Decision No. 89/2006/QD-BNN promulgating the Regulation on the management of plant protection drugs

Issue nQ 06l0ctQber 2006 (Gong BaD nos 27-28/0ctober 16,2006) OFFICIAL GAZETTE 15 THE MINISTRY OF AGRICULTURE AND RURAL DEVELOPMENT DECISION No. 89/2006/QD·BNN OF OCTOBER 2, 2006, PROMULGATING THE REGULATtON ON MANAGEMENT OF PLANT PROTECTION DRUGS THE MINISTER OF AGRICULTURE AND RURAL DEVELOPMENT PursuanttotheGovernment's Decree No. 86120061 ND-CPof July 18, 2003, definingthe functions, tasks, powersand organizational structureof the Ministryof Agriculture and RuralDevelopment; Pursuantto the July 25, 2001 Ordinance on Plant Protection and Quarantine; Pursuant to theRegulation onmanagement ofplant protection drugs, issued together with the Government's DecreeNo. 58/2002/ND-CP of June3, 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 DevelopmentMinister'sCircular No. 75/2000m-BNN KHCN of july 17, 2000. Article 3.- The directors ofthe 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 © VIETNAM LAW & LEGAL FORUM 16 OFFICIAL GAZETTE Issue no061October2006 (Gong Bao nos 27-2810ctober 16, 2006) REGULATION ON MANAGEMENT OF PLANT PROTECTION DRUGS (Promulgated together with the Agriculture and Rural Development Minister's Decision No. 89/2006/00 BNN of October 2, 2006) Chapter I GENERALPROVISIONS Article 1.- Governing scope This Regulation provides the procedures for registration; production, processing rebottling and pack.ing; import and export; trading; preservation and transport; use;destruction; labelingand packaging of; seminars on, and advertisementfor plant protection drugs in Vietnam. Article 2.- Scope of application This Kegulation applies to domestic and foreign organizations and individuals conducting above activities in Vietnam. ChapterJJ PROCEDURES I=OR REGISTRATION 01= PLANT PROTECTION DRUGS Article 3.- General principles 1. Eachproducermayregisteronlyonetradename for one active ingredient or plant protection drug material (technical drug). 2. A domesticor foreign organization or individual that produces an active ingredient or material (technical drug) may directly registeronetrade name for that active ingredientor material (technical drug) or authorize another organization or individual to do so. 3. An authorized organization or individual may registeronly one trade namefor oneactiveingredient or material (technical drug) of any authorizer. The registering organization or individual may changethe producer uponrequestor transferthe 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. Whenusepurposesarc changed, anothertrade name may be registered for one use purpose. 5. Fordrugsof chemical originforWhich registration is applied for the first time for epidemic prevention and control (except for herbicides for fruit trees and tea), for regulation of thegrowthof fruit trees after the period of fructification, tea and vegetableor for post harvest preservation of farm produce, tests must be conducted in order to re-determine the isolation durationin Vietnam. Thedurationof conducting these testsmustnotexceedthedurationof conducting tests of the bio-effectof the drugs and these tests shall be carried out under the Agriculture and Rural Development Ministry's regulations ontestingof plant protection drugs for registration in Vietnam. 6. Drugs of chemical originwith active ingredients of group-III or -IV toxicityas prescribed in Sections 1 and 9, Appenoix 7 to tms Regulation or With active ingredients notbelonging to theorganicchlorine group andhaving the isolation duration of at mostsevendays in Vietnam or the resultsof bio-effecttests in Vietnam satisfying the prescribed requirements may be registered for use for epidemic control. regulation of thegrowthof fruittreesaftertheperiodoffructification, tea or vegetable, or for post-harvestpreservation of farm produce. 7.Fordrugs whichhavebeenseparately registered for prevention of the same epidemic, their mixturefor use may be recommended. but such mixture mustnot 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 © VIETNAM LAW & LEGAL FORUM Issue no06/0ctober 2006 (Gong Baa nos 27-28/0cfooor 16, 2006j OFFICIAL GAZETTE 17 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 aJ 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. bl 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 aJ 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. bl 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-effeot tests shall be carried out in the north and thesouth under theAgriculture and Rural Development Ministry's regulations on testing of plant protection drugs for registration in Vietnam. 3. Exceptional registration aJ 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 © VIETNAM LAW & LEGAL FORUM 18 OFFICIAL GAZETTE Issue no0610ctober 2006 (C6ng BaD nos 27-2B10ctober 16, 2006) Regulation and not mixed with drugsof chemicalorigin. bJ 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 hefore 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. Arlicle 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 properly 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, ifthe NationalOfficeof 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. Kesponsibilities of the agency in charge of registration aJ To receive dossiers and drug samples. bJ To appraise, archive and keep dossiers confidential. cJ 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. dlToorganize 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 © VIETNAM LAW & LEGAL FORUM Issue no061October 2006 (Gong BaD nos 27-28/0ctober 16, 2006) OFFICIAL GAZETTE 19 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. el 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. fl 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. glTocollect chargeand fees for grantof 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. Chapterlfl PRODUCTION, PROCESSING, REBOTILING AND PACKING OF PLANTPROTECTION 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 Regulationon 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/municipalPlant ProtectionSub-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 tile 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 druqs, issued together with the Government's Decree No. 58/20021 ND-CP of June 3, 2002, and wish to conduct activities of production, processing, rebottlingor 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: alA report on the production, processing, rebottfing or packing of plant protection drugs; bfA copy of the econo-technical report on the form of operation (production, processing. rAhottling or packing), categories of drugs to be produced, processed, rebottled or packed) and the operation duration of the project; cl 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 © VIETNAM LAW & LEGAL f:"ORUM 20 OFFICIAL GAZEITE Issue no0610ctober 2006 (Gong Bao nos 27·2810ctober 16, 2006) production, processing, rebottling and packing 1. To report in writing to the Plant Protection Department on the situation of plant protection drug production, processing, reboUling 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 ofthe 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, reboWing 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 011 the import of plant protection drugs to the Plant Protection Department. © VIETNAM LAW & LEGAL FORUM Issue no06/0ctober 2006 (Gong Baa nos 27-28/0ctob!er 16, 2006) OFFICIAL GAZETTE 21 Article 16.-Conditions for an enterprise to import or export plant protection drugs 1. Having a business registration certificate showing the businessline of plantprotection drugs or aqricultural supplies. 2. Having a certificate of registration of the importing/exporting enterprise's code, issued by a provinciallmunicipal custom office; 3. Havinga 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 goons ara re-exported, the unit shall submit to the PlantProtection Department a copyof thecustoms 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 permittedfor use or restrictedfrom 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 importsplant protection drugs on the list of those restricted from use in Vietnam shall submit to the Plant Protection Departmentan application clearly stating the name, quantityand 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; thf! n~mf! and quantity of the drug to be imported;and the place and time of importation. 3. An organization or individual that imports plant protection drugsfor re-exportshall submitto the Plant Protection Department one notarized copy of the export contract and one notarizedcopy of the import contract signedwith a foreignpartner. The processof temporary importfor re-export of plantprotection drugs isstipulated in Clause2, Article 12of theGovernment'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 inVietnam shallsubmitto the Plant Protection Departmenta notarizedoopyuf the foreign investment licenseissuedby a competent Vietnamese agency (to be submittedfor the first time only). 5. Permits for the import of plant protection drugs shall be made accordingto a set form and be valid for thewholegoods lotwithintheperiodindicated therein. ChapterV TRADINGIN PLANT PROTECTION DRUGS Article 18.- General principles Organizations and individuals trading in plant protectiondrugs mustmeetall conditions set inArticle 16 of the Regulation on management of plant protection drugs, issued together with the Government's DecreeNo. 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 goodsand servicesbannedfrom business, restricted from business or subject to conditional business. It isonly permitted to tradeinplantprotection drugs on the list of those permitted for use or restrictedfrom use, issued annually by the Agriculture and Rural Development Ministry. It is onlypermitted to tradeinplantprotection 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 provisionsof law on goods labels. rei VIFTNAM LAW & LEGAL FORUM 22 OFFICIAL GAZETTE Issue no06/0ctober 2006 (Gong Bao nos 27-28/0ctober 16, 2006) Persons who directly trade in plant protectiondrugs must have a practice certificate issued by a provinciaII 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 Govern ment's Decree No. 58/2002/ND-CP of June 3,2002. Article 20.- Procedures for issue of practice certificales for Irading 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 TRANSPORTAND 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, nospttats, marketplaces or dally-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 ptant 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 leakageof drugs. Goods owners shall payall expenses © VIETNAM LAW & LEGAL FORUM Issue no06/0ctober 2006 (Gong Bao nos 27-28/0ctober 16, 2006) OFFICIAL GAZETTE 23 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 placardsbeing orange rectangles with the letters UN (United Nations) in the middle. The size ofthe 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 tile 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 containersstipulatedin Clause 1,Section II, AppendiX8 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 protectionand quarantine agencies, environment management agencies and the nearest People's Committee and bear all expenses for this work. Chapter VII USEOF PLANTPROTECTION DRUGS Article 26.