THE HEALTH MINISTER

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.

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

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.

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.

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:

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�s Decision No.505/BYT-QD of April 13, 1992; the provisions on hygiene in the Law on Protection of People�s 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.

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.

Chapter III

ASSAY OF INSECTICIDAL AND GERMICIDAL CHEMICALS AND PREPARATIONS

Article 14.- All insecticidal and germicidal chemicals and preparations must be assayed before the application for registration for their circulation in Vietnam.

Article 15.- The Health Ministry shall designate institutes or sub-institutes to conduct the assay of insecticidal and germicidal chemicals and preparations as follows:

1. Units assaying the safety and effects of insecticidal chemicals and preparations:

- The Central Hygiene and Epidemiology Institute.

- The Pasteur Institute of Ho Chi Minh City.

- The Nha Trang Pasteur Institute.

- The Central Highlands Hygiene and Epidemiology Institute.

- The Central Malaria- Parasite- Insect Institute.

- The Quy Nhon Malaria-Parasite- Insect Institute.

- The Malaria-Parasite- Insect Sub-institute of Ho Chi Minh City.

2. Units assaying germicidal chemicals and preparations:

- The Central Hygiene and Epidemiology Institute.

- The Pasteur Institute of Ho Chi Minh City.

- The Nha Trang Pasteur Institute.

- The Central Highlands Hygiene and Epidemiology Institute.

- The Labor Medicine and Environmental Hygiene Institute.

- The Public Health Hygiene Institute of Ho Chi Minh City.

Article 16.- The insecticidal or germicidal chemicals and preparations- assaying units must abide by the assaying processes promulgated by the Health Ministry and be accountable before law for the assay results.

Article 17.- The assay shall be conducted in the following procedural order:

1. Sending the written application for assay to the Health Ministry.

2. For chemicals on the lists announced annually, within 10 days after receiving the assay application, the Health Ministry shall issue a written permission for the assay and appoint units to conduct the assay.

3. For chemicals not on the annually announced lists, the Health Ministry shall consider case by case to permit the assay and designate units to conduct the assay. If rejecting the assay, it shall make a written reply, clearly stating the reason(s) therefor.

4. The establishments applying for assays must pay assaying fees at the Health Ministry and receive official letters permitting the assay.

5. The establishments shall contact the assaying units in order to carry out procedures for assay.

6. After obtaining the assaying results, the establishments applying for assays shall finalize dossiers of circulation registration and submit them to the Health Ministry for appraisal, consideration and approval of the circulation registration as provided for in Chapter IV of this Regulation.

Chapter IV

REGULATIONS ON REGISTRATION OF INSECTICIDAL AND GERMICIDAL CHEMICALS AND PREPARATIONS

Article 18.- Insecticidal and germicidal chemicals and preparations can be circulated in Vietnam only when they are granted the circulation registration certificates by the Health Ministry.

Article 19.- The insecticidal and germicidal chemicals and preparations circulated in Vietnam must be subject to circulation registration:

1. Insecticidal and germicidal chemicals and preparations on the annually announced lists but not yet given circulation registration numbers.

2. Insecticidal or germicidal chemicals and preparations, which have been granted circulation registration certificates but have undergone chages in product forms, active element concentration, solvents, additives or mixtures of insecticidal or germicidal chemicals and preparations into new insecticidal or germicidal chemicals and preparations.

3. If insecticidal or germicidal chemicals and preparations do not fall under the regulation scope of Clauses 1 and 2 of this Article, the Health Ministry shall consider case by case to permit the circulation registration provided that there are adequate scientific dossiers decided by competent authorities.

Article 20.- Each insecticidal or germicidal chemical or preparation turned out by an establishment is allowed for registration under only one trade name.

Article 21.- Establishments allowed to register under their own names for the circulation of insecticidal and germicidal chemicals and preparations in Vietnam include:

1. Establishments in Vietnam which function to produce insecticidal and germicidal chemicals and preparations.

2. Establishments in Vietnam which are authorized in writing by foreign enterprises with function to produce insecticidal and germicidal chemicals and preparations.

3. Representative offices of foreign enterprises which have the function of producing and/or trading in insecticidal and germicidal chemicals and preparations.

