Circular No. 29/2011/TT-BYT on management of insecticidal or germicidal chemicals and preparations for household and medical use

OFFICIAL GAZE.TTE Issue nos06·07/July 2011 (Cong BaD nos 425-426/July 28,2011) Circular No. 29/20UffT-BYT of June 30, 2011, on management of insecticidal or germicidal chemicals and preparations for hnusehuld and medical use Pursuant to the Government's Decree No. 18812007/ND-CP of December 27, 2007,-defi"ill('7he junctions, tasks, powers and organiz!f1i.onal structure of the Ministry of Health;· PUrslt!!!;t to the November 21,2007 Law on Chemicallf; PursfJ'!!'1f to theNovember 21,2007 Law on Produet-:;"d Goods QUit/ity; PursJtf!ht to the June 14, 2005 Commercial Law; PursEt to the Government's Decree No. 1081200~D-Cr ofOctobel' 7,2008, detailing and gUitb' a number ofarticles ofthe Law on Chemic-MM PUNI)fJ(lffllt to the Government's Decree No. 26120llitm-CP ofApn'18, 2011. amendingand supple~ting a number of articles of the Govemmetu's Decree No. 10812008/ND·CP of UctobeR-:- 2UU8, detailing and guiding a ~ number~rticles of the Law on Chemicals; pur'!U?!ht to the Government's Decree No. .J3212008/ND-CP of December 31, 2008, detailing and guiding the Law on Product arui Goods Quality; Pursuant to the Government's Decree No. 12I2oo6/ND-CP ofJanuary 23,2006, detailing the Commercial Law regarding international goods trading and goods sale and purchase agency, processing and transit with foreign countries; At the proposal oj the director ofthe Heauti Environment Management Agency - the Ministry ofHealth, Chapter I GENERAL PROVISIONS Article 1. Scope of regulation This Circular provides the circulation registration; testing and assay; import, export and circulation of insecticidal and germicidal chemicals and preparations for household and medical use in Vietnam. Article 2. Interpretation of tenus In this Circular, the terms below are construed as follows: 1.Active ingredient means a substance with active insecticidal or germicidal properties. 2. Insecticidal or germicidal chemical means a product containing active ingredients in a technical fonn for processing into preparations or for direct use (below referred to as chemical). 3. Insecticidal or germicidal preparation means a product containing active ingredients and having a specific trade name for direct use (below referred to as preparation) . 4. Assay result slip means a document issued by an assaying unit to indicate conclusions on the effects and safety of a chemical or preparation drawn after carrying out the assessment process under the Ministry of Heath's regulations. © VIETNAM LAW & LEGAL FORUM Issue nos OS.07/July 2011 (Gong Bao nos 425·4261July 28, 2011) OFFICIAL GAZETTE 39 or preparations with valid circulation registration numbers; dI It is prohibited to use the names of active ingredients of chemicals or preparations astheir trade names; el It is prohibited to give chemicals or preparations trade names with me;mings irrelevant to their effects and safety;:: 2.Trade names may only be cha~ upon: aI Exportation of home-made ch~caJ.Sand • • preparations with valid circulation ~tration numbers; .,. Dossiers of request for permissioeeechange trade names and the dossier-appra~g order cornpl y with the law on certificates §gree sale for imported and exported products~ goods; bl Issuance of written conclusiou:!Jy a state agency in charge of intellectual pr~ty or a court on trademark infringcmcnts~volving chemicals or preparations with valid-;:Culation registration numbers. Article 3. Lists of chemicals and preparations I. Lists of chemicals promulgated by the Ministry of Health include: Chapterll CIRCULATION REGISTRATION FOR CHEMICALS AND PREPARATIONS a/ List of ohe.micals permitted for liSP registration; bl List of chemicals permitted for registration for restricted use; cl List of chemicals banned from use. 2. Grounds for promulgation of lists of chemicals: aJ Recommendations of the World Health Organization; bl Scientific research Iindlngs approved by competent authorities; cl Information on chemicals and preparations released by ministries and sectors. Article 4. Trade names of chemicals and preparations I. Trade names of chemicals and preparations shall begiven under the following regulations: <J! FOI each chemical or preparation of a single producer, only one trade name may be registered in Vietnam; bl It is prohibited to use a single trade name for two or more chemicals or preparations of a single producer; cl Trade names of chemicals or preparations must not be identical with those of chemicals Article 5. Circulation registrantc 1. Units eligible to curry out 4Wculation registration for chemicals and pr rations include: al Vietnam-based organ izasions and individuals that are owners (pro~ers) of chemicals or preparations. Owners~ are not producers of chemicals or preparations must have documents proving their rights to own such chemicals or preparations; bl Vietnam-based organizations and individuals that produce or trade in chemicals or preparations or Vietnam-based permanent representative offices of foreign enterprises lSI VIETNAM LAW & LEGAL fORUM OFFICIAL GAZETTE Issue nos OS.07/July 2011 (Gong Bao nos 425-4261July 28, 2011) which are authorized by chemical or preparation owners to carry out the registration; c/ Vietnam-based permanent representative offices of foreign chemical or preparation producers. 2. In case chemical or preparation owners permit the unit they authorize to carry out the registraGn of chemicals or preparations to further ~t the authorization to another unit, they 5~c1early indicate such pcrrnission in the autl$zation paper. 