Regulation on management of aquatic veterinary drugs

No. 21 (1 !'i-ti-?00?) THE MJNJSTRY OF AQUATIC RESOURCE!J. DECISION No. 03/2002/QDwBTS OF JANUARY 23, 2002 PROMULGATING THE REGULATION ON MANAGEMENT OF AQUATIC VETERINARY DRUGS THE MIN\STER OF AQUATIC RESOURCES Pursuant to the Government's Decmo No.50/CP of .June 21, 1994 defining the tasks, powers and organizational apparatus of the Ministry of Aquatic Resources. Purnuant to the Govemment's Decree No.93/CP of November 27, 1993 guiding the implementation of th.e Veterinary Ordinance; Pursuant to the Government's Decree No. 30120001 ND-CP of Augus(11; 2000 on the annulment of a number of permilsand}icenses and conversion of some others into busine'ss conditions; Pursuant to the Goyerrimehfs Decree No.86/20011 ND-GP of November 16; 26Mion the conditions for the engagement in aquitic /)U$f11ess lines; Pursuant to Circu!arNo·: 02lfS!TTof June 25, 1994 of the Ministry of Aquati; R~;Q1,1n;es guiding the implementation of the •G~vefttmeilr'1 Decree No. 931 GP of November 27, 1993'c'6h f/et~rinary work for aquatl. animals andptoducts thereof,, ' .. ·. ,. , . At the pmfjosf.llofth~ dirbcti!i~ of the Aquatic Resource Proteqtion Departmerrt) DECIO!:$: Article 1. ~Jo Issue fog et)l er with thls Decision the Regulation on management of aquatic veterim::ry drugs. Article 2.wThis Decision takes effect 15 days after its signing. The Regulation issued together with this Decision shall replace the provisions of Section IV, Circular No.02--TS/lT of June 25, 1994 of the Ministry of Aquatic Resources. Artie/a 3.~ The directors of the Office and Departments and the cl1ief inspector of the Ministry; the director of the Aquatic Resource Protection 0eparlment, the dtrecto1· of the Center for Aquatic Product Ouality and HygiRne Inspection, tho directors of tfle provi11cial/munidpaf Aquatic /~esource Services as well as Agricultlm·i and Ru r a I Development Sei\/ice-s l,in1m\.11•2.d tl,e manage.{w~nt o\ ,wr..1ntic resources) shall have to implement tt1i~; Decision. For the Minister of Aquatic R~sources Vice Minister NGUYEN VIET THANG REGULATION ON MANAGEMENT OF AQUATIC VETERINARY DRUGS . . .. (Issued together With Decision No. 03/2002/QD~B TS) , .·:· Article 1.- This Regufatlon prescribes uniform procedures and cor'ldltipn~ forthe production, trading, import and test q(aqiJ¢1tlc veterinary drugs on the Vietnamese territory:;, ' . Article 2 ... ,,Organizations and individuals (hereinafter ca 11,ed:establ!shments )inv~ived in aquatic veterinary drug' activities · must ' strittly a bide by the provisions of th is, Reg ufation. : : Article 3.- In this Regulation; ,the following words .· and phrases shall be construed as follows: 1. Aquatic veterinary drugs are proClucts (including finished products, semi-ilnhshed products and raw materials) originating from animals, plMts, minerals, pharmaceutical chemistry or biology, used in aquaculture for: a/ Disease prevention and treatment bl Diagnosis Df diseases. cl Regulation of the reproductiori, growth and development processes. di Environmental improvement anci '· ~'atment. 2. Test of aquat'1c veterinary drugs means determination of the efficiency and safety of those drugs when they are put to use in aquaculture (ttle(r efficacy in epidemic prevention and treatment for aquatic animals, their safety for men and domestic animals, neither causing environment<:11 pollution nor destroying the ecological environment). No. 2'! (15-~-2002) ?,. At'\ua\k, \leteriria,>' urng-re~a\ea at",\\-.J\\\es cover the management, production, trnding, import and experimentation of aquatic veterinary drugs. Article 4.• Stotc management ogcncrcs in charge of aquatic veterinary drugs: 1. At the central level: The Aquatic Resource Protection Department shall assist the Minister of Aquatic Resources in performing the function of State management over aquaoc veterinary drugs throughout tho country. 