Bản dịch văn bản 35/2006/QĐ-BYT
Decision 35/2006/QĐ-BYT
Cơ quan ban hành: Bộ Y tế
Ngày ban hành: 2006-11-10

DECISION Promulgating the Regulation on management of cosmetics THE MINISTER OF HEALTH Pursuant to December 24, 1999 Ordinance No. 18/1999/PL-UBTVQH10 on Goods Quality; Pursuant to the Government's Decree No. 179/2004/ND-CP of October 21, 2004, stipulating the state management of goods quality; Pursuant to the Government's Decree No. 49/2003/ND-CP of May 15, 2003, defining the functions, tasks, powers and organizational structure of the Ministry of Health; At the proposal of the Director of the Vietnam Drug Administration , DECIDES: Article 1.- To promulgate together with this Decision the Regulation on management of cosmetic. Article 2.- This Regulation takes effect 15 days after its publication in "CONG BAO" and repeals the Health Minister's Decision No. 3629/1998/QD-BYT of December 19, 1998, promulgating the list of cosmetics subject to quality registration at the Ministry of Health, Decision No. 19/2001/QD-QLD of April 27, 2001, of the director of the Vietnam Drug Administration, promulgating the Provisional Regulation on registration for distribution of imported cosmetics directly affecting human health and Official Letter No. 3716/QLD of July 3, 2001, of the Vietnam Drug Administration, promulgating quality standards of cosmetics. Article 3.- The director of the Office, the chief inspector of the Ministry of Health, the director of the Vietnam Drug Administration, heads of units attached to the Ministry, directors of provincial/municipal Health Services, and heads of branch-based health agencies shall implement this Decision. Minister of Health TRAN THI TRUNG CHIEN REGULATION ON MANAGEMENT OF COSMETICS (Promulgated together with the Health Minister's Decision No. 35/2006/QD-BYT of November 10, 2006, promulgating the Regulation on management of cosmetics) Chapter I GENERAL PROVISIONS Article 1.- Scope of regulation and subjects of application This Regulation provides the management of cosmetics that are manufactured and distributed in the country and cosmetics that are manufactured abroad and imported for distribution in Vietnam. This Regulation applies to all organizations and individuals engaged in manufacturing, importing, or registering for distribution of, cosmetics in Vietnam. Article 2.- Interpretation of terms In this Regulation, the terms below are construed as follows: 1. Cosmetics are substances or preparations which are used in contact with external parts of the human body or with the teeth, gums or mucous membranes of the oral cavity for exclusively or mainly cleaning them, perfuming them, changing their appearance or the body odor and/or protecting or preserving them in good conditions. 2. Substances which are not regarded as cosmetic ingredients: a/ Impurities in raw materials used in the manufacture of cosmetics. b/ Raw materials and additives used in the process of preparation but not present in final products. c/ Raw materials used in necessary minimal quantities such as solvents or carriers for aromatic ingredients. 3. Cosmetic stability is the quality stability capability of a cosmetic which is preserved in given conditions to maintain its inherent physical, chemical, microbiological characteristics, safety, etc., within the prescribed limits. 4. Cosmetic shelf life is the use duration set for a cosmetics after the expiration of which the cosmetic may not be used. Article 3.- Cosmetic information and advertisement Cosmetic information and advertisement shall comply with the Health Ministry's Regulation on information on and advertisement of drugs and cosmetics currently in force. Chapter II REGULATIONS ON REGISTRATION FOR DISTRIBUTION AND ANNOUNCEMENT OF QUALITY STANDARDS OF COSMETICS Article 4.- Requirements on registration for distribution of cosmetics, announcement of quality standards 1. Foreign cosmetics imported into Vietnam for distribution must be registered for distribution under the provisions of Chapter III of this Regulation. The fee for registration for distribution of cosmetics shall be paid according to current regulations on charges and fees. 2. For cosmetics manufactured in the country for distribution, their quality standards must be announced under the provisions of Chapter III of this Regulation. 3. The list of cosmetic products subject to announcement of quality standards and registration for distribution is included in Appendix 1 to this Regulation. Article 5.