Regulation on the manner of distribution of veterinary medicinal products in certain categories and on the manner of prescribing and issuance of veterinary medicinal products

7 jy,111 2012 1979. OEJABA .[(oroBopoT rroMefy Brra,[\arn Ha Perry6rr11Ka MaKe,J \o­ HMja l1 Brra,L\arn Ha Perry6rr11Ka KocoBo 3a 3aei\rna rrpamrn IIOMOIII BO Kpl1BWIHl1 npe,L\MeTl1, paTMcjJHKyBaH co 3aKOH 3a paTMcjJMKaUMja Ha .[(oroBopoT noMefy Brra,[\arn Ha Perry6 JIIIKa MaKe!--\OHMja II Brra,L\arn Ha Perry6rrMKa KocoBo 3a 3a­ eMHa npaBHa IIOMOIII BO Kpl1BWIHII npe,L\Menr (,,Crry w:6eH BeCHMK Ha PM" 6p. 178/2011 ), Ke BJie3e BO cMrra Ha 24 j y ­ HII 2012 fO,[\IIHa. 30 Maj 2012 fO,[\IIHa CKoITje MIIHIICTep, M-p H1rn:oJia IloITorn:11, c.p. AfEffQIIJA 3A XP AHA II BETEPIIHAPCTBO 1980. Bp3 OCHOBa Ha "!JieH 47 CTaB (3) O!--\ 3aKOHOT 3a BeTepH­ HapHO-Me,[\IIl \IIHCKII ITpeITapaTII ("Crryw:6eH BeCHl1K Ha Pe­ ITy6rrIIKa MaKe!--\OHIIja" 6poj 42/10 II 136/11 ), !--\IIpeKTopoT Ha AreHUIIjaTa 3a xpaHa II BeTepIIHapcTBO !--\OHece IIPABMJIHMK 3A HAqJIHOT HA PACIIOPE,IJ;YBAlbE HA BETE­ PMHAPHO-ME,IJ;MQMHCKMTE IIPEIIAPATM BO OMEJIHM KATErOPMM II HA qJIHOT HA IIPE­ IIMIIIYBAlbE II M3,IJ;ABAlbE HA BETEPMHAPHO ME,IJ;MQMH CKMTE IIPEIIAP ATM(') 1IrreH 1 Co oBoj ITpaBIIJIHIIK ce ITpoITmITyBa Haql1HOT Ha pacITo­ pe,L\yBaH,e Ha BeTepIIHapHO-Me,[\HUIIHCKIITe ITpeITapaTII BO O!--\!--\eJIHII KaTeropIIII, HaqIIHOT Ha ITpeITIIIIIYBafue II l13!--\aBa­ H,e Ha BeTepIIHapHO-Me,[\IIl \IIHCKIITe ITpeITapaTl1. • Co oBoj rrpaBHJIHHK ce Bprrrn ycornacyBa!he co onpen6ttTe Ha ,[{ttpe KTHBaTa 2001/82/EK Ha EBpOIICKllOT IIapna~rnHT tt Ha CoBeTOT on 6 HoeMBpll 2001 ronttHa 3a KoneKC BO onHoc Ha BeTepttHapHO-Men tt­ l.(llHCKllTe rrperrapam Ha 3aenHttl.(aTa CELEX 6p. 32001L0082; H3Me­ Hern tt norroJIHeTa co ,[{ttpeKTllBaTa 2004/28/EK Ha EBpOIICKllOT IIap­ JiaMeHT H Ha CoBeToT on 10 <DeBpyaptt 2004 ronttHa CELEX 6p. 32004L0028; ll3MeHeTa tt norroJIHeTa co ,[{ttpeKmBaTa 2009/9/EK CELEX 6p. 32009L0009; mMeHern H norronHern co PerynaTHBaTa (EK) Ep. 470/2009 Ha EBporrcKHOT