The DECISION, issued temporary regulations cosmetic quality management directly impact to human health _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ DIRECTOR of the DRUG ADMINISTRATION of VIETNAM pursuant to Decree 86-CP on 08-12-1995 on the assignment of responsibility to the State management for the quality of the goods.
Base circular health-science, technology and the environment number 07/TTLB on 1-7-1996 guide implementation Decree No. 87/CP on 08-12-1995 on the assignment of responsibility to the State management for the quality of the goods.
Pursuant to decision No. 547/TTg dated 13 August 1996 by the Prime Minister on the establishment of the Vietnam pharmaceutical Management Bureau affiliated to the Ministry of health.
Pursuant to decision No. 2062/BYT-QĐ on 4-11-1996 of the Minister of Health issued listing the goods cosmetics mandatory registration of quality at the Ministry of health.
At the suggestion of drug registration office and cosmetics quality assurance of medicines and cosmetics.
Article 1 DECISION. Attached to this decision a temporary regulation cosmetic quality management directly affect human health.
Article 2. All the cosmetic directly affects to human health are in the category specified by the Ministry of health was produced in the country or abroad would like to circulate in Vietnam must proceed properly registered under the provisions mentioned in article 1.
Article 3. This decision takes effect from the date 01-01-1997.
Article 4. Head of the Vietnam pharmaceutical Management Bureau in the room, the Director of the Health Department of the province, the city and the heads of the units of production, trade, export and import products directly affect human health is responsible for the implementation of this decision.
                                                                            (Signed) Nguyen Vi Ninh TEMPORARY REGULATIONS COSMETIC QUALITY MANAGEMENT DIRECTLY AFFECT HUMAN HEALTH (issued decision No. 964/QLD-QD on 27 December 1996) the cosmetics said in this provision are: the cosmetics directly affects to human health in the category to be registered in the Ministry of health quality (cosmetics).
A. REGISTRATION of COSMETIC QUALITY DIRECTLY AFFECTS to HUMAN HEALTH: 1-enterprises or individuals in foreign countries, and foreign investment (referred to as the base) production, trading on the market of cosmetics in Vietnam "directory of cosmetics mandatory registration of quality at the Ministry of health" must apply to register chemicals the amount prescribed in the Vietnam pharmaceutical Management Bureau.
The registration profile is cosmetic quality regulation technique to production made in manufacturing, business; is the legal basis for the inspection, quality control of the goods, complaint resolution, to report on the quality of the goods and the economic contract disputes between the customer and the production facilities. The manufacturing facility must have the vote attached to each test batch.
Valuable registration number 2 years from the date issued. Before the expiration of 6 months registration, if want to continue manufacturing facility must do the registration records.
2-regulations for the quality standard.
The base subscription standard of quality of cosmetics can apply the Vietnam standards, national standards of foreign countries or standard basis but not lower than the standards of Vietnam (if available): must have the quality targets for each type of product to be hygienically guaranteed , the safety of cosmetics.
Cosmetics must have the required norms to ensure no harmful effects to the human body, such as skin irritation, skin allergy, causing pimples to water, ... must be specified in the quality standards.
3-The cosmetic has been the Ministry of Health issued quality registration number, when circulation in the market is true according to the professional profile has been approved, is in the number sign up the label.
The only facility that is circulating the cosmetics that have been tested and quality assurance have been registered. Not been circulating the expired cosmetics.
In the process of circulating on the market, production, sales, imports must take responsibility for the quality of its products and the complications it causes including economic damage.
4-during the time of validity of registration of cosmetic quality: 4.1-cosmetic name changes or the trademark or the type of packaging, the need:-to apply the change.
-New product sample, label Template for that change.
-A results retrieval of trademarks at the industrial property Directorate, Ministry of science, technology and the environment for the production of cosmetics in the country; country license granted to change that for foreign cosmetics (if available).
4.2-All other changes are to make new registration records as prescribed.
5-registered quality products do not violate the regulations on industrial property of Vietnam as well as the international conventions to which Vietnam participates.
6-application for registration of the quality are made into 3 sets of which at least 1 original or certified photocopy; the profile is made of Vietnamese for domestic production; Vietnamese or English for overseas production, to be sure to avoid loss, the printed word is clear, not erasing, presented on A4 size paper.