- General principles Il is unly permitted to use plant protection drugs on © VIETNAM LAW s LEGAL FORUM 24 OFFICIAL GAZETTE Issue nQ 06/0ctober 2006 (Gong 8ao nos 27·2810clober 16, 2006) the list of those permitted for use or the list of those restricted from use, issuedannuallyby theAgriculture and Rural Development Ministry. It is strictly prohibited to use plantprotection drugs banned from usc 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 plantprotection drugsmustcomplywith the set principles and the isolationduration indicated in their labels. Article 27.-Responsibilities of plantprotection 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 unknownorigin, causing bad impactson the health of human beings, livestor.k and the ecologic~1 environment If l"'.8using material damage to others, they shall pay compensations therefor. Article 28.- Responsibilities of management agencies and units trading in plant protection drugs 1.Agenciesinchargeof statemanagement of plant protectionandquarantinein provinces or centrally run cities shall coordinate with functional agencies in inspecting the use of plant protection drugs in production areas,especiallyin areasundervegetable, 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 tradingand useof plant protection drugsin 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. Domesticor foreign organizationsor individuals that trade in plant protection drugs must provide detailed andclear instructions to drugpurchasers and, at the same time, are held responsiblebefore law for, and paycompensations for economicdamagecaused by, incomplete, improper or inaccurate instructions and advertisements on plant protection drugs, confusing drug purchasers and users and causingbad impacts on the health of human beings, livestock and the ecological environment as well as production activitias. Chapter VIII DESTRUCTION OF PLANT PROTECTION DRUGS AND DRUGPACKAGES Article 29.- General principles The destructionof plant protectiondrugs anddrug packages must satisfy requirements prescribed in Article 22 of the Regulation on managementof plant protection drugs, issued together with the Government's DecreeNo. 58/2002/ND-CP of June 3, 2002,and complywith the law on destruction of piant protection drugs. Article 30.- Destruction The destruction of plant protection drugs and drug packages must comply with the provisions of the Requlation on management of hazardous waste, issuedtogetherwith the PrimeMinister'sDecision No. 155/1999/QD-TTg of July 16,1999, Section5, Part II ofthe Prime Minister's DirectiveNo. 29/1998/CT-TIg of August 25, 1998, and other legal provisions on destruction of plant protection drugs. Organizations and individuals havingdrugsor drugpackages subject © VIETNAM LAW & LEGAL FORUM Issue no06/0ctober 2006 (Cong Bao nos27-28/0ctober 16, 2006) OFFICIAL GAZETTE 25 to destruction shall pay all destructionexpenses. 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 labelcontentsmustbe compliantwith thecontents ot the label forms approved by the Plant protection Department together with the consideration and approval of the registrationand current regulations on goods labeling. The contents of drug labels may be changedonly with the approvalof the PlantProtection Department. 2. Labels are printed with letters of at least of size 8, legibleand unfadableandare noteasilytorn during the processot 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. Fordrugs put in small packages, their labelsare also printed with letters of at least of size 8, and in case of lack of space for printing compulsory information, theremustbeanadditional labelenclosed with each package. 7.All Changes Inthe contentsof drug labelsagainst the label samples alreadyapproved upon approvalof 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. Tradenames,ingredients and contentsof active ingredients expressed in gil 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 methodsof preservation; 6. Use registration number, net volume in I or ml (for liquid drugs); net weigllt in kg or g (for drugs in powder or granUles); the weight of one tablet, in g, and the numberof tablets (for drugs in tablets); 7. Name of the producer, addresses of the production place, nameandaddressof theprocessing or supplying establishment; 8. Date of manufacture or packing, use duration; 9. Symhols 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 © VIETNAM LAW & LEGAL FORUM 26 OFFICIAL GAZETTE Il>l>ue no OO/October 2006 (Gong Bao nos 27-2810ctober 16, 2006) 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: al Being durable during the course of preservation, circulation and use. bl Not changing ingredients, properties and effects of the drug. a preserving the quality of the drug against the impacts of environmental factors. Article 35.- Packing The weight or volume of packed plant protection nrugs must ha true to the net weight or volume (plus allowable error) shown in their labels. Chapter XI SEMINARS ON ANDADVERTISEMENTS 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. 96/2004mLT/BCHTI-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 © VIETNAM LAW & LEGAL FORUM