2. At the local level: The Aquatic Resource Protection Sub~Departnients shaf l assist the directors ofthE~ provinCial/mLinicipalAquaUcResource Services or Agriculture and Rural l;)evelopment Services iovo/ved in: aquatic resoilrce m'i117agement in performing the function of State management over aquatic veterinary drugs. - .: , --- · In localities where Aquatic Resource Protection Si.!b-Depattments are not ~vailabfe', the agencies performlng the above-mentioned lasl< $hall be designated byth~ provincial/municipa\Agrie\.llture and Rural OevelopmenrSeNices; . <: · :.' .. ··.: :: . Chapter IF .· . . PROVISIONS ON AQUAllC \IElHR\NARY DRUG~RELATED ACTJVITIES A,ticle 5.- Conditions for aquatic veterinary drug production Establishments producing aquatic veterinary drugs must meet all thefollowfng.conditions: 1. Their locations, workshops, warehouses and waste treatment systems must satisfy the environmental protection and veterinary hygiene criteria prescribed by the Ministry of Aquatic Resources. 2. Their facilities and equipment must meet the requirements of production and preservation of raw rnaterials and products. '.3. They have technicians and specialized technic'l~I workers. The persons in charge of technical matters regarding aquatic veterinary drug production rnust be veterinarians, aquaculture f-mgineern, bachelors of biology or biological chemistry, or pharmacists. No. 21 (15-5--2002) OFFICIAi. GAZFTTE 4. They have means to inspect the quality of drugs before they are released from factories. 5. The products released from factories must ensure the announced quality and stuck with goods labels. The contents inscribed on goods labels shall comply with Circular No. 03/2000/TT-BTS of September 22, 2000 of the Ministry of Aquatic Resources guiding the implementation of the Prime Minister's Circular No.178/1999/QD-TTg of August 30, 1999, which promulgated the Regul<=1tion on the labeling of domestically circulated goods as well as import and export goods; · 6. They have registration certificates for aquatic veterinary drug production granted by the Aquatic Resource Protection Department . . : . . . 7. Theyi:ir~:allo'\Ned to produce ori!y those kinds of aquatic V~lerihary drug; which have been inscribed in the; regis,fra'tt6n certificates for aquatic veterinary drug prod~ctiono:' .:·· ' Article 6.-.:CohdiUons for aquatic veterinary drug trading : : · ·· · EstabUshmsrtst'radirig in aqu'atlc veterinary drugs must meet all the foUoi.ving conditions: 1. Hteir busin(;lss locations must ensure the veterinary.hygiene criteri.a prescribed by the Ministry of Aquatic Resources. ·•· · 2. They.haveJacirities and equipment for aquatic· veterinary drug 'Pfj:3S0 rvatibn. 3. The persons who manage aquatic veterinary drug stores must obtarn, at least, diplomas of intermediate veterinary or aquacultural schools. 4. They a re a II owed to trade in only those· kinds of aquatic veterinary drug, whfch are on the list of those permitted for use promulgated by the Ministry of Aquatic Resources. Article 7.- Test of aquatic veterinary drugs 1. The aquatic veterinary drugs outside the list of those permitted for use promulgated by the Ministry of Aquatic Resources must be tested before being imported into Vietnam or produced in the country for tile first time. 2. The test of aquatic veterinary drugs shall comply with the stipulations of the Ministry ot Aquatic Resources. Article 8.- Import of aquatic veterinary drugs The import of aquatic veterinary drugs shall com ply with the Ministry of Aquatic Resources' regulations on the management of specialized aquatic goods import and export. Chapter Ill ·· CONTENTS AND PROCEDURES FOR THE GRANTING OF AQUATIC VETERINARY DRUG PRODUCTION REGISTRATION .. Article 9.~ DbSsier for registration of aquatic Vl;!terinary drug prodLJction · . : ./ :- :; .. · 1. An applicat!on for registration of aquatic veterinary drug prbductiori; ,epc!osed with a list of drugs to be produc~d: . ·· ·. · 2. A disposition on. the•C~riditicms for aquatic vet~tin~rydrug productio:n .. ·. · · · · · .... , : ·.,. ·' '· . 