Circular No. 38/2010/TT-BNNPTNT providing for the management of plant protection drugs

Issue nos04-051July 2010 (CongBao nos 390-3931July 12. 2010) OFFICIAL GAZETTE 5 Circular :\0. 38/2010/TT-B:\:\PT:\T of June 28. 2010. providing for the management of plant protection drugs PIII-.'1l/UIl! to the GO\,CrIlII1Cllt's Decree iVO. all ~(I(lS/\D-CP of J{/IIII{/n 3. cOOS. de/ill/llg the [uncti onx. [asks, powers and org.tni.ruion«! structure n(rlle Ministr; (~l',-\gric/l!tllrcwid Rural DCl'chJ!)/}H'IlI, and Decree ;,\'/0. 75/2009/ND-CP ur ,')'eptcm!Jcr 10, 2009, amending Article 3 q{ Decrc« No. O//2()08/ND-CP: Pursuant to the Jut, 25, 200J Ordinance on Plant Protection and Quarantine; Pursuant to the Regulation Oll management (~{ plant protection .lrug». issued together witl: the Gnvcnuncnt's Decree ;\/0. 58/2002/iVD-CP O{JIlIIC 3, lOr)']: Pursuuut to the Govennncnts Decree No, /()-J/~()()9/ND-CP oj November 9, 2009, nroviding for the list of dangerous good.\ transnorted by mud motor vehicle»: The Ministv: of Agriculture unrl Rural Develoinncnt !Jw\'ides jor the nutnugcmcnt (~f plant protection drugs as .f(J//OIl'5,: Chapter J GENERAL PROVISIONS Article 1. Scope of regulation This Circular provides the registration: production. processing bottling and packinr': import and export trading: preservation and transportation: use: destruction: labeling: and pJckJging of: seminars Oil. and advertisement for: and testing and inspection of quality and residues of. plant protection drugs in Vietnam. Article 2. Subjects of application Thi-,Circular applies to domestic ami forcirn orp ani zati on-, and individuals conduct ing activities related to the manacemcnt of plant protection drugs, Cluuner If REG]STHATIO", OF PLANT PROTECTION DRUGS Article 3. General principles I. A producer may register only one trade namc for one active ingredient or technical drug used for pest prevention and control or plant growth regulation. If these drugs are also used for disinfection of storehouses and storing yards: preservation of agricultural or forestry products or as termite killers for construction works and dikes. one more trade name mal.' be registered for each of these drugs. 2. A domestic or [orci£.n Olpni/u!Jon or © VIETNAM LAW & LEGAL FORUM 6 OFFICIAL GAZETTE Issuenos 04·05IM-Z01 0 {G6ng Rio nos 390-393/July 12 201(' individual that produces an active ingredient or technical drug may directly register one trade name for that active ingredient or technical drug or once authorize another to do so. 3. The registering organization or individual mav change the producer upon request or transfer the registered trade name under agreement. After the transfer. the registering unit and the unit that is transferred the right to registration may not use the active ingredient of the same type for registering another trade name. The change of producers D[ transfer of registered trade names is subject to approva! of the Plant Protection Department and must go through relevant legal procedures. 4. For registration. all plant protection drugs must pass bio-cffcct tests in Vietnam. Bio-effect tests shall be conducted under Chapter XII of this Circular. For official ft'gistrJtion or registration of trade J)3111eS and compounds. plant protection drugs of chemical origin must pass narrow-area and wide-area bio-etfcc: tests. For official registration or registration of trade names and compounds. plant protection drugs of biological origin must pass wide-area bio effect tests: for additional registration of usages. dosage. use method. drug formulation or contents of active ingredients. plant protection drugs must pass wide-area bio-effcct tests. 5. For first-time registration. plant protection drugs of chemical origin for pest prevention and control (except herbicides for fruit trees and tea). for reguiotion of the growth of each kind of fruit trees after the period of fructification. tea and vegetable or for post-harvest preservation of farm produce. must be tested to re-determine their isolation duration in Vietnam under Chapter XI[ of this Circular. 6. For plant protection drugs of chemical origin with active ingredients of group-In or -IV acme toxicity prescribed in Sections I and 7. Appendix 4 to this Circular inot printed herein) or with acti\ (: ingredients not belonging to the orgJnic chlorine group and lwving an isolation duration in Vietnam of up to 7 days. if the results of their bio-cilect rests in Vietnam satisfy the pre scribcd requirements. they may be registered for USc for pest prevention and control, regulation of the growth of fruit trees, tea or vegetable or for post harvest preservation of farm produce. 7. For plant protection drugs which have heen separately registered for prevention and control of the same pc st. their mixture mu)' be recommended for usc. but such mixture may not bear a proper name unless approval 01 the Agriculture and Rural Development rv1ini:-tr:/ is obtained. Article 4. Plant protection drugs subject tu use registration in Vietnam 1. Drugs with active ingrcdic'nts nol yet named on the list of plant protcctiun drugs permitted for lise in Vietnam: 2. Drugs \\ith active ingredients named on the list of plum protection drugs permitted Cor use III Vietnam but bearing other tradl' names: 3. Drugs \>.,ith trade names on till' list or plant protection drugs permitted for use \\hich have their usages and dosage: usc method. fonuulatiou and contents of active ingredients modi tied, or whirl: are mixed \vith other drugs to form nc\\ ones. 4. Drugs in the form of finished products 01 group-l acute toxicity or drugs in the form of finished products of group-It acute toxicity with active ingredients of group-I toxicity prescribed in Sections 1 and 7. Appendix 4 to this Circular which arc used for disinfection of storehouses and storing yards: drugs for preservation of forest products: drugs for termite extermination tor construction works and dikes: and rodenticides. © VIETNAM LAW & LEGAL FORUM Issuenos 04·0S/July 2010 (Cong BaD ncs 390·393IJu/y 12, 2010; OFFICIAL GAZETTE 7 Article 5. Plant protection drugs disallowed for use registration in Vietnam I. Drugs on the list of plant protection drugs banned from use: drugs on the list of plant protection drugs restricted from use in Vietnam for control of field pests. 2. Drugs with active ingredients invented by foreign organizations or individuals but not yet ret:istered for use in foreign countries. 3. Drugs with trade names identical with the names of active ingredients or trade names of rt'~istered drugs: 4. Drugs in the fonn of finished products of group-l acute toxicity or drugs in the form of finished products of group-IJ acute toxicity with active ingredients of group-I acute toxicity prescribed in Sections 1 and 7. Appendix 4 to this Circular. except those specified in Clause 4. Article 4 of this Circular. S. Drugs on \V3lCh lists of the United Nations Food and Agriculture Organization (FAO) and the United Nations Environment Program n l:'\EP): and drugs in Anncx • to the Rotterdam Convention. 6. Drugs containing methyl bromide. Article 6. Forms of registration 1. Ollicial registration Official registration applies to: 'J!Plant protection drugs newly created in the country and recognized as plant protection drug by the Plant Protection Department. bl Plant protection drugs being commodities in foreign countries but put into use for the first time in Vietnam. 2. Additional registration Additional registration applies to: al Plant protection drugs with active Ingredients similar to those of drucs of other- , organizations and individuals for which official registration has been made for 3 years since the effective date of the Agriculture and Rural Development Ministrys circular promulgating the list of plant protection drugs. bl Plant protection drugs bearing trade names different from those of drugs with similar active ingredients on the list of plant protection drugs permitted for usc. c/ Supplementation of usage and dosage. use method, drug formulation and content of active ingredients: dJ New products being mixtures of2 or more active ingredients: 3. Extension of registration aJExtension of registration applies to all drugs on the lists of plant protection pcrrniucd for use or restricted from usc inVietnam upon expiration of their registration certificates. b/ Dossiers of registration extension must be filed at least 3 months before the expiration of registration certificates. Plant protection drugs for which procedures for registration extension arc not carried out in time shJII be excluded from the lists of plant protection drugs permitted for lise or restricted from use in Vietnam. c/ Plant protection drugs defined ill Clauses 4 and 5. Article 5 of this Circular are nl'!t entitled to registration extension upon expiration of their registration certificates. Article 7. Dossiers of registratioll,.of plant protection drugs 1. A dossier of official registration comprises: al An application for registration of plant protection drugs. made according to a form provided in Appendix 1 to this Circular inot primed herein): b/ An authorization paper of the producer of the active ingredient or technical drug applied for registration: © VIETNAM LAW & LEGAL FORUM 8 OFFICIAL GAZETTE Issuenos 04,Q~lill'2010 (Cong Baa nos 39Q.