Friday, August 18, 2017

Plant protection products

DECISION No. 89/2006/QD-BNN OF OCTOBER 2, 2006, PROMULGATING THE REGULATION ON MANAGEMENT OF PLANT PROTECTION DRUGS

THE MINISTER OF AGRICULTURE AND RURAL DEVELOPMENT

Pursuant to the Government's Decree No. 86/2006/ND-CP of July 18, 2003, defining the functions, tasks, powers and organizational structure of the Ministry of Agriculture and Rural Development;

Pursuant to the July 25, 2001 Ordinance on Plant Protection and Quarantine;

Pursuant to the Regulation on management of plant protection drugs, issued together with the Government's Decree No. 58/2002/ND-CP of June 3, 2002;

At the proposal of the director of the Plant Protection Department;

 

DECIDES:

 

Article 1.- To promulgate the Regulation on management of plant protection drugs together with 11 appendices (not printed herein).

Article 2.- This Decision takes effect 15 days after its publication in "CONG BAO" and replaces the Agriculture and Rural Development Minister's Decision No. 145/2002/QD-BNN of December 18, 2002, and Section I, Part II of the Agriculture and Rural Development Minister's Circular No. 75/2000/TT-BNN-KHCN of July 17, 2000.

Article 3.- The directors of the Office and the Plant Protection Department, heads of units under the Ministry of Agriculture and Rural Development, directors of provincial/municipal Agriculture and Rural Development Services, and concerned organizations and individuals shall implement this Decision.

For the Minister of Agriculture and Rural Development
Vice Minister
BUI BA BONG

REGULATION ON MANAGEMENT OF PLANT PROTECTION DRUGS

(Promulgated together with the Agriculture and Rural Development Minister's Decision No. 89/2006/QD-BNN of October 2, 2006)

Chapter I

GENERAL PROVISIONS

Article 1.- Governing scope

This Regulation provides the procedures for registration; production, processing rebottling and packing; import and export; trading; preservation and transport; use; destruction; labeling and packaging of; seminars on, and advertisement for plant protection drugs in Vietnam.

Article 2.- Scope of application

This Regulation applies to domestic and foreign organizations and individuals conducting above activities in Vietnam.

Chapter II

PROCEDURES FOR REGISTRATION OF PLANT PROTECTION DRUGS

 

Article 3.- General principles

1. Each producer may register only one trade name for one active ingredient or plant protection drug material (technical drug).

2. A domestic or foreign organization or individual that produces an active ingredient or material (technical drug) may directly register one trade name for that active ingredient or material (technical drug) or authorize another organization or individual to do so.

3. An authorized organization or individual may register only one trade name for one active ingredient or material (technical drug) of any authorizer. The registering organization or individual may change the producer upon request or transfer the registered trade name. After the transfer, the registering unit and the unit that is transferred the right to registration may not register the active ingredient of the same type for another trade name. The change of producers or transfer of registered trade names is subject to approval by the Plant Protection Department and to relevant legal procedures.

4. When use purposes are changed, another trade name may be registered for one use purpose.

5. For drugs of chemical origin for which registration is applied for the first time for epidemic prevention and control (except for herbicides for fruit trees and tea), for regulation of the growth of fruit trees after the period of fructification, tea and vegetable or for post-harvest preservation of farm produce, tests must be conducted in order to re-determine the isolation duration in Vietnam. The duration of conducting these tests must not exceed the duration of conducting tests of the bio-effect of the drugs and these tests shall be carried out under the Agriculture and Rural Development Ministry's regulations on testing of plant protection drugs for registration in Vietnam.

6. Drugs of chemical origin with active ingredients of group-III or -IV toxicity as prescribed in Sections 1 and 9, Appendix 7 to this Regulation or with active ingredients not belonging to the organic chlorine group and having the isolation duration of at most seven days in Vietnam or the results of bio-effect tests in Vietnam satisfying the prescribed requirements may be registered for use for epidemic control, regulation of the growth of fruit trees after the period of fructification, tea or vegetable, or for post-harvest preservation of farm produce.