3. In"ellse a chemical or preparation owner authori~woor more units in Vietnam to carry out re~ration for a single chemical or preparart'On, the Ministry of Health (the Health-Envirorpent Management Agency) shall only accept~ process the complete and valid dossie~ichis first submitted. ArtiHti 6. Forms of circulation regisu atiou 1.o!ial registration applies to: aI ~icals and preparations which are newlypiitluced in the country;--b/ C~icals and preparations which have been ~itted for use in foreign countries but are im~ted for the first time for use in VietnarJf'"""l cI cM!1nicals and preparations which have ~ beeng~ed circulation registration numbers but see cuanges in the form of product, solvents, additives or contents of acti ve ingredients: dJ Chemicals and preparations which have been granted circulation registration certificates but are not re-registered within the time limit specified in Clause 2,Article 9 of this Circular. 2. Additional registration applies to chemicals and preparations with valid circulation registration numbers which see: a! Change in packagillg specifications: bl Change in the form or contents of specimen labels; cI Change in the address of the producer or registrant; dJ Change in the right to own the circulation registration certificate; el Supplementation of a new production establishment to the officially registered one; fI Domestic bottling or packaging in replacement of overseas bottling or packaging; g/ Change in effects, quality criteria or use methods. 3. Rc-rcgistration applies to chemicals and preparations which have been granted circulation registration certificates with circulation registration numbers to be about to expire under Clause 2, Article 9 of this Circular. Article 7. Dossiers of official circulation registration 1. A dossier of official registration for circulation of a home-made chemical or preparation comprises the following documents: aJ A written request for official circulation regisuatlon (made according to a set form - not printed herein); bl The registrant's business registration certificate, investment certificate or establishment license, for registrants being represen tative offices; c/The paper of authorization to carrying out circulation registration, tor the case specified © VIETNAM LAW & LEGAL FORUM Issue nos 06-07/July 2011 (Gong Bao nos 42S·4261July 28, 2011) OFFICIAL GAZETTE 41 at Point b. Clause 1.Article 5 of this Circular; dJ Results of testing of the composition and contents of active ingredients of the chemical or preparation; eJ The assay result slip (supplemented under Point b, Clause 3, Article 12of this Circular); fl The producer's written environmental protection commitment or decision Issued by a competent state agency approving the producer's environmental impact assessment report; gJTechnical documents of the chemical Or preparation requested for registration (covering the details specified in Appendix 2 to this Circular, not printed hcreiny; hJ The specimen label and its content registered for circulation in Vietnam. 2. A dossier of official registration for circulation of an imported chemica! or preparation comprises the following documents: al A written request for official circulation registration (made according to a set form); bJ In addition to the papers specified at Points b, c, d, e, f g and h, Clause 1 of this Article, a valid certificate of free sale granted by a competent authority of a country permitting the circulation of the chemical or preparation requested for registration is required. Article 8. Dossiers of additional circulation registration 1. A written request for additional registration for circulation of a chemical or preparation (made according to a set fonn). 2. Documents pertaining to modified Or supplemented contents: aJ In case of changing packaging specifications: the specimen label of the chemical or preparation indicating the new packaging specifications; bl In case of changing the fonn or content of the specimen label: The specimen label in the new fl'mtl orwith a new content: Written explanations about ch~sof the content of the specimen label; cJ In case of changing the address of the producer or registrant: The business registration ccmficate or ~ investment certificate; :::: A specimen label of the cVical or preparation indicating the new ad~s of the producer or registrant. dJ In case of changing the ri~ [0 own circulation registration certificates: The paper of authorization to~rry out circulation registration. for the ca~pecified at Point b, Clause 1, Article 5 of th\li Circular,-- A written request for pennissiottJ transfer the right to own the circulation nistration number. made by the circulation ~tration number owner; A written request for permi~:>.iol:t:DJ receive the right to own the circulation registration number and commitment to trading in the chemical or preparation in accordance with the dossier approved by the Ministry ofHealth (the Health Environment Management Agency), made by the transferee; The establishment license, for transferees @ VIETNAM LAW 60: l.EGAl fORUM 42 OFFICIAL GAZETTE Issue nos 06..Q71July 2011 (CongBao nos 425-426/July 28, 2011) being Vietnam-based permanent representative offices, business registration certificate or investment certificate of the transferee; The specimen label of the chemical or preparation, if there is any change in the form or content of labels. . eI In case of registering a new production establis'=!:fm (0 the officially registered one: Th~w specimen label of the chemical or prep~ion, if there is any change in the label's ~ent or form; ThGrtificate of free sale, granted by a competOOS authority of at least one country permitt~ the circulation of chemicals or prepar<fffT)ns manufactured by the new • producti~stablishment requested for additional registr;]~n (applicable only to imported chemi~dpreparations); Th&Msay result slip (supplemented to the-dossier ~er Point b, Clause 3, Article 12 of this Circe:r). f/ln~ of registering the domestic bottling or pack.a~gof the chemical or preparation in replace~t of overseas bottling or packaging: ~ 'fIlt!!usiness registration certificate or invesbn.n+ certificate of the unit bottling or packagi~it in Vietnam; ...... 