IIapna~rnHT H Ha COBeTOT on 6 Maj 2009 ronttHa; ll3MeHeTa tt norroJIHeTa co ,[{ttpeKTllBaTa 2009/53/EK Ha EBpOIICKllOT IIapnaMeHT tt Ha CoBeTOT on 18 jyHH 2009 fOLlllHa CELEX 6p. 32009L0053; mMeHern H norronHern co PerynaTHBaTa (EK) Ep. 596/2009 Ha EBporrcKHOT IIapna~rnHT H Ha CoBeTOT on 18 jyHH 2009 ronttHa CELEX 6p. 32009R0596; H ,[{ttpeKTHBaTa 2006/130/E3 Ha KOMHcttjaTa on 11 neKe~rnptt 2006 ronttHa, 3a crrpo­ BenyBa!he Ha ,[{ttpeKTllBa 200 l/82/E3 Ha EBpOIICKllOT rrapna~rnHT tt Ha CoBeTOT BO BpCKa co YTBpnyBa!heTO KpHTepttyMH 3a ocno6onyBa!he Ha onpeneHll BeTepttHapHll Menttl.(llHCKll rrpOll3BOnll 3a )KlfBOTHll 3a rrpott3BoncTBO Ha xpaHa on 6apa!heTo BeTepttHapeH pe11errT CELEX 6p. 32006L0130. Ep. 70 - CTp 9 1Ineir 2 ( I ) BeTep111mpHO-i\'le!--\ l1Ul1HCKl1Te ITpeITapaTII, cITope!--\ CBOHTe oco611H11 l1 Ha0rnI-JOT I-Ia 113naBmhe II npm1e1-m, a on acITeKT Ha 3aIIITl1Ta 1-ra 3npaBjeTo 1-ra .TJy feTo, 3npaBCTBe1-ra 3alllTHTa Ha W: 11BOTJ-Jl1Te l1 3all1Tl1Ta I-Ia W:HBOTHaTa cpenn­ Ha, ce pacITope!--lyBaaT Bo: BeTepmrnpHo-MennUI-IHCKl-l rrperrapaT!-l BO cno6oneH ITpoMeT; BeTepnHapo-MennUI-IHCKl-l npeITapaT!-l IIITO ce H3llaBa­ aT BO BeTeprrnapHa aITTeKa 6e3 peueITT; BeTeprrnapHO-MellIIUHHCKH ITpeITapaTH IIITO ce H3na­ BaaT BO BeTeprrnapHa aITTeKa caMo Ha peueITT; BeTeprrnapHo-MemrunHcKn ITpeITapaTn IIITO ce y ITo­ rpe6yBaaT caMo BO BeTeprrnapmr npy IIIrna; BeTeprrnapHo-MemrunHcKn ITpeITapaTn IIITO Mow:e na ce y ITorpe6yBaaT caMO on noKTOpH ITO BeTepnHapHa Menn­ UHHa; n BeTeprrnapHo-MemrwrncKn ITpeITapaTn co IToce6eH Ha0rnH Ha ITpoMeT n y ITorpe6a. (2) BeTep1rnapHO-Me1lIIUI1HCKIITe ITpeITapaTH (BO ITOHa­ TaMOIIIHHOT TeKcr: ITpeITapanr) ce pacITopenyBaaT BO on­ nerrHn KaTeropmr BO ITOCTaITKarn 3a ono6pyBafue 3a crnBa­ H,e BO ITpoMeT ITpn ITonHecyBafue Ha 6apallieTo 3a ono6py ­ Bafue 3a crnBafue BO ITpoMeT Ha ITpeITapaTnTe. (3 ) ITpn ITonHecyBafue Ha 6apallieTO on crnB ( 2) Ha OBOj '-IJieH ITOnHOCHTeJIOT Ha 6apallieTO Tpe6a na ja o6erre­ W:H ITpenrror KaTeropnjarn Ha ITpeITapaToT cor.TJacHo oBoj ITpaBHJIHHK BO