Tiếng Việt| THE MINISTRY OF PUBLIC HEALTH | SOCIALIST REPUBLIC OF VIET NAM |
| No: 3486/2001/QD-BYT | Hanoi, August 13, 2001 |
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:
...
...
...
FOR THE HEALTH MINISTER
VICE MINISTER
Nguyen Van Thuong
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)
...
...
...
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.
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.
...
...
...
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.
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.
...
...
...
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).
...
...
...
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.
ASSAY OF INSECTICIDAL AND GERMICIDAL CHEMICALS AND PREPARATIONS
...
...
...
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.
...
...
...
- 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 17.- The assay shall be conducted in the following procedural order:
1. Sending the written application for assay to the Health Ministry.
...
...
...
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.
REGULATIONS ON REGISTRATION OF INSECTICIDAL AND GERMICIDAL CHEMICALS AND PREPARATIONS
1. Insecticidal and germicidal chemicals and preparations on the annually announced lists but not yet given circulation registration numbers.
...
...
...
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.
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.
...
...
...
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.
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.
...
...
...
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.
...
...
...
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.
...
...
...
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.
...
...
...
3.2.1. 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.
...
...
...
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.
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:
...
...
...
4.1.2. 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.
1. The packages of insecticidal and germicidal chemicals and preparations must ensure:
a) They are durable in the course of preservation, circulation and use;
b) They do not affect the composition, utilities and effects of the insecticidal and germicidal chemicals and preparations;
c) They can prevent the environmental impacts on the quality of insecticidal and germicidal chemicals and preparations;
...
...
...
2. Insecticidal and germicidal chemicals and preparations must be contained in specific packs; types of packages used exclusively for containing food, drinks and other consumer goods must not be used for containing insecticidal and germicidal chemicals or preparations.
1. The insecticidal and germicidal chemicals and preparations with their granted certificates of registration for circulation in Vietnam remaining valid.
2. Active elements and raw materials for the production of insecticidal and germicidal chemicals and preparations with granted certificates of registration for circulation in Vietnam remaining valid;
3. For insecticidal and germicidal chemicals and preparations not mentioned in Clauses 1 and 2 of this Article, the import thereof for the purpose of research, assay, experiment, used for particular non-business purposes, as samples, for exhibitions or trade fairs, must be approved in writing by the Health Ministry. Particularly for insecticidal and germicidal chemicals and preparations for participation in exhibitions and/or trade fairs, they must be re-exported after the conclusion thereof.
4. Insecticidal and germicidal chemicals and preparations for domestic and medical uses, when being imported into Vietnam, must remain valid for at least 2/3 of the use duration.
INSPECTION, EXAMINATION AND HANDLING OF VIOLATIONS
...
...
...
1. Upon receiving the Health Ministry�s decisions on withdrawal of their circulation registration certificates, the concerned establishments engaged in the production of and/or trading in insecticidal and germicidal chemicals and preparations must implement the following provisions:
a) Quickly stopping the production and trading thereof, and notifying such to customers.
b) Proceeding with the recovery of insecticidal and germicidal chemicals and preparations.
c) Asking for opinions of competent State bodies on handling measures and proceeding with the handling of the recovered insecticidal and germicidal chemicals and preparations according to the current regulations.
d) Reporting to the Health Ministry in writing on the causes and development thereof as well as the handling results.
2. Establishments having insecticidal and germicidal chemicals and preparations recovered must bear all expenses therefor and pay damage compensations according to law provisions.
...
...
...
2. The provincial-level Health Services shall have to organize the implementation of the Regulation on management of insecticidal and germicidal chemicals and preparations in their respective localities and notify the provisions of this Regulation to the establishments engaged in the production of and/or trading in insecticidal and germicidal chemicals and preparations for knowledge and implementation, examine and inspect the implementation of this Regulation in their respective localities.