- Composition of cosmetics Ingredients in cosmetics must comply with the provisions in the appendices and annexes to the Agreement on ASEAN Harmonized Cosmetic Regulatory Scheme on the management of cosmetics. Article 6.- Requirements on quality standards of cosmetics Quality standards of cosmetics must satisfy the following minimum requirements: 1. Conditions: The form of preparation, characteristics, form and appearance must be clearly stated. 2. Limits of acids and alkali: are prescribed by the manufacturer at appropriate levels to ensure safety for users. 3. Allowable limits of lead and arsenic: are prescribed by the manufacturer at appropriate levels to ensure safety for users. 4. Limits of bacteria and fungi: must at least meet the standards prescribed in the Health Minister's Decision No. 3113/1999/QD-BYT of October 11, 1999, promulgating the standard limits of bacteria and fungi in cosmetics and methods of skin allergic reaction tests. 5. Degree of skin allergic reaction: is prescribed by the manufacturer depending on each kind of product and only permitted at the following levels: a/ From inconsiderable allergic reaction to no allergic reaction for products applied to skin for a long time; b/ From mild allergic reaction to no allergic reaction (for products applied shortly to skin, such as shampoo and face lotions). The method of skin allergic reaction tests shall comply with the provisions of the Health Minister's Decision No. 3113/1999/QD-BYT of October 11, 1999. Article 7.- Provisions on cosmetic stability study and cosmetic shelf life 1. Provisions on cosmetic stability study. a/ Cosmetics, once manufactured, must be preserved under the conditions required by manufacturers on the basis of stability studies. b/ Stability study documents must describe in detail: + Preservation conditions (temperature, humidity) + Packing. + Method of study. + Results of standard tests of at least 3 different product lots. + Conclusions on product stability. c/ Results of cosmetic stability studies conducted with the accelerated testing method shall only be used for predicting the shelf life of cosmetics. In the process of distribution of cosmetics, manufacturers must monitor the stability of products under normal conditions. 2. Provisions on cosmetic shelf life. a/ The determination of the shelf life of a cosmetics must be based on the stability study results. b/ The prescribed shelf life of a cosmetics must not be longer than its shelf life already determined through study. Article 8.- Requirements on cosmetic labels 1. Organizations and individuals manufacturing, trading or importing cosmetics must label cosmetic goods as provided for by current law. 2. The contents and presentation of cosmetic labels must be compatible with the inherent nature of cosmetic products, must neither mislead consumers as to nor over-advertise the utility of those products. 3. Labels and industrial designs of cosmetics must comply with the law on intellectual property. Article 9.- Changes subject to new registration: When cosmetics which have been granted distribution registration codes have any of the following changes, they must be registered as new ones: 1. Change of cosmetic name. 2. Change of preparation form. 3. Change of ingredients in formula. 4. Change of quality standards and testing methods. 5. Change of cosmetic utility. 6. Change of manufacturer. 7. Change of place of manufacture. Article 10.- Changes subject to submission of additional dossiers: When cosmetics which have been granted distribution registration codes have any of the following changes, additional dossiers must be submitted: 1. Change of shelf life. 2. Change of name and address of registering unit. 3. Change of registering unit. 4. Change of cosmetic label. Chapter III PROVISIONS ON DOSSIERS OF REGISTRATION FOR DISTRIBUTION OF COSMETICS, DOSSIERS OF ANNOUNCEMENT OF QUALITY STANDARDS OF COSMETICS Article 11.- Requirements on language and presentation in dossiers of registration for distribution of cosmetics, dossiers of announcement of quality standards of cosmetics 1. Language: a/ Dossiers of announcement of quality standards of cosmetics of units manufacturing cosmetics in Vietnam must be written in Vietnamese. b/ Dossiers of registration for distribution of foreign cosmetics in Vietnam must be written in Vietnamese and/or English. c/ Documents in dossiers of registration for distribution mentioned in Clauses 2, 3 and 4, Article 12 of this Regulation must be consularly legalized. The consular legalization shall be effected in accordance with the Foreign Affairs Ministry's Circular No. 01/1999/TT-NG of June 3, 1999, stipulating procedures for legalization of papers and documents. d/ If documents in dossiers of registration for distribution mentioned in Clauses 2, 3 and 4, Article 12 of this Regulation are not written in English, in addition to the compliance with the provision of Point c, Clause 1 of this Article, the Vietnamese translations of these documents are also required, which must be notarized in accordance with Vietnamese law. e/ Documents specified at Points c and d, Clause 1 of this Article, if being copies, must be notarized or authenticated in Vietnam. 