Integrated document No. 7/VBHN-BYT dated March 16, 2021 Circular on cosmetic management

• Official number: 7/VBHN-BYT
• Legislation Type: Integrated document
• Organization: The Ministry of Health
• Signer: Truong Quoc Cuong
• Issued Date: 16/03/2021

MINISTRY OF HEALTH -------	SOCIALIST REPUBLIC OF VIETNAM Independence – Freedom – Happiness ----------------
No. 7/VBHN-BYT	Hanoi, March 16, 2021

CIRCULAR

ON COSMETIC MANAGEMENT

Circular No. No. 06/2011/TT-BYT dated January 25, 2011 of Minister of Health on cosmetic management coming into effect from April 1, 2011 is amended under:

Circular No. 29/2020/TT-BYT dated December 31, 2020 of Minister of Health on amendments to legislative documents promulgated and jointly promulgated by Minister of Health coming into effect from February 15, 2015.

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

Pursuant to Decree No. 132/2008/ND-CP dated December 31, 2008 by the Government elaborating a number of Articles of the Law on Products and Goods Quality;

Pursuant to Decree No. 24/2003/ND-CP dated March 13, 2003 of the Government on elaborating to implementation of Ordinance on Advertisement;

Pursuant to Decree89/2006/ND-CP dated August 30, 2006 of the Government on labeling products;

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Pursuant to Decision No. 10/2010/QD-TTg dated February 10, 2010 of the Prime Minister on Certificate of Free Sale for import, export commodities and products;

For implementing Agreement on ASEAN Harmonized Cosmetic Regulatory Scheme signed on September 2, 2003 (hereinafter referred to as “ASEAN Cosmetic Agreement”), Ministry of Health prescribes cosmetic management as follows: 1

Chapter I

GENERAL PROVISIONS

Article 1. Scope and regulated entities

1. This Circular prescribes management of domestically manufactured cosmetic products and imported cosmetics for circulation in Vietnam territory, including: announcement of cosmetic products; product information file; product safety requirements; cosmetic labeling; cosmetic advertisement; cosmetic import and export; cosmetic sampling for quality control; inspection and imposing penalties; responsibilities of individuals and organizations manufacturing, trading, importing cosmetics and consumers' rights.

2. This Circular applies to cosmetic regulatory agencies, organizations and individuals conducting affairs related to announcement of cosmetics, communication, advertisement, import, export and trade of cosmetics in Vietnam.

Article 2. Term interpretation

In this Circular, terms below are construed as follows:

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2. “cosmetic name” refers to name assigned to a cosmetic product which can be a new name and brand or name of the manufacturer. Letters of cosmetic name must be Latin-based letters.

3. “organization or individual responsible for introducing cosmetic product to the market” refers to organization or individual whose name is included in declaration of cosmetic product and responsible for that cosmetic product on the market.

4. “receipt number of written cosmetic product declaration” is a number issued by a regulatory agency upon receiving declaration of cosmetic product. Receipt number of written declaration can be used to certify that cosmetic products introduced to the market by organizations and individuals that declare to competent cosmetic regulatory agencies are eligible for circulation on the market without certifying that the cosmetic products qualify safety, effectiveness and all requirements of ASEAN Cosmetic Agreement and Annexes attached thereto.

5. “owner of cosmetic products” refers to an organization or individual possessing formula, manufacturing process, product quality and standard.

6. “product stability” refers to ability of cosmetic products to remain original properties and retain safety requirements in particular when preserved in suitable conditions.

7. “amount of cosmetic products” refers to amount of cosmetic products in net weight or volume in metric system or both metric system and imperial system.

8. “cosmetic label” refers to written copies, printed copies, drawn copies and photocopies of letters, drawings and images directly pasted, printed, attached, forged, embossed or engraved on products, commercial packaging thereof or other materials attached on products or commercial packaging thereof.

9. “cosmetic labeling” refers to displaying basic details and necessities of cosmetics on labels to enable users to acknowledge, select and use appropriately; enable manufacturers to advertise their products and allow authorities to conduct inspection.

10. “original label” refers to label displayed on commercial packaging of cosmetics for the first time.

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12. “commercial packaging of cosmetics” refers to packaging that contains and circulates with cosmetics. Commercial packaging of cosmetics consists of: Inner packaging and external packaging.

a) Inner packaging will directly contain products, make contact with the products, create shapes or be wrapped along product contour.

b) External packaging refers to packaging for one or multiple product units in inner packaging.

13. “cosmetic circulation” refers to display, transport and storage of products during trade process, except for cases of transporting products of organizations and individuals that import products from border checkpoints to storage.

14. “cosmetic manufacturing batch number” refers to a code in number or letter or a combination of both serving to recognize manufacturing batch and allow traceability of background of a product batch including all stages of manufacturing process, quality control and distribution.

15. “cosmetic date of manufacture” refers to the date on which manufacturing, processing, packaging or other activities are completed to finish the last stage of a product batch.

16. “cosmetic expiry date” refers to a date designated for a cosmetic batch after which the cosmetic batch must no longer be circulated and used.

17. “best before date” refers to a date recommended by manufacturers where product quality is at its highest.

18. “cosmetic origin” refers to a country or territory where cosmetics are produced in their entirety or where the final basic preparation stage is conducted in case multiple countries or territories participate in manufacturing the cosmetics.

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20. “use instruction” refers to necessary information that guides users to use cosmetics safely and reasonably. Use instruction can be printed directly on packaging or introduced in form of documents attached to commercial packaging of cosmetics which specify use instruction and other details as per the law.

21. “cosmetic advertisement” refers to introduction and marketing of cosmetics to promote manufacturing process, sale and use of cosmetics.

22. “cosmetic introduction conferences and events” are conferences for introducing or discussing specialized issues relating to cosmetics with consumers.

23. “advertisers” are organizations and individuals wishing to advertise cosmetics that they produce and/or distribute.

24. “advertisement distributors” are organizations and individuals bringing cosmetic advertisements to consumers, these include press agencies, communication agencies, television agencies, publishing houses, computer network managers, organizers of cultural programs, sports programs, fairs, exhibits and organizations, individuals employing other forms of advertisements.

25. “ASEAN Cosmetic Committee” (hereinafter referred to as “ACC”) is the agency acting ASEAN member countries to monitor, decide and deal with disputes regarding implementation of ASEAN Cosmetic Agreement.