·J93./juiV 12. 2010 c! A written certification (original or lawful copy) of being the producer of the active ingredient or technical drug. issued by a competent management authority of the host country: d/ Detailed technical documents in Vietnamese or English which are copied or translated (rom the originals and certified by the producer ofthe active ingredient or technical drug specified in Appendix 3 to this Circular (1101 printed herein r. e/ A copy of the registration [or usc of the drug in foreign countries: f/ A specimen label of the drug as prescribed in Chapter IX of this Circular; g/ Results of bio-effect tests and isolation duration tests ;J,S prescribed; hi Lawful copies of industrial property right protection titles. issued by VietlElJ11"S T\ational Office otlntcltcctual Property. or a lawful copy of the authori/Jtion paper or paper on licensing of industrial property right protection titles of products in \ 'ictnam. made hy the O\\I1L~r of these products (if any). 2. Dossiers of additional registration: a./ For registration of trade name s or compounds. the follov....'ing papers are required: An application for registration of plant protection drugs. made according to a form provided in Appendix I to this Circular: An authorization paper. issued by the producer of the active ingredient or technical drug applied for registration: A \\Titten certification (original or lawful copy) of being the producer of the active ingredient or technical drug applied for registration. issued by a competent management authority,' of the host country: Detailed technical documents in Vietnamese or English which are copied or translated from the originJls and certified by the producer of th,~ active ingredient or technical drug specified in Appendix .1 to this Circular: A specimen label of the drug as prescribed in Chapter IX of this Circular: Results of bio-clfcct tests and isobtion duration tests as prescribed: Lawful copies or industrial property right protection titles. issued by Victnarns National Office of Intellectual Property. or a la\\ ful copy of the authorization paper or paper on licensing of industrial property right protection titles of products in Vietnam. ITIJde by the owner of these goods (If any). b/ For supplementation of drug lormulatiun and contents of active ingredients. the fllllo\\ing papers are required: An application for registration of plant protection drugs. made according to a form provided in Appendix 1 to this Circular: ~ The finished product-.' dcuulcd ll'chnica! documents in \'ictnalllC'sC' or English which MC copied or translated from the original:- and certified by the producer orille- ~lcti\ (' in&"l"cdicllt or technical drug specified in Appendix .1 tll this Circular: ..-\ copy of the drug registration certificate: The specimen label of the drug as prescrihed in Chapter IX of this Circular: Results of hio-effcct tests and isolatio» duration tests as prescribed. cI For supplementation of drug usagt'. dosage and use methods. the following papers arc required: An application for registration of plant protection drugs. made according to a form provided in Appendix I to this Circular: ~ A copy of the drug registration certi Itcatc: A specimen label of the drug as rrescribed in Chapter IX or this Circulilr; © VIETNAM LAW & LEGAL FORUM Issuenos 04-051July 2010 iConq Bao nos 390-393/July 12.2010) OFFICIAL GAZETTE 9 Results of bin-effect tests and isolation duration tests as prescribed. 3. A dossier of registration extension comprises: a/ An application for registration of plant protection drugs. made according to a form provided in Appendix I to this Circular: b/ The original of the plant protection drug registration certificate: c/ A report on the quantity or value of drugs annually imported into or produced. processed. bottled. packaged. traded and used in Vietnam: d! A specimen label of the drug as prescribed In Chapter IX of this Circular. 4. A dossier of application for change of producer comprises: aJ An application for change of producers. made according to a form provided in Appendix :2 to this Circular (not printed herein): bl An authorization paper issued by the producer of the active ingredient or technical drug: c/ A wiiucn certification (original or lawful copy) of being the producer of the active ingredient or technical drug applied for rl'gistration. issued by a competent management authority of the host country': d/ Dcta ilcd technical documents in Vietnamese or English which are copied or translated from originals and certified by the producer of the active ingredient or technical drug specified in Appendix 3 to this Circular: el The plant protection drug registration certificate. the original: fI A specimen label of the drug as prescribed in Chapter IX of this Circular. 5. Dossiers of application for change of trade names Arter being registered. the trade name of a plant protection drug may only be changed upon issuance of written conclusions of the state agency in charge of intellectual property or a court 011 trademark infringement. The old trade name shall be revoked and may nut be used again. A dossier of application for change of the trade name of a plant protection drug sent to the registration agency comprises: aJ An application. made according to a form provided in Appendix 2 to this Circular: bl The document on trademark infringement. issued by the state agency in charge of'irrtellectual property or a court: cl The original of the plant protection drug registration certificate: d/ A specimen label of the drug as prescribed in Chapter IX of this Circular. 6. A dossier of transfer of registered plant protection drugs comprises: a/ An application for transfer or registered drugs. made according to Appendix ? to this Circular: hi A lawful copy of the product transfer contract or agrecmeut: cl The plant protection drug rq!lstration certificate. the original: d! A specimen label of the drug as prescribed in Chapter IX of this Circular. Article 8. Drug samples Applicants for official registration of plant protection drugs or registration of lr~l(tl' names and compounds shall submit drug samples to registration agencies upon issuance of test permits, The weight of a to-be-submitted drug sample is 2 (two) grams. Drug samples must have their quality certified by producers and have" use duration of 2 years or marc. Article 9. Agency in charge of registration and its responsibilities © VIETNAM LAW & LEGAL FORUM 10 OFFICIAL GAZETTE Issue nos04-051July 2010 (Gong BaD nos 190-393/Juiy 12, 2010.' I. 