2. Presentation: a/ Names of ingredients in cosmetic formulas must be original names or international nonproprietary names (INN). b/ Dossiers must be printed on A4-sized papers and arranged in the order prescribed in Article 12 of this Regulation. Each dossier shall be made in three sets, including one original set. Technical documents on formulas, quality standards, testing methods, technical or clinic data (if any), label forms and written commitments must be certified by the manufacturer or owner (with signature and stamp). If cosmetic label forms are glued or pinned on A4-sized papers in the dossier of registration, an overlapping stamp must be appended on the label forms. c/ Each dossier of announcement of quality standards or registration for distribution shall be required per product. Cosmetics are regarded as a single product in a dossier when they share all the following details: - Cosmetic name. - Preparation form. - Ingredients. - Quality standards. - Uses. - Manufacturer. - Registering unit. Cosmetic packages of products sharing the same name for sale in a single kit (combination products in a single kit) may be registered under a single dossier. In this case, such a dossier must still contain technical documents for each component product. Article 12.- Dossiers of registration for distribution of foreign cosmetics imported into Vietnam comprise: 1. An application for distribution of cosmetics (made according to a set form). 2. Permit for distribution of products in the host country. This permit is granted by a competent agency of the country where products are marketed, which also indicates the country of manufacture. 3. Operation license of the factory, which certifies the factory's satisfaction of hygiene, safety and quality requirements, or the certificate of good manufacturing practice for cosmetics, which is granted by a competent agency in the country of manufacture. 4. Founding license or certificate of business registration or investment license of the organization or individual registering for distribution of cosmetics. 5. If the registering unit is other than the product manufacturer, a paper of authorization issued by the manufacturer to the registering unit is required. 6. Formula: All ingredients, concentration, content or ratio of each ingredient must be indicated (according to a set form). 7. Quality standards and testing methods (clearly indicating the standard levels and testing protocol). 8. Original testing slip issued by the manufacturer or testing slip issued by the laboratory accredited in good laboratory practice. 9. Technical or clinical data to prove special uses of products (if any). 10. Stability study documents. 11. The manufacturer's or ownerư's commitments that the product formulas do not contain prohibited substances and they observe the content limits of restricted substances and that products are manufactured strictly according to the announced formulas. 12. Label form. 13. Product specimen: 3 packed units. Article 13.- Dossiers for re-grant of distribution codes of foreign cosmetics imported into Vietnam comprise: 1. Application for re-grant of cosmetic distribution registration code 2. Original distribution permit granted by the Vietnam Drug Administration. 3. Label forms. 4. Product specimens: 3 smallest packed units. 5. Report on the process of distribution of products. Article 14.- Dossiers of announcement of quality standards of domestically manufactured cosmetics comprise: 1. Written announcement of quality standards of cosmetics. 2. Business registration certificate or investment license of the manufacturer showing the manufacturer's function of manufacturing cosmetics (a copy notarized or authenticated in Vietnam). 3. Formula: All ingredients, concentration, content or ratio of each ingredient must be indicated. 4. Quality standards and testing methods. 5. Technical or clinical data to prove special uses of products (if any). 6. Stability study documents. 