Article 22.- Registration forms:

1. Official circulation registration

The official circulation registration applies to insecticidal and germicidal chemicals and preparations prescribed in Article 19 of this Regulation.

2. Circulation re-registration

The circulation re-registration applies to insecticidal and germicidal chemicals and preparations, which have been registered for circulation in Vietnam but their circulation registration certificates have expired. The time limit for submitting the re-registration dossiers is 6 months before the expiration of the circulation registration certificate.

3. Additional registration:

The additional registration applies to:

1. Insecticidal and germicidal chemicals and preparations with granted certificates of registration for circulation in Vietnam remaining valid but the scope of use thereof is to be expanded.

2. Insecticidal and germicidal chemicals and preparations with their granted certificates of registration for circulation in Vietnam remaining valid, which are subject to change of trade names for the purpose of export but without changing the product forms, active element concentration, solvent, additives or mixtures of insecticidal or germicidal chemicals or preparations into new ones.

The additional registration does not involve the change of circulation registration number.

Article 23.- The insecticidal and germicidal chemical and preparation registration dossiers must be made in two sets, of which one contains original documents and one contains copies thereof. Documents in foreign languages must be translated into Vietnamese and the lawful documents must be the originals or the valid copies. The dossiers must be bound with covers and enclosed with lists of documents.

Within 60 days after receiving the complete and valid dossiers, the Health Ministry shall grant the circulation registration certificates; if refusing to grant the certificate it must reply in writing, clearly stating the reasons therefor.

A circulation registration certificate shall be valid for 5 years.

Article 24.- The registration dossiers:

1. Official circulation registration

1.1. The dossiers of application for registration shall be submitted to the Health Ministry. Such a dossier shall include:

1.1.1. The registration application.

1.1.2. The business registration certificate or other valid papers proving that the establishment has the function of producing and/or trading in insecticidal and germicidal chemicals and preparations.

1.1.3. The written results of test of the composition and concentration of insecticidal and germicidal chemicals and preparations, granted by competent bodies in Vietnam. Where competent agencies in Vietnam are unable to test the composition and concentration, the results of composition and concentration tests by prestigious producers in the world or by countries which have signed agreements on goods quality with Vietnam can be used. In case of doubts, the Health Ministry shall send samples overseas for tests and the registration-applying establishments shall have to bear all expenses therefor.

1.1.4. The written reply on test results of testing units designated by the Health Ministry.

1.1.5. The written certification or confirmation by a competent body that the products have been permitted for circulation or the free sale certificate of the host country or at least one country which permits the use thereof (for imported insecticidal and germicidal chemicals and preparations).

1.1.6. The technical documents on the following:

a) Composition, structure.

b) Effects and use instructions.

c) Side effects, the remedies therefor.

d) The stability and preservation method.

e) The manufacturing process.

1.1.7. The contents of labels of insecticidal and germicidal chemicals and preparations to be registered.

1.2. For the following insecticidal and germicidal chemicals and preparations, apart from the documents mentioned in Section 1.1., the following documents must be added:

1.2.1. For insectifical and germicidal chemicals and preparations, which have been researched into and produced for the first time in Vietnam, the research results recognized by the Health Ministry under the current regulations are required.

1.2.2. For insecticidal and germicidal chemicals and preparations, which are produced in Vietnam according to technological processes of foreign producers, there must be letters of authorization (the original or notarized copies) permitting the use of their technological processes and trade marks.

1.2.3. For chemicals and preparations which are produced in Vietnam according to publicized technological processes, the producers must supply the originals or notarized copies of the documents on their already publicized formulas and manufacturing processes.

1.2.4. For chemicals and preparations, which are produced in Vietnam according to simple, common technological processes or manually such as dilution, manual packing, the producers only need to describe the manufacturing processes but have to make written commitments to ensure effects and safety for users and the environment.

1.3. The Health Ministry shall not make registration for chemicals and preparations which do not have clear origins and fail to comply with the current regulations.

2. Circulation re-registration:

2.1. The application for re-registration.

2.2. The business registration certificate or other valid papers proving that such establishment has the function of dealing in insecticidal and germicidal chemicals and preparations.

2.3. The report on business results in Vietnam, clearly stating whether or not any violations of the Regulation were committed, and the form of handling violations, if any.