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 aJ To receive dossiers and drug samples. b/ To appraise. archive and keep dossiers confidential. cJ To give appraisal results and issue a test permit (made according to a form provided in Appendix 12to this Circular -not printed herein) within 3 working days after receiving a valid and complete dossier. In case of refusal to issue a test permit. it shall notify such in \\Titing to the registrant. d/ To organize working sessions of the Advisory Council to consider and approve applications for official registration of drugs. consult ~mbcrs of the Advisory Council on applicatioas for additional registration of drugs and prepare dossiers for submission to the Minisuv of Agriculture and Rural Development for promuluation a circular Oil the lists of plant protection drugs rcnniHcd for use or restricted from usc after they are considered and proposed for recognition by the Advisory Council. To giyc written replies to applicants for registration of plant protection drugs whose applicatiens arc rejected by the Advisory Council for techm.;al reasons. el To issue plant protection drug registration certificates according to the form provided in Appendix J 3 to this Circular - not printed herein, after a circular on the lists of plant protection drugs permitted for use, restricted from use or banned from use is issued by the Agriculture and Rural Development Ministry. f! To re-grant plant protection drug registration certificates. gl To colltct c!Jarges iJnd fees for issuance of test permits and plant protection drug registration certificates according to current regulations. Article 10, Validity duration of permits The validity duration of a plant protection drug registration certificate or a test permit is 5 years. Article 11. Registration charges and fees Organizations and individuals that regi~ler plant protection drugs shall pay registratioll charges and fees according to regulations. Chapter l1J PRODUCTION. PROCESSI:'-iG BOTTLING AND PACKlNG OF PLANT PROTECTIOt\ DRUGS Article ]2, General princirks 1. [t is only permitted to produce. proC('SS, bottle and pack drugs on the lists of plant protection drugs permitted for USt.' or restrictc:d from use in Vietnam and drugs already pcrrnittcd for import for processing and re-export under contracts signed with foreign parties. 2. Organizations and individuals carryill& out the production. processing, bottling and packing of plant protection drugs must meet all conditions prescribed in Article 7 of the Regulation 011 the management of plant protection drug, issued together with the Government's Decree No. 58/ 20021l"D-CP of June 3. 2002 (below referred to as Decree No. 58/2002/ND-CP). and Article 12 of the Governrncnts Decree No. I08/20llS/ND epof October 7. 200S. detailing and guiding a number of articles of the Law on Chemicals. 3. Persons directly managing the production, processing. bottling or packing of plant protection drugs must possess a pracricing certificate issued by a provincial-level Plant Protection Sub-Dcpanment. © VIETNAM LAW & LEGAL FORUM j~s ue nos04-05/July 2010 (Cctu; Baonos 390-393!Ju/y 12 2010) OFFICIAL GAZETTE 11 4. Applicants for practicing certificates for production. processing. bottling or packing of plant protection drugs must satisfy all conditions prescribed in Article 8 of the above Regulation 011 the management of plant protection drugs. 5. Procedures for the issuance of practicing certificates for production. processing, bottling or packing of plant protection drugs arc defined in the Agriculture and Rural Development Minister's Decision No. 97!2008/QD-BNN of October 6. ~002. providing for the issuance of practicing certificates for production, processing. bonling and packing of and trading in plant protection drugs. Article 13. Re~istration for production. processing. bottling or packing of plant protection drugs 1. Competent state agencies shall only issue Certificates of business registration for production. processing. rcbottling or packing of plant protection drugs if persons directing Illdnaging and adrninistering these activities possess practicing certificates issued by! local state m<-lllagl:ment agencies in charge of plant protection. 2. Foreign organizations or individuals salisfying all conditions prescribed in Articles 7 and S of the Government's Decree No. 58120021 T\D-CP that \\ish to carry out production. processing. bottling or packing of plant protection drugs in Vietnam shall send dossiers to the Ministry of Agriculture and Rural Development (the Plant Protection Department). A dossier comprises: aJ A report on the production. processing. bottling or packing of plant protection drugs: bl A lawful copy of the econo-tcchnical report 011 the form of operation (production. processing. boll ling or packing). categories of drugs to be produced. processed. bottled or packed and the operation duration of the project: c/ Curriculum vitae and lawful copies of professional diplomas of the person directly managing production. processing. hottling or packing activities. if he/she is a foreigner. Article 14. Responsibilities of organizations and individuals carrying out the production. processing. bottling and packing of plant protection drugs I. To report to the Plant Protection Department on the production. processing. bottling and packing of plant protection drugs in the fourth quarter every year. 2. To notify in writing to the Plant Protection Department changes in the location of factories and workshops: production output. form of operation and categories of produced. processed. bottled and packed drugs. including the stoppage of the plant protection drug production. processing. bottling or packing. 3. To take responsibility before law if their plant protection drug production. processing. bottling or packing activities caLIse adverse impacts to people. livestock or the environment: and to be answerable for the quality of their products which are put into circulation and lISC. Article 15. Responsibilities of the Plant Protection Department 1. To receive foreign O[g,.llllzations or individuals' dossiers on plant protection drug production. processing. bottling and packing. 2. To give written replies to units applying for permission to carry out plant protection drug production. processing. bottling and packing within ? working days after receiving complete dossiers as stated in Clause 2. Article 1::; of this Circular. 3. To receive reports on production. processin~. bottling and packin~ activities and © VIETNAM LAW & LEGAL FORUM 12 OFFICIAL GAZETTE Issue nos04·051July 2010 (Gong BaD nos 390-393/3uly 12.2010) notices of the stoppage of plant protection drug production. processing, bottling and packing activities of organizations and individuals for reporting to the Ministry ofAgriculture and Rural Development. 4. To organize inspection and examination of plant protection drug production. processing. bottling or packing establishments annually or upon request. Chapter IV IMPORT AND EXPORT OF PLANT PROTECTION DRUGS Artidc.16. General principles 1. Organizations and individuals that have business, registration certificates covering the business tiDe of trading in plant protection drugs or agricultural supplies or certificates of registratro» of importing/exporting enterprise codes i~cd by the General Department of Taxation mdY import and export plant protection drugs. 1. Plant protection drugs and drug materials on the li'L of those permitted for use in Vietnam issued bl the Ministry of Agriculture and Rural Development. when imported. are only subject to cusrour, procedures at customs offices. 3. For plant protection drugs and drug materials OIl the list of those restricted from usc in Vietnam issued by the Ministry of Agriculture and Rura) Development; plant protection drugs not yet named on the list of those permitted for used in Vietnam. if they need to be imported for research and test or for use under foreign projects in Vietnam. for use in other special cases or for re-export under contracts signed with foreign parties. an import permit issued by the Ministry of Agriculture and Rural Development Ministry or a unit authorized by the Ministry ofAgriculture and Rural Development is required. 4. Jt is prohibited to import plant protection drugs and drug materialson the listof those banned from usc in Vietnam issued by the Ministry of Agriculture and Rural Development. When samples of plant protection drugs on the list of those banned from use need to be imported lor inspection of drug residues and smuggled plant protection drugs. an import permit issued by the Ministry of Agriculture and Rural Development or a unit authorized by the Ministry ofAgricuiturc and Rural Development is required. S. Plant protection drugs on the lists of those permitted for use or restricted from usc. when imported in the form of finished products, must have the contents of active ingredients and drug formulation equivalent to those of drugs in finished products already registered: drugs in the form of materials (technical drugs) must have the contents of active ingredients at least equal to the contents of active in~redielHsof materials on the list of plane protection drugs permitted for lISC or restricted from use in Vietnam. G. When imported. plan: protection dnJ~s Oll the list of those permitted for use or restricted from use must he accompanied with a certificate of origin and satisfy all technical criteria of dru~s already registered in Vietnam. 