11liWsay result slip for the chemical or prepar~ bottled or packed in Vietnam (supplemented to the dossier under Point b, Clause 3, Article 12 of this Circular): The written environmental protection commitment of the bottling or packaging unit or decision issued by a competent state agency approving its environmental impact assessment report; The specimen label of the chemical or preparation indicating the name and address of the bottling or packaging unit ill Vietnam. g/ In case of changing the effects, quality criteria or use methods: The speci men label of the chemical or preparation indicating the added effects, quality criteria or use methods; The assay result slip for the chemical or preparation after its effects, quality criteria or use methods are changed (supplemented to the dossier under Point b, Clause 3, Article 12 of this Circular). Article 9. Dossiers of circulation re registration 1. A dossier of circulation re-registration comprises the following documents: aJ A written request for re-registration for circulation of the chemical or preparation (made according to a set form); b/ The busjncss reg istration certificate, investment certificate or establishment license, for permanent representative offices in Vietnam; c/ The assay result slip, for the chemicals and preparations specified at Point b, Clause 2 of this Article (supplemented to the dossier after the assaying unit completes the assay and sends the assay result slip to the Ministry of Health); dJ The paper of authorization to carry out circulation registration, for the case specified at Point b, Clause 1, Article 5 of this Circular; et The specimen label and its content registered for registration of circulation in Vietnam; f/ A report on the product circulation process © VIETNAM LAW & LEGAL FORUM Issue nos 06·071July 2011 (Gong Bao nos 425·4261July 28, 2011) OFFICIAL GAZETTE 43 (made according to a set form), 2. Time limits for submission of dossiers of circulation re-registration: al For raw materials used for producing preparations with valid circulation registration numbers granted by the Ministry of Heath (the Health Environment Management Agency), dossiers of circulation re-registration must be submitted at least 20 (twenty) working days before the expiry date of circulation registration numbers; hIFor chemicals and preparations other than those specified at Point a of this Clause, dossiers of circulation re-registration must be submitted at least 14(fourteen) months before the expiry date of circulation registration numbers; Past the lime lirnits sped Iied at Points a and b of this Clause, if registrants wish to continue circulating these chemicals or preparations, they shall carry out official circulation registration, Article 10. Requirements on circulation registration dossiers 1. Adossier ofofficial registration, additional registration or re-registration for circulation of a chemical or preparation shall be made in one set. 2. For foreign-language documents, their originals must be enclosed with Vietnamese versions. For documents in a foreign language other than English, their Vietnamese versions must be certified by a notary public or a translation service provider. 3, Documents included in a dossier must be legibly printed and arranged as required for each form of registration specified in Article 7,8 or 9 of this Circular. A dossier must have covers, an index of documents, and color sheets "(~par~tine c1iff~rp,nl part" 4. Papers in a circulation registration dossier which must be originals: aJ The paper of authorization to carry out circulation registration, for the cas~cified at Point b, Clause 1, Article 5 of thittircular; bl The assay result slip; cl Results of testing of ingrect'n!'nts and contents, 5. Papers in a circulanon regislral~dossier which may be notarized or certifiedeepies: aJ The registrant's business re~tration certificate, investment certit=slte or establishment license, for registr. being Vietnam-based representative officfli:: bl The producer's written enviJiliWiDcntal protection commitment or the deci~ issued by a competent state agency appas.;ing the producer's environmental impact ~se~sment report; cJ The certificate of free sale slfisjfied in Clause 2, Article 7 of this Cjrc~r. This certificate must be consularly legali~except cases exempt from consular legalizatfI!tR under law. 6. Other papers in a circulation rmstration dossier must be appended with the registrant's seal. Article ll. Receipt of circulation registration dossiers Registrants shall submit dossiers of registration for circulation of chemicals or preparations directly or by post to the Ministry © VIETNAM LAW & LEGAL FORUM 44 OFFICIAL GA7E'TTE Issue nos 06.071July 2011 (Gong 8ao nos 425-426/July 28,2011) of Health (the Health Environment Management Agency). Article 12. Appraisal of circulation registration dossiers 1.For a dossier of registration for circulation of a chemical or preparation specified at Point a, b, c o~ Clause 2, Article 6 of this Circular, within ztr(twenty) working days after receiving the doss";;, the Ministry of Health (the Health Enviro~ntManagementAgency)shall issue ~ . a docUIlJ,l:Jlt requesting dossier supplementation orindic~g its agreement or disagreement with the conif:!! of the additional registration. . 2.F~ dossier of registration for cjrcu lat ion of a chernecal or preparation specified at Point a, Clau~, Article 9 of this Circular: a! If:;'he dossier is incomplete or invalid, within~ve) working days, the Ministry of Health S Health Envtronment Management Agency~allissue a written request for dossier suppJel~t:-ltion At least i (five) working days before& expiry date of the circulation registf*.