THE MINISTRY OF PUBLIC HEALTH
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SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
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No: 3486/2001/QD-BYT
Hanoi, August 13, 2001
 
DECISION
PROMULGATING THE REGULATION ON MANAGEMENT OF INSECTICIDAL AND GERMICIDAL CHEMICALS AND PREPARATIONS FOR DOMESTIC AND MEDICAL USES
THE HEALTH MINISTER
Pursuant to the Law on Protection of People’ Health of July 11, 1989;
Pursuant to the Government’ Decree No.68/CP of October 11, 1993 defining the functions, tasks, powers and organizational apparatus of the Ministry of Health;
Pursuant to the Prime Minister’ Decision No.197/1998/QD-TTg of October 10, 1998 assigning the Ministry of Health the responsibility of State management over insecticidal and germicidal chemicals and preparations for domestic and medical uses;
Pursuant to the Enterprise Law and the legal documents guiding the implementation thereof;
Pursuant to the State Enterprise Law and the legal documents guiding the implementation thereof;
After obtaining the consent of the Government Office in Official Dispatch No.2924/VPCP-VX of June 29, 2001 and the agreements of the Trade Ministry in Official Dispatch No.2319/TM/CSTNTN of May 23, 2000, and of Official Dispatch No.4706/TM-CSTNTN of October 24, 2000, of the Ministry of Agriculture and Rural Development in Official Dispatch No. 1467/BNN-BVTV of May 5, 2000, and of the Ministry of Science, Technology and Environment in Official Dispatch No.1146/BKHCNMT-NN;
At the proposal of the director of the Prophylactic Medicine Department, the Health Ministry,
DECIDES:
Article 1.- To promulgate together with this Decision the Regulation on Management of Insecticidal and Germicidal Chemicals and Preparations for Domestic and Medical Uses.
Article 2.- This Decision takes effect 15 days after its signing and replaces Decision No.1654/1999/QD-BYT of May 29, 1999 of the Health Minister promulgating the Regulation on management of insecticidal and germicidal chemicals and preparations for domestic and medical uses; Circular No.18/1999/TT-BYT of September 20, 1999 of the Health Ministry guiding the organization of granting of circulation registration certificates, the certificates of satisfaction of the criteria and conditions for production of and trading in insecticidal and germicidal chemicals and preparations for domestic and medical uses.

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Article 3.- The director of the Office, the chief inspector, the director of the Prophylactic Medicine Department and directors of the Departments, of the Health Ministry; the director of the Vietnam Pharmaceutical Management Department; the director of the Department for Food Quality, Hygiene and Safety Control; the heads of units attached to the Ministry, the directors of the provincial/municipal Health Services; the owners of establishments which produce or trade in insectical and germicidal chemicals and preparations for domestic and medical uses shall have to implement this Decision.
 

 

 
FOR THE HEALTH MINISTER
VICE MINISTER




Nguyen Van Thuong
 
REGULATION
ON MANAGEMENT OF INSECTICIDAL AND GERMICIDAL CHEMICALS AND PREPARATIONS FOR DOMESTIC AND MEDICAL USES
(Issued together with the Health Minister’ Decision No.3486/2001/QD-BYT of August 13, 2001)
Chapter I
GENERAL PROVISIONS
Article 1.- This Regulation prescribes the conditions for production of and trading in, assay, circulation registration, storage, destruction, advertisement, labeling, packing and import of insecticidal and germicidal chemicals and preparations; chemicals and preparations of cleansing, cleaning or deodorizing effects for domestic and medical uses (hereinafter called insecticidal and germicidal chemicals and preparations for short).
Article 2.- Establishments engaged in the production of, trading in and import of, and organizations registering the circulation, storage and/or advertisement of, insecticidal and germicidal chemicals and preparations on the Vietnamese territory must abide by the provisions of this Regulation. Where the international agreements which Vietnam has signed or acceded to otherwise provide for, such international agreements shall apply.

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Article 3.- The insecticidal and germicidal chemicals and preparations governed by this Regulation shall include:
1. Chemicals and preparations which have the effects of killing, restricting, driving away or attracting medicinal insects of various kinds, for domestic and medical uses.
2. Chemicals and preparations which have the disinfecting and germicidal effects for domestic and medical uses.
3. Chemicals and preparations which have the principal cleansing, cleaning and/or deodorizing effects for domestic and medical uses.
Article 4.- Annually, the Health Minister shall issue lists of insecticial and germicidal chemicals and preparations, which are permitted for registration for use, permitted for registration for restricted use, and banned from use in domestic and medical fields on the Vietnamese territory.
The insecticidal and germicidal chemicals and preparations not on the annual lists shall be considered on a case-by-case basis by the Health Ministry.
Article 5.- In this Regulation, the terms below shall be construed as follows:
1. Active elements mean substances with activity in the insecticidal and germicidal chemicals and preparations.
2. Chemicals mean chemical substances containing the active element concentration, for use for processing into preparations or for direct use.
3. Preparations mean products turned out according to technological processes recognized by competent State bodies, meeting the quality standards and having trade marks as prescribed.