7. For plant protection drugs subject to entrusted import. units undertaking the entrusted import must produce a letter of Juthorization issued by units registering these plant protection drugs in Vietnam. 8. At the end of the fourth quarter every year. importers shall send reports on the import of plant protection drugs to the Plant Protection Department. 9. Plant protection drug import permits shall be made according to a form provided in Appendix 7 to this Circular - uo: printed herein, and valid for the whole goods lot during the per-iod indicated [herein. © VIETNAM LAW & LEGAL FORUM Issue nos04-0SIJuly 2010 (Gong Bso ms390-393/July 12, 2,010) OFFICIAL GAZETTE 13 Article 17. Dossiers of application for import pcrmit , of plant protection drugs and drug matcriu!-, I. An application for an import permit for plant protection drugs and drug materials. made according to a form provided in Appendix 6 of this Circular - not printed herein: 2. A lawful copy of the business registration certificate showing (he business line of trading in plant protection drugs or agricultural supplies (to be submitted upon first-time application): 3.A lawful copy of the certificate of registration ofthe importing/exporting enterprise code. issued by the General Department of Taxation (10 bc submitted upon first-time application): I. A lawful copy of the export contract and a lawful copy of the import contract signed with a foreign partner and a copy of the customs clearance certificate issued by the border-gate customs ofrice for the goods lot in question after th(' re-export is carried out. for cases of importing plant protection drugs or drug materials for re c xport. 5. Acopy of the investment license issued by a competent vietnamese agency. for cases of importing plant protection drugs or drug fllJteri,:lls \\-jthout trade names and \\-ith active ingredients on the list of those permitted for usc ill Vietnam for use under foreign investment projects in Vietnam (to be submitted upon first time application). Article 18. Import and export of plant protection drugs containing methyl bromide 1. It is prohibited to import or export plant protection drugs containing methyl bromide from or to any country which docs not accede to the Montreal Protocol. 2. Organizations importing plant protection drugs containing methyl bromide must obtain a ... "' .. certificate of qualification for fumigation. They' shall register with the Plant Protection Department the volume of methyl bromide to be imported for use for quarantine and prcshipmcnt (QPS) and non-QPS purposes in the subsequent year before December 15 every year. 3. The Plant Protection Department shall complete the allocation of import quotas of methyl bromide before January 30 based on registrations and operation scopes of fumigation service providers and the roadmap for gradual elimination of methyl bromide committed by Vietnam with the international community. 4. The form of methyl bromide import permit is provided in Appendix 8 [0 lhis Circular (nor primed herein). An import permit will be valid through December 31 of the year of its issuance and no extension will be given in <lily cases. 5. Organizations may not import methyl bromide if fal1ing in any of the follcl'Aing cases: al Failing to comply with reporting regulations or making dishonest reports on the import. USc and trading of methyl bromide. bl Using methyl bromide for purposes other than registered ones or changing thl' use purpose from QPS to non-QPS. cl Conducting supplementary import of methyl bromide for non-QPS uses. 6. Responsibilities of importers and ..exporters of plant protection drugs containing methyl bromide al To use methyl bromide for proper purposes as registered with the Plant Protection Department and be subject to inspection and examination by state management agencies regarding the use of methyl bromide: bl To sell drugs containing methyl bromide only to organizations qualified for providing fumigation services under law: cl To make annual reports 011 fumi8ation activities as well as the sale and purchase of © VIETNAM LAW & LEGAL FORUM 14 OFFICIAL GAZETTE Issue nos04·05fJuly 2010 (Cong Saonos 390-393!July 12. 2010) methyl bromide according to a form provided in Appendix 9 to this Circular (1101 primed herein) to the Plant Protection Department. The deadline for submission of biannual reports is July 15 while annual reports must be submitted before January 15 of the subsequent year: d! Apart from the above requirements. exporters of plant protection drugs containing methyl bromide shall comply with Clause 1. Article 16 "f this Circular. Chapter II TRAD1NG IN PLANT PROTECTION DRUGS Articje 19. General principles I. Planl protection drug traders must meet all conditions prescribed in Article ]() of the Governrn..... t"s Decree No. 58/2(XJ2!ND-CP and Article 7 of the Govcrnmcnts Decree No. 591 20()6/"iI)..CP of June 12. 2006. detailing the implemcrnation of the Commercial Lav rcgardin~ goods and services banned from business. restricted from business or subject to conditional husincs«. 2. It is only permitted to trade in plant protection drugs on the list of those permuted for use or restricted from use issued annually or addiiionallv by the Ministry of Agriculture and , • C Rural Development. 3. It is only permitted to trade in plant protection drugs which are finished products and have their use duration not yet expired and clear origin and labels compliant with Chapter IX of this Circular and other regulations on goods labeling. 4. Persons who directly trade in plant protection drugs must have a practicing certiticatc issued by a provincial-level Plant Protection Sub-Department. Article 20. Registration for trading in plant protection drugs 1. Competent state agencies shall only; issue business registration certificates for the busillC~,S line of trading in plant protection drugs to traders that possess practicing certificates issued h:y provincial-level Plant Protection Sub Departments. 2. Applicants for practicing certificates for trading in plant protection drugs must meet <1\ 1 conditions prescribed in Article 17 of the Government's Decree No. 58!2002/ND-CP 3. The procedures for the issuance of practicing certificates for trading in plant protection drugs are prescribed in Decision No. 97/2008/QD-J)t\N of October (J. 2008. of the :Minister of Agriculture and Rural Development providing for the issuance or practicing certificates for the production. processing and bottling of and trading in plant protection drugs. Article 21. Places of plant protection drug trading The. locations of plant protection drugs shups must he approved in writing by commune-level administrations: he distant from residential quarters. schools, hospitals. marketplaces and water sources: ensure safety for people. livestock and the environment: not become inundated in an) circumstances: and be equipped with adequate tlil' and explosion protection devices and meet the requirements set in Clau-,c 2. Article 19 01 the Governrnenrs Decree No. 58/2002/ND-CP. Chapter iii TRANSPORTATION AND I'RESERVArION OF PLANT PROTECTION DRUGS Article 22. General principles 1. The iransponan on of plant protection drugs and drug materials must comply with the © VIETNAM LAW & LEGAL FORUM Issue nos04·051July 2010 (Cong BaD nos 390-393/Jufy 12. 2010) OFFICIAL GAZETTE 15 Goverumcnts Decree No. lO-l/2009/!'iD-CP of !\ou.:rnbcr 9. 2009. promulgating the list of dallgcrou:-; goods and providing for the transportation of dangerous goods by road motor \chicles. the lal,..v Oil road. railway and inland \\ atcrway traffic order and safety and relevant laws. 2. Planr protection drugs and drug materials must be transported along routes stared in contracts or other papers related to the transportation of plant protection drugs signed between vehiclc owners and goods owners. 3. The transportation of plJJH protection drugs dnd drug material» must ensure safety for people and the environment. Vehicles carrying plant protection drugs and drug materials must not stop in crowded areas or ncar schools. hospitals. marketplaces or daily-life Rater sources. 