Chapter II

ANNOUNCEMENT OF COSMETIC PRODUCTS

Article 3. Regulations on announcement of cosmetic products

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2. Fees for declaring cosmetic products shall conform to applicable laws.

3. Organizations and individuals responsible for bringing products to circulation on the market must be licensed for operating in cosmetic sector in Vietnam.

4. Declaration of characteristics of cosmetic products (use purposes of the products) must conform to ASEAN’s guidelines on declaring cosmetic products’ characteristics (Annex 3-MP).

Article 4. Declaration of cosmetic products

Declaration of cosmetic products consists of following documents:

1. Written declaration of cosmetic products (2 copies) and declared data (soft copies of the written declaration);

2.2 (annulled);

3. Master registers or legitimate certified true copies of power of attorney of manufacturers or product owners authorizing organizations and individuals responsible for introducing products to the market to circulate cosmetic products in Vietnam (applicable to imported cosmetics and domestically manufactured cosmetics where organizations and individuals responsible for introducing products to the market are not manufacturers). For import products, power of attorney must contain authenticated signatures and be consular legalized as per the law, except for cases in which consular legalization is exempted according to international agreements to which Vietnam is a signatory. Power of attorney must satisfy all requirements under Article 6 hereof.

4.3 CFS for imported cosmetic products is regulated as follows:

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- Cosmetic products produced domestically in member countries of Comprehensive and Progressive Agreement for Trans-Pacific Partnership where participation in this ASEAN Cosmetic Agreement has been approved by competent agencies of said member countries (hereinafter referred to as “CPTPP member countries”);

- Cosmetic products are circulated and exported from CPTPP member countries: Enterprises responsible for introducing products to the market must submit written proof of products’ circulation in the CPTPP member countries issued by competent agencies of CPTPP member countries (license for circulation of cosmetic products or written declaration of cosmetic products issued with receipt number or other legislative documents certifying products’ certification in CPTPP member countries) and consular legalized as per the law, except for following cases:

+ Consular legalization is exempted according to international agreements to which the Socialist Republic of Vietnam (hereinafter referred to as “Vietnam”) is a signatory or according to principle of reciprocity between Vietnam and other countries;

+ Legislative documents are verified via written documents or email sent by foreign consular missions or competent regulatory agencies in cosmetics or agencies issuing legislatives documents of CPTPP member countries to Drug Administration of Vietnam;

+ Enterprises responsible for introducing products to the market shall send lookup results of legislative documents from information websites in English of agencies issuing legislative documents of CPTPP member countries bearing conformation seal of enterprises together with documents providing information on link address to Drug Administration of Vietnam. Enterprises must be legally responsible for legitimacy, accuracy of documents, information and lookup results of enterprises.

- Cosmetic products issued with receipt number of written cosmetic product declaration in countries affiliated to ASEAN: Enterprises responsible for introducing products to the market must submit written cosmetic product declaration issued with receipt number in ASEAN countries that has been consular legalized as per the law, except for following cases:

+ Consular legalization is exempted according to international agreements to which Vietnam is a signatory or according to principle of reciprocity between Vietnam and other countries;

+ Cosmetic product declaration is verified by written documents or email sent by foreign consular missions or competent regulatory agencies in cosmetics or agencies issuing written cosmetic product declaration to Drug Administration of Vietnam.

+ Enterprises responsible for introducing products to the market send lookup results of cosmetic product declaration from website of competent regulatory agencies in English of ASEAN member countries that issue notice on receipt of cosmetic product declaration bearing confirmation seals of enterprises together with documents on lookup address to Drug Administration of Vietnam. Enterprises must be legally responsible for legitimacy, accuracy of documents, information and lookup results of enterprises;

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- Valid CFS issued by competent agencies of countries manufacturing or exporting cosmetics to Vietnam (master registers or certified true copies). In case CFS does not specify duration, the copies must be issued within 24 months from the date of issue of the CFS;

- CSF must be consular legalized as per the law, except for cases in which CFS satisfies any of following regulations:

+ Consular legalization is exempted according to international agreements to which Vietnam is a signatory or according to principle of reciprocity between Vietnam and other countries;

+ CFS is confirmed in writing or email sent by competent agencies capable of issuing CFS or foreign consular missions to Drug Administration of Vietnam;

- CFS must contain basic information under Article 36 of Law on Foreign Trade Management and Clause 3 Article 10 of Decree No. 69/2018/ND-CP dated May 15, 2018 of the Government on elaborating to Law on Foreign Trade Management (hereinafter referred to as “Decree No. 69/2018/ND-CP”).

Article 5. Preparation of written cosmetic product declaration and declared data

1. Written cosmetic product declaration:

a) Written cosmetic product declaration shall be produced using Form No. 01-MP. Written declarations must be signed by legal representatives and bear seals of organizations and individuals responsible for introducing products to the market. Specify other contents in written cosmetic product declarations as instructed under Annex No. 02-MP.

b) Each cosmetic product must be declared in a written declaration.

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Products of the same owners falling under any of following cases may be included in the same written declaration:

- Products are packed under general names and sold as product packs.

- Products with the same name, in the same produce line with similar formula but in different color or scent. Regarding hair dye and perfume products, produce declarations for each color.

- Other forms shall be added to decisions of ASEAN Cosmetic Committee by Drug Administration of Vietnam - Ministry of Health.

c) Methods of specifying formula components of cosmetic products:

- Components in product formula must be specified in full in order of descending content. Perfume, flavoring components and ingredients thereof can be written as perfume, fragrance, flavor or aroma. Components with less than 1% of contents can be specified in any order behind components with more than 1% of contents. Pigments can be specified in any order behind other components based on color indicators or name under Annex IV of ASEAN Cosmetic Agreement. For cosmetic products for make up in various colors, list all pigments in the section “possibly contain” or “+/-”.

- Specify percentage of components regulated in terms of concentration and contents under Annexes of ASEAN Cosmetic Agreement. Use a comma (“,”) as a decimal separator.

- Components must be specified according to International Nomenclature of Cosmetic Ingredients (INCI) in the latest publications: International Cosmetic Ingredient Dictionary, British Pharmacopoeia, United States Pharmacopoeia, Chemical Abstract Services, Japanese Standard Cosmetic Ingredient, and Japanese Cosmetic Ingredients Codex. Plants and extract thereof must be specified in scientific name including their genus and species (genus can be abbreviated). Animal-based components must include scientific name of the animal species.