>n number, the registrant shall supple~t documents as required. Past this time I~ the submitted dossier will become invalid "rltl the Ministry of Health (the Health Enviro~tManagement Agency) shall not re-granI:1:'be circulation registration number; blra= dossier is complete and valid, within 15 (fifteen) working days, the Ministry of Health (the Health Environment Management Agency) shall re-grant the circulation registration number, 3. For a dossier of registration for circulation of a chemical or preparation other than those specified in Clauses I and 2 of this Article: a/Within I month after receiving the dossier, the Ministry of Health (the Health Environment Management Agency) shall issue an assay permit. In case of refusal, it shall issue a written reply clearly stating the reason; bl Within 12 months after obtaining an assay permit from the Ministry of Health (the Health Environment Management Agency), the registrant shall submit an assay result slip for supplementation to the circulation registration dossier. Past this time limit, if the registrant fails to submit this slip, the submitted dossier will become invalid for circulation registration; cl Within 20 (twenty) working days after receiving an assay result slip from the registrant for supplementation to the dossier, the Ministry of He a lth (the Health Environment Management Agency) shall: Grant or refuse to grant a circulation registration number. In case of refusal, it shall issue a written reply clearly stating the reason, for dossiers of registration for circulation orthe chemicals or preparations specified in Clause 1, Article 6, and Point b. Clause 2, Article 9, of this Circular; Issue a document indicating its agreement or disagreement with the content of the additional registration. If disagreeing with the content of the additional registration, it shall issue a written reply clearly stating the reason, for dossiers of registration for circulation of the chemicals or preparations specified at Points e, f and g, Clause 2, Article 6 of this Circular. Article 13. Circulation registration numbers and certificates 1. Each chemical or preparation may be © VIETNAM LAW & LEGAL FORUM Issue nos OS-OJ/July 2011 (Gong Bao nos 425·4261July 28,2011) OFFICIAL GAZETTE 45 granted only one circulation registration number. 2. The circulation registration number of a chemical or preparation shall be granted in the fOM ofcirculation registration certificate which is valid for 5 (five) years from the date of issue. The circulation registration certificate shall be made according to a set form. Article 14. Cases subject to revocation of circulation registration number 1. Registrants have forged registration dossiers. 2. The chemicals ur preparations in circulation are unconformable with the granted circulation registration certificates or registration dossiers: labels of the chemicals or preparations in circulation are unconformable with those approved by the Ministry of Health (the Health Environment Management Agency) and registrants fail to take remedies at the request of competent state management agencies. 3. Reg istran ts lease or lend the II' c ircularion registration certificates; or modify their circulation registration certificates without permission. 4. Registrants terminate chemical or preparation production or trading activities. 5. Registrants no longer satisfy the conditions for registration for circulation of chemicals or preparations. 6. The chemicals or preparations in circulation no longer assure the effects and safety requirements as indicated in their dossiers registered with the Ministry of l Icalth (the Health Environment Management Agency). Article 15. Charges for appraisal of circulation registration dossiers 1. Organizations and individuals requesting circulation registration Of assay of chemicals or preparations shall pay dossier appraisal charges according to the law on charges and fees. 2. Dossier appraisal charges shall be paid upon dossier submission to the Ministry of Health (the Health Environment Mtmigement Agency). Chapter III TESTING AND ASSAY OF CHEMICALS AND PREPARATIONS Section [ TESTING OF CHEMICALS~D PREPARATIONS Article 16. Cases SUbject to testDj: 1. Chemicals and preparatiOl:i5.jjrior to official circulation registration. 2. Chemicals and preparations oorrently in circulation in Vietnam. Article 17. Testing contents I. Testing of chemicals or prepaMtlonS fOT circulation registration covers the idf;tification........ of the content and composition. of active ingredients of these chemicals or p~rations.-2. Testing of chemicals or p~arations currently in circulation covers the identification of the composition and content of main active ingredients and other quality criteria of these chemicals or preparations. The testing of chemicals and preparations currently in circulation complies with the Law on Product and Goods Quality and other laws. e VIETNAM LAW & LEGAL FORUM 46 OFFICIAL GAZETTE Issue nos06-07/Julv 2011 (Cong Bao nos 425-4261July 28, 2011) Article 18. Testing units I. Units which are set up under Vietnamese law and have the function of testing the composition and content of chemicals and preparations. 2. In case Vietnam-based testing units are unable to test the content and composition of chemicG or preparations requested for registrasen, the Ministry of Health (the Health Envicvellt Management Agency) may consideG..tnd accept testing results of their produceQr an independent lab, and registrants shall tag: responsibility before law for the lawfulnG8 of testing results they produce. Section 2 ASSA'[oP CHEMICALS AND TESTING Artie 19. Cases subject to assay 1. C&nicals and preparations prior to offICial ulation registration. 