7. For drugs which have been separately registered for prevention of the same epidemic, their mixture for use may be recommended, but such mixture must not bear a separate name unless the approval of the Agriculture and Rural Development Ministry is obtained.

 

Article 4.- Plant protection drugs subject to registration for use in Vietnam

1. Drugs without active ingredients named on the list of plant protection drugs permitted for use in Vietnam;

2. Drugs with active ingredients and trade names on the list of plant protection drugs permitted for use in Vietnam but bearing other trade names;

3. Drugs with trade names on the list of plant protection drugs permitted for use with changes in their uses and dosage; use method, use purposes, drug forms, contents of active ingredients or mixed with other drugs to formulate new drugs.

 

Article 5.- Plant protection drugs which may not be registered for use in Vietnam

1. Drugs on the list of plant protection drugs restricted from use in Vietnam  (except for extension of registration);

2. Active ingredients of plant protection drugs created by foreign organizations or individuals and not yet registered for use in foreign countries;

3. Drugs with trade names identical with the names of active ingredients or materials (technical drugs);

4. Drugs in the form of finished products of group-I toxicity or drugs in the form of finished products of group-II toxicity with active ingredients of group-I toxicity as prescribed in Sections 1 and 9, Appendix 7 to this Regulation, except for drugs exclusively used for disinfection of warehouses and yards, drugs for treatment of timber, construction works and dikes; drugs outside the aforesaid groups of toxicity but on the watch lists of the United Nations Food and Agriculture Organization and the United Nations Environment Program which guide the enforcement of the Rotterdam Convention.

 

Article 6.- Forms of registration

1. Official registration

a/ Official registration applies to:

- Drugs newly created in the country and approved and recognized as plant protection drugs by a competent scientific council of branch or higher level.

- Drugs being commodities in foreign countries but put into use for the first time in Vietnam.

b/ Except for drugs for specific trees, small-scale and extensive bio-effect tests (referred to as tests for short) in northern and southern regions are required for all cases of official registration. Bio-effect tests are carried out under the Agriculture and Rural Development Ministry's regulations on testing of plant protection drugs for registration in Vietnam.

2. Additional registration

a/ Additional registration applies to:

- Drugs of other organizations or individuals with active ingredients similar to those of drugs for which official registration has been made for three years since the effective date of the registration decision issued by the Agriculture and Rural Development Ministry;

- Changes in the uses and dosage; use method, drug form, content of active ingredient and unit of active ingredient;

- Drugs bearing other trade names;

- New products being the mixture of two or more active ingredients;

- Change in use purposes.

b/ Tests of bio-effect in Vietnam are required for all cases of additional registration. For changes in uses, dosage, use method, drug form, content or unit of active ingredient, an extensive bio-effect test is required. For addition of trade names, mixtures or changes in use purposes, small-scale and extensive bio-effect tests shall be carried out in the north and the south under the Agriculture and Rural Development Ministry's regulations on testing of plant protection drugs for registration in Vietnam.

3. Exceptional registration

a/ Exceptional registration means a form of registration without filling in procedures for consideration and approval like additional registration and official registration. Exceptional registration applies only to drugs of biological origin in the forms of finished products of group-III or -IV toxicity as prescribed in Sections 1 and 9, Appendix 7 to this Regulation and not mixed with drugs of chemical origin.

b/ For drugs of biological origin for which exceptional registration is applied, bio-effect tests in Vietnam provided in Clauses 1 and 2, Article 6 of this Regulation are not required. The results of Vietnam-based research (for drugs researched by domestic organizations or individuals) or the results of tests of bio-effect in Vietnam (for drugs created by foreign countries) must be assessed and certified by a scientific council of departmental or equivalent level before the drugs are considered for registration for use in Vietnam.