The following chemicals are not considered cosmetic products:

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- Auxiliary materials used for technical purposes but absent in final products.

- Ingredients used in necessary quantity namely solvent or carrier of perfume components.

d) Language used in written declaration shall be either Vietnamese or English. Details under Section 3 (Use purposes), Section 7 (Information on organizations and individuals responsible for introducing the products to the market), Section 8 (Information on legal representatives of the Company), and Section 9 (Information on importing Company) in the written declaration must be specified in Vietnamese or both Vietnamese and English.

2. Declared data (soft copies of written declaration): Organizations and individuals may submit declared data specified under Clause 1 Article 4 hereof by:

a) person: Organizations and individuals declaring cosmetic products shall send request for issuance of accounts for logging into database on cosmetic management to Drug Administration of Vietnam - Ministry of Health and declare directly on the database. Written declaration submitted to competent regulatory agencies must be printed from the database.

b) online: Access website of Drug Administration of Vietnam, download database of written declaration of cosmetic products (Annex No. 01-MP), fill in the form on the database as per the law and copy in electronic storage devices (USB, CD-ROM, etc.). Written declaration submitted to competent regulatory agencies must be printed from the database.

Organizations and individuals declaring cosmetic products must be fully responsible for conformity of information in written declaration of cosmetic products (copies that bear signatures and seals) to declared data (soft copies) declared or submitted to supervisory agencies.

Article 6. Regulations on power of attorney

1. Language used must be Vietnamese, English or both.

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a) Name and address of manufacturers; in case authorizing parties are product owners, specify name, address of product owners and name, address of manufacturers;

b) Name and address of authorized organizations, individuals;

c) Scope of authorization (representing for declaration and distribution of cosmetic products in Vietnam);

d) Authorized brand or products;

dd) Duration of authorization

e) Commitment of manufacturers or product owners to provide adequate product information file (PIF) to organizations, individuals responsible for introducing products to Vietnamese market;

g) Name, title, and signature of representatives of authorizing parties.

Article 7. Procedures for receiving and processing declaration of cosmetic products

1. Declaration of cosmetic products shall be compiled and submitted in person or via post service to competent regulatory agencies as follow:

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b) For domestically produced cosmetics: Organizations and individuals responsible for introducing cosmetic products to the market shall submit declaration of cosmetic products at Departments of Health where manufacturing plants are based. Cosmetic products manufactured and packed from imported semi-finished products shall be considered as domestically manufactured cosmetic products.

c) For cosmetic products traded within Commercial – Industrial Zone within Moc Bai border economic zone of Tay Ninh Province, declare at Board for management of Moc Bai border economic zone; cosmetic products traded within Lao Bao Special Commercial – Economic Zone of Quang Tri Province, declare at Board for management of economic zone of Quang Tri Province.

Introduction of cosmetic products from Commercial - Industrial Zone within Moc Bai border economic zone of Tay Ninh to other functional zones within Moc Bai border economic zone of Tay Ninh Province or to domestic market for trade or introduction of cosmetic products from Lao Bao Special Commercial – Economic Zone of Quang Tri Province to domestic market for trade must be declared at Drug Administration of Vietnam - Ministry of Health according to this Circular (organizations and individuals declaring these cosmetic products must be licensed for trading cosmetic products in Vietnam and situated beyond these 2 zones).

2. Process declaration of cosmetic products

a) Within 3 working days from the date on which adequate application and fees are received, competent regulatory agencies are responsible for issuing receipt number of written cosmetic product declaration.

b) In case of inadequate declaration according to this Circular, within 5 working days from the date on which the declaration is received, receiving agencies shall inform declarants in writing about inadequate details for revision.

Request for revision consists of:

- Written explanation for revision to be conducted by declarants;

- Declaration of cosmetic products together with declared data (soft copies of written declaration) or other revised documents;

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In case revised declaration fails to satisfy regulations hereof, within 5 working days from the date on which revised declaration is received, receiving agencies shall issue notice on rejecting issuance of receipt number of written cosmetic product declaration.

c) Within 3 months from the date on which the notice under Point b of this Clause is issued, if competent regulatory agencies do not receive revised declaration of declarants, the declaration will be invalidated. In this case, declarants will have to submit new declaration and fees as per the law should they wish to continue.

Article 8. Regulations on specifying receipt number of written cosmetic product declaration

Receipt number of written cosmetic product declaration shall consist of: order number + slash – year of issuance (last 2 digits) + slash + CBMP + dash + acronym of province, city, Board for management of economic zone or Drug Administration of Vietnam (QLD) according to Annex 04-MP.

For example: 135/11/CBMP-HN means the 135^th receipt number issued by Department of Health of Hanoi in 2011.

Article 9. Revision to declared contents

For cosmetic products declared and issued with receipt number of written cosmetic product declaration, in case of any change to contents specified under Annex No. 05-MP, organizations and individuals responsible for introducing the products to the market must issue request for issuance (for contents that do not require new declaration), attach documents related to contents to be revised and receive written permission of competent authorities, or produce new declaration (for contents that require new declaration).

Article 10. Effective period of receipt number of written cosmetic product declaration

Receipt number of written cosmetic product declaration shall be valid for 5 years from the date of issue. If organizations and individuals wish to continue to circulate cosmetic products on the market after 5 years, they must adopt declaration procedures and submit fees before the previous receipt number of written cosmetic product declaration expire.

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COSMETIC PRODUCT INFORMATION FILE

Article 11. General provisions on cosmetic product information file

Each cosmetic product upon being introduced to the market must possess a product information file (PIF) produced according to ASEAN’s guidelines and stored at organizations and individuals responsible for introducing the cosmetic product.

Article 12. Contents of cosmetic product information file

1. A cosmetic product information file consists of 4 parts as follows:

a) Part 1: Administrative documents and product summary;

b) Part 2: Ingredient quality;

c) Part 3: Final product quality;

d) Part 4: Safety and effectiveness.

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2. Part 1 of product information file must be presented to inspecting authorities at request; other parts must be presented within 15-60 days from the irregular inspection of authorities if said parts are insufficient at the time of inspection.

Chapter IV

COSMETIC PRODUCT SAFETY REQUIREMENTS

Article 13. Cosmetic product safety requirements

Organizations and individuals responsible of introducing cosmetic products to the market must ensure that the cosmetic products to be introduced do not harm human’s health when used in normal conditions, suitable conditions according to instruction, suitable dosage form and with adherence to information on label, instruction, cautions and other information provided by manufacturers or product owners.

