circulating in the market bear labels with incorrect origin or place of manufacture information.

Point d) Cosmetics circulating in the market bear labels with false descriptions of their inherent characteristics and functions.

Point đ) Cosmetics are unsafe for users.

Point e) Cosmetics contain prohibited ingredients or substances exceeding permitted concentrations or quantities.

Point g) Cosmetics are concluded by authorized state agencies to infringe intellectual property rights or counterfeit another product's label which has been allowed to circulate.

Point h) Cosmetics are banned from circulation in their country of origin.

Point i) Organizations or individuals bringing products to the market submit a request for revocation of the registration number for the Cosmetic Product Notification Form.

Point k) There is no Product Information File (PIF) presented to the competent authority as stipulated in Article 12 of this Circular.

Point l) Forgeries of documents, use of fake seals, or counterfeits of signatures or stamps of Vietnamese or foreign competent authorities, manufacturers, or product owners.

Point m) False declarations of contents in the Cosmetic Product Notification Form.

Clause 2. Competent authority to issue decisions to revoke the registration number for the Cosmetic Product Notification Form:

Point a) The Drug Administration of Vietnam under the Ministry of Health issues decisions to revoke the registration number for the Cosmetic Product Notification Form for domestically produced cosmetics issued before April 25, 2009, and imported cosmetics nationwide.

Point c) Management Boards of Moi Bai Border Economic Zone (Tien Giang Province) and Quang Tri Province Economic Zone issue decisions to revoke the registration number for the Cosmetic Product Notification Form for cosmetics issued by themselves.

Independence - freedom - happinessArticle 47. Cases for Temporarily Suspending Acceptance of Notifications for Cosmetic Products, Advertising Registration Applications, and Organization of Seminars and Events Introducing Cosmetics

Clause 1. The competent state management authority will temporarily suspend examination and acceptance of notifications for cosmetic products for six months for organizations or individuals engaging in any of the following behaviors:

Point a) Trading in smuggled cosmetics, counterfeit cosmetics, or cosmetics of unknown origin or place of manufacture.

Point b) Trading in cosmetics without a registration number for the Cosmetic Product Notification Form issued by the competent state management authority.

Point c) Failure to recall non-compliant cosmetics as notified by the competent state management authority.

Point d) Manufacturing or trading in cosmetics at facilities not adhering to the Good Manufacturing Practices (GMP) standards recognized by the ASEAN Cosmetics Council or equivalent standards.

Point đ) Manufacturing or trading in cosmetics containing prohibited ingredients or exceeding permitted concentrations or quantities for specified substances as stipulated by current laws.

Point e) Using raw materials for cosmetics that have been banned for circulation by the producing country.

Point g) Importing or trading in cosmetics or raw materials for cosmetics that have been banned for circulation by the producing country.

Point h) Manufacturing or trading in cosmetics with formulas differing from those declared in the notification form.

Point i) Forgeries of documents, use of fake seals, or counterfeits of signatures or stamps of Vietnamese or foreign competent authorities, manufacturers, or product owners.

Point k) False declarations of contents in the Cosmetic Product Notification Form.

Point l) Lack of a Product Information File (PIF) kept by the enterprise as required.

Clause 2. The competent state management authority will temporarily suspend examination and acceptance of advertising registration applications, organization of seminars, and events introducing cosmetics for six months for organizations or individuals engaging in any of the following behaviors:

Point a) Advertising cosmetics, organizing seminars, or events introducing cosmetics without a received application form for advertising registration, seminar organization, or event introduction issued by the competent state management authority as prescribed by law.

Point b) Advertising cosmetics or organizing seminars or events introducing cosmetics for products without a registration number for the Cosmetic Product Notification Form.

Point c) Advertising cosmetics in a manner that may mislead consumers into believing they are drugs; using the name, emblem, image, or correspondence of medical or pharmaceutical organizations or health workers in cosmetic advertisements; making claims about the efficacy of cosmetics without sufficient scientific basis.

Clause 3. The competent state management authority will consider temporarily suspending acceptance of notifications for cosmetic products, advertising registration applications, organization of seminars, and events introducing cosmetics for organizations or individuals failing to submit annual reports on production and business activities as required.

After the suspension period ends, once the entity has fully rectified violations and submitted a report, the competent state management authority will continue to examine and accept notifications for cosmetic products, advertising registration applications, organization of seminars, and events introducing cosmetic products from the entity.

Chapter X
RESPONSIBILITIES OF ORGANIZATIONS AND INDIVIDUALS MANUFACTURING, TRADING IN, AND IMPORTING COSMETICS AND RIGHTS OF CONSUMERS

Article 48. Responsibilities of organizations and individuals producing, trading, and importing cosmetics for circulation on the Vietnamese market

2. Organizations and individuals bringing cosmetic products into circulation on the market shall be responsible for monitoring, detecting, and immediately recalling substandard cosmetic products, implementing recall notifications from competent state management agencies, reporting the recall of cosmetics to competent state agencies; promptly addressing customer complaints about the quality of cosmetics, compensating customers for losses according to the law. At the same time, they must refund the purchase price to buyers and cover any additional costs incurred during the storage, transportation, and circulation of the product.

3. In case of discovering serious adverse effects affecting consumer lives due to the quality of cosmetic products, organizations and individuals bringing the products to the market must report to the Drug Administration Department - Ministry of Health within seven days from the date of receiving the first information about such adverse effects according to Model 18-MP. Detailed reports about these serious adverse effects must be sent to the Drug Administration Department - Ministry of Health within the following eight days.

