The Decision 3490/2001/qd-Byt: Regulation On Chemical Management, Preparations For Destroying Insects In The Field Of Entomology, Bactericide Used In Medical Field

Original Language Title: Quyết định 3486/2001/QĐ-BYT: Về việc ban hành quy chế quản lý hoá chất, chế phẩm diệt côn trùng trong lĩnh vực côn trùng, diệt khuẩn dùng trong lĩnh vực y tế

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The DECISION of the MINISTER of Health On issuing regulations chemicals, preparations for destroying insects in the field of insect antibacterial used in the field of health the MINISTER of health pursuant to the law to protect people's health on July 11, 1989;

Pursuant to Decree No. 68/CP dated 11/10/1993 of the Government functions, tasks, powers and organization of the Ministry of health;

Pursuant to decision No. 195/1998/QD-TTg dated 10/10/1998 of the Prime Minister assigned to the Ministry of health is responsible for the management of chemical substances, preparations for destroying insects, bactericide used in household and medical field;

Pursuant to the law of business and legal documents guiding the implementation of the enterprise law;

Pursuant to the law on State business and legal documents guiding the implementation of the law on State enterprises;

After the opinion of the Government Office at no. 1 VPCP-VX on 29/6/2001 and the agreement of the Ministry of Commerce at no. 2419/TM-CSTNTN on 23/5/2000, no. 5030/TM-CSTNTN on 24/10/2000; The Ministry of agriculture and rural development at no. 1467/BNN-HERBICIDE on 05/5/2000; The Ministry of science, technology and the environment in no. 1147/BVHTT-NN;

According to the proposal of the Director General of preventive medicine-Ministry of health decision: article 1. Attached to this decision of chemical management regulation, preparations for destroying insects, bactericide used in household sector and health: article 2. This decision takes effect 15 days from the date of signing and replacing decision No 1654/1999/QD-BYT on 29/5/1999 of the Minister of health on issuing regulations chemicals, preparations for destroying insects, bactericide used in household sector and of health circular No. 18/1999/TT-BYT on 20/9/1999 of the Ministry of health the implementation guide registered certification organizations circulate, qualified certificate, the production conditions, the chemical business, preparations for destroying insects, bactericide used in household and medical fields.

Article 3. Chief, Chief Inspector, head of preventive medicine and Director of the Service of the Ministry of health, Director of the Vietnam Pharmaceutical Management Bureau; Director of quality management, sanitation, and food safety; Heads of subdivisions; The Director of the Health Department of the province, central cities; Home base for production, trade of chemicals, insecticides, preparations used in sterilizing medical and household sector is responsible for the implementation of this decision.

 

CHEMICAL MANAGEMENT REGULATION, PREPARATIONS for DESTROYING INSECTS, BACTERICIDE USED in HOUSEHOLD and medical FIELDS (attached to decision No 3391/2001/QD-BYT on 13/8/2001 of the Minister of health) chapter I GENERAL PROVISIONS article 1. This regulation stipulates the conditions of production, trafficking; the assay; Register circulation; Save contains; destruction; advertising; labels, packaging and chemical imports, preparations for destroying insects, bactericide; chemicals, cleansing effect preparations, cleansing, deodorant used in household sector and health (hereinafter referred to as chemicals, preparations for destroying insects, bactericidal).

Article 2. The basis of the production, trafficking, importing and the organization name register circulation, contains advertising, chemicals, preparations for destroying insects, bactericide on Vietnam territory subject to the provisions of this regulation. In the case of international treaties to which Vietnam signed or otherwise specified, the applicable international treaties.

Article 3: chemicals, preparations for destroying insects, sterilization was adjusted in this Regulation include: 1. chemical preparations, have the effect of eliminating, restrict, repel or attract insects in the field of medicine and medical appliances.

2. chemical effects products, antiseptic, bactericide used in household and medical fields.