Manufacturers and product owners must assess safety of each cosmetic product according to ASEAN Guidelines for the Safety Assessment of a Cosmetic Product. Limit of heavy metal and microorganisms in cosmetic products must satisfy ASEAN’s requirements under Annex No. 06-MP. Formula components of cosmetic products must satisfy all Annexes in the latest edition of ASEAN Cosmetic Agreement (address: www.dav.gov.vn or www.aseansec.org).

Article 14. Prohibited substances, components regulated in terms of concentration and content limit and use conditions within formula components of cosmetic products

Organizations and individuals must not introduce cosmetic products that contain following substances to the market:

1. Substances prohibited from use in cosmetic products with conditions thereof under Annex II.

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3. Pigments other than those listed under Annex IV, section 1, except for cosmetic products containing pigments solely for dyeing hair.

4. Pigments listed under Annex IV, section 1 used in conditions other than those specified.

5. Preservatives other than those specified under Annex VI, section 1.

6. Preservatives listed under Annex VI, section 1 with excess contents or not in permitted conditions, except for cases where these substances are used for special purposes unrelated to their preservative purposes.

7. Ultraviolet filters not specified under Annex VII section 1.

8. Ultraviolet filters specified under Annex VII, section 1 with excess contents or not in permitted conditions.

Presence of substances listed under Annex II in minimum contents is allowed if such presence is unavoidable according to “Good manufacturing practices for cosmetics” while safety of cosmetics specified under Article 13 hereof is guaranteed.

Article 15. Components allowed for cosmetic product circulation

1. Components or ingredients listed under Annex III, section 2 adhering to specified limit and conditions until the date specified under column (g) of this Annex.

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3. Preservatives listed under Annex VI, section 2 adhering to specified limit and acceptable conditions until the date specified in column (f) of this Annex. However, several components may be used in different contents for specific purposes and shown clearly in presentation form of products.

4. Ultraviolet filters specified under section 2 of Annex VII adhering to permitted limit and regulated conditions until the date specified under column (f) of this Annex.

Regulations on use of substances under aforementioned Annexes may subject to changes decided by ASEAN Cosmetic Committee. These regulations shall be updated automatically and valid in Vietnam.

Chapter V

COSMETIC PRODUCT LABELLING

Article 16. Cosmetic label position

1. Cosmetic labels must be attached to products and/or commercial packaging thereof in a visible spot, conforming to all regulations on labels and easily seen without detaching product components.

2. If external packaging cannot or do not open, labels must be applied on the external packaging and containing all basic information.

Article 17. Dimension, form and contents of labels

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2. Color of letters, numbers, drawings, images, symbols presented on cosmetic product‘s labels must be clear. Color of letters and number must provide a contrast to that of the background.

Article 18. Basic contents of labels

1. Cosmetic product’s labels must conform to ASEAN’s cosmetic labeling requirements. Basic information to be shown on labels:

a) Product’s name and functions, except for cases where presentation form already shows product’s functions;

b) Use instruction, except for cases where presentation form already shows product’s instruction;

c) Full formula components: Specify components according to international nomenclatures in the latest publications of those specified under Point c Clause 1 Article 5 hereof (do not specify percentage of components);

d) Manufacturing country;

dd) Name and address of organizations and individuals responsible for introducing products to the market (specify in full in Vietnamese according to Business registration certificates or Investment permit);

e) Amount of cosmetic products in net weight or volume in metric system or both metric system and imperial system;

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h) Date of manufacture or expiry date must be shown clearly (e.g. date/month/year). Date must be specified in month, year or date, month, year in precise order. May use “expiry date” or “best before”, if necessary, may include conditions to be guaranteed to ensure product’s stability.

For products with less than 30 months of stability, expiry date must be specified;

i) Safety warnings during use, especially according to remarks in “Use conditions and mandatory warnings to be displayed on labels” column under annexes of ASEAN Cosmetic Agreement and cautions must be shown on product’s labels.

2. In case dimension, form or packaging material do not allow full description of information under Clause 1 of this Article on original labels, these information must then be specified on auxiliary labels attached to cosmetic products and cosmetic’s labels must specify where the information is shown.

Following information must be specified on original labels of inner packaging of cosmetic products:

a) Product name;

b) Manufacturing batch.

Article 19. Language used on cosmetic’s labels

Details under Article 18 hereof must be displayed in English or Vietnamese; information under Points b, dd, and i Clause 1 Article 18 must be specified in Vietnamese.

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Organizations and individuals may specify other information on cosmetic’s labels. Additional information must not contradict regulations and law, must be truthful, accurate and true to cosmetic products’ nature, must not obstruct or deviate from basic contents of cosmetic’s labels.

Chapter VI

COSMETIC ADVERTISEMENT

(annulled)4

Chapter VII

COSMETIC IMPORT AND EXPORT

Article 32. Cosmetic export

Cosmetic export shall be conducted at customs authority as per applicable law and requirements of importing countries.

Article 33. Application and procedures for issuance of CFS for cosmetics domestically produced for export5

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2. Procedures for issuance of CFS for export cosmetics shall conform to Article 11 of Decree No. 69/2018/ND-CP.

3. Fees for issuance of CFS based on products shall correspond to 1 written cosmetic product declaration issued with receipt number.

4. Departments of Health of provinces and central-affiliated cities shall issue and manage CFS for export cosmetics manufactured in administrative divisions where cosmetic manufacturing facilities are based.

Article 34. Application and procedures for issuance of Certificate for compliance with “Cosmetic Good Manufacturing Practices” of ASEAN (CGMP-ASEAN) serving export demands

1. Manufacturers applying for Certificates for compliance with “Cosmetic Good Manufacturing Practices” of ASEAN (CGMP-ASEAN) to serve export shall send application for inspection to Drug Administration of Vietnam - Ministry of Health. Application includes:

a) Application for inspection for “Good Manufacturing Practices for Cosmetics” (Annex No. 13-MP);

b)6 (annulled);

c) Organizational structure and personnel graphs of manufacturing facilities (organizational structure charts must specify name, title, technical level of officials in charge of each section), working progress and experience in assigned tasks of officials in charge of each section (manufacturing, quality control, quality assurance, warehouse);

d)7 (annulled);

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e) List of currently available equipment of manufacturing facilities (including manufacturing equipment and quality control equipment) must display equipment name, year of manufacturing, manufacturing country and equipment conditions;

g)8 (annulled);

h) Self-inspection record for “Good Manufacturing Practices for Cosmetics” (Self-inspection records must specify time of inspection, composition of inspectorate for self-inspection, objectives of self-inspection, results of self-inspection and proposed time and measures for drawbacks).