7-the cosmetics regulations list registered at the Ministry of health has been competent authorities before the registration of the quality level, or allow imports still circulate with the old license, registration number until the expired license, registration number. (However to have the facility to check the quality of the cosmetics, the base pay of drug administration of Vietnam in the first quarter of 1997: a list of cosmetics that have been allowed to circulate in Vietnam included as standard to check its quality). After this time, if the facility to register a quality back, then proceed to register under the provisions of the Ministry of health.
8-the base please register the quality cosmetics must pay according to the current rules.
RULES for QUALITY REGISTRATION DOSSIER I-COSMETIC REGISTRATION PROFILE COSMETIC QUALITY DOMESTIC MANUFACTURING 1-application for registration of: model 1.
2-standard, product quality: as point 2 of part a. 3-Slip testing: testing by the Institute or Institute level.
4-the demonstration formula:-Scientific Name of each substance.
-The amount of use of the substances in the formula of a packing unit.
-Standard of each component.
-The use and mechanism of action of the product.
5-Sample label: full content must be the following:-product name.
-Name, address, the production base.
-The form of the product.
-Recipe.
-Packing: weight, capacity, the number of products in a single package.
-The registration number (SĐK-by QLDVN level), control number (SKS), term used to HD).
-Uses, dosages, caution when used (if any).
-Conditions of preservation.
The content must be presented by the Vietnamese, if there is a foreign language to have smaller Vietnamese sizes.
6-product samples: 1 sample.
7-other related documents: if available.
II-REGISTERED RECORD FOREIGN COSMETICS QUALITY 1-registered: model 2.
2-registered quality license cosmetics: due to the competent authorities of the country (the country has production facilities).
3-standards and product quality: as point 2 of part a. 4-testing: test Votes Votes of product quality inspection of manufacturing facilities or by the Agency's national water quality control departments at provincial level.
5-demonstration formula:-Scientific Name of each substance.

-The amount of the substance in the formula of a packing unit.
-Standard of each component.
-The use and mechanism of action of the product.
6-Sample label: label templates are already circulating in the country, official but must have more translations into English or Vietnamese (Note: stating the country of origin; ensure the necessary information as for the cosmetics brand in the country).
7-product samples: 1 sample.
8-other related documents: if available.
III-APPLICATION of QUALITY COSMETICS DUE to FOREIGN INSTITUTIONS, venture INVESTMENT LICENSE in VIETNAM PRODUCED 1-application for registration of: model 3.
2-investment license: copy.
3-standards and product quality: as point 2 of part a. 4-Slip testing: testing by the Institute or Institute level.
5-demonstration formula:-Scientific Name of each substance.
-The amount of use of the substances in the formula of a packing unit.
-Standard of each component.
-The use and mechanism of action of the product.
6-Sample label: full content must be the following:-product name.
-Name, address, the production base.
-The form of the product.
-Recipe.
-Packing: weight, capacity, the number of products in a single package.
-The registration number (SĐK), control number (SKS), term used in (HD).
-Uses, dosages, caution when used (if any).
-Conditions of preservation.
The content on the right by Vietnamese, if there is a foreign language to have smaller Vietnamese sizes for label products circulating in the country; with the label production for export can print the content on the website in English (only for export).
6-product samples: 1 sample.
7-other documents: if available.
IV-QUALITY REGISTRATION DOSSIER for COSMETICS PRODUCTION: The production is only done with the products were allowed to circulate in Vietnam or abroad has the franchise basis. Records the herd using Vietnamese.
1-application for registration of: Model 4.
2-registered quality license cosmetics franchise by the competent authority in Vietnam or the country for franchise basis.
3-quality standards and testing methods: is a hallmark of franchise basis.
4-Slip testing: testing by the Institute or Institute level.
5-demonstration formula:-Scientific Name of each substance.
-The amount of the substance in the formula of a packing unit.
-Standard of each component.
-The use and mechanism of action of the product.
7-Sample label: the label of model is the basis of the franchise. To print more, use the manual by Vietnamese. Specify the name and address of the receiving facility. In the case of export, can print in English (only for export).
8-product samples: 1 sample.
9-other documents: if available.
V-LEVEL PROCEDURE of REGISTRATION of quality when receiving valid registration documents, Vietnam pharmaceutical Management Bureau will respond to the latest result is 12 months from the date of the profile.