ITOJieTO 2.3. on o 6pa3eUOT Ha 6apallie 3a ono6peHne 3a cTaBafue BO ITpoMeT Ha BeTep1rnapHo-Menn­ UHHCKH ITpeITapaTH. (1 ) TipeITapaTnTe ce pacITopenyBaaT BO KaTeropnja Ha ITpeITapaTn BO crro6oneH ITpoMeT noKorrKy ce BO cornac­ HOCT co '-IJieH 4 CTaB (1 ) TO'-IKH 1), 2 ), 3), 4), 5), 6), n 8) Ha OBOj ITpaBHJIHHK II ce HaMeHeTH 3a W:l1BOTHH KOH He ce KO­ pHCTaT 3a ncxpaHa Ha rry fe. (2) ITpeITapaTnTe 011; KaTeropnjarn Ha ITpeITapaTn HaBe­ neHa BO CTaB ( 1) Ha OBOj '-IJieH ce: 1) n3naBaaT BO BeTeprrnapmr aITTeKn, BeTep1rnapmr npy IIITBa n/nmr cITeunjarrmnpaHn ITponaBHHUH ono6pemr n/nrrn penrcrpnpamr on crpaHa Ha AreHunjarn 3a xpaHa n BeTepnHapCTBo; 2) KYII)'BaaT, ITocenyBaaT n y ITorpe6yBaaT on coITcrne­ HHUHTe nmr onrrrenyBa'-IIITe Ha W:HBOTHHTe; II 3) anMrrnncrpnpaaT on noKTOpH ITO BeTepnHapHa Me­ nHUHHa nmr on BeTeprrnapmr Te:-.:mrcrapn. CTp 10 - Ep. 70 1foeH 4 (l) IIperraparnTe ce pacrrope.uyBaaT BO KaTeropHja Ha rrperrapan1: lllTO ce H3,UaBaaT BO BeTep HHap1rn arrTe1rn 6e3 pel \eTTT ,UOKOJIKY ce HaMeHeTH 3a )KllBOTHH KO H ce KOpH­ CTaT 3a 11cxpa11a Ha rryte rr : 1) HIIBHarn a.uM11H11CTpal(11ja ce orpaHwryBa Ha cpo pMy ­ rral(llII KOH He 6apaaT oco6eHO 3Haea,e II BelllTHHa npll KO­ p11CTefueTo; 2) npenapaTOT He npeTCTaByBa .u11peKTeH llJlll llH,Ullpe­ KTeH pII3IIK 3a JIIIl \eTO Koe ro a,UMHHIICTµHpa II 3a OKOJIH­ HaTa .UYPH H ,UOKOJIKY HenpaBHJIHO ce a,UMllHHCTµHpa Ha rreKyBaHHTe )KllBOTHH; 3) 36HpHHOT H3BelllTaj 3a oco6HHHTe Ha npenapaTOT He CO,Up)KH HHKaKBH npe.uynpe.uyBafua 3a noTeHI \HJaJIHll ce­ pH03HH HecaKaHH .ueJCTBa lllTO npOH3Jlery BaaT OJ:( HeroBa npaBHrrHa ynorpe6a; 4) npenapaToT HJIH .upyr npenapaT lllTO Ja co.up)KH HCTaTa aKTIIBHa cyncTaHl(Hja, He 6Hrre npe,UMeT Ha 1IeCTll, cepH03HH HecaKaHH .ueJCTBa BO H3BelllTaHTe 3a BeTepHHap­ Ha cpapMaKOJIOlllKa BHHMaTeJIHOCT; 5) 36HpHHOT H3BelllTaj 3a oco6HHHTe Ha npenapaTOT He ce O,UHecyBa Ha KOHTpaHH,UHKal(HH noBp3aHH co npenapa­ TH lllTO B006H1IaeHO ce KOpHCTaT 6e3 pel(enT; 6) npenapaToT He ce cKrra.uHpa no.u cnel(Hj arrHH y crro 7) He noCTOH onacHOCT