2. Entitlement for application receipt and resolution:

Drug Administration of Vietnam - Ministry of Health is responsible for reviewing application, planning, issuing decisions on forming inspectorate and informing manufacturing facilities at least 10 days before inspection date.

3. Certificate for compliance with “Cosmetic Good Manufacturing Practices” is valid for 3 years from the date of issue.

4. Manufacturers applying for Certificate for compliance with Good Manufacturing Practices shall submit fees for appraisal of cosmetic standards and manufacturing conditions as per applicable laws.

Article 35. Cosmetic import

1.9 (annulled).

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a) Organizations and individuals importing cosmetics for research and experiment must send manifests of imported cosmetics used for research and experiment to Drug Administration of Vietnam - Ministry of Health (Annex No. 14-MP). Maximum quantity for each product is 10 specimens.

Manifests of imported cosmetics for research and experiment shall be made into 3 copies. After receiving approval, 2 copies shall be stored at Drug Administration of Vietnam while 1 copy is sent to the importers. The copy sent to importers must bear the seal specifying “Copy for enterprise” in order to be presented to customs authorities during customs clearance procedures.

Imported cosmetic products for research and experiment must be used for the right purposes and not introduced to the market for circulation.

b) Organizations and individuals receiving cosmetics as gifts donation shall adopt import procedures at customs authorities as per the law. Total value of cosmetic products received each time must not exceed duty-free product value as per applicable laws.

Cosmetic samples imported as gifts and donations must not be introduced to the market for circulation.

c) Organizations and individuals importing cosmetics for display at fairs, exhibits and other cases of temporary import for re-export must adopt procedures for issuance of temporary import for re-export permit of Ministry of Industry and Trade as per applicable laws.

Chapter VIII

COSMETIC SAMPLING FOR QUALITY CONTROL

Article 36. Sampling principles

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2. Amount of samples to be collected for analysis and storage depends on inspection, quality control requirements and testing methods as long as it is sufficient for 3 analyses or sufficient for testing methods that guarantee accurate and reliable results.

3. Samples for analysis and storage must be stored in containers, welded shut and labeled. Labels of sample containers must specify product name, name of organizations and individual responsible for introducing the products to the market, manufacturing batch, expiry date, sampling location, sampling date.

4. Produce records of cosmetic sampling using Form under Annex No. 09-MP: records of cosmetic sampling must specify product name, manufacturing batch, sampling date, sampling location, records regarding irregularities that occur during sampling process, name and signatures of individuals collecting samples, representatives of manufacturing facilities producing cosmetic products that are sampled and witnesses (if necessary). Records shall be made into 3 copies: 1 copy is stored at manufacturing facility producing cosmetic products that are sampled, 1 copy is stored at inspecting authority and 1 copy s stored at cosmetic quality control authority.

Article 37. Rights and responsibilities of sample collectors

1. Present inspector cards or quality control officials or letters of introduction or decisions on establishment of inspectorate signed by heads of cosmetic quality control agencies when performing tasks.

2. Request manufacturing facilities to present documents related to origin, quantity and quality of cosmetic product batches that are sampled, and provide sampling methods, amount of samples for analysis and storage collected from cosmetic product batches.

3. Examine and collect samples from any package in cosmetic shipments upon having any suspicion regarding product quality and safety.

4. Be legally responsible for techniques and legal procedures during sampling, transport and transfer to inspecting authorities.

Article 38. Sample transport and transfer

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2. Collected cosmetic samples must be packed in appropriate packaging and transported via appropriate means to guarantee preservation as per the law, avoid damage and irreversible deformation during transport.

Article 39. Quality control conclusion of cosmetic samples

1. Quality control results are only legitimate and applicable to the whole cosmetic product batches as long as cosmetic samples collected by competent regulatory authorities regarding quality control must represent the whole cosmetic product batches and be analyzed in accredited laboratories.

2. In case cosmetic samples are sent to state quality control authorities by organizations and individuals for quality control, quality control results are only legitimate for sent samples.

Article 40. Expenditure on cosmetic sampling and cosmetic quality inspection

1. Expenditure on sampling and expenditure on inspecting cosmetic samples for quality control in manufacturing, concocting and circulating on the market shall be incurred by quality control authorities that decide on sampling and sample inspection according to Joint Circular No. 28/2010/TTLT-BTC-BKHCN dated March 3, 2010 of Ministry of Finance and Ministry of Science and Technology providing guidelines on management and use of expenditure for state inspection regarding commodity quality.

2. In case cosmetic samples are concluded to be inadequate by cosmetic quality control authorities, organizations and individuals responsible for introducing the products to the market must reimburse quality control authorities for all expenditure on sampling and inspecting cosmetic samples according to Article 10, Article 12, Article 14, Article 16 and Article 41 of Joint Circular No. 28/2010/TTLT-BTC-BKHCN dated March 3, 2010 of Ministry of Finance and Ministry of Science and Technology providing guidelines on management and use of expenditure for state inspection regarding commodity quality and relevant law provisions.

3. In case cosmetics are complained and/or accused in terms of quality where the complaints and/or accusations are concluded to be incorrect by inspecting authorities, individuals filing complaints and/or accusations must reimburse inspecting authorities for all expenditure on sampling, analyzing and inspecting cosmetic samples specified under Clause 1 of this Article.

4. Expenditure on cosmetic sampling for quality control and expenditure on inspecting cosmetic samples are allocated in operational cost estimates of state quality control authorities for cosmetics according to Joint Circular No. 28/2010/TTLT-BTC-BKHCN dated March 3, 2010 of Ministry of Finance and Ministry of Science and Technology providing guidelines on management and use of expenditure for state inspection regarding commodity quality.

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EXAMINATION, INSPECTION AND ACTIONS AGAINST VIOLATIONS

Article 41. State inspection of cosmetic quality

1. Cosmetic quality control authorities:

a) Central cosmetic quality control authority is Drug Administration of Vietnam - Ministry of Health. Drug Administration of Vietnam shall direct inspection systems on a nationwide scale. In state inspection for cosmetic quality, Drug Administration of Vietnam shall cooperate with inspectors of Ministry of Health, National Institute of Drug Quality Control, Institute of Drug Quality Control - Ho Chi Minh City, Departments of Health of provinces and central-affiliated cities in implementing and supervising post-sale activities for cosmetic products.