3. The chemicals, the major effects products is washing, cleaning, deodorizing used in household and medical fields.

Article 4. Every year, the Minister of Health issued the list of chemicals, insecticides, preparations sterilizing are allowed to register to use, but registration is allowed limited use, prohibits the use in household and medical sector on the territory of Vietnam.

The chemicals, preparations for destroying insects, not bactericidal in the category every year, the Ministry of health will consider for each specific case.

Article 5. In this regulation, a number of terms below are interpreted as follows: 1. active substances is active in chemicals, insecticides, preparations: 2. germicidal chemicals are chemicals that contain the active ingredient concentrations are used for machining, processing into products or used directly.

3. Products are products that are produced according to the process technology has been the competent State Agency recognition, quality standard, branded goods according to the regulation.

4. assay of biological testing process is to evaluate the effect, safety of chemicals, insecticides, preparations sterilizing procedure were the promulgation of Ministry of health.

5. Register the circulation is the process of assessing the validity and safety of insect products chemicals, bactericidal and the legality of the registration documents to allow for circulation by the grant of the certificate of registration.

6. Advertising is the commercial behaviour of the production facilities, chemical trade, preparations for destroying insects, bactericide to introduce goods and services to trade promotion.

Article 6. Service of preventive medicine-Ministry of health responsible advised the Minister of health in the implementation of State management of chemical substances and preparations, insect sterilization in nationwide.

The Department of health, the central cities (hereafter referred to as the Department) staff responsible for the people's Committee in implementing State management functions with respect to chemicals, preparations for destroying insects, kill bacteria.

Article 7. The evaluation to allow assay, registration certificates in circulation of chemicals, insecticides, preparations are sterilizing currency fees in accordance with the law on fees.

 CHAPTER II DEFINED the CONDITIONS of production, TRADE of chemicals, INSECTICIDES, PREPARATIONS STERILIZING article 8. Manufacturing, trade of chemicals, insecticides, preparations produced only bactericidal, traded chemicals, preparations for destroying insects, bactericide has been the Ministry of Health issued a certificate of registration in Vietnam.

Article 9. Chemical production base, SCS, insect sterilization must have the following conditions: 1. The Executive producer must have a university degree related to the field of chemicals, insecticides, preparations are bactericidal.

2. Staff, technical workers with qualifications and capacity to meet the requirements of production.

3. People directly in production have certificate by the health medical authority district level upwards.

4. production process technology ensures consistent product quality.

5. the commitment to implement the provisions of the law on the environment and responsible before the law if violated.

6. to build and equip the means of troubleshooting: fire, explosion, natural disasters, hurricanes, accidents, intoxication ... and lasting harm to humans and the environment.

7. Full labor protection appliances toxic for people directly under provisions of the law.

8. Ensure adequate standards of hygiene and labor regulation in some interim standards on hygiene issued together with decision No. 505/BYT-QĐ on 13/4/1992 of the Minister of health, the regulation on hygiene in the law to protect people's health and hygiene conditions attached Decree No. 23-dated January 24, 1991 of the Council of The major (now the Government).


Article 10. Chemical production facilities, preparations for destroying insects, bactericide production is only allowed when the conditions specified in article 9 of this regulation and the production facility has submitted a commitment to the Health Ministry.

Article 11. For chemicals, the major effects products is washing, cleaning, deodorizing, the production base to publish quality standards according to provisions of the law on quality of goods, ensure effective, safe for the user and the environment and have a commitment to submit to the Ministry of health.

Article 12. Chemical trade establishments, preparations for destroying insects, bactericide must have the following conditions: 1. for enterprises, operators must have a high school degree or above majored in relation to chemicals, insecticides, preparations are bactericidal. For individual business households, households must have participated in professional training related to chemicals, insecticides, preparations are bactericidal trafficking due to the unit specified by the Ministry of health.

2. People directly traded chemicals, preparations for destroying insects, bactericide must have a health certificate by the medical authority district.