no 6e36e,UHOCTa Ha norpollly ­ Ba'IOT BO O,UHOC Ha pe3H.UYHTe BO x paHarn OJ:( rpeTHpaHll )KllBOTHH, II BO crry11aj npenapaTHTe .ua ce KOpllCTaT Henpa­ BIIJIHo ; II 8) HeMa orracHOCT TIO 6e36e,UHOCTa Ha TTOTpolllyBa<rOT 3a pa3BOj Ha aHTHMHKpo6Ha HJIH aHTHXeJIMllTWIHa pe3ll­ CTeHTHOCT II BO crry <raj npenapaTHTe lllTO rrr CO,Up)KaT Tile cyncrnHI \HH .ua ce KOpHCTaT HenpaBHJIHO. (2) ITpenapaTHTe pacnope.ueHH BO KaTeropHJarn HaBe­ .ueHa BO CTaB (1) Ha OBOj <rrreH ce: 1) ll3,UaBaaT BO BeTeprrHapHIITe anTeKII rr BeTepHHap­ HHTe .upylllrna; 2) KyrryBaaT, noce.uyBaaT II y norpe6yBaaT o.u concrne­ Hlll(HTe IIJIII o.urrre.uyBa'IHTe Ha )KllBOTHHTe; II 3) a,UMHHHCTµHpaaT OJ:( ,UOKTOp no BeTepHHapHa Me,Ull 1 \HHa HJIH OJ:( BeTepHHapeH TeXHH<rap. 1IrreH 5 (1) ITpenapaTHTe ce pacnope.uy BaaT BO KaTeropHJa Ha npenapaTH lllTO ce H3,UaBaaT BO BeTepHHapHa anTeKa ca~rn Ha pel(enT ,UOKOJ!Ky: l) HIIBHarn a,UMHHHCTµal(Hja ce orpaHH<ry Ba Ha cpopMy ­ rral(HH KOH He 6apaaT oco6eHO 3Haea,e H BelllTHHa npll KO­ pHCTefueTO H npenapaTOT He npeTCTaBy Ba ,UHpeKTeH llJlll 7 j y 1111 2012 m -r.uHpeKTer-r pH3HK 3a JIHlleTo Koe ro a .u~ rmmcrpHpa rr 3a OKOJIHHaTa, .uyprr rr .uoKom<y HenpaBHJIHO ce a.u~rmmcrprr­ pa Ha rr eK)'BaI-m Te )KllBOTI-m; ll l(OKOJI KY ce: npenapaTH 1-mMe1-1eT11 3a Tpenrai-m mrn 1iaTorro wK11 npouec11 3a KO H wTo e n orpe61-m npeTx om-m To c11-m .UHjar­ H03a, IIJIII cmjawTo y norpe6a MO)Ke n a ro n o npecm HJIH He­ raTHBHO na BJillJae Bp3 rrocrr el(OBaTe JIHH l(HJarHOCTWIKH HJ!ll TepaneBTCKH noCTaIIKH; npena pan-1 HaMeHeTll 3a )KllBOTHll llllll rrpmBBOl(lI ce KOpHcTaT 3a HcxpaHa Ha rry te ocBeH ITpeITapaTHTe BO cor­ rracHocT co '-!JleH 4 0 1( OBOj ITpaBIIJIHHK; HOBH npeITapanr KOH COl(pl!(aT aKTIIBHa c y ITCTaHUHJa Koja e ono6peHa 3a y IToTpe6a BO ITpeITapaT ITOMaJIKY on ITeT ronHmr; formula officinalis, con racm, '-LTieH 3 crnB (2) TO'-IKa 2) 01( 3aKOHOT 3a BeTep1rnapHO-Mel(HUHHCKH ITpeITapanr, HaMeHeTH 3a )KIIBOTHII '-!IHI ITpOIBBOl(H ce KOpHCTaT 3a IIC­ xpaHa Ha rry te; M arIIcrparrmr ITpeITapanr; II rarreHCKII