On the basis of cosmetic inspection results of state inspection authorities, Drug Administration of Vietnam - Ministry of Health shall conclude quality of cosmetics on a nationwide scale.

b) Cosmetic quality control authorities in local administrative divisions shall be Departments of Health of provinces and central-affiliated cities. Departments of Health of provinces and central-affiliated cities shall organize post-sale activities for domestically manufactured cosmetics and imported cosmetics in local administrative divisions and deal with issues related to cosmetic quality as per the law. Monitor and record cosmetic quality control affairs in local administrative divisions.

Conclude cosmetic quality on the basis of cosmetic inspection results of state inspecting facilities for cosmetics in local administrative divisions.

2. State inspection system for cosmetic includes:

a) In central level: National Institute of Drug Quality Control, Institute of Drug Quality Control - Ho Chi Minh City;

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3. Heads of cosmetic quality control authorities are legally responsible for cosmetic quality control results.

Article 42. Forms of inspection

1. Periodic inspection: Periodic inspection shall be notified to inspected entities by competent authorities to enable inspected entities to prepare for inspection in advance.

2. Irregular inspection: Irregular inspection shall be conducted as soon as unqualified products, products not conforming to circulation regulation or under complaints of customers. In an emergency, competent authorities have the rights to conduct inspection without advance notice.

Article 43. Contents of inspection

1. Inspection for compliance with regulations and law on cosmetic manufacturing activities:

a) Compliance with principles and standards of “Cosmetic Good Manufacturing Practices” of ASEAN (CGMP-ASEAN) or equivalent accredited by ASEAN Cosmetic Committee;

b) Cosmetic product labeling;

c) Product information file (PIF) according to ASEAN’s regulations;

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2. Inspection for settlement of disputes, complaints and accusations regarding quality and other issues related to cosmetics (if any).

3. Inspection for issuance of announcement on cosmetic recall as per the law (if any).

Article 44. Order of priority in post-sale inspection and supervision

Post-sale cosmetic inspection and supervision should focus on importing, distributing and manufacturing entities. Order of priority in post-sale cosmetic inspection and supervision depends on type of products, origin, brand, label, product formula according to ASEAN’s guidelines on post-sale inspection and supervision (Annex No. 08-MP).

Article 45. Circulation suspension and recall of cosmetics

1. Cosmetics are suspended and recalled when any of the following occurs:

a) Cosmetics are circulated without being issued with receipt number of written cosmetic product declaration by competent regulatory agencies; or

b) Cosmetics unqualified and unsafe for users; or

c) Cosmetics having formula inconsistent with declaration; or

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dd) Cosmetics having labels that specify use inconsistent with declaration or incompliant with regulations on product labeling hereof, implement suspension or recall depends on level of violation; or

e) Cosmetics manufactured by manufacturing facilities not satisfactory to “Cosmetic Good Manufacturing Practices” of ASEAN (CGMP-ASEAN) or equivalent accredited by ASEAN Cosmetic Committee, implement suspension or recall depends on level of violation; or

g) Cosmetics past expiry date or recommended date of manufacturers; or

h) Fake cosmetics, illegally imported cosmetics, cosmetics with unclear origin, cosmetics without full packaging; or

i) Cosmetics subject to voluntary recall issued by organizations and individuals responsible for introducing the cosmetics to the market.

2. Entitlement for issuance of decisions on recalling violating cosmetics:

a) Drug Administration of Vietnam - Ministry of Health issues decisions on recalling violating cosmetics on a nationwide scale.

b) Departments of Health of provinces and central-affiliated cities, Board for management of Moc Bai border economic zone (Tay Ninh Province), Board for management of economic zone of Quang Tri Province implementing announcement of Drug Administration of Vietnam - Ministry of Health regarding recalling violating cosmetics as per the law in local administrative divisions and reporting to Drug Administration of Vietnam.

Article 46. Revocation of receipt number of written cosmetic product declaration

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a) Cosmetics having 2 unqualified shipments as concluded by regulatory agencies specialized in cosmetic quality; or

b) Cosmetics having formula inconsistent with declaration; or

c) Cosmetics having labels specifying incorrect origin; or

d) Cosmetics having labels specifying incorrect innate functions of the products; or

dd) Cosmetics unsafe for users; or

e) Cosmetics containing substances prohibited from use in cosmetics, substances with excess contents, concentration; or

g) Cosmetics concluded by competent authorities to be violating intellectual property rights or imitating labels of other products licensed for circulation; or

h) Cosmetics prohibited from circulation in home countries; or

i) Organizations and individuals introducing cosmetics to the market request revocation of receipt number of written cosmetic product declaration in writing; or

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l) Imitating documents, using counterfeit seals or imitating signatures, seals of Vietnamese or foreign authorities, of manufacturers or product owners; or

m) Untruthfully declaring details under written cosmetic product declaration.

2. Entitlement for issuance of decisions on revocation of receipt number of written cosmetic product declaration number:

a) Drug Administration of Vietnam - Ministry of Health issues decisions on revocation of receipt number of written cosmetic product declaration for cosmetic products manufactured domestically and issued with receipt number by Drug Administration of Vietnam before April 25, 2009 and imported cosmetic products on a nationwide scale.

b) Departments of Health of provinces and central-affiliated cities issue decisions on revocation of receipt number of written cosmetic product declaration for locally manufactured cosmetic products that they have issued.

c) Board for management of Moc Bai border economic zone (Tay Ninh Province) and Board for management of economic zone of Quang Tri Province issue decisions on revocation of receipt number of written cosmetic product declaration that they have issued.