4. Plant protection drugs and drug materials con be transported only after they are properly packed and labeled and a transport permit is ixsucd by a competent ~jgcncy as defined in Article 2-l of this Circular. S. Plant protection drugs which may interact with one another may not be transported on the same vehicle 6. Plant protection drugs and drug materials 1l1<1)' not he transported on the same vehicles together vi t h passengers. livestock. food. foodstuff. inflarnmablcs. explosives and other goods (except fertilizers). Article 23. Transportation of plant protection drugs and drug materials I. Carriers of plant protection drugs and drug materials aJ Drivers and escorts must clearly understand the danger of plant protection drugs and drug materials such as being toxic, inflammable. explosive and corrosive, be able to respond to incidents which may occur during transportation and comply with the law on transportation of dangerous goods. bl Apart from drivers certificates as required b~y current regulations, drivers of vehic le s carrYing plant protection drugs or drug materials must possess a certificate of training in lJbor safety in the transportation of plant protection drugs and drug materials. cI Escorts must be trained in labor safety in the transportation of plant protection Qfugs and drug materials. 2. Packages. tanks and containers of plant protection drugs or drug materials during transportation must: <J! Be made of elastic. durable and water-proof materials. bl Be stuck \vith a danger symbol sfwwing a black skull and crossbones in a lopsided white background square. The size of the danger symbol attached to each tank of plant protection drugs or dru~ materials is 100 mm x JOU rom whilc the size of those stuck on each contJ.incr is ].50 mm x :250 mm as pre-scribed in Clause, Section 11. Appendix 5 to this Circular (liar printed hercin: c/ Display a danger sign which is an orange rectangle with the United Nations (UN) code in the middle. The size of this danger ~n is 300 mm x 300 mm as prescribed in Clause 2. Section [I. Appendix 5 to this Circular. The dalIger sign shall be displayed below tbe danger symboL 3. Vehicles carrying plant protection drugs and drug materials aJ Ordinary means of transport which are permitted for cargo transportation may be used for carrying plant protection drugs and drug materials. hi A vehicle carrying plJnt protection drugs or drug materials must satisfy the following technical conditions: © VIETNAM LAW & LEGAL FORUM 16 OFFICIAL GAZETTE Issue nos04-0SIJuly ZOlQ (Cong Bao nos 390·3931July 12. 2010; ~ Being other than trailers: Being furnished with fire extinguishing devices suitable to plant protection drugs and drug materiJ.ls during transportation: Having a finn roof or canvas hood for the trunk so as to ensure its impermeability during transportation. cl If no special-usc ferry is available for carrying dangerous goods. a vehicle carrying plant protection drugs or drug materials must be the last vehicle boarding a feny. dJ Vehicles carrying tanks of plant protection drugs or drug materials must be stuck with the danger symbol correspondent to the group of the transported goods on both sides and at the back. The size of such danger symbol is 500 mm x 500 mrn. 4. Response to incidents Upon occurrence of incidents such as spills or traffic accidents during the transportation of plant protection drugs or drug materials. drivers and escorts or goods owners shall respond to the incidents and. concurrently. notify such to the nearest local administration or competent state agency for the latter to take measures to prevent and remedy consequences caused by' drug leakage. Violators shall bear all expenses for these efforts. Article 24. Permits for transportation of plant protection drugs and drug materials 1.Organizations and individuals that transport plant protection drugs or drug materials of J.(lOO kg or more/vehicle must obtain a dangerous goods transportation permit issued by a competent agency. 2. Provincial-level Agriculture and Rural Developments shall issue or authorize local plant protection agencies to issue permits for the transportation of plant protection druQS and drug c " materials. These permits arc valid nationwide. 3. The validity duration of a permit for the transportation of plant protection drugs and dru~ materials corresponds with each shipment orcJch period but must 110t exceed 12 months from the date of issuance. 4. The form of permit for the transportation of plant protection drugs and drug materia». is provided in Appendix II to this Circular (/101 printed herein). Article 25. Procedurcs for the issuance of permits for the transportation of plant protection drugs and drug materials 1. Dossiers: aJAn application for a permit. made according to a form provided in Appendix 10 to this Circular (/lot primed herein): bl A copy of the certificate of training inlabor safety in the transportation of plant protccrion drugs and drug materials (producing the original for comparison): c/ A lawful copy of the plant protection drug Jnd drug muter;Jl supply or transpnrt contract: dl The transport route. address and telephone number of the goods O\\'I1CT. 2. Issuance time limit: ~ working days aner the date of receipt of u valid and complete dossier. Article 26. Contents of training in labor safety in the transportation of plant protection drugs and drug materials Contents of training provided to vchic!c drivers. escorts and storekeepers include: J. Contents of labor safety training prescribed in Circular No. 37/2005ITT-BLDT13XH of December 29. 2005, of the Ministry of Lahar. War Invalids and Social Affairs. guiding labor safety' and sanitation training: 2. Documents on the transportation and preservation of dangerous chemicals: 3. Properties ofplant protection drugs: © VIETNAM LAW & LEGAL FORUM Issue nos04·0SIJuly 2010 (Cong Bao nos 390-3931July 12, 2010) OFFICIAL GAZETTE 17 4. Danger signs and symbols: 5. Measures for assuring safety.' during transportation of plant protection drugs and drug rn.iteriais (first-aid measures. road safety and basic knowledge on the use of protection devices): 6. Measures for preventing and responding to incidents with regard to each kind of plant protection drug. Article 27. Responsibilities for organizing training courses and issuing training certificates I, The Pbnt Protection Department under the \linistry of Agriculture and Rural Development shall develop training contents and programs for storekeepers of plant protection drug storehouses and escorts and drivers of vehicles carrying plant protection drugs. ~, Provincial-levc) People's Committees shall coordinJtc wirb trai ni nj; and vocational in-rinuion« and enterprises in organizing training courses according to training contents and progrClms defined in Clause I of this Article and issue training certificates or authorize local plant protection Jgencies to do so. ~. Units conducting the transportation of plant protection drugs and drug materials must ensure that drivers and escorts of vehicles carrying plant protection drugs and storekeepers of plant protection drug storehouses are trained in contents defined in Article 26 of this Circular, Annually, they shall organize supplementary training and tests for these persons. Article 28. Storehouses of plant protection drugs and drug materials Storehouses of plant protection drugs and drug materials must satisfy the following requirements: I, The locations of storehouses outside industrial parks must be approved in writing by commune- or higher-level administrations. ~, Storehouses must be firmly built with refractory materials. not prone to inundation. well-ventilated and accessible by fire engines. 3, Storehouses must be equipped with fire extinguishing. toxicity control and first-aid equipment and signboards showing the danger symbol with a black skull and crossbones in a lopsided white-background square and of a size similar to the danger symbol displayed on vehicles or containers stipulated in Clause I. Section II, Appendix 5 to this Circular, 4, Storehouses must satisfy requirements set by the law on environmental protectioo. Article 29. Preservation of plant protection drugs 1, The preservation of plant protection drugs must ensure safety for people, livestock and the environment in surrounding areas. 2. Storekeepers must be trained in labor safety in the preservation or plant protection drugs. 