3. Who traded the insect products type, bactericide (sandalwood drive mosquitoes, insect sprays, creams, chemical removal, panels flush flush electric mosquito, cockroach removal products, flies) then there is no need to have the certificate prescribed in paragraph 1, 2 of this Thing.

4. Shop, warehouses have the equipment necessary for the prevention of fire, explosion, labor safety and ensure environmental hygiene.

5. The transport of chemicals, insecticides, preparations to ensure a safe sterilizing according to the requirements of each type of chemical substances, preparations for destroying insects, bactericidal according to the current rules.

6. do not trade in chemicals, insecticides, preparations with antibacterial medicinal products, food, food, soft drinks and other consumer goods in the same store. For the establishments of the pest products, commonly used sterilizing according to the provisions in paragraph 3 of this article are permitted to trade in a store but are to in private.

Article 13. Chemical trade establishments, preparations for destroying insects, bactericide trade allowed only after having had enough of the conditions specified in article 2 of this regulation and the home base of trade sent a commitment to the Department of health, the central city where the base headquarters.

 CHAPTER III CHEMICAL ASSAY, PREPARATIONS for DESTROYING INSECTS, BACTERICIDE article 14. All the chemicals, insecticides, preparations sterilizing before registered in Vietnam must pass assay.

Article 15. The Health Ministry indicated the Institution, the Institute performs the chemical assay, preparations for destroying insects, bactericide as follows: 1. The unit safety and assay the effect of chemicals, preparations for destroying insects:-Central Institute of hygiene and epidemiology.

-The Pasteur Institute in Ho Chi Minh City.

-The Pasteur Institute In Nha Trang.

-The Institute of hygiene and epidemiology Highlands.

-Institute of malaria-parasite – insect Central.

-Institute of malaria-parasite – insect Quy Nhon.

-Institute of malaria-parasite – insect in Ho Chi Minh City.

2. chemical assay units, sterilizing preparations:-Central Institute of hygiene and epidemiology.

-The Pasteur Institute in Ho Chi Minh City.

-The Pasteur Institute In Nha Trang.

-The Institute of hygiene and epidemiology Highlands.

-Institute of Labour Medicine and sanitation.

-The Institute of hygiene and public health in Ho Chi Minh City.

Article 16. The unit of chemical assay, preparations for destroying insects, bactericide must comply with the khảonghiệm process by the Ministry of Health issued and responsible before the law about assay results.

Article 17. Procedure to conduct the assay according to the following sequence: 1. The application of the Ministry of health sent assay.

2. With respect to the chemicals contained in the catalogue published annually, within 10 days from receipt of application to the assay, the Ministry of health will have text allows for assay and specify the unit perform the assay.

3. for the chemicals not included in the list published each year, the Department of health will consider each specific case to allow assay and specify the unit perform the assay. If you do not agree to allow the assay will reply in writing stating the reason.

4. Please allow basal assay to assay fees at the Health Ministry and receive dispatch allows for assay.

5. contact base with the unit to make the assay procedure the assay progresses.

6. After the assay results, basis please complete assay registration and circulation records filed at the Ministry of health to conduct the evaluation, registration review is released under the provisions of chapter IV of this regulation.

CHAPTER IV REGULATING the REGISTRATION of CHEMICAL SUBSTANCES, PREPARATIONS for DESTROYING INSECTS, BACTERICIDE Article 18. The chemicals, preparations for destroying insects, bactericide only allowed to circulate in Vietnam when the Department of Health issued a certificate of registration.

Article 19. The chemicals, preparations for destroying insects, bactericide in Vietnam must register circulation: 1. chemical preparations, insect, bactericide in items published annually but have not got the registration number.

2. Chemicals, preparations for destroying insects, bactericide has been granted registration certificates in circulation but changed the form of the product, its active substances, solvents, additives or mixtures of chemical substances, preparations for destroying insects, the bactericidal chemicals, preparations for destroying insects, new bactericidal.

3. If chemical substances, preparations for destroying insects, not bactericidal in scope of account 1, 2 things about this particular case, the Department of health will consider to allow registration of circulation on condition that full scientific dossier by the competent decision.