3. Additional registration:

3.1. Addition of use scope:

3.1.1. The official letter applying for addition of scope of using chemicals and preparation.

3.1.2. The written results of assaying objects to be added.

3.1.3. Samples of labels of insecticidal or germicidal chemicals and preparation after the addition of the use scope.

3.2. Change of trade names:

3.2.1. The official letters applying for change of trade names of chemicals and preparations.

3.2.2. The new names of chemicals or preparations.

3.2.3. The names of countries or enterprises of the countries which will import such chemicals, preparations.

3.2.4. The contents of model labels of insecticidal and germicidal chemicals and preparations after the trade name change.

Article 25.- In cases where products have already been granted the definite-term circulation registration certificates but the organizations, enterprises or establishments which have registered such products under their own names are subject to organizational changes such as separation, merger, the organizations or enterprises which receive such products must report thereon to the Health Ministry and get its written consent.

Chapter V

REGULATIONS ON STORAGE, DESTRUCTION, ADVERTISEMENT, LABELING, PACKING AND IMPORT OF INSECTITICAL AND GERMICIDAL CHEMICALS AND PREPARATIONS

Article 26.- The storage and destruction of insecticidal and germicidal chemicals and preparations shall comply with the provisions of the Regulation on management of hazardous wastes, issued together with the Prime Minister�s Decision No.155/1999/QD-TTg of July 16, 1999 and other relevant law provisions.

1. The advertisement of insecticidal and germicidal chemicals and preparations must comply with the law provisions on advertisement.

2. The advertisement is made only for insecticidal and germicidal chemicals and preparations which have been granted the circulation registration certificates by the Health Ministry; the advertisement contents and information must be strictly truthful to the utilities and effects of the registered insecticidal and germicidal chemicals and preparations.

3. Establishments wishing to organize workshops to advertise for or introduce their new products in order to register for their circulation must ask for permission of the Health Ministry and may organize the workshops only after they are permitted in writing by the Health Ministry.

Article 28.- The labels of insecticidal and germicidal chemicals and preparations shall comply with the current law provisions on labeling of domestically circulated goods and imported goods. Besides, the compulsory contents of the labels of insecticidal and germicidal chemicals and preparations must be inscribed with:

1. The registration number granted by the Health Ministry for the circulation of insecticidal and germicidal chemicals and preparations in Vietnam.

2. Notes on safety: Supplying users with information on ways to prevent bad effects of the insectifical and germicidal chemicals and preparations (for example: Not to let the insecticidal or germicidal chemicals or preparations contact with eyes, skin�; washing or taking bath after the use thereof�).

3. First-aid instructions in case of intoxication of insecticidal and/or germicidal chemicals or preparations:

Inscribing clearly the first-aid methods upon the intoxication of insecticidal or germicidal chemicals and/or preparations; what to do when appear poisoning symptoms during or after the use of insecticidal or germicidal chemicals and preparations, what are the poisoning symptoms and what are the antidotes.

4. For highly poisonous insecticidal and germical chemicals and preparations (of groups I and II under the World Health Organization�s classification), the following must be additionally inscribed:

4.1. The color stripes indicating the poisonous degrees:

4.1.1. For insecticidal and germicidal chemicals and preparations of poison group I, it is red stripe.

4.1.2. For insecticidal and germicidal chemicals and preparations of poison group II, it is yellow stripe.

4.1.3. These color stripes are placed at the bottom of the labels with the length equal to the length of the labels and the height being equal to 10% of the labels� height.

4.1.4. The background colors of the labels must not be identical to the colors indicating the poisonous degrees of insecticidal and germicidal chemicals and preparations.

4.2. Information on poisonous degrees: Such information as "Extremely poisonous", "highly poisonous", "dangerous", "with care" and the symbols indicating the poisonous degrees corresponding to each type of insecticidal and germicidal chemical or preparation must be placed above the main column in the labels.

Biannually and annually, the provincial/municipal Health Services shall sum up and report on the situation of examining the implementation of the Regulation on management of insecticidal and germicidal chemicals and preparations in their respective localities to the Health Ministry (the Prophylactic Medicine Department).

For the Health Minister
Vive Minister
NGUYEN VAN THUONG