3. In case ofdrllg leakage or dispersal. causing adverse impacts on the ceo-environment. drug owners shall remedy the consequences under the guidance or inspection of plant ptJ{)(ection agencies. environment management agencies and the People's Committee of the nearest locality and bear all expenses for this work, Chapter VII USE OF PLANT PROTECTION DRUGS Article 30. General principles L It is only permitted to use plant protection drugs on the list of those permitted for usc or the list of those restricted from use. issued by the Ministry ofAgriculture and Rural Development, 2, ft is strictly prohibited to use plant protection drugs banned from usc in Vietnam: drugs outside the list of those permitted for use © VIETNAM LAW & LEGAL FORUM 18 OFFICIAL GAZETTE issue pos 04-05iJuly 2010 (Cong BEW nos 390-J93/JUlY 12. 2010 or the list of those restricted from use: drugs of unknown origin: and drugs without labels or with labels presented in foreign languages only. 3. Plant protection drugs must be used in accordance with the instructions given in their labels. t. Plant protection drugs must be used in a proper manner (using proper drugs at a proper time with proper dOS3gC and concentration under a proper method) and ensuring the isolation duration indicated on their labels. Articl., 31. Responsibilities of plant protection drug users Plant protection drug users shall take responsibility before law for the following acts: 1. Improperly using drugs or failing to comply with recommended techniques. failing to ensure the set isolation duration. leading to excessive plant protection drug residues in farm produce 0\-:1" the permitted limit: i USiJl£ banned drugs. drugs outside permitted lists or using drugs of unknown origin: 3. Disposing of empty packages or drugs and drug solUitions in contravention of regulations. causing bad impacts on the health ot people. livestock and the ceo-environment. If causing material damage to others. they shall pay compensations therefor. Article 32. Responsibilities of management agencies and plant protection drug traders 1. State management agencies in charge of plant protection and quarantine in provinces or centrally run cities shall coordinate with functional agencies in inspecting the lise of plant protection drugs in production regions. especially in areas under vegetable. tea and fruit trees: detect and handle intentional violations of general principles on the lise of plant protection drugs prescribed m Article 30 of this Circular. ! Commune-level administrations shall manage the trading <1I1d usc of plant protection drugs in their localities: coordinate with professional agencies in charge of plant protection and quarantine in disseminating and guiding the effective use of plant protection drugs and in handling related violations. 3. Domestic or foreign organizations or individuals that trade in plant protection druus must provide detailed and clear instructions ~(J drug purchasers and. at the same time, take re spon si hi lity before law for. and pay compensations for economic damage caused hy'. incomplete, rmproper or inaccurate communication. advertisements and instructions on plant protection drugs. confusinc drug purchasers and users and causing bad impacts on the health of people. livcxinck. tilt- teo environment and production activities. Chapler VI// DESTRUCT10C\i OF PLA:-iT I'ROTECTJOi\ DRUCiS Al\;D DRUCj I'l"\CKAGES Article 33. General principles The destruction of plant protection drugs and drug packages must comply \vith requirements prescribed in Article 22 of the Governmems Decree No. 58/2002/ND-CP. and the la\l on destruction of hazardous waste. Article 34. Destruction 1. During the process of collecting and destroying plant protection drugs and drug packages. no hazardous \\;15tC must be strewed. dispersed or discharged into the environment. ensuring absolute safety for people. livestock Jnd the ceo-environment. 2. The destruction of plant protection drugs and drug packages must comply with the law on environmenral prorccnon, © VIETNAM LAW & LEGAL FORUM [gsue nos 04·05/July 2010 (Cong Bao nos 390-393/Jufy 12.2010) OFFICIAL GAZETTE 19 J. Organizations and individuals having drugs 01 drug packages subject to destruction shalt bear all destruction expenses. For plant protection drugs and drug packages wirhou: owners. provincial-level Pcoples Committees shall allocate local bud&ct funds for the destruction under regulations. Chapter IX LABELS OF PLANT PROTECTION DRUGS Article 35. General principles 1.All plant protection dru&s put up for trading and use must have their labels presented in Vietnamese with contents compliant with the contents of the label samples approved by the Plant Protection Department upon approval of their registration and with current regulations on );oods labeling in the Govcrnments Decree No. SCi/200(,/i\'D-CP of August 30. 2006. on goods lahl'ling and the guidance of the Harmonized S:'stcm on Goods Classification and Labeling. 2. Labels are printed with letters of size S or hig~cL le!;iblc. unfadable and durable in the process of circulation. preservation. transportation and usc. 3. Labels must he stuck or printed on drug packages. 4. The color of the label background must be different from the color indicating the toxicity of plant protection drugs. 5. The name of an active ingredient or material (technical drug) may be printed only in the section "ingredients." (1. For drugs put in small packages. their labels are also printed with letters of size 8 or bigger. and in case of insufficient space for printing compulsory' information. there must he an additional label attached to each package. In this case. the main label of the package must be printed II ith the phrase ·'Read carefully the attached additional label berorc usc." Such details as trade name; name of the organization or individual in charge of tile dwg: packed quantity: date of mallllfacturc and use duration must be displayed on the main label. 7. A.I! changes in (he contents of drug labels compared to the specimen labels already accepted upon approval of registration must he approved in writing hy.' the Plant Protection Department. Artide 36. Contents of dru& labels 1. Drugs in the (orrn of finished products a/ Product information Trade name; Drug formulation which is coded according to the EA.-O International formulation coding system applicable to plant protection drugs: Names, composition and contents of a~~ti\'c ingredients expressed in g/kg (for plantprotccrion drugs in the form of solid. VI\COllS liquid. sol gas or cvaporable liquid); gil (for drugs in other liquid forms) or \veight ratio \\/w): ~ Solvents (if their existence cause change in the toxicity of the drug): names and contents of 501\,('I11S expressed similarlv to those of active ingredients. Net volume expressed in \ or ml (for liquid drugs): net weight expressed in kg or g (for drugs in powder or pellets): the number of tablets and ncr weight expressed in kg or g (for drugs llJ tablets). b/ Safety intern]]at;on ~ Information on toxicity us prescrihcd in Sections I and 7, Appendix 4 to this Circular: Symhols and color stripes indicating the toxicity and toxicity group of the drug: Safety measures upon usc. after use and first aid treatment for poisoning. c! Use information © VIETNAM LAW & LEGAL FORUM 20 OFFICIAL GAZETTE Issue nos 04·051July 2010 (Gong Baonos OgO·090/July 12. 2010: liSt' instructions in compliance with the registered contents; Instructions on methods of preservation. preparation and use (if any): Isolation duration (day): Possibility of mixing with other drugs (if any). dI Other information Rc,<:i.stration number: Nam" of the producer and address of the production place: Name and address of the processor or supplier; D<rte of manufacture. bottling or packing: use duration (to be written in the same location. possibly in abbreviation): Preservation conditions. 