Article 20. Each of the chemicals, insecticides, preparations by a bactericidal basis of produce are only allowed to register a trade name.

Article 21. The premises are registered name circulating chemicals, preparations for destroying insects, bactericide in Vietnam including: 1. The base in Vietnam has the function of producing chemicals, preparations for destroying insects, kill bacteria.

2. The base in Vietnam have authorization of the foreign enterprise has the function of chemical production, insect removal preparations, bactericidal.

3. Representative offices for foreign businesses have production function, chemical trade, preparations for destroying insects, kill bacteria.

Article 22. Forms to register: 1. Subscribe to the official circulation.

Subscribe to circulate officially applied to the chemicals, preparations for destroying insects, sterilization provisions of article 19 of this regulation.

2. Register the circulation again.

Subscribe to circulate again applied to the chemicals, preparations for destroying insects, sterilization was registered in Vietnam, but the circulation registration certificate has expired. The time limit for submission of registration is 6 months before the circulation registration certificate expires.

3. additional registration.

1. additional registration applied for: chemicals, preparations for destroying insects, bactericide has been issued a certificate of registration issued in Vietnam longer duration but adds the scope to use.

2. Chemicals, preparations for destroying insects, bactericide has been issued a certificate of registration issued in Vietnam longer duration but renamed trade export purposes without changing the form of the product, its active substances, solvents, additives or mixtures of chemical substances, preparations for destroying insects bactericidal, into chemicals, insecticides, preparations of new bactericide.

Additional registration doesn't have to change the registration number.


Article 23. Registration of chemicals, insecticides, preparations must be made into two bactericidal, a set is the original, a Ministry is the copy. Documents in foreign languages must be translated into Vietnamese, the text legally must be original or valid copy. To close the cover profile, containing the list of documents.

Within 60 days of receipt of a valid application, the Ministry of health will issue a certificate of registration issued, if not then will reply in writing stating the reasons not to.

The term of the certificate of registration is issued for 5 years.

Article 24. Profile register: 1. Subscribe to the official circulation.

1.1 application for registration filed in the Ministry of health. Content of the application for registration include: 1.1.1 application for registration.

1.1.2. the business registration certificates or other valid documents proving the basis which has the function of producing, trafficking in chemicals, preparations for destroying insects, kill bacteria.

1.1.3. A component test results and levels of chemicals, insecticides, preparations sterilizing of competent agencies in Vietnam. In case the competent authority in Vietnam not tested was the content and components can use test results on the composition and concentration of prestigious manufacturers in the world, or of the agreement on the quality of the goods with Vietnam. In case of doubt, the Health Ministry will send samples abroad for testing and base registered must bear all costs for the testing.

1.1.4. A reply the assay results of the unit by the Vietnam Ministry of health assay.

1.1.5. The certificate or document certified by the competent authorities on products were allowed to circulate or sell certificates of freedom or of at least one country is allowed to use (for chemicals, insecticides, preparations imported bactericidal).

1.1.6. Technical documentation about the following issues: a) the composition, structure, composition;

b) effects and manual;

c) side effects, how to handle;

d) stability and preserving;

e) production process.

1.1.7. The content label chemicals, preparations for destroying insects, sterilization would sign.

1.2. With respect to the chemicals, preparations for destroying insects, the following, in addition to sterilizing the documents referred to in item 1.1 must be complemented with the following documents: 1.2.1. The chemicals, preparations for destroying insects, sterilization was first manufactured in Vietnam, then research must have the research results be recognized by the Ministry of health according to current rules.

1.2.2. The chemicals, preparations for destroying insects, bactericide produced in Vietnam are to apply technological processes of foreign manufacturers must have a letter of authorization (original or notarized) allows the use of process technology and trademarks.

1.2.3. The chemicals, products are manufactured in Vietnam to apply technological processes were announced, the manufacturer must provide the documents about the formula, manufacturing process was announced by the originals or certified copies.