Article 47. Cases of ceasing to receive declaration of cosmetic products, application for cosmetic advertisement, organization of cosmetic introduction conferences and events

1. Competent regulatory agencies shall cease to review and accept declaration of cosmetic products for 6 months for organizations and individuals that:

a) trade illegally imported cosmetics, counterfeit cosmetics, cosmetics with unclear origin; or

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c) fail to recall violating cosmetics under announcement of competent authorities;

d) manufacture or trade cosmetics in facilities unsatisfactory to principles and standards of “Cosmetic Good Manufacturing Practices” of ASEAN (CGMP-ASEAN) or equivalent accredited by ASEAN Cosmetic Committee; or

dd) manufacture or trade cosmetics containing substances prohibited from use in cosmetics or substances with excess contents, concentrations as per applicable law; or

e) use materials prohibited from circulation by manufacturing countries for cosmetic production; or

g) import or trade cosmetics or cosmetic materials prohibited from circulation by manufacturing countries; or

h) manufacture or trade cosmetics containing formula inconsistent with declaration;

l) imitate documents, use counterfeit seals or imitate signatures, seals of Vietnamese or foreign authorities, of manufacturers or product owners; or

k) untruthfully declare details under written cosmetic product declaration; or

l) fail to obtain PIF stored in enterprises as per the law.

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a) advertise cosmetics or organize cosmetic product introduction conferences and events without obtaining notice of receipt of application for cosmetic advertisement, organization of cosmetic product introduction conferences and events issued by competent regulatory agencies as per the law; or

b) advertise cosmetics or organize cosmetic product introduction conferences and events for cosmetic products that have not been issued with receipt number of written cosmetic product declaration; or

c) advertise cosmetics in a way that can cause consumers to mistake the cosmetics as medicine; advertise cosmetics in a way that involve credit, name, symbol, images or credentials of medical or pharmaceutical organizations or health officials; advertise cosmetics with functions and uses that lack scientific basis.

3. Competent regulatory agencies shall consider ceasing to accept cosmetic product declaration, application for cosmetic advertisement, organization of cosmetic product introduction conferences and events for organizations and individuals that fail to submit reports on annual business results as per the law.

At the end of the period in which declaration and application are ceased to be reviewed and accepted, if entities have fully rectified all violations and produced reports, competent regulatory agencies shall continue to review and accept cosmetic product declaration and application for cosmetic product advertisement, organization of cosmetic product introduction conferences and events.

Chapter X

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

Article 48. Responsibilities of organizations and individuals manufacturing, trading, importing cosmetics for circulation in Vietnamese market

1. Organizations and individuals responsible for introducing cosmetics to the market must be totally responsible for contents listed under written cosmetic product declaration, totally responsible for safety, effectiveness and quality of product in order to guarantee that circulated products satisfy all requirements of ASEAN Cosmetic Agreement and annexes attached thereto.

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3. In case side effects that seriously damage consumer’s life stem from cosmetic product quality, organizations and individuals introducing cosmetic products to the market must submit reports to Drug Administration of Vietnam - Ministry of Health using Form under Annex No. 18-MP within 7 days from the date on which they are first informed about these side effects. Detail reports on these side effects must be submitted to Drug Administration of Vietnam - Ministry of Health within the next 8 days.

4. Organizations and individuals responsible for introducing cosmetic products to the market must retain product information file for at least 3 years from the date on which the last batch is introduced to the market and present at request of inspecting authorities.

5. Cosmetic manufacturers must implement and satisfy principles and standards of “Cosmetic Good Manufacturing Practices” of ASEAN.

6. Organizations and individuals trading cosmetics must implement requirements of competent authorities in inspection for cosmetic product quality, recall violating cosmetic products and have the rights to produce complaints about conclusions and forms of penalties according to regulations and law on complaints and accusations.

7. Organizations and individuals responsible for introducing products to the market must conform to Vietnamese regulations and law on Intellectual property. Once competent authorities issue conclusions regarding brand and industrial shape that violate intellectual property rights, organizations and individuals must cease manufacturing, trade and import to replace brand and industrial shape as per the law, pay damages and deal with consequences (if any).

Article 49. Rights of cosmetic consumers

Consumers have the rights to be informed about cosmetics, file complaints, reports and request cosmetic trading entities to pay damages as per the law for cosmetic products manufactured and/or circulated in an unqualified, unsafe manner.

Chapter XI

IMPLEMENTATION

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1. Drug Administration of Vietnam - Ministry of Health is responsible for updating and implementing regulations related to ASEAN Cosmetic Agreement on website of Drug Administration of Vietnam (address: www.dav.gov.vn). Regularly inform relevant entities and organizations, individuals manufacturing, trading cosmetics about changes to technical criteria decided by ASEAN Cosmetic Committee while cooperate in implementing these changes and decisions in Vietnam. All decisions on cosmetic management approved by ASEAN Cosmetic Committee shall be adopted in Vietnam.

2. Drug Administration of Vietnam, Departments of Health of provinces and central-affiliated cities, Board for management of Moc Bai border economic zone (Tay Ninh Province) and Board for management of economic zone of Quang Tri Province are responsible for uploading resolution results of violations in cosmetic sector on their website; develop roadmap for uploading list of cosmetic products issued with receipt number of written cosmetic product declaration and resolved cosmetic information, advertisements on their website to serve post-sale inspection and supervision.

3. On June 30 and December 31 each year, Departments of Health of provinces and central-affiliated cities, Board for management of Moc Bai border economic zone (Tay Ninh Province) and Board for management of economic zone of Quang Tri Province shall submit reports on quality control and post-inspection of cosmetics in local administrative divisions, reports on issuance of receipt number of written cosmetic product declaration (Annex No. 15-MP), reports on issuance of notice on receipt of application for cosmetic product advertisements, organization of cosmetic product introduction conferences and events (Annex No. 16-MP) to Drug Administration of Vietnam – Ministry of Health.

4. On January 30 each year, organizations and individuals responsible for introducing products to the market must send reports on their business results of the previous years to Drug Administration of Vietnam - Ministry of Health and local Departments of Health (Annex No. 17-MP).

Article 51. Schedules and Annexes attached hereto

1. Written cosmetic product declaration: Form No. 01-MP.

2. Documents guiding declaration of cosmetic products: Annex No. 02-MP.

3. ASEAN’s guidelines for publicizing functions of cosmetic product: Annex No. 03-MP.

4. Acronyms of provinces, central-affiliated cities and Boards for management of economic zone: Annex No. 04-MP.

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6. ASEAN’s requirements for limit of heavy metal and microorganisms in cosmetic products: Annex No. 06-MP.

7. Product information file: Annex No. 07-MP.

8. ASEAN’s guidelines on post-sale cosmetic inspection: Annex No. 08-MP.

9. Record of cosmetic sampling for quality control: Annex No. 09-MP.

10. Application for cosmetic advertisement, organization of cosmetic product introduction conferences and events: Annex No. 10-MP.