3. Copies:~{diploma; of the persons in charge of technical matters, . . .·•. 4, Tec:hnical r.iQSsier, inducting: a/ The }iCldUCtion process and product quality standards. for:'each> kind olr~gistered drugs, drug labels reg{steredJorcircu.latioh. .. b/The in;pection. result card certifying the satisfaction of the· already registered quality standards, granted by the 1:,tate inspection agency. 5. Copies of papers related to the founding of the production establishment such as founding decision, business regfstratfon certificate, investment license. Article 10.- Procedures for consideration and granting of registration certificates for aquatic veterinary drug production 1. When receiving dossiers, the registration granting agencies shall base themselves on Article 9 to consider the dossiers and guide the establishments to supplement incomplete contents. 2. Within 10 working days after receiving the valid dossiers, the Aquatic Resource Proh.:~ction ClfFICIAI GA/1-'ITF No. 21 (15-f.ir2002) Department shall have to evaluate the pmduction conditions. Jf aJJ conditions nrc met, the Aquatic Resource Protection Department sl1all grnnt the registration certificates for aquatic veterinary drug production to production establishments. If the evalua'tion conclusions show that the production establishments fail to meet the conditions for aquatic veterinary drug production, such estab1ishments may request the reevaluation after overcoming the shortcomings revealed !n the first evaluation. Article 11,~- Inspection of conditions for aquatic:: veterinary drug production The inspectron of conditions foraquatic veterinary drug production shall be :conducted in the following cases: 1. The first-time inspection shai! apply to establishments thatNw~Just begun to participate in · production and 'establishments that have beeri registered for prod~cud:n:but change their production · locations. . . . 2. The re-i~s·P~ct/bri shall app!yto establis,hments that have been in:S:p~ctted 'bvt fail to meet the . production conditions and establishments that expand. their production locations.and productioh chains. 3. The period,ical :iiiSpE:;ction ;h~H be'. conducted once a year, aiming lo supervtse the maintenance of production condition$, : - - - --- -· - - · '. ·. :." . . 4. The extraordinary inspection shall be conducte.d when the managing agencies deem it necessary. Article 12.- Agencies inspecting conditions for aquatic veterinary drug production 1, The Aquatic Resource Protection Department shall be the agency inspecting the production conditions for establish men ts producing aquatic veterinary drugs throughout the country. 2. The provincial Aquatic Resource Protection Sub Departments shalf be the agencies inspecting production conditions tor establist1rnents producing aquatic veterinary drugs under the Aquatic Resource Protection Department's autl1orlzation. Article 13,- The effective duration of mgistn.1tio11 certificate~; for aquatic veterinary drug production shall be mw y(,m (from the date or if;su,mcE.!). up, ,n the expiry thernot, es1ablishments shall have to apply for registration extension if wishing to continue the production of those aquatic veterinary drugs. Tl,e extension of 112igistrc:1tion certificates shall be valid for one year. Article 14.~ Extension of pmduction registration certificates 1. Dossier of application for extension: a/ The extension application. b/ The report on the establishment's production activities in -the effective duration of the granted production registration -cer!ificale. cl The granted production registration certificate. 2. Extension consideration procedures: Within 7 working days after r~ceiving the valid dossiers., the Aquatic Resoutce Protection Department must consider them ~nd 11otify the consideration results. Chapter IV RESPONSIBILITIES ANDPt>WERS OF STATE MANAGEMENTAGENCIES AND RELEVANT ESTABUSHMENTS ENGAGED IN A;QUATIC VETERINARYDRUG ACTIVITIES . . . Article 15.