2. Tc-dmical drugs: aJ Names of active ingredients: b! 0iaulCs. composition and courents of active ingredjcnt'S in g!kg. gil or weight ratio (0i- w/w): cI Ncr volume or net \vcight: dl Name and address of the importer: el Name of the producer and place of productioe: fl Date of production and use duration (to be written on the same position as abbreviated notations] . Chapter X PACKINGS AND PACKAGING OF PLANT PROTECTION DRt:GS Article 37. General principles The packaging of plant protection drugs must comply with Vietnam's standard TCVN 5507:91 and the followmg requirements: 1. Plant protection drugs must be packed in high-quality paekings. a/ Plant protection drug packings must be finn enough to stand normal shocks and impacts during goods transportation. transshipment and loading of goods by manual or mechanical methods. bl Packing's must he air-tight to prevent chemical leakage during transportation or upon impact or temperature. moisture or pressure increase. cI The outer sides of pac kings must be clean and free of hazardous chemicals. The above requirements apply 10 all kinds of plant protection drug packings. including recycled or reused ones. 2. Packing parts in direct contact with plant protection drugs must meet the follo\\"ing requirements: a! Neither being affected nor deteriorated hy the packed chemicals: bl Not causing dangerous impacts, orcutalytic or interactive effects on the packed drug:...: c/ Possibly using an appropri.n« incn layer as a protective lining separating the packing from the packed drug. 3. When packing liquid drugs. it is required to leave a necessary room to ensure that packages will not leak or deform due to an increase in the volume of the packed liquid drug upon temperature increase during transportatio». 4. For dual-layer packings. it must be assured that. under normal transport conditions. the inner layer cannot be broken. pierced or leaked. 5. Inner layers which are easily broken or pierced such as those made of glass. ceramics or some certain kinds of ptastics must be insulated with appropriate materials from the oiner layer. 6. Plant protection drug.s may not he packed together in all outer packing layer or in a trunk if they can interact with one another leading 10: © VIETNAM LAW & LEGAL FORUM Issue nos04-05/July 2010 (Cong Rio nos 390-393/July 12 2010) OFFICIAL GAZETTE 21 aJ Burst of flame or heat emission: hi Heat emission or hurst of flame which emit asphyxiatinr; gas. oxidants or toxic gas; c/ Strongly corrosive substances: clJ Undurablc substances. 7. Packings of evaporable drugs must be tight enough to ensure that packed liquids will not decrease be low the se: limit during trJnsportation. 8. Liquids must be packed in packings of a durability standing the inner pressure built up during transportation. 9. Plant protection drug pac kings which are produced. recycled or reused must ensure technical requirements as prescribed. 10. Plant protection drug containers and packages. once emptied. must be managed like p.1ckagcs containing plant protection drugs. 11. All packings for containing plant protection drugs in liquid form must be tested in lcakinc~s before use. 12. Packing~ of plant protection drugs in granules or powder must be tight enough to prevent leakage or lined with tight cushions. Chapter XI SEMll'\ARS ON AND ADVERTISEMENTS OF PLA"iT PROTECTION DRUGS Article 38. General principles I. It is only permitted to hold seminars on. or make advertisements of. drugs on the list of those permitted for use: or to hold seminars on drugs on the list of those restricted from usc with a viev... ' to providing instructions on proper and safe use. The contents of seminars on. and advertise ments of. plant protection drugs must be con sistent with the registered contents of these drugs. 2. It is prohibited to advertise plant protection drugs on (he list of chose restricted [rom use or drugs outside the list of those permitted for use in Vietnam. 3. All commercial seminars on plant protection drugs held by traders must ll<.lvC a session to introduce "Safe use of planl protection drugs", The content of this session shall be guided by the Plant Protection Department. Article 39. Advertisements and seminars 1. Advertisements of plant protection drugs must comply with: The November 16. 200l Ordinance on Advertisement: Clause 3. Article. 35 of the Ordinance on Plant Protection and Quarantine; Joint Circular No. 9612004fITLTIBVHTI BNN&PTNT of November 3. 2004. of the Ministry of Culture and Information and the Ministry of Agriculture and Rural Development. guiding the advertising of a number of goods in agriculture and rural development: Joint Circular No. 06l2007fTTLT/B\'HTT BNN&PTNT of February 18. 20m. of the Ministry of Culture and Information. tile Ministry of Agriculture and Rural Development and the Min istry of Construction. guiding the inter agency one-stop shop procedures for the issuance of advcnising permits. 2. The contents of advertisements of plant protection drugs in central mass media must be approved in writing by the Plant Protection Department. 3. The contents of seminars or customer conferences on plant protection drugs held in localities and advertisements of plant protection drugs in local mass media must be approved in wr it i ng by local Plant Protection Sub Departments. If a unit wishes to advertise in local mass media a drug that has been permitted to be advertised in central mass media. it shall send a copy of the Plant Protection Department's written apprOlJl of Ihe COIJlCIJI of thc advcrtiscment of © VIETNAM LAW & LEGAL FORUM 22 OFFICIAL GAZETTE Issue nos04·051July 2010 (Gong BaD nos 390·393Wy 12.2010) thelt drug to the Plant Protection Sub-Department of the locality' where the advertisement is to be placed. Chapin Xlii TESTS OF PLANT PROTECTION DRUGS fOR REGISTRATION Il\' VIETNAM Article 40. General principles L Te>1J; of plant protection drugs not yet named 0" Vietnam's lists of plant protection drugs perraittcd for use or restricted from usc in Vietnamese territory may be conducted only after obtaining a test permit. 2. Bib-effect test means determining epidemic prevention and control effects of drugs and cvaiuating their impacts on plants. people. livestock and the cco-cnvironme nr under differcnj cultivation conditions in Vietnam's major production regions. J. Isahttion duration lest means identifying ihe period from the last use of a plant protection drug to tl1e time of hanest under different cultivation conditions in Victnams major production regions. 4. Tests of plant protection drugs for registration in the list of those permitted for use Vietnam Include: a/ Bib-effect rest: hi Isolation duration test: cl For plant growth regulation drugs. apart from bio-ettect test. it is necessary to evaluate the effects of drugs on some quality criteria according to regulations on testing plant growth regulation drugs. Article 41. Testing forms and scales Testing forms and scales applicable 10 some kinds of plants and pests: L Bio-etTect test 3/ Narrow-area tt'st means a lest conducted on a small scale. The te.'·iting area will be 25-50 sq.m/plot. on which test will be repeated .j--+ times. One test must be conducted in ell least 2 production regions (northern and southern) witl: :2 locations in each region and :1 different crops. For plants available or harmful pests "ppearin~ in only one production region, tests may only hi.:~ conducted in different location, in such production region. bl Wide-area test means a test conducted on a large scull' in a minimum area of 300-500 SqJ1J and must be carried out in 1 production regions (northern and southern) with at least J 10catieJl1 in each region and during l production crop. For plants available or harmful pests appearing in only one production region. tests may only Il(' conducted in :2 locations in such production region. cl For perennial trees and specillc ohj':ClS (pests harmful to farm produce in stock. in:-;eets and pests lw.nnful to forest lrcc.'i and rats in fidds. storehCHlscS and rcsidcutial quarters). thl' ",ill' of testing plots must comply,' \\'1tl1 specialized k"ling processes. dl For plants available or harmful '[lest5 appcarinc in only one production region. tests may be conducted in 2 locations in such production region. 2. Isolation dur:..tlion test Tests to identify the isolation duration of plan: protection drugs for plants shall he conducted in 2 production regions (northern and southern) during 2 crops. For plants with only one crop pel" year. tests shall be conducted in 2 different location: during such crop. For plants available only in I production region. isolation duration tests shall be conducted in 2 locations during 2 crops in such fl'f:lon. FDr plants available only in I production region with © VIETNAM LAW & LEGAL FORUM Issue nos04·05/July 2010 (Cong Baa nos 39Q-393/Ju/y 12.20101 OFFICIAL GAZETTE 23 I crop per vcar. tests shall be conducted in 4 different loc.nions in such production region. Article "'2. Conditions on organizations conducting tests on plant protection drugs I. Persons in charge must have a university or postgraduate degree in plant protection. cultivation or biology and a certificate of training ill plant protection drug test. 2. Having a contingent of plant protection staff members who have been trained in plant protection drug test. 3. f1avinf': technical and physical foundations for plant protection drug test as prescribed by the Plant Protection Department. 