4. Extension of registration

Extension of registration applies to all drugs on the lists of plant protection permitted for use or restricted from use in Vietnam upon the expiration of their registration certificates. Extension dossiers must be filed at least 6 months before the expiration of registration certificates. Plant protection drugs for which the procedures for registration extension are not carried out in time must be excluded from the lists of plant protection drugs permitted for use or restricted from use in Vietnam.

 

Article 7.- Dossiers and drug samples

An organization or individual that makes registration shall submit to the Plant Protection Department a dossier and drug sample, comprising:

1. An application for registration, made according to a set form;

2. Notarized copies of the industrial property right protection titles or notices on reference of marks, issued by the National Office of Intellectual Property, or the notarized copies of the authorization papers or papers on the transfer of the right to use titles of protection of the right to own the products in Vietnam, made by the owner of these goods (if any). After the registration is made, if the National Office of Intellectual Property issues a conclusion on mark infringements, the name of that drug shall be deleted and replaced with another name on the basis of the notice on the results of reference of marks or the certificate of registered mark, issued by the National Office of Intellectual Property;

3. The authorization paper, or its notarized copy, issued by the producer of the active ingredient or material (technical drug) applying for registration;

4. The certificate, or its notarized copy, of being the producer of the active ingredient or raw material (technical drug), issued by a competent management agency of the host country;

5. Documents must be in Vietnamese or English, be detailed and copied or translated from the originals and certified by the producer of the active ingredient or material (technical drug);

6. Standard substance (as required in Appendix 2 to this Regulation) and label form (as required in Chapter IX of this Regulation).

Article 8.- Registration charges and fees

Organizations and individuals applying for registration shall pay registration charges and fees according to current regulations.

Article 9.- Agency in charge of registration and its responsibilities

1. The Plant Protection Department is the agency in charge of registration of plant protection drugs in Vietnam.

2. Responsibilities of the agency in charge of registration

a/ To receive dossiers and drug samples.

b/ To appraise, archive and keep dossiers confidential.

c/ To give appraisal results and issue test permits (made according to a set form) within 03 working days after receiving valid and complete dossiers. In case of refusal to grant test permits, it shall clearly state the reasons therefor.

d/ To organize two sessions of the Advisory Council in the first and third quarters every year to consider and approve drugs of chemical origin for which registration is applied and after they are considered and recognized by the Advisory Council, prepare dossiers for submission to the Agriculture and Rural Development Ministry for decision on official registration or additional registration.

e/ In the last month of each quarter, to examine documents and compile dossiers for submission to the Agriculture and Rural Development Ministry for decision on exceptional registration of drugs of biological origin.

f/ To grant plant protection drug registration certificates (according to a set form) within 15 days after the effective date of the registration decisions of the Agriculture and Rural Development Ministry.

g/ To collect charge and fees for grant of test permits and plant protection drug registration certificates according to current regulations.

 

Article 10.- Validity of permits

The validity term of a test permit is three years and that of an official registration, additional registration, exceptional registration or registration extension certificate is five years.

 

Chapter III

PRODUCTION, PROCESSING, REBOTTLING AND PACKING OF PLANT PROTECTION DRUGS

Article 11.- General principles

It is only permitted to produce, process, rebottle and pack drugs on the lists of plant protection drugs permitted for use or restricted from use in Vietnam and drugs already permitted for import for processing and re-export under contracts signed with foreign parties.

Organizations and individuals engaged in the production, processing, rebottling and packing of plant protection drugs must meet all conditions set in Article 7 of the Regulation on management of plant protection drug, issued together with the Government's Decree No. 58/2002/ND-CP of June 3, 2002.

It is strictly prohibited to organize the production, processing, rebottling and packing for retail of plant protection drugs when the conditions set in Article 7 of the above Regulation are not fully satisfied.

Persons directly managing the production, processing, rebottling or packing of plant protection drugs must process a practice certificate issued by a provincial/municipal Plant Protection Sub-Department.

Applicants for practice certificates for production, processing, rebottling or packing of plant protection drugs must satisfy all the conditions set in Article 8 of the above Regulation on management of plant protection drugs.