1.2.4. for preparations, chemicals manufactured in Vietnam which apply the simple process technology, popular and craft production as diluting, packing, manufacturers need only describe the manufacturing process but must have a commitment to ensure effective, safe for the user and the environment.

1.3. The Ministry of health does not accept cases of chemical preparations, there is no clear origin and not correct according to the current rules.

2. registration circulation: 2.1. Application for registration.

2.2. business registration certificate or other valid documents proving the basis which has the function of chemical business, preparations for destroying insects, kill bacteria.

2.3. Results reported business in Vietnam, which clearly have violated regulations or not, if yes then how form processing.

3. additional registration: 3.1. Supplements the range of use: 3.1.1. Dispatch please supplement the range of use of chemical substances, preparations.

3.1.2. A assay results with additional please audience.

3.1.3. Samples of the label of the chemical substances, preparations for destroying insects, after sterilizing supplements the range of use.

3.2. trade name Change: 3.2.1. Dispatch please change trade names of chemical substances, preparations.

3.2.2. The new name of chemical substances, preparations.

3.2.3. names of countries or the business of the country will import chemical substances, preparations for it.

3.2.4. the sample content label of chemicals, insecticides, preparations antibacterial after change of trade name.

Article 25. In this case, the product has been granted a certificate of registration in circulation longer term but the organisation, business or trade name base register products that have organizational changes such as splitting, merging organizations, the enterprises that receive that product shall report the Ministry of health and the Ministry of health must be agreed in writing.

 Chapter V CONTAINS the RULES, destruction, advertising, labels, packaging, IMPORTING chemicals, PREPARATIONS for DESTROYING INSECTS, BACTERICIDE Article 26. The archive contains, destruction of chemicals, insecticides, preparations sterilizing performed as prescribed in the regulations for hazardous waste management attached to decision No 155/1999/QD-TTg dated 16/7/1999 of the Prime Minister and the other provisions of the relevant laws.

Article 27.

1. The promotion of chemicals, insecticides, preparations sterilizing must comply with the provisions of the law on advertising.

2. Just be advertising these types of chemicals, insecticides, preparations had bactericidal registration certificate issued by the Ministry of health; advertising content, the right to information of features, the effects of chemical substances, preparations for destroying insects, such as sterilizing has registered.

3. The base like to organize seminars to advertise or introduce new products aim to register circulation must ask permission and just hosted the workshop when the consent of the Ministry of health in writing.

Article 28. Label the chemical substances, preparations for destroying insects, bactericide made under the provisions of current legislation on the labelling of goods circulation in domestic and imported goods.

In addition to the mandatory content of the label chemicals, preparations for destroying insects, bactericide to record: 1. The registration number issued by the Ministry of health to a circulation of chemical substances, preparations for destroying insects, bactericide in Vietnam.

2. Note about safety: Take some information for the user to know how to prevent the bad effects of chemical substances, preparations for destroying insects, bactericide (for example: avoid to chemicals, preparations for destroying insects, bactericidal, skin contact with eyes ...; wash hands after using the bathroom or...).

3. Indications of chemical poisoning, emergency preparations, insect sterilization: specify the method of first aid when poisoning chemicals, preparations for destroying insects, bactericide; during or after the use of chemical substances, preparations for destroying insects, bactericidal if see what poisoning symptoms, symptoms of intoxication, antidote.

4. for the chemicals, preparations for destroying insects, toxic higher bactericidal (groups I and II according to the classification of the World Health Organization) must then be added: 4.1. The only toxic oxidized spectral lines records: 4.1.1. For chemicals, preparations for destroying insects, poisonous group of bar I: bactericidal red jerseys.

4.1.2. for chemicals, preparations for destroying insects, poisonous Group II: bactericidal yellow line.

4.1.3. The starting line this variety, placed in the bottom part of the label and of length equal to the length of the label, the height equivalent to 10% of the height of the label.