7. The manufacturer's or owner's commitments that the product formulas do not contain prohibited substances and they observe the content limits of restricted substances and that products are manufactured strictly according to the announced formulas. Chapter IV PROCEDURES FOR RECEIPT OF DOSSIERS OF ANNOUNCEMENT OF QUALITY STANDARDS, DOSSIERS OF REGISTRATION FOR DISTRIBUTION OF COSMETICS Article 15.- Agency receiving and processing dossiers of announcement of quality standards of cosmetics and dossiers of registration for distribution of cosmetics The Vietnam Drug Administration shall receive dossiers of announcement of quality standards of cosmetics; and receive and appraise dossiers of registration for distribution of cosmetics. Article 16.- Procedures for receipt and processing of dossiers of announcement of quality standards of domestically manufactured cosmetics Within 15 working days after receiving valid dossiers of announcement of quality standards, if they are proper, the Vietnam Drug Administration shall issue slips of receipt of written announcements of quality standards (according to a set form). If a dossier is improper, the Vietnam Drug Administration shall notify in writing the improper contents to the applicant for revision and re-announcement. Article 17.- Procedures for receipt and processing of dossiers of registration for distribution of foreign cosmetics imported into Vietnam. 1. With 30 working days after receiving valid dossiers of registration for distribution of cosmetics and full fees, the Vietnam Drug Administration shall issue replies on the results of appraisal of the dossiers. If dossiers are proper, the Vietnam Drug Administration shall grant cosmetic distribution permits; when a dossier is improper, the Vietnam Drug Administration shall notify in writing the improper contents to the applicant for amendment and supplementation. If the amended and supplemented dossier is proper, the Vietnam Drug Administration shall grant a cosmetic distribution permit; if the amended and supplemented dossier remains improper, the Vietnam Drug Administration shall notify in writing the improper contents to the applicant for submission of a new dossier and payment of a fee. 2. At the expiration of the period of 60 working days counting from the date of receipt of the Vietnam Drug Administration's notice on the contents which need to be amended and supplemented, if the applicant fails to amend and supplement the dossier, the submitted dossier is no longer valid. Chapter V SUPERVISION AND INSPECTION OF COSMETIC QUALITY Article 18.- Legal grounds for quality supervision 1. Legal provisions on assurance of goods quality. 2. Written announcements on cosmetic quality standards and written distribution registrations already received and approved by the Vietnam Drug Administration. Article 19.- Conclusions on cosmetic samples that are quality-tested 1. For cosmetic samples which are taken by state agencies competent to conduct quality examination and ensure representation for the whole cosmetic lot, quality conclusions are legally valid for the whole cosmetic lot. 2. Cosmetic samples which are sent by organizations or individuals to state agencies in charge of quality examination for quality certification, quality conclusions are valid for those samples only. Article 20.- State agencies in charge of examining cosmetic quality The central drug test institute, the Ho Chi Minh City drug test institute and drug-cosmetic test institutes of provinces and centrally run cities are state agencies competent to conduct quality examination. The heads of the above cosmetic quality examination agencies shall take responsibility before law for their cosmetic quality conclusions. Article 21.- Recall of cosmetics The Vietnam Drug Administration, the Health Ministry Inspectorate and provincial/municipal Health Services shall supervise and oversee the recall of cosmetics showing quality violations. 1. The Vietnam Drug Administration shall issue notices on recall of cosmetics which fail to satisfy quality standards in the whole country. 2. Provincial/municipal Health Services and branch-based health agencies shall: a/ Issue notices on recall of cosmetics within their management which fail to satisfy quality standards as concluded by local agencies competent to conduct cosmetic quality examination. b/ Implement notices of the Vietnam Drug Administration on recall of cosmetics failing to satisfy quality standards, handle violations in accordance with law and report thereon to the Vietnam Drug Administration. 