Procedures for the grant of practice certificates for production, processing, rebottling or packing of plant protection drugs are defined in the Agriculture and Rural Development Minister's Decision No. 91/2002/QD-BNN of October 11, 2002.

 

Article 12.- Dossiers

1. Foreign organizations or individuals that meet all conditions set in Articles 7 and 8 of the Regulation on management of plant protection drugs, issued together with the Government's Decree No. 58/2002/ND-CP of June 3, 2002, and wish to conduct activities of production, processing, rebottling or packing of plant protection drugs in Vietnam shall send dossiers to the Plant Protection Department (the Ministry of Agriculture and Rural Development).

2. A dossier comprises:

a/ A report on the production, processing, rebottling or packing of plant protection drugs;

b/ A copy of the econo-technical report on the form of operation (production, processing, rebottling or packing), categories of drugs to be produced, processed, rebottled or packed) and the operation duration of the project;

c/ Notarized copies of diplomas of the person directly managing production, processing, rebottling or packing activities, if he/she is a foreigner.

 

Article 13.- Responsibilities of organizations and individuals engaged in the plant protection drug production, processing, rebottling and packing

1. To report in writing to the Plant Protection Department on the situation of plant protection drug production, processing, rebottling and packing, including the changes in design output, form of operation and categories of produced, processed, rebottled and packed drugs, in the fourth quarter every year.

2. To notify in writing to the Plant Protection Department on the stoppage of the plant protection drug production, processing, rebottling and packing under their projects.

3. To be held responsible before law if plant protection drug production, processing, rebottling or packing activities cause adverse impacts to human beings, livestock or the environment; and to be answerable for the quality of their products which are put into circulation and use.

 

Article 14.- Responsibilities of the Plant Protection Department

1. To receive foreign organizations' or individuals' dossiers on plant protection drug production, processing, rebottling and packing.

2. To give written replies to units applying for plant protection drug production, processing, rebottling and packing within three working days after receiving complete dossiers as stated in Article 12 of this Regulation.

3. To receive reports on production, processing, rebottling and packing activities and notices on the stoppage of plant protection drug production, processing, rebottling and packing activities of organizations and individuals and sum up these notices for reporting to the Agriculture and Rural Development Ministry.

4. To organize annual and unexpected inspection and examination of establishments engaged in plant protection drug production, processing, rebottling or packing when necessary.

 

Chapter IV

IMPORT AND EXPORT OF PLANT PROTECTION DRUGS

 

Article 15.- General principles

1. Organizations and individuals of all economic sectors may import and export plant protection drugs in accordance with the provisions of law.

2. Organizations and individuals that import plant protection drugs on the list of those restricted from use or plant protection drugs not on the list of those permitted for use in Vietnam for research and test or for use under foreign projects in Vietnam or import plant protection drugs for re-export under contracts signed with foreign parties must have import permits issued by the Agriculture and Rural Development Ministry.

3. It is only permitted to import plant protection drugs which are on the lists of those permitted for use or restricted from use and in the form of finished products with the contents of active ingredients equivalent to the registered contents of active ingredients in finished products; materials (technical drugs) with the contents of active ingredients of at least equivalent to the contents of materials on the list of plant protection drugs permitted for use or restricted from use in Vietnam.

4. It is only permitted to import plant protection drugs which are on the list of those permitted for use or restricted from use and of clear origin and meet all technical criteria of drugs already registered in Vietnam.

5. At the end of the fourth quarter every year, organizations and individuals that import plant protection drugs shall send written reports on the import of plant protection drugs to the Plant Protection Department.

 

Article 16.- Conditions for an enterprise to import or export plant protection drugs

1. Having a business registration certificate showing the business line of plant protection drugs or agricultural supplies.