2. CUlicals and preparations with valid circulati~registration numbers granted by the MiDist~f Health (the Health Environment ManagE!rn@ntAgency) requested for additional • • cin;:Ula[~egis[raLiun under Points e, for g, ClauseUrticle 6 of this Circular. 3. ~llicals and preparations with the circulation registration numbers granted by the Ministry of Health (the Health Environment Management Agency) to be about to expire requested for circulation re-registration under Point b, Clause 2, Artie Ie 9 of this Circular. 4. Chemicals and preparations without cieculatiulllegi:-.ttatiulllluJIloers tu be imported in large volumes for exterminating insects or bacteria on board aircraft. Article 20. Assay contents 1.Assessment of the effects of chemicals or pte parat i un» La wards La! geteu objec LoS as requested by registrants. 2. Assessment of the safety for: aJ Persons directly assaying chemicals or preparations, in case of laboratory assay; bl Persons directly assaying chemicals or preparations and persons living in assay areas, in case of field assay. Article 21. Assaying units 1. Units assaying the safety and effects of insecticidal chemicals and preparations: aJ The National Institute of Hygiene and Epidemiology; b/The Pasteur Institute of Ho Chi Minh City; cl The Pasteur Institute of Nha Trang; d/ The Central Highlands Institute of Hygiene and Epidemiology; e/ The National Institute of Mala! iulogy, Parasitology and Entomology; flThe Institute of Malariology, Parasitology and Entomology of Ho Chi Minh City; fl The Institute of Malariology. Parasitology and Entomology of Quy Nhon. 2. Units assaying the safety and effects of germicidal chemicals and preparations: aJ The National Institute of Hygiene and Epidemiology; b/The Pasteur Institute ofHo Chi Minh City; d The Pasteur Institute of Nha Trang; © VIETNAM lAW & LEGAL FORUM Issue nos 06·07!July 2011 (Gong Baanos 425-4261July 28,2011) OFFICIAL GAZETTE 47 dl The Central Highlands Institute of Hygiene and Epidemiology; el The Nations1Institute of Occupational and Environmental Health; f/The Institute of Hygiene and Public Health of Ho Chi Minh City. 3. For units other than those specified in Clauses 1 and 2 of this Article, the Ministry of Health may accredit them to be qualified for assaying chemicals or preparations on the basis of their functions, tasks and capabilities, if they so wish. 4. In case Vietnam-based units are unable to assay chemicals or preparations for circulation registration, the Ministry of Health (the Health Environment Management Agency) may consider and accept assay results of foreign countries. Chapter IV IMPORT AND EXPORT OF CHEMICALS AND PREPARATIONS Article 22. Principles of import and export of chemicals and preparations 1. The import and export of chemicals and preparations comply with the law on goods import and export. 2. In case importing countries require certification of free sale of chemicals or preparations in Vietnam, registrants shall comply with the law on certificates of free sale of imported and exported products and goods. 3. Chemicals and preparations with valid circulation registration certificates granted by lite Mi uistry of Health (the Health Environment management agency) may be imported on demand in unlimited volume or value. Import procedures shall be carried out at customs offices without requiring the Ministry of Health's approval. Importers shall take responsibility before law for their operations. 4. Chemicals and preparationso~ listof those eligible tor on-demand imporPiust still have at least 2/3 (two-thirds) oftheiHhelflife, counting from the date of arrival i~tnam. 5. When granting circulation r~ation numbers; for chemic als or preparation~oduced at home from imported raw materia~t have no circulation registration numbers if'i'f;ietnam, the Ministry of Health (the Health Er§'onment Management Agency) shall issue aeecurnent attesting that such raw materials ar~rmittcd for import. This document is as =id as a circulation registration number ~ted to chemicals or preparations. Article 23. Import licenses 1. Chemicals and preparations::Dquiring import licenses: al Chemicals and preparations-without circulation registration numbers for~h assay permits have been granted by {he .l\4inistry of Health (the Health Environment M~gement . . -Agency) and WhICh are Imported fOP"'ftssay or testing; b/ Chemicals and preparations without circulation registration numbers which are imported for research, donation or other particular purposes (which are gifts or presents or in case similar products or methods are unavailable in the market). @ VIETNAM LAW &LEGAL FORUM 48 OFFICIAL GAZETTE Issuenos 06-07/July 2011 (Gong Baanos 425-4261Ju/y 28, 2011) 2. Dossiers and procedures of application for import licenses for chemicals and preparations without circulation registration numbers to be imported for assay or testing: aJ An application for a license to import chemicals or preparations (made according to a set form); bl ~in 5 (five) working days after receivintthe application, the Ministry ofHealth. (the HeW Environment ManagementAgency) shalliss~ document indicating its acceptance or reje~n of the import of chemicals or preparaas for assay or testing and clearly state thereas;;' 3. Dossiers and procedures of application for import ~nses for chemicals and preparations withouta'll"culation registration numbers to be import~ for research, donation or other partieulE:Purposes:-aI A ~ssier of application for a license to importf3micals or preparations: An:lpplication for an import license (made aCCOf(n~toa set form); A'-IWtarized copy of the business registr~certificate or other papers proving the leg~tity