4. Organizations and individuals responsible for bringing products to the market must retain the Product Information File (PIF) for a minimum period of three years from the date of the last batch being brought to the market and present it when competent authorities inspect or audit.

5. Cosmetic manufacturing units must implement and comply with the Good Manufacturing Practices (CGMP-ASEAN) principles and standards of the Association of Southeast Asian Nations (ASEAN).

6. Organizations and individuals engaged in cosmetic trade must comply with the requirements of competent state agencies regarding inspections and audits of cosmetic quality, recalls of non-compliant cosmetics, and have the right to appeal against conclusions and forms of handling violations according to the law on appeals and complaints.

7. Organizations and individuals responsible for bringing products to the market must comply with Vietnamese laws and regulations on intellectual property rights. When there is a conclusion by a competent state agency regarding trademark or design infringements of intellectual property rights, organizations and individuals must cease production, trading, and importation to make changes to trademarks and designs in accordance with the regulations and bear responsibility for compensation and handling consequences (if any).

Article 49. Rights of cosmetic consumers

Consumers have the right to be informed about cosmetics, the right to lodge complaints and accusations, and request compensation from cosmetic trading units according to the law for damages caused by using cosmetics that do not meet quality and safety standards.

Chapter XI
IMPLEMENTATION

Article 50. Information and Reporting System

1. The Drug Administration Department - Ministry of Health is responsible for updating and implementing regulations related to the ASEAN Cosmetics Agreement on the Department's electronic information website (address: www.dav.gov.vn). Regularly disseminating to relevant units and organizations and individuals producing and trading in cosmetics changes in technical criteria decided by the ASEAN Cosmetics Council, and coordinating the implementation of those changes and decisions in Vietnam. All management decisions made by the ASEAN Cosmetics Council are applied in Vietnam.

Article 51. Forms and Annexes accompanying this Circular

1. Form of the Cosmetic Product Notification Certificate: Annex No. 01-MP.

2. Guidance Documents on Cosmetic Product Notification: Annex No. 02-MP.

3. ASEAN Guidelines on Cosmetic Product Function Notification: Annex No. 03-MP.

4. Abbreviations for the Names of Provinces and Central Cities and Some Management Boards of Economic Zones: Annex No. 04-MP.

5. Changes After Cosmetic Product Notification: Annex No. 05-MP.

6. ASEAN Limitations on Heavy Metals and Microorganisms in Cosmetics: Annex No. 06-MP.

7. Product Information File: Annex No. 07-MP.

8. ASEAN Post-market Inspection Guidance Documents: Annex No. 08-MP.

9. Sample Collection Record for Quality Testing of Cosmetics: Annex No. 09-MP.

10. Advertisement Registration Form for Cosmetics, Organizing Seminars, and Introduction Events: Annex No. 10-MP.

11. Receipt Form for Advertisement Registration Files for Cosmetics, Organizing Seminars, and Introduction Events: Annex No. 11-MP.

12. Free Circulation Certificate (CFS) Form: Annex No. 12-MP.

13. Good Manufacturing Practice (GMP) Inspection Application Form: Annex No. 13-MP.

14. Import Order Form for Research and Testing Purposes: Annex No. 14-MP.

15. Report Form of Registered Cosmetic Products with Notification Certificate Numbers: Annex No. 15-MP.

16. Report Form of Registered Advertisement Files for Cosmetics, Organizing Seminars, and Introduction Events: Annex No. 16-MP.

17. Production and Business Activity Report Form for Cosmetics: Annex No. 17-MP.

18. Adverse Reaction Notification Form for Cosmetics: Annex No. 18-MP.

Article 52. Transitional Provisions

1. From the date this Circular takes effect, all organizations and individuals responsible for bringing cosmetic products to the Vietnamese market must comply with the product notification requirements set forth in this Circular.

2. For products that have been notified since March 10, 2008 (as stipulated in the Cosmetic Management Regulation issued together with Decision No. 48/2007/QD-BYT dated December 31, 2007 of the Minister of Health) and have valid Notification Certificate numbers, if they meet the provisions of this Circular, they may continue production (for domestically produced cosmetics) or importation (for imported cosmetics) until the expiration date of the Notification Certificate.

3. Cosmetics put into circulation that do not meet the safety requirements for cosmetic products as specified in Chapter IV of this Circular shall be recalled entirely by the organizations and individuals responsible for bringing them to the market and shall comply with the provisions of this Circular.

4. Cosmetics already circulating during the validity period of their permits, if they meet the safety requirements for cosmetic products as specified in Chapter IV of this Circular, may continue to circulate in the market until the expiration date of the product.

Article 53. Effective Date

1. This Circular takes effect from April 1, 2011.

2. Abolish Decision No. 48/2007/QD-BYT dated December 31, 2007 of the Minister of Health on the issuance of the Cosmetic Management Regulation, Decision No. 40/2008/QD-BYT dated December 26, 2008 of the Minister of Health on the delegation of state management functions over cosmetics produced in Vietnam, Decision No. 22/2008/QD-BYT dated July 2, 2008 of the Minister of Health on the delegation of cosmetic management functions to the Management Board of Mo Cay Border Economic Zone, Tay Ninh Province, Decision No. 3450/QD-BYT dated September 21, 2010 of the Minister of Health on the delegation of cosmetic management functions to the Management Board of Quang Tri Province.

4. In the process of implementation, if there are difficulties or obstacles, organizations and individuals should report to the Ministry of Health (Department of Medicine Administration, 138A Giang Vo Street, Ba Dinh District, Hanoi City) for the Ministry of Health to consider and resolve./.