4.1.4. The color of the background labels not coincide with the independent group's only color chemicals, preparations for destroying insects, kill bacteria.

4.2. Information about toxic: the information as "very toxic", "toxic", "dangerous", "careful and iconic expression corresponding to each type of toxic chemicals, insecticides, preparations are bactericidal located above the main column's label.

Article 29.


1. The packaging of chemicals, insecticides, preparations antibacterial should ensure: a) Durable during preservation, circulation and use;

b) does not affect the components and features, the effects of chemical substances, preparations for destroying insects, bactericide c) prevents are the elements of the environment affects the quality of chemical substances, preparations for destroying insects, bactericide;

d) not vulnerable to explosion, broke out, rotting during storage and use.

2. Chemicals, insecticides, preparations must be contained in sterilizing packaging, not used to the kind of packaging that contains food, drinking water and other goods to contain chemicals, preparations for destroying insects, kill bacteria.

Article 30. Enterprises have imported chemicals, functional products, sterilizing insect gets: 1. chemical preparations, insect, bactericide has been issued a certificate of registration issued in Vietnam longer deadlines.

2. The active ingredient, raw material for the production of chemicals, preparations for destroying insects, bactericide has been issued a certificate of registration issued in Vietnam longer deadlines.

3. The chemicals, preparations for destroying insects, not bactericidal in account 1, 2 of this Thing, then the import for the purpose of research, assay, tested, used only for specific purposes without trading, making samples, participate in exhibitions, fairs and health must be agreed in writing. Particularly for chemicals, preparations for destroying insects, bactericide exhibits, the fair after the end to re-export.

4. The chemicals, preparations for destroying insects, bactericide used in household and medical sectors when imported into Vietnam are still at least 2/3 of the time limit for use.

 CHAPTER VI INSPECTIONS, checking and PROCESSING of VIOLATION of article 31. The Ministry of health, the Health Department of the province, the central cities in cooperation with the relevant authorities inspect, inspect periodically or irregularly in the production, trade in chemicals, preparations for destroying insects, bactericide, the conditions of the production, trafficking in chemical preparations, insect , kill bacteria.

Article 32. The Ministry of health will decide to revoke the certificate of registration issued in the case: chemicals, preparations for destroying insects, bactericide has had the registration number in circulation but unsatisfactory in quality or incorrect with records registered.

Article 33.

1. Upon receipt of the decision to revoke the certificate of registration issued by the Ministry of health, the production base, sales of chemicals, insecticides, preparations antibacterial should carry the following regulations: a) urgently suspended production, trade and notify the customers know.

b) proceed to the recovery of chemicals, preparations for destroying insects, kill bacteria.

c) Please the opinion of competent State agencies about measures for the handling and processing of chemicals, insecticides, preparations sterilizing recovered under current rules.

d) Ministry of health report in writing about the cause, happenings and results processing.

2. The basis of chemicals, insecticides, preparations were passive feedback bactericidal must bear all costs, compensation under the provisions of the law of Article 34. Organizations and individuals violating the provisions of this regulation and the provisions of the relevant law, the offense level would subject to penalty administrative violations or prejudice criminal responsibility, if the damage is compensated according to the provisions of the law.

 CHAPTER VII IMPLEMENTATION Article 35.

1. preventive health Services in collaboration with the Service and inspection functions-the Ministry of health is responsible for guidance, organization, inspection, inspection of the implementation of the regulation on management of chemical substances, preparations for destroying insects, bactericide in nationwide.

2. the Department of health is responsible for the organization implementing the regulation of chemical management, preparations for destroying insects, bactericide and notice provisions of this regulation to the production facilities, chemical trade, preparations for destroying insects, bactericide to know and implement , test, inspection of the implementation of this regulation within the scope of local management.

Article 36. Six months, 12 months, the Department of health, report the situation to check the implementation of the regulation on the management of chemicals, insecticides, preparations on sterilizing of the province of the Department of health (Health Service)./.