status of the import license applicaWwhich must be appended with the applicam seal; 'Iechnical documents of chemicals or preparations; The research outline (for chemicals and preparations imported for research) or written explanations about the use purposes of chemicals or preparations (for those imported for particular purposes); A GMP or ISO certificate of the manufacturer and circulation permits of the chemicals or preparations granted by the country of origin or circulation permits granted by other countries in which the chemicals or preparations have been registered and sold, in case of importing chemicals or preparations for donation or other particular purposes III a total weight of 50 (fifty) kilograms upon each importation; The assay result slip, for the case specified in Clause 4, Article 19 of this Circular (supplemented to the dossier after the import license applicant receives it from the assaying unit); b/ Within 15 (fifteen) working days after receiving a valid and complete dossier, the Ministry of Health (the Health Environment Management Agency) shall issue a reply stating its acceptance or rejection of the import. In case of rejection. the reason must be clearly stated; c/ For the cases specified in Clause 4, Article 19 of this Circular: Within 5 (five) working days, the Ministry uf Heallh (the Health Environment management agency) shall issue a written request for assay; Within 10 working days after receiving the assay result notice from the import license applicant, the Ministry of Health (the Health Environment management agency) shall issue a document stating its acceptance or rejection ofthc import. In case ofrejection, it shall clearly state the reasons. Chapter V CIRCULATION OF CHEMICALS AND PREPARATIONS © VIETNAM LAW &LEGAL FORUM Issue nos06·071July 2011 (Cong BflOnos 425-426JJuly 28,2011) OFFICIAL GAZETTE 49 Article 24. Labels of chemicals and preparations 1. When circulated in Vietnam, chemicals and preparations must have Vietnamese labels like the approved specimen labels enclosed with the circulation registration certificates granted by the Ministry of Health (the Health Environment Mnn ag crnent Agency) ;lnd compliant with the law on labeling of goods circulated in the country and imports and exports. 2. Labels must be printed with legible and untadabie letters of at least ~ mm in size and must be durable in the process of circulation, preservation, transportation and use. 3.Labels must be securely stuck to or printed on chemical or preparation packages. 4. The color of label background must be different from the color indicating the toxicity class of chemicals and preparations. 5. Compulsory details of chemical or preparation labels: a/ Trade name of the chemical or preparation; bJ Composition and contents of active ingredients: cf Effects; dJ Use and preservation instructions; e/ Walllillgs about J!Ussibk uilllgcrs (0 huruan health and the environment; ff First-aid treatment for cases of chemical or preparation poisoning; g/ Name and address of the producer; hJ Name and address of the processing, bottling or packaging unit (if any); iJ Name and address of the unit responsible for the chemical or preparation; jf Manufacture lot number; k/ Date of manufacture; IJ Shelf life: mJ Number of registration for circulation in Vietnam. 6. For chemicals and preparaticas put in small packages, their labels shall alsc1'l'!'eprinted with letters at least 8 mm in size, a;~ case of insufficient space for printing c~u1.Pulsory information. an additional label must be. ~~ attached to each package. In thiU<lse, the principal label of the package mustdbplay the phrase "Read carefully the attachecf1fatlitional label before use." Such details as trade name, cffc~nllmcof-the unit responsible for the chefnical or preparation, quantity, date of manuG7ture and shelf life, must be displayed on th~rincipal label. 7. In addition to the details s~itied in Clause 5 of this Article, the labels oQemicals and preparations of toxicity classes ~*, HI;and [V according to the Worl~Health Organization's classification mu~i:-' contain--toxicity symbols (as specified in Appendix 6 to this Circular, not printed herein) as1"ollows: aJA color strip indicating the to>tte1tyof the chemical or preparation running cross the label with a height equal to 10% of that of the tube! shall be printed at the bottom of the label: , Red strip, for chemicals and preparations of toxicity classes 13 and Ib; Yellow strip, for chemicals and I @ VIETNAM LAW & LEGAL FORUM 50 OFFICIAL GAZETTE Issue nosQ6-07lJuly 2011 (Gong Baanos 425-4261July 28, 2011) preparations of toxicity class II; Blue strip, for chemicals and preparations of toxicity class Ill; Green strip, for chemicals and preparations of toxicity class IV. bI Information on toxicity: "Ve2l. toxic" (toxicity classes La and Ib) with thtftt>xicity symbol being a skull and crossbo~in a lopsided square; • '~y toxic" (toxicity class II) with the toxicity ~mbol being a cross in a lopsided square; "D'f:§erous" (toxicity class ITT) with the toxicity ~bol being an interrupted line in a lopsided sl!luare; ''C~ul'' (toxicity class IV) without any toxicity ;;;;nbol.-sym~s indicating toxicity classes of chemica~and preparations must be printed above thw trade names. Arti~25. Packaging of chemicals and preparat~s 1.~ circulated in Vietnam, chemicals and pr~ations must be put in packages satiSfyi~efollowing requirements: a1P~ges must be firm enough to stand normal;:ampucts an~ shocks during transportatIOn, transshipment and handling by manual or mechanical methods. bl Packages must be tight to prevent leakage of chemicals or preparations during transportation or being transported under impacts of vibration or increase of temperature, moisture or pressure. cl Each package may be disposable. Glass, glazed terracotta and porcelain bottles may be re-used after being cleansed; df The outer surface of packages must be clean and free of any hazardous chemicals. 