4. Neither undersigning their names nor being authorized to register plant protection drugs in Vietnam. Article ·n. Responsibilities of units conducting plant protection drug tests I. To make registration with the Plant Protection Department for participation in tilt.' plant protection drug testing network. ) To comply with national technical regulations. national standards and testing processes. 3. To refrain from organizing or guiding visits to fields under plant protection drug test without approval of the Plant Protection Department's test management agenc.y. 4. To take responsibility before law for the truthfulness of test results. 5. To make reports on test results according to forms provided in Appendices 16 and 17 to lhis Circular (no! printed herein). Article 44. Responsibilities of organizations and individuals having plant protection drugs to be tested I. To abide bv the Ordinance on Plant Protection and Quarantine. Decree No. 581:20021 ND-CP and other relevant rc.sulations. 2. To provide the Plant Protection Department with information on to-be-tested products under Articles 7 and 8 of this Circular and. at the same time. take responsibility before law for the truthfulness of such information. For cases in which a test conducted based on technical information accompanying to-be-tested products causes damage to people. plants. animals and the environment. organizations and individuals having such products shall raJ compensation according to Vietnamese laws. Article 45. Responsibilities 01' tlle Plant Protection Department 1. To manage plant protection drug tests. 2. To designate qualified org.mizaiions to test plant protection drugs, 3. To train plant protection drug testing stuffs. 4. To inspect and evaluate results 01' plant protection drug tests. S. To usc testing results to conduct evaluation for drug registration and provide usc instructions after drugs arc permitted for use in Vietnam, Article 46. Charges and fees 1. Expenses for sampling and inspection of plant protection drug quality and residues are prescribed in Articles 31. 37. 41 and 58 of the Law on Product and Goods Quality. 2. Organizations and individuals that have their plant protection drugs tested shall pay charges and fees under current regulations. Chapter XIII INSPECTION OF PLANT PROTECTION DRUG QUALITY AND RESJDLES Article 47. General provisions J. Quality inspection ofplant protection drugs © VIETNAM LAW & LEGAL FORUM 24 OFFICIAL GAZETTE Issue nos 04-051July 2010 (G6ng Bao nos 390-393iJu1y 12. 201G) means the determination of contents of active ingredients. drug formulation and contents of impurities which may' be poisonous to plants or people or cause environmental pollution (if any). the contents of additives with the effect of improving safety for people or plants (if any): and chemical and physical properties related to bio-effect andSafely.' ofdrugs during preservation and use. 2. Inspection of plant protection drug residues in agricultural and forestry products. food and the environment (referred to as objects for short) means the determination of toxic active ingredient.. and products transformed from plant protection drugs left in objects. 3. Plant protection drugs subject to quality inspection include imported technical drugs and plant protection drugs in the form of finished products: plant protection drugs in the form of finished products which are kept at storehouses or production workshops or bottled. packaged or traded. 4. Imported plant protection drugs and drug materials lTlust be sampled for quality inspection before importation according to the Agriculture and Rural Development Ministry's Circular No. 77/2009m-BJ\:--J-PTNT of December 10.2009. providing for state inspection of quality of imported plant protection drugs. 5. State management agencies in charge of plant protection and quarantine shall take samples of plant protection drugs in the form of finished products ftlr quality inspection at production. processing. bottling and packaging establishments once a year. for establishments possessing Good Manufacturing Practice (GYlP) cenificates or having ISO (international standards organization) qualitymanagement systems, orat most twice a year. for other establishments. 6. State inspection of quality of plant protection drugs circulated in the market shall be conducted under the Law on Product and Goods Quality and Circular No. 16/2009/TT BKHCN of June 2. 2009. guiding state inspection of quality of goods circulated un the market. 7. Inspection of plant protection drug 'luality and residues shall be conducted at qualified organizations designated by the Ministry of Agriculture and Rural Development. Article 48. Grounds for inspection of plant protection drug quality and residues I. Sampling for inspection of plant protection drug quality and residues must comply with national standards, Records on taking samples for inspection of plant protection drug quality and residues shall be made according to Appendices 14 and 15 to this Circular (Ilol printed herein). 2. Inspection of plant protcction drug qualit) and residues must comply.' withnational technic3! regulations. national standards or in-house standards issued by the Plant Protection Department (if no national technical regulation or nutional standard is available). If none of these grounds is available, international or rcgiona: documents or documents issued by producers may apply. 3. Samples used for inspection of plant protection drug qualityandresidues musthe kept for 3 months from the date of receipt. 4. Results of inspection of plant protection drug quality and residues must be kept for 3 years after the date of issuance. Article 49. Responsibilities of the Plant Protection Department 1. To manage the inspection of ptam protection drug quality and residues. 2. To evaluate. appraise and propose the Ministry of Agriculture and Rural Development to designate qualified orgJnizJtiolts to inspect © VIETNAM LAW & LEGAL FORUM Issue nos04-051July 2010 (Cong BaD nos 390-393/July 12,2010) OFFICIAL GAZETTE 25 plant protection drug quality and residues. 3. To train inspectors of plant protection drug quality and residues. Article 50. Charges and fees I, Expenses for sampling and inspection of plant protection drug quality and residues are provided in Articles 31, 37. 41 and 58 of the Law on Product and Goods Quality, 2. Organizations and individuals that request inspection of plant production drug quality and residues shall pay charges and fees under regulations. Chapter XIV IMPLEYlENTATION PROVISIONS Article 51. Effect This Circular takes effect 45 days from the date of its si~lling. To annul Decision No, 89/2006/QD-BN:'oJ of October 2. 2()()6. promulgating the Regulation on management of plant protection drugs; Decision :--la, (,3/2007/QD-B:'oJ:--l of July 2, 2007. amending and supplementing a number of articles of the Regulation on management of plant protection drugs issued together with Decision :'oJo 89!200(,/QD-BI\N: Decision No. 91/2008/ QD-131\1\ of September 9.2008. issuing the form of plant protection drugimport permits: Decision No. 50/2003/QD-BNN of March 25. 2003. of the Minister of Agriculture and Rural Development. issuing the Regulation on inspection of plant protection drug quality and residues and test of plant protection drugs for registration in Vietnam: and Decision No. 79/ 2003/QD-BNN of August 8. 2003. amending Clauses 2 and 3. Article 11 of the Regulation on inspection of plant protection drug quality and residues and test of plant protection drugs for registration in Vietnam issued together with Decision No. 50/2003/QD-BNI\. Article 52. Implementation responsibilities Units attached to the Ministry of Agriculture and Rural Development. provincial-level Agriculture and Rural Development Departments and concerned organizations and individuals shall implement this Circular. Any difficulties and problems arrsing the course of implementation should be reported to the Ministry of Agriculture ..Nl Rural Development (the Plant Protection Department) for timely supplementation and modiflClttion. For the Minister of Agriculture and Rural Development Deputy Minister BUI BA BONC, © VIETNAM LAW & LEGAL FORUM