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4. Assay means the process of biological test to evaluate the effect and safety of insecticidal and germicidal chemicals and preparations according to the process promulgated by the Health Ministry.
5. Circulation registration means the process of appraising the effects and safety of insecticidal and germicidal chemicals and preparations as well as the legality of the dossiers of registration for permitted circulation by granting the circulation registration certificates.
6. Advertisement means the commercial acts of establishments engaged in production of and/or trading in insecticidal and germicidal chemicals and preparations in order to introduce commodities and services for trade promotion.
Article 6.- The Prophylactic Medicine Department of the Health Ministry is responsible for advising the Health Minister on performing the function of State management over insecticidal and germicidal chemicals and preparations throughout the country.
The Health Services of the provinces and centrally- run cities (hereinafter referred collectively to as provinces) are responsible for advising the provincial-level People�s Committees on performing the function of State management over insecticidal and germicidal chemicals and preparations in their respective localities.
Article 7.- Fees may be collected for the evaluation to permit the assay and/or to grant certificates of circulation registration of, insecticidal and germicidal chemicals and preparations under the provisions of the legislation on charges and fees.
Chapter II
REGULATIONS ON CONDITIONS FOR PRODUCTION OF AND TRADING IN INSECTICIDAL AND GERMICIDAL CHEMICALS AND PREPARATIONS
Article 8.- Establishments engaged in the production of and/or trading in insecticidal and germicidal chemicals and preparations can only produce and/or trade in the insecticidal and germicidal chemicals and preparations which have been granted certificates of registration for circulation in Vietnam.
Article 9.- The insecticidal and germicidal chemicals and preparations-producing establishments must satisfy the following conditions:

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1. The production managers must have the university degree related to insecticidal and germicidal chemicals and preparations being produced.
2. The contingent of their cadres and technical workers have the qualifications and capabilities which satisfy the production requirements.
3. People directly involved in production must have certificates of health fitness, granted by medical authorities of the district or higher level.
4. Their production technological process is appropriate, ensuring the quality of products.
5. They commit to abide by the law provisions on the environment and bear responsibility before law for their violations, if any.
6. They work out reserve plans and be equipped with means to handle incidents: fire, explosion, natural disaster, storm and flood, labor accidents, toxication’as well as long-term adverse impacts on human beings and surrounding environment.
7. They adequately supply safety devices against hazardous labor for people personally involved in production as provided for by law.
8. They fully satisfy the criteria on labor hygiene prescribed in " A number of provisional criteria on hygiene" issued together with the Health Minister’ Decision No.505/BYT-QD of April 13, 1992; the provisions on hygiene in the Law on Protection of People’ Health and the Hygiene Regulation issued together with Decree No.23-HDBT of January 24, 1991 of the Council of Ministers (now the Government).
Article 10.- The insecticidal and germicidal chemicals and preparations- producing establishments may start production only when they fully meet the conditions prescribed in Article 9 of this Regulation and the establishment owners have already sent their written commitments to the Health Ministry.
Article 11.- For chemicals and preparations with principal effects of cleansing, cleaning and/or deodorization, the production establishments must themselves announce the quality standards according to the law provisions on goods quality, ensuring effects and safety for users and the environment and send their written commitments to the Health Ministry.

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Article 12.- Establishments trading in insecticidal and germicidal chemicals and preparations must satisfy the following conditions:
1. For enterprises, their managers must have intermediate or higher degrees in specialties related to the insecticidal and germicidal chemicals and preparations being traded in. For individual business households, the household heads must have the certificates of participation in training courses relating to the insecticidal and germicidal chemicals and preparations being traded in, granted by units designated by the Health Ministry.
2. People personally dealing in insecticidal and germicidal chemicals and preparations must have health certificates granted by medical authorities of the district or higher level.
3. People dealing in insecticidal and germicidal preparations of common categories (mosquito repelling incense sticks, insecticide sprayer, mosquito-repelling cream, electrically-operated mosquito-killing or repelling chemical devices, cockroach- and fly-killing preparations) need not to have the certificates as provided for in Clauses 1 and 2 of this Article.
4. Their shops and storehouses must be equipped with necessary devices to prevent and fight fires and explosions, to ensure labor safety and environmental hygiene.
5. The transportation of insecticidal and germicidal chemicals and preparations must ensure safety as required for each type of insecticidal and germicidal chemicals or preparations according to the current regulations.
6. They must not trade in insecticidal and germicidal chemicals and preparations together with pharmaceuticals, food, foodstuffs, refreshment drinks and other consumer goods in the same shops. For establishments dealing in insecticidal and germicidal chemicals and preparations of common categories as provided for in Clause 3 of this Article, they are allowed to trade in them in the same shops but must place them in separate show-cases.
Article 13.- The insecticidal and germicidal chemicals and preparations-trading establishments may conduct the trading therein only after they have met all the conditions prescribed in Article 12 of this Regulation and the establishment owners have already sent their written commitments to the Health Services of the provinces or centrally-run cities where the establishments are headquartered.

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