2. Having a certificate of registration of the importing/exporting enterprise's code, issued by a provincial/municipal custom office;

3. Having a contract signed with a foreign partner (in case of import for re-export) which clearly states the category and quantity of the drug to be imported for re-export, the time and border gate for re-export. After goods are re-exported, the unit shall submit to the Plant Protection Department a copy of the customs clearance certificate issued by the border-gate customs office for the goods lot in question.

4. Filing an application for the import of drugs not on the list of those permitted for use or restricted from use for research, experimentation, testing or assay or for use under foreign investment projects in Vietnam (clearly stating the addresses in Vietnam).

 

Article 17.- Procedures for issue of permits for import of plant protection drugs

1. An organization or individual that imports plant protection drugs on the list of those restricted from use in Vietnam shall submit to the Plant Protection Department an application clearly stating the name, quantity and origin of the drug to be imported and the time and place for the import.

2. An organization or individual that imports drug samples for research or test in Vietnam shall submit to the Plant Protection Department a report clearly stating the reasons, place and time for the research or test; the name and quantity of the drug to be imported; and the place and time of importation.

3. An organization or individual that imports plant protection drugs for re-export shall submit to the Plant Protection Department one notarized copy of the export contract and one notarized copy of the import contract signed with a foreign partner. The process of temporary import for re-export of plant protection drugs is stipulated in Clause 2, Article 12 of the Government's Decree No. 12/2006/ND-CP of January 23, 2003, detailing the Commercial Law regarding goods sale and purchase activities.

4. An organization or individual that imports plant protection drugs not yet named on the list of those permitted for use in Vietnam for use under a foreign investment project in Vietnam shall submit to the Plant Protection Department a notarized copy of the foreign investment license issued by a competent Vietnamese agency (to be submitted for the first time only).

5. Permits for the import of plant protection drugs shall be made according to a set form and be valid for the whole goods lot within the period indicated therein.

 

Chapter V

TRADING IN PLANT PROTECTION DRUGS

 

Article 18.- General principles

Organizations and individuals trading in plant protection drugs must meet all conditions set in Article 16 of the Regulation on management of plant protection drugs, issued together with the Government's Decree No. 58/2002/ND-CP of June 3, 2002, and Article 7 of the Government's Decree No. 59/2006/ND-CP of June 12, 2006, detailing the implementation of the Commercial Law regarding goods and services banned from business, restricted from business or subject to conditional business.

It is only permitted to trade in plant protection drugs on the list of those permitted for use or restricted from use, issued annually by the Agriculture and Rural Development Ministry.

It is only permitted to trade in plant protection drugs which are in the form of finished products, have their use duration not yet expired, have clear origin and labels compliant with Chapter IX of this Regulation and other provisions of law on goods labels.

Persons who directly trade in plant protection drugs must have a practice certificate issued by a provincial/municipal Plant Protection Sub-Department.

Plant protection drugs may not be traded in marketplaces or other places in violation of the provisions of Article 21 of this Regulation.

 

Article 19.- Conditions for issue of practice certificates for trading in plant protection drugs

Applicants for practice certificates for trading in plant protection drugs must meet all conditions set in Article 17 of the Regulation on management of plant protection drugs, issued together with the Government's Decree No. 58/2002/ND-CP of June 3, 2002.

 

Article 20.- Procedures for issue of practice certificates for trading in plant protection drugs

The procedures for issue of practice certificates for trading in plant protection drugs are stipulated in Decision No. 91/2002/QD-BNN of October 11, 2002, of the Agriculture and Rural Development Minister.

 

Article 21.- Places for plant protection drug trading

The locations of plant protection drugs shops must be approved in writing by commune, ward or equivalent level administrations; be far from residential quarters, schools, hospitals, marketplaces and water sources; ensure safety for human beings, livestock and the environment; not become inundated in any circumstance; and be equipped with adequate fire and explosion protection devices, meeting the requirements set in Clause 2, Article 19 of the Regulation on management of plant protection drugs, issued together with the Government's Decree No. 58/2002/ND-CP of June 3, 2002.