3. Cosmetic trading organizations and individuals: Upon receiving recall notices, cosmetic trading units shall: a/ Immediately and thoroughly recall cosmetic lots that fail to satisfy quality standards. b/ Send reports on the recall and handling of cosmetic lots that fail to satisfy quality standards to the Vietnam Drug Administration and concerned functional agencies. c/ Remedy consequences caused by cosmetics that fail to satisfy quality standards. Article 22.- State management agencies in charge of cosmetics performing the function of examining and inspecting cosmetic quality 1. The Vietnam Drug Administration shall perform the function of supervising in accordance with law the observance of regulations on management of cosmetic quality. 2. The Vietnam Drug Administration and the Health Ministry Inspectorate shall: a/ Supervise and inspect the observance of the law on cosmetic quality, propose measures to prevent, handle and stop acts that violate the law on cosmetic quality. b/ Consider and settle disputes, complaints and denunciations related to cosmetic quality. c/ Handle violating units. 3. Provincial/municipal Health Services, branch-based health agencies and local health inspectorates shall supervise and inspect cosmetic quality management work and handle acts of violation in their respective provinces or cities. Chapter VI RESPONSIBILITIES OF ORGANIZATIONS AND INDIVIDUALS MANUFACTURING, TRADING IN, IMPORTING AND REGISTERING COSMETICS AND RIGHTS OF COSMETIC CONSUMERS Article 23.- Responsibilities of organizations and individuals manufacturing, trading in, importing and registering cosmetics 1. Organizations and individuals manufacturing, trading in, importing or registering cosmetics may only distribute cosmetics that satisfy their announced or registered quality standards, remain in their shelf life, do not infringe upon intellectual property rights, and comply with regulations on goods labeling. 2. Organizations and individuals manufacturing, trading in, importing or registering cosmetics shall ensure truthfulness and accuracy in the information and advertisement on their cosmetic quality. 3. Organizations and individuals manufacturing, trading in, importing or registering cosmetics shall monitor, discover and promptly recall cosmetics that fail to satisfy quality standards; immediately settle customers' claims about cosmetic quality; and pay compensations in accordance with law for damage caused to customers. 4. Upon receiving conclusions of the National Office of Intellectual Property under the Ministry of Science and Technology on marks or industrial designs that infringe upon intellectual property rights, organizations or individuals shall cease manufacture, trading or import so as to change those marks or industrial designs according to regulations, pay indemnities and remedy consequences (if any). 5. Cosmetic trading organizations and individuals shall comply with the requests of competent state agencies that conduct cosmetic quality examination and inspection and may lodge complaints about the latter's conclusions and forms of handling of violations in accordance with the law on complaints and denunciations. 6. Cosmetic trading organizations and individuals shall take full responsibility for the quality of cosmetics that they manufacture, trade in, import or register. Article 24.- Rights of cosmetic consumers Consumers are entitled to information on cosmetic quality, to lodge complaints and denunciations, and to request cosmetic trading units to pay compensation in accordance with law for damage caused by manufactured or distributed inferior quality cosmetics. Chapter VII HANDLING OF VIOLATIONS Article 25.- Stoppage of distribution of cosmetics Cosmetics shall be stopped from distribution when one of the following circumstances occurs: 1. Distributed cosmetics fail to meet quality standards stated in their registration or announcement dossiers. 2. Distributed cosmetics have a formula different from that stated in their registration or announcement dossiers. 3. Distributed cosmetics have labels inconsistent with the provisions of Article 8 of this Regulation. Article 26.- Handling of violations Organizations and individuals violating regulations on cosmetics shall, depending on the nature and severity of their violations, be administratively sanctioned or examined for penal liability; if causing any damage, they shall pay compensation therefor in accordance with law. Chapter VIII IMPLEMENTATION PROVISIONS Article 27.- The Vietnam Drug Administration, the Health Ministry Inspectorate, provincial/municipal Health Services and branch-based health agencies shall guide and organize the supervision and inspection of the implementation of this Regulation.