1-if the eligible level quality registration number:-promulgating the list be issued quality registration number.
-In 45 days when granted registered production facilities must submit 3 samples of the official product label released was granted registration number (for production base in the country). After that, the registration certificate of quality.
2-If no qualified level of registration: registration of agency answer basis does not grant the registration number; Yet the registration number; the profile is added or not added profile and specific reasons stated.
3-in case the required test quality control facility, the facility must submit registration form please and fees according to the current rules.
B. REGULATIONS on EXPORT, import the PRODUCT DIRECTLY AFFECTS to HUMAN HEALTH 1-Ministry of health (the Vietnam pharmaceutical Management Bureau) reviewed the list, importing the product.
2-Only domestic enterprises have business functions, export, import new direct import-export for cosmetics.
3-procedure for permission to export, import of cosmetics:-step 1: enterprises must apply for permission (as defined in point 4 of this part), the Vietnam pharmaceutical Management Bureau to review.
-Step 2: on the basis of consent of the Vietnam drug administration, enterprises doing import-export procedures with the General Department of customs or the Agency can function in accordance with the current rules.
4-procedure please consider the import of cosmetics in Vietnam Drug Administration: I-The Vietnam Ministry of health cosmetic grade quality registration number: only those products are Vietnam Drug Administration issued quality registration number or, as at point 7 A new part was imported to circulate in Vietnam. Application for permission as follows:-application (form 5).
-List of products please enter password (Form 6).
II-the cosmetics not yet Vietnam Drug Administration issued quality registration number are not allowed to import into Vietnam. These items, only the Vietnam pharmaceutical Management Bureau confirmed that allows putting into Vietnam with the aim of: participation in fairs, exhibitions in Vietnam to learn the market, as a template please register quality. This is only brought into Vietnam with a limited number (custom specific case, the Vietnam pharmaceutical Management Bureau will review). Application for permission as follows:-application: (form 7).
-List of products please allow (form 8).
5-only these products are Vietnam Drug Administration issued quality registration number or, as at point 7 A new joint was exported to overseas trade. Application for permission pursuant to the provisions of the water intended for export.
III-provisions on the quality of cosmetics imported into Vietnam:-the cosmetics imported into Vietnam to have the votes to check the original quality requirements accompany each shipment.
-The import of cosmetics in Vietnam must be quality control agency (Institute, Institute, or other authority be specified) according to the quality control standards have registered in Vietnam before the standard certification. To avoid these losses can happen, enterprises can base on import orders was browsing, send the form to the Agency the State quality inspection to check the quality before entering the goods into Vietnam.
C. COSMETIC CIRCULATION DISTRIBUTION DIRECTLY INFLUENCE HUMAN HEALTH products can be sold in the premises of pharmaceutical trade or business establishments, Department stores of the institutions of State, collective, individual, but must have a dedicated area for cosmetics to ensure preservation conditions hygiene goods due to manufacturing regulations. The area must meet the business implementation.
D. INSPECTION QUALITY CONTROL 1-Vietnam drug administration Inspector, Ministry of health in collaboration with the Department of management to organize the market Inspector, examine the implementation of the regulation on cosmetic quality management of the facilities nationwide. The Department of health, Department of health, in collaboration with the pharmaceutical business market management Bureau organized, check on local scope themselves in charge.
Vietnam pharmaceutical Management Bureau, the quality control agency (Institute, testing Institute), stations, medical testing centre province, central cities have the right to take samples in the market under the current drug samples sent on quality control agency to check. When the results are sent to the production facility, where sampling and the function body.
The basis of the needs and create all favorable conditions for taking the bar examination, sampling, to check quality at its base.
2-circulating suspension cosmetics on the market in cases: unsatisfactory cosmetic batch as registration records.

3-Unplug the registration number in the case: the same product from 3 times over the violation as point 2 this section.
4-Vietnam drug administration is the agency that issued the decision to suspend the circulation, to withdraw the registration number quality cosmetic.
5-production base in circulation must withdraw thoroughly, timely production of quality batch number has been suspended, totally responsible, material compensation due to the production of, traffic quality cosmetics cause and have sent reports about the Vietnam pharmaceutical Management Bureau , of the relevant authorities.
Vietnam pharmaceutical Management Bureau reported to the unit to know and implement. If the base would violate the custom level, will be dealt with according to the provisions of the law.