2. Packaging parts in direct contact with chemicals or preparations must meet the following requirements: aJ Neither being affected nor deteriorated in quality due to impacts of packaged chemicals or preparations; bl Not affecting the composition, properties or effects of the packaged chemicals or preparations. 3. When packaging liquid chemicals or preparatioris, a nerf"ssary space must be left to ensure packages will not be leaked or deformed due to an increase in volume of packaged liquids when temperature increases during transportati on. 4. Inner packages which are breakable or easily holed such as those made of glass, glazed tcrracotta, porcelain and some certain kinds of plastics must be insulated with appropriate shock-absorbing materials from the outer packaging layers. 5. Packages of volatile substances must be tight enough to ensure the volume of liquids will not decrease below the set limit during transportation. 6. Packages of liquids must stand the inside pressure buill up during transportation. 7. Packages of liquid chemicals or preparations must be tested for leakage before © VIETNAM LAW & LEGAL FORUM Issue nos06.Q71July 2011 (C6ng Bao !lOS 425-4261JUly 2B, 2011) OFFICIAL GAZETTE 51 use. 8.Packages of granule or powdery chemicals or preparations must he tight enough to prevent leakage or have tight lining layers. 9. Packages must have a capacity corresponding to the net weight or volume shown on chemical or preparation labels. Article 26. Transportation of chemicals and preparations i. Chemical or preparation carriers shall comply with the provisions on transportation of hazardous goods in the laws on road, inland waterway. railway, air and sea transportation and other relevant laws. 2. Upon occurrence of chemical incidents during transportariou, drivers. goods owners and vehicle owners shall promptly take measures to mitigate consequences and remedy the incidents and, at the same time, notify the incidents to fire brigades, concerned agencies and units and the administration of the nearest locality for coordinated response and remedy. Article 27. Preservation of chemicals and preparations 1. Presetvat ion of chemicals and preparations must assure human, livestock and environmental safety. 2. Storekeepers must be trained in labor safety and fire and explosion prevention and fighting in chemical and preparation preservation, 3. Upon occurrence of serious chemical incidents, chemical or preparation owners shall promptly take response measures under Clause 2, Article 26 of this Circular. Responsibilities to coordinate in responding to incidents comply with Clause 3, Article 42 of the Chemical Law. Chemical or preparation owners shall bear all expenses for remedying the incidents. Article 28. Destruction of chemicals and preparations 1. Cases subject to destruction: aJ Chemicals and preparations i~duction and trading with an expired shelf lift;. bJContainers and packages of che.ii!E:1lls and preparations which are not permitte~ re-use; wastes generated from the productio~~ading of chemicals and preparations. 2. Chemicals and preparations fOllftleusehotd or personal use only must be 3Acarded according to producers' recommenSons and the environmental protection law so~ assure human and environmental safety. 3. Organizations and perso!jFhaving chemicals and preparations or ch~cal and preparation packages subject to destrOon shall he:!f ;\ 11 df':stn iction expenses For ch~aJs and preparations or chemical and p=aration packages with unidentified owners, ~vincial­ level People's Committees of localores where such chemicals or preparations ar8f'1!1anaged shall allocate their budget funds for <l'truc:tion according to regulations. 4. In the process of collecting and destroying chemicals and preparations and chemical and preparation packages, hazardous waste must not be scattered, dispersed or increased in the environment and must be treated with appropriate technologies in accordance with the @ VIETNAM LAW& LEGAL FORUM 52 OFFICIAL GAZETTE Issue nos 06-07/July 2011 (Gong BaD nos 425·4261July 28,2011) environmental protection law. Article 29. Advertisement of chemicals and preparations Advertisement of chemicals and preparation complies with the advertisement law. Chapter VT IMPL.E!lVtENTATION RESPONSIBILITIES Art~30.The Ministry of Health's Health Envirornsent Management Agency ~ ....... 1. It'i'assist the Minister of Health in perfo~~ the state management of chemicals and pre~ationsnationwide. 2. To act as the standing body of the Chemi<:$ and Preparation Appraisal and Approv4tt::ouncil. 3. T~ceive dossiers of registration for circulamin, import and advertisement of . chemicaJi and preparations; to consider and decide~e grant and revocation of circulation registrati.J,;j,n numbers; to preserve dossiers of registrm1'on for circulation, import and advertLstITIent of chemicals and preparations '-, under ~Circular. 4. TGue, under authorization, decisions to granto.jrculation registration numbers for chemkl.I[and preparations. 5. To issue, under authorization, decisions to revoke circulation registration numbers of chemical and preparation producers and traders violating Artie Ie 34 of this Circular. 6. To prepare modifications and supplementations to the lists of chemicals specified in Article 3 of this Circular for submission to the Minister of Health for promulgation on an annual basis, if there are any changes in chemicals and preparations in these lists. 