11. Notice on receipt of application for cosmetic advertisement, organization of cosmetic product introduction conferences and events: Annex No. 11-MP.

12. Certificate of free sale (CFS): Annex No. 12-MP.

13. Application for inspection for “Good Manufacturing Practices for Cosmetics”: Annex No. 13-MP.

14. Shipment manifest imported for research and experiment: Annex No. 14-MP.

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16. List of cosmetic products issued with notice on receipt of application for cosmetic advertisement, organization of cosmetic product introduction conferences and events: Annex No. 16-MP.

17. Reports on cosmetic business results: Annex No. 17-MP.

18. Notice on disadvantageous effects of cosmetics: Annex No. 18-MP.

Article 52. Transition clauses

1. Starting from the effective date hereof, all organizations and individuals responsible for introducing cosmetic products to Vietnamese market must declare cosmetic products according to this Circular.

2. For products declared from March 10, 2008 (according to Regulations on cosmetic management attached to Decision No. 48/2007/QD-BYT dated December 31, 2007 of Minister of Health), issued with valid receipt number of written cosmetic product declaration and satisfactory to regulations under this Circular, these products may be manufactured (for domestically manufactured cosmetics) and imported (for imported cosmetics) until expiry date of written cosmetic product declaration.

3. Organizations and individuals responsible for introducing cosmetic products for circulation that are not satisfactory to cosmetic product safety requirements according to Chapter IV hereof must recall all products and comply with this Circular.

4. If cosmetic products circulated during effective period of license are satisfactory to cosmetic product safety requirements under Chapter IV hereof, the cosmetic products shall remain being circulated on the market until expiry date of the cosmetic products.

Article 53. Entry into force10

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2. Annul Decision No. 48/2007/QD-BYT dated December 31, 2007 of Minister of Health on Regulations on cosmetic management, Decision No. 40/2008/QD-BYT dated December 26, 2008 of Minister of Health on decentralization of state management for cosmetics manufactured in Vietnam, Decision No. 22/2008/QD-BYT dated July 2, 2008 of Minister of Health on authorizing Board for management of Moc Bai border economic zone of Tay Ninh Province in Commercial – Industrial Zone within Moc Bai border economic zone of Tay Ninh Province for implementation of cosmetic management, Decision No. 3450/QD-BYT dated September 21, 2010 of Minister of Health on authorizing Board for management of economic zone of Quang Tri Province for implementation of cosmetic management.

3. Heads of entities affiliated to Ministry of Health, entities affiliated to Ministry of Health; directors of Departments of Health of provinces and central-affiliated cities and relevant organizations, individuals are responsible for implementation of this Circular.

4. Difficulties that arise during implementation of this Circular shall be reported to Ministry of Health (Drug Administration of Vietnam)./.

PP. MINISTER
DEPUTY MINISTER




Truong Quoc Cuong

1 Circular No. 29/2020/TT-BYT dated December 31, 2020 of Minister of Health on amendment and annulment of legislative documents issued by Minister of Health, jointly issued with the following basis of issuance:

“Pursuant to Law on Issuance of Legislative Documents dated June 22, 2015 and Law on amendments to Law on Issuance of Legislative Documents dated June 18, 2020;

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Pursuant to Decree No. 54/2017/ND-CP dated May 8, 2017 of the Government on elaborating to Law on Pharmaceuticals;

Pursuant to Decree No. 69/2018/ND-CP dated May 15, 2018 of the Government on elaborating to Law on Foreign Trade Management;

Pursuant to Decree No. 96/2012/ND-CP dated November 15, 2012 of the Government on treatment for addiction to narcotic equivalents with substitutes;

Pursuant to Decree No. 15/2018/ND-CP dated February 2, 2018 of the Government on elaborating to Law on Food Safety;

Pursuant to Decree No. 34/2016/ND-CP dated May 14, 2016 of the Government on elaborating to Law on Issuance of Legislative Documents;

Pursuant to Decree No. 75/2017/ND-CP dated June 20, 2017 of the Government on functions, tasks, powers and organizational structure of Ministry of Health;

At request of Directors of Department of Legal Affairs,

Minister of Health promulgates Circular on amendment and annulment to legislative documents issued by Minister of Health and jointly issued by Minister of Health.”

2 This Clause is amended according to Clause 2 Article 12 of Decree No. 155/2018/ND-CP dated November 12, 2018 of the Government on amendment to regulations relating conditions for businesses under state management of Ministry of Health, coming into force from November 12, 2018.

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4 This Chapter is annulled according to Clause 2 Article 24 of Circular No. 09/2015/TT-BYT dated May 25, 2015 of Minister of Health on verifying advertisement contents for special products, commodities and services under management of Ministry of Health, coming into force from July 16, 2015.

5 This Article is amended according to Point c Clause 1 Article 1 of Circular No. 29/2020/TT-BYT, coming into force from February 15, 2021.

6 This Point is annulled according to Clause 2 Article 12 of Decree No. 155/2018/ND-CP, coming into force from November 12, 2018.

7 This Point is annulled according to Clause 2 Article 12 of Decree No. 155/2018/ND-CP, coming into force from November 12, 2018.

8 This Point is annulled according to Clause 2 Article 12 of Decree No. 155/2018/ND-CP, coming into force from November 12, 2018.

9 This Clause is annulled according to Clause 2 Article 12 of Decree No. 155/2018/ND-CP, coming into force from November 12, 2018.

10 Article 3, Article 4, Article 5 of Circular No. 29/2020/TT-BYT, coming into force from February 15, 2021 specify as follows:

“Article 3. Entry into force

1. This Circular comes into force from February 15, 2021.

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3. Regulations related to submission of documents, applications and online lookup are applied during Covid-19 period until Ministry of Health adjusts accordingly.

Article 4. Transition clauses

1. Applications submitted to receiving agencies before effective date hereof and being processed shall conform to relevant regulations hereof or regulations before effective date hereof whichever benefits the applicants.

2. Regulations on publicizing information, updating, declaring and reporting online in this Circular shall be implemented according to order of competent authorities.

Article 5. Responsibilities for implementation

Director of Department of Legal Affairs, Chief of Ministry Office, Chief Inspector of Ministry, Directors, Directors General of Departments, General Departments affiliated of Minister of Health and relevant agencies, organizations and individuals are responsible for implementation of this Circular./.”