 

Chapter VI

TRANSPORT AND PRESERVATION OF PLANT PROTECTION DRUGS

Article 22.- General principles

The transport of plant protection drugs and drug materials must comply with the provisions of law on land road, railway and inland waterway traffic order and safety and relevant provisions of law.

The transport of plant protection drugs must be carried out along the route stated in the contract or other papers related to the transport of plant protection drugs signed between the vehicle owner and the goods owner.

Plant protection drugs and drug materials may not be transported on the same vehicles together with passengers, livestock, food, foodstuff, inflammables substances, explosives and other goods (except for fertilizers).

Vehicles carrying plant protection drugs and drug materials must ensure safety for human beings and the ecological environment, operate on the prescribed routes and must not stop in crowded areas, near schools, hospitals, marketplaces or daily-life water sources.

 

Article 23.- Transport of plant protection drugs and drug materials

1. Transporters of plant protection drugs and materials

Drivers and cargo escorts must understand that plant protection drugs and drug materials are dangerous such as toxic, inflammable, explosive and corrosive and they are able to respond to incidents which may occur during the transport of plant protection drugs and drug materials.

2. Upon occurrence of incidents

When a breaking, spilling or leaking incident or a traffic accident occurs during the transport of plant protection drugs or drug materials, the driver, cargo escort or goods owner shall immediately notify that incident to the nearest local administration or competent state agency for the latter to take measures to prevent and remedy consequences caused by the leakage of drugs. Goods owners shall pay all expenses for the remedy of consequences.

3. Tanks and containers of plant protection drugs or drug materials during the transport

- Tanks of plant protection drugs or drug materials must be made of elastic, durable and impermeable materials.

- Tanks and containers of plant protection drugs and drug materials must bear the danger symbol of black skull and crossbones in a white background in lopsided square. The size of the symbol displayed on a plant protection drug tank is 100 mm x 100 mm and on a plant protection drug container is 250 mm x 250 mm (Clause 1, Section II, Appendix 8 to this Regulation). The symbol must be displayed at both sides of a tank and at both sides and the back of a container.

- Tanks and containers of plant protection drugs and drug materials must display danger placards being orange rectangles with the letters UN (United Nations) in the middle. The size of the placard is 300 mm x 300 mm (Clause 2, Section II, Appendix 8 to this Regulation). The placard must be displayed below the danger symbol.

4. Vehicles used for carrying plant protection drugs and drug materials

- Ordinary means of transport which are permitted for cargo transport by competent agencies may be used for carrying plant protection drugs and plant protection drug materials.

- A vehicle carrying plant protection drugs or plant protection drug materials must have a roof or canvas hood to protect the goods against rain and wind during the transportation.

- If no special-use ferry is available for carrying dangerous cargo, vehicles carrying plant protection drugs or plant protection drug materials will be the last vehicles boarding a ferry.

- Vehicles carrying tanks of plant protection drug or plant protection drug materials must have the danger symbols and the danger placards displayed on both sides. The specifications of the danger symbol and the danger placard are similar to those displayed on a container.

 

Article 24.- Plant protection drug storehouses

Plant protection drug storehouses must satisfy the following requirements:

1. The locations of plant protection drugs storehouses (outside industrial parks) must be approved in writing by local administrations of commune, ward or equivalent level.

2. Storehouses must be built firmly with refractory materials, not become inundated, and ensure air ventilation and accessible for fine engines.

3. Storehouses must be equipped with fire extinguishing, anti-toxicity, and first aid equipment and signboards showing the danger symbol, a black skull and crossbones in a white background in a lopsided square, of a size similar to the danger symbol displayed on vehicles or containers stipulated in Clause 1, Section II, Appendix 8 to this Regulation.

 

Article 25.- Preservation of plant protection drugs

The preservation of plant protection drugs must ensure safety for human beings, livestock and the environment in surrounding areas.

In case of drug leakage, causing adverse impacts on the ecological environment, drug owners shall remedy the consequences under the guidance or inspection of plant protection and quarantine agencies, environment management agencies and the nearest People's Committee and bear all expenses for this work.