7 Tn manael' dos,;f'r ;lpprai,;!1 charge under law. 8. To assume the prime responsibility for, and coordinate with concerned agencies in, conducting inspection and examination of chemicals and preparations nationwide. Article 31. The Ministry of Health's Inspectorate 1. To inspect the implementation of this Circular nationwide in accordance with the inspection law. 2. To settle complaints and denunciations and handle detected violations committed by units engaged in chemical- and preparation related activities nationwide. Article 32. Chemical- and preparation assaying units 1.To conduct assays for official registration, re-registration and additional registration of chemicals and preparations after obtaining assay permits from the Ministry of Health (the Health Environment Management Agency). 2. To conduct chemical and preparation assays according to the assay process promulgated by the Ministry of Health. 3. In case chemicals and preparations are permitted for assay but no relevant assay processes have been promulgated by the Ministry of Health, assaying units shall develop a process and submit it to the Ministry ofHealth (the Health Environment ManagementAgency ) © VIETNAM LAW &LEGAL FORUM Issue nos 06·071July 2011 (Cong Bao nos1251261Ju}y 28,2011) OFFICIAL GAZETTE 53 for summarization, appraisal and submission to the Minister of Health for promulgation. 4. To take responsibility before law for the results of chemical and preparation assays. 5. To make periodical reports On chemical and preparation assays on June 15 and December 15 every year to the Ministry of Health (the Health Environment Management Agency). When detecting any differences in the actual dosage and the rlosage recommended hy the producer indicated on the product label, assaying units shall report such in writing to the Ministry of Health (the Health Environment Management Agency) for consideration and settlement. 6. The Ministry of Health shall consider removing assuying units that fail to comply with Clauses 1,2,3,4 and 5 of this Article from the list of quali fied assay units. Article 33. Provincial-level Health Departments 1. To guide chemical and preparation producers, traders and users under their management in implementing this Circular and other relevant laws. 2. To coordinate with functional agencies in organizing inspection, periodical and unexpected examination and handling administrative violations in the field of chemical and preparation production, trading and use in their localities according to this Circular. 3. To send annual reports (made according to a set form) to the Ministry of Health (the Health Environment Management Agency) on December 15 every year or upon request of the Ministry of Health. Article 34. Chemical and preparation producers and traders 1. To comply with this Circular and other relevant laws. 2, To send periodical reports oit:2)'tlemical and preparation production and ITading to I ,.,. ~ ~ provincial-level Health Dep~ents of localities where they are headq~r~ered on November 30 every year. 3. To notify in writing the MinistrfofHealth . (the Health Environment Managemess.Agency) ~ of chaugcs ill the Hames of che"l'fti.;al or preparation registrants or produ~ due to separation, merger or orgaMational transformation or of termination o+:themlcal :,.,..... and preparation production a~ading activities. 4. To take responsibility before{1lw jf their chemical and preparation prod~on and trading activities cause adverse acts on people. livestock and the environmetteand take responsibility for the quality of thcl:ttJroducts which are circulated and used. 5. To be subject to inspection, examination and handling of violations under laW· 6, To recall, dispose of and destroy chemicals and preparations upon competent agencies' issuance of conclusions on violations involving chemicals and preparations. Article 35. Chemical and preparation users I. To only use chemicals and preparations . e VIETNAM LAW & l.EGAL FORUM 54 OFFICIAL GAZETTE Issue nos 06·071July 2011 (Gong Bao nos425-4261July 28, 2011) with valid circulation registration numbers. 2. Importers and users of chemicals or preparations which are permitted to be imported as donations or for use for particu lar purposes by the Ministry of Heal th (the Health Environment Management Agency) shall take full responsibility for the use of these chemicals orprepac=ons. 3. TOofequest chemical suppliers to provide suffici~formationon hazardous properties of chemiQjls and preparations and requirements for assag their effects and safety; to be entitled =compensation as provided by law from suPiDiers for damage they suffer when using c~icals and preparations due to untruthf~information provided by suppliers. . 4. T0i"ictly follow use instructions shown On pro~ labels or attached to chemicals and prepara.s and take full responsibility for . -llnprope~se, to assure safety for themselves, the envt::nment and community; if using chemic~mdpreparations causing damage to the heal(W life or property of others, to pay compenrnnon according to law. Chapter VII IM~ENTATION PROVISIONS Arti.36. Effect Thi~rcular takes effect on January 1, 2012. r;om the effective date of this Circular, the Minister of Health's Decision No. 3486/2001/ QD-BYT ofAugust 13,2001, promulgating the Regulation on management of insecticidal and germicidal chemicals and preparations for household and family use and Section 1lI un the import of insecticidal and germicidal chemicals and preparations for household and family usc of Circular No. 08/2006/TT-BYT, guiding the import of vaccines, medical bio preparations, insecticidal and germicidal chemicals and preparations for household and family use and medical devices, cease to be effective. Any problems arrsmg in the course of implementation should be promptly reported to the Ministry of Health for consideration and settlement. For the Minister of Health Deputy Minister TRINH QUAN HUAN e VIETNAM LAW & LEGAL FORUM