- Responsibilities and powers of the Aquatic Resource Protection Department 1. Responsibilities· a/ To elaborate and submit to the Ministry for promulgation legal documents on the management of aquatic veterinary drugs. b/ Annually or periodically, to draw up lists of aquatic veterinary drugs perrniited for use, restricted or banned from use in Vietnam and submit them to the Ministry's Jcaders for decis.ion on the promulgation t!1ereof. cl To settle disputes, complaints and denunciations related to the mana~Jcment of aquatic veterinary drugs of estabJishments, which 1af/ under its competence. 2. Powers: a/ To ~1rant c111d witi)drnw ffi~Ji~;lration certificates or:FICIAl. G/-1/1:rrr: for aquatic veterinary drug production from organilations and individuals throughout the country bl Tu examine and inspect aquatic veterinary drug·· related activities. cl To request organizations and ind ivid u a Is producing and trading in aquatic veterinary drugs to supply relevant documents and materials. di To collect charges as prescribed. Arlicle 16.- Responsibilities arid powers of Aquatic Resource Protection Su b~DepartITlents, or agencies designated by the provinciallm uriicjpal Agriculture and Rural Development Services to assist the Service directors in exerdsiilg the State management over aquatic veterfna1/cirtJgs · . 1. Re'sp9nsibillties: al To {/rganize ,the management ol'aquatic veterinary-dr(ig-retated activities in localities. , -. - b/ Jo:res;;iv:e ~~o settle proposals, complaints and denu0,c:iatlcins.r~g$tding the management of aquatic veterin<,1ry: ,dt1Jgs' With in the -ambit of -their vested powers orJr~nsf~rthem-t9 otheLccfrnpetent agendes for settlement • 2. Powers: al Tb ,j nspe¢t pro.d uctlQil• conditions fdr authorized establishfuents:, examine)md handle law violations on aquatic>velerihary•drugs in lac,alities. bl To request 'o~ganlzatiobs and indi~idual? producing and trading i n aquatic veterinary drugs ih localities ta supply relevant documents ~nd materials. cf To collect and use charges as prescribed. A rtlcle 17. - Responsibilities of estab//shrrtents To abide by all tt1e provisions of.this Regulation and submit to supervision•and inspection by the State agencies managing aquatic veterinary drugs. Chapter V CHARGES AND THE USE THEREOF A1ticle 18.- lm:;pection :Jgencies arc allowed to collect charges for- inspection of aquatic veterinary drug production condition~ :n cases or first-time i nspE·,cti1J11, re-ins pe cti on and period ica I i 11 s pectio n. Article 19.- The cl1arge rates as well GS charge management and use sfiaH comply with the Finance Ministry's stipulatiorn; and guidance. Chapter VI COMPLAINTS, DENUNCIATIONS AND HANDLING OF VIOLATIONS Article 2Cb Organizations and individuals engaged in aquahc veterinary drug-related activities shaJJ have the right to complain about or denounce conclusions and handling measures of agencies inspecting and examining aquatic veterinary dnigs in their respective establishments according t9theprovisions of the Law on.Complaints and Denurttiatfohs. . Article 21. ~ Organ izatibns and:inq ivid uals engaged · in aquatic veterinary drug-reJfited :activities that fail to . Observe or. breach the.· p royisioHs· of .this Reg u!ation shaH be adm inistrative/y sanc(ipn~d :according to law provisJciris. .. . '..,·.· ·. .. . .. Article n>Personsre~pons~bleJor exercising the . St~te management over aq uatlc vet~ri nary drugs, who commit acts o(v[ofating the provfsions of this R~gl!lation: :sha!l;,, dependihg\Jn the seriousness of their violatio·ns; be disciplined, administratively sanctionecl or examined for penal liabilities according to law. prnvisions. Chapter VII IMPLEMENTATION PROVISIONS Article 23.~AII amendments and/or supplements to the contents of this Regulation shall be considered and decided in w1·iting by the Minister of Aquatic Resources. Article 24.- The Aquatic Hesource Protection Department shall hnve to guide, inspect 3nd organize Hie implementation of this Regulation. For tho Minister of Aquatic Resources Vice Minister NGUYEN VIET THANG