 

Chapter VII

USE OF PLANT PROTECTION DRUGS

Article 26.- General principles

It is only permitted to use plant protection drugs on the list of those permitted for use or the list of those restricted from use, issued annually by the Agriculture and Rural Development Ministry.

It is strictly prohibited to use plant protection drugs banned from use in Vietnam; drugs outside the list of those permitted for use or the list of those restricted from use; drugs of unknown origin; and drugs with their labels presented in foreign languages only.

Plant protection drugs may not be used in contravention of the instructions given in their labels.

The use of plant protection drugs must comply with the set principles and the isolation duration indicated in their labels.

 

Article 27.- Responsibilities of plant protection drug users

Plant protection drug users are held responsible before law for improper use or failure to comply with the set isolation duration or techniques, leading to excess of plant protection drug residues in farm produce against the permitted limit; use of banned drugs, drugs outside lists or drugs of unknown origin, causing bad impacts on the health of human beings, livestock and the ecological environment. If causing material damage to others, they shall pay compensations therefor.

 

Article 28.- Responsibilities of management agencies and units trading in plant protection drugs

1. Agencies in charge of state management of plant protection and quarantine in provinces or centrally run cities shall coordinate with functional agencies in inspecting the use of plant protection drugs in production areas, especially in areas under vegetable, tea and fruit trees; to detect and handle intentional violations of general principles on the use of plant protection drugs prescribed in Article 26 of this Regulation.

2. Commune, ward and equivalent level administrations shall participate in the management of the trading and use of plant protection drugs in their localities; coordinate with professional agencies in charge of plant protection and quarantine in disseminating and guiding the rational and efficient use of plant protection drugs and in handling related violations.

3. Domestic or foreign organizations or individuals that trade in plant protection drugs must provide detailed and clear instructions to drug purchasers and, at the same time, are held responsible before law for, and pay compensations for economic damage caused by, incomplete, improper or inaccurate instructions and advertisements on plant protection drugs, confusing drug purchasers and users and causing bad impacts on the health of human beings, livestock and the ecological environment as well as production activities.

 

Chapter VIII

DESTRUCTION OF PLANT PROTECTION DRUGS AND DRUG PACKAGES

 

Article 29.- General principles

The destruction of plant protection drugs and drug packages must satisfy requirements prescribed in Article 22 of the Regulation on management of plant protection drugs, issued together with the Government's Decree No. 58/2002/ND-CP of June 3, 2002, and comply with the law on destruction of plant protection drugs.

 

Article 30.- Destruction

The destruction of plant protection drugs and drug packages must comply with the provisions of the Regulation on management of hazardous waste, issued together with the Prime Minister's Decision No. 155/1999/QD-TTg of July 16, 1999, Section 5, Part II of the Prime Minister's Directive No. 29/1998/CT-TTg of August 25, 1998, and other legal provisions on destruction of plant protection drugs. Organizations and individuals having drugs or drug packages subject to destruction shall pay all destruction expenses.

 

Chapter IX

LABELS OF PLANT PROTECTION DRUGS

 

Article 31.- General principles

1. All plant protection drugs put up for wholesale, retail and use must have their labels in Vietnamese; the label contents must be compliant with the contents of the label forms approved by the Plant Protection Department together with the consideration and approval of the registration and current regulations on goods labeling. The contents of drug labels may be changed only with the approval of the Plant Protection Department.

2. Labels are printed with letters of at least of size 8, legible and unfadable and are not easily torn during the process of circulation, preservation, transportation and use.

3. Labels must be stuck or printed on drug packages.

4. The color of the label background must be different from the color indicating the toxicity of the plant protection drugs.

5. The name of an active ingredient or material (technical drug) may be printed only in the section "ingredients."

6. For drugs put in small packages, their labels are also printed with letters of at least of size 8, and in case of lack of space for printing compulsory information, there must be an additional label enclosed with each package.

7. All changes in the contents of drug labels against the label samples already approved upon approval of registration are considered violations of current regulations on goods labeling.

 

Article 32.- Contents of drug labels

1. Information on toxicity in compliance with the provisions in Sections 1 and 9, Appendix 7 to this Regulation;

2. Trade names, ingredients and contents of active ingredients expressed in g/l for weight/volume; g/kg for weight/weight or ratio (%); drug formulation; and uses of drugs as registered;

3. Use instructions in compliance with the registered contents;

4. Safety measures upon use, after use and first aid treatment of poisoning;

5. Possibility of mixture with other drugs (if any), and methods of preservation;

6. Use registration number, net volume in l or ml (for liquid drugs); net weight in kg or g (for drugs in powder or granules); the weight of one tablet, in g, and the number of tablets (for drugs in tablets);

7. Name of the producer, addresses of the production place, name and address of the processing or supplying establishment;

8. Date of manufacture or packing, use duration;

9. Symbols guiding the preservation, preparation and use (if any);

10. Isolation duration, symbol and color stripes indicating the toxicity, toxic group and physic nature of the drug.

 

Article 33.- Plant protection drug labels

Plant protection drug labels include one-column, two-column and three-column labels and additional labels.

 

Chapter X

PACKAGES AND PACKING OF PLANT PROTECTION DRUGS

 

Article 34.- General principles

1. Plant protection drugs must be contained in separate packages.

2. It is prohibited to use packages of food or drinks for containing drugs or using packages of plant protection drugs to contain food or drinks.

3. Drugs may not be contained in packages which can be easily damaged, causing danger to users; drugs may not be contained in glass syringes.

4. Drug packages must meet the following requirements:

a/ Being durable during the course of preservation, circulation and use.

b/ Not changing ingredients, properties and effects of the drug.

c/ Preserving the quality of the drug against the impacts of environmental factors.

 

Article 35.- Packing

The weight or volume of packed plant protection drugs must be true to the net weight or volume (plus allowable error) shown in their labels.

 

Chapter XI

SEMINARS ON AND ADVERTISEMENTS OF PLANT PROTECTION DRUGS

 

Article 36.- General principles

1. It is only permitted to organize seminars on, or make advertisements of, drugs on the list of those permitted for use; or to organize seminars on drugs on the list of those restricted from use with a view to providing instructions on proper and safe use. The contents of seminars on, and advertisements of, plant protection drugs must be consistent with the registered contents of these drugs.

It is prohibited to advertise plant protection drugs on the list of those restricted from use or drugs outside the list of those permitted for use in Vietnam.

2. All commercial seminars on plant protection drugs organized by business units must have a session to introduce "Safety in use of plant protection drugs". The content of this session shall be guided by the Plant Protection Department.

 

Article 37.- Advertisements and seminars

1. Advertisements for plant protection drugs must comply with the provisions of the November 16, 2001 Ordinance on Advertisement; Clause 3, Article 35 of the Ordinance on Plant Protection and Quarantine; Joint Circular No. 96/2004/TTLT/BCHTT-BNN&PTNT of November 3, 2004, of the Ministry of Culture and Information and the Ministry of Agriculture and Rural Development, guiding the advertisements of a number of goods in the domain of agriculture and rural development; Article 10 of the Government's Decree No. 68/2005/ND-CP of April 20, 2005, on chemical safety.

2. The contents of advertisements of plant protection drugs on central mass media must be approved in writing by the Plant Protection Department.

3. The contents of seminars on plant protection drugs held in localities and advertisements for plant protection drugs on local mass media must be approved in writing by the local Plant Protection Sub-Departments. If a unit wishes to advertise on local mass media a drug that has been permitted to be advertised on central mass media, it shall send a copy of the Plant Protection Department's written approval on the content of the advertisement of that drug to the Plant Protection Sub-Department of the locality where the advertisement is to be displayed.

For the Minister of Agriculture and Rural Development
Vice Minister
BUI BA BONG

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