ITpeITapanr. (2) TipeITapanue pacITopen emr BO KaTeropIIJaTa HaBe­ n eHa BO CTaB ( 1) Ha OBOj '-!JleH ce: l ) H3l(aBaaT BO BeTep1rnapmr aITTeKII II BeTep1rnapmr n p y lllrna; 2) K)' II}' Baa-r, ITocen y BaaT II y ITorpe6y BaaT o n coITcrne­ HHUHTe llJlll onrrreny Ba'-IllTe Ha )KllBOTHHTe; H 3) al(MllHllCTµHpaaT 01( l(OKTOpH ITO BeTepnHapHa Me­ l(llUHHa llJlll 01( BeTepHHapHll TeXHWrapn. 1IrreH 6 (1) TipeITapaTHTe ce pacITopen y BaaT BO KaTeropIIja Ha ITpeITapaTH lllTO ce y IT0Tpe6y BaaT ca~rn BO BeTepIIHapHII llPYlllTBa l(OKOJIK)' ce ITpeITapaTH pa3JIWIHH 0 1( OHIIe HaBe­ l(eHll BO '-!JleHOBHTe 3, 4, 5, 7 rr 8 0 1( OBOj ITpaBILTIHIIK. (2) TipeITapaTHTe pacITope.ueHII BO KaTeropIIjarn HaBe­ l(eHa BO CTaB ( 1) Ha OBOj '-IJieH He MO)KaT na ce II3l(aBaaT BO BeTepHHapHll aITTeKll ll CITeUH JaJIH3Hpamr ITpon aBHIIUH II He MO)KaT na ce K)'II}' BaaT, ITocen y BaaT II y ITorpe6y BaaT on COITCTBeHHUHTe IIJIII onrrreny Ba'-IllTe Ha )K llBOTHH. (3) TipeITapaTHTe pacITopeneHII BO KaTeropIIjarn HaBe­ n eHa BO crnB ( 1) MO)Ke n a ce ITpon aBaaT ca~rn Ha BeTepII­ HapHH llP)' lllTBa II n a ce an~rnHIICTµIIpaaT 0 1( l(OKTOpII ITO BeTepnHapHa M emrwrna nmr o zi; L!p y rn HIIUa Bpa6oTemr BO BeTep1rnapHOTO LlP)' IllTBO ITO)l mrpeKTHa O)l fOBOpHOCT Ha )JOKTOpIITe ITO BeTep1rnapHa M el(lIUIIHa. 1I.TieH 7 (1) TipeITapanue ce pacITope!ly BaaT BO KaTeropIIJa Ha ITpeITapanr IllTO M O)Ke )la ce y ITorpe6y BaaT ca~rn OJJ; L!OKTO­ pH ITO BeTep1rnapHa Memrwrna L!OKOHKY ce: 7 j y ,111 2012 I ) nperrapanr KOH ce rrpe.uMeT Ha ocjmu11j am-111 orpar-m­ •ryBaH,a 33 Ha6aBKa TIJTTI YITOTPe6a, TI Toa: orpaHwryBaH,a KaKo pe3ymaT Ha cnpoBe.UyBa1-r,e Ha KOHBeHUliTI Ha O6e,UHHeTHTe H3Ul111 33 1rnpKOTWIHl1 TI nc11 XOTPOnHTI cyITCTa HUM, orpaHWiyBaH,a 3a yIToTPe6a Ha ITpeITapaT11 corrracHo 3aKOHOT 3a BeTep11HapHO-Me,Ul1UliHCKl1 npeITapaTli (* l ) 2) npenapaT11 3a KOli IIITO TPe6a .ua ce npe3eMaT noce6 Hl1 MepKli Ha ITpeTITa3Jll1BOCT OJ:( CTPaHa Ha ,UOKTOpOT ITO BeTeprrHapHa Me.u11u11Ha, co uerr .ua ce rr36er11e KaKoB 611rro HecaKaH prr3TIK no: uerrHTITe BTI,UOBTI )KlfBOTHTI, rrrruaTa IIITO rrr npHMenyBaaT npenapaT11Te Ha )KlfBOT HOTo, TI )KlfBOTHaTa cpe,UrrHa. (2) ITpenapaTrrTe pacnope.ueHrr BO KaTerop11jarn HaBe­ .ueHa BO CTaB (l) Ha OBOj •rneH He MO)KaT .ua ce TI3,UaBaaT BO BeTeprrHapHrr anTeKTI rr cneurrJarrrr3rrpa11rr npo.uaB1111u11 11 He MO)KaT .ua ce KyrryBaaT, noce.uyBaaT rr y IToTPe6yBaaT o.u conCTBeHTIUTITe TIJTTI o.urrre.uyBa'!TITe Ha )KlfBOTHTI. (3) ITpenapaTrrTe pacnope.ueHrr BO KaTerop11jarn HaBe­ .ueHa BO crnB (l) MO)Ke .ua ce npo.uaBaaT ca~rn Ha BeTep11 HapHrr .UPYIIITBa TI .ua ce a,UMTIHTICTprrpaaT ca~rn OJ:( ,[(OKTO­ prr no BeTeprrHapHa Me.urrurrHa. 1IrreH 8 (l) ITpenapaT11Te ce pacITope.uyBaaT BO KaTerop11Ja Ha npenapaTrr co noce6eH Ha'!TIH Ha npoMeT rr yIT0Tpe6a .uo­ KOITKY HTIBHaTa ,UTICTPTI6yurrja TI npo,Ua)K6a 3apa.u11 33IIIT11 Ta Ha 3,UpaBjeTO Ha rryfeTO TI )KlfBOTHTITe e ITO,[( ITOCTojaH TI .urrpeKTeH Ha,U3op Ha AreHurrjarn 3a xpaHa rr BeTep11Hapc­ TBO. (2) ITpenapaTrrTe pacnope.ueHrr BO KaTerop11Jarn HaBe­ .ueHa BO CTaB (l) OJ:( OBOj qrreH MO)Ke .ua ce ,[(l1CTPl16y11paaT, KyrryBaaT, noce.uyBaaT, TI3,UaBaaT TI YITOTPe6yBaaT ,UOKOJTKY rrr rrcnorrnyBaaT .uonorrHTITeJTHTITe ycrrOBli 33 HliBHO CTaBa­ H,e BO npoMeT corrracHo 3aKOHOT 3a BeTep11HapHo-Me.urr­ UTIHCKTI npena pa TH. 1IrreH 9 (l) .[(oKTOpHTe no BeTeprrHapHa Me,UliUTIHa TI BeTep11 HapHHTe .UPYIIITBa OJ:( qrreHOBTITe 6 rr 7 OJ:( OBOj npaBliJTHliK, Tpe6a .ua BO,UaT .ueTarrHa eBrr,UeHurrja 3a ceKoja Ha6aBKa Ha npenapaTrrTe rr 3a ynoTPe6eHrrTe npenapaT11 eB11,UeHT11paj­ KTI rrr HajMaJTKY crre,UHTITe no.uaTOUTI: l) npel(TI3HTI no.uaTOUTI 33 npenapaTOT (rrMe, Cl1Jll1Ha, cpapMaueBTCKa cpopMa, naKyBaH,e, ceprrcKrr 6poj Ha npo113 BO,UCTBO 03Ha'!eH Ha naKyBaH,eTO, TITH.) TI 2) KOJTWITIHa Ha Ha6aBeH npenapaT; 3) .uaTyM Ha Ha6aByBaH,e; Ep. 70 - Crp. 11 4) rrMe rr a.upeca Ha no6aByBa 0roT rra rrperraparnT; 5) naTyM Ha rrprrMerra Ira rrperraparnT; 6) Korrwmrra Ha rrperrapaT Koja e y IT011Je6e1ra ; 7) rrMe rr 3Barhe 1-rn Jll1UeTo onroBop r-ro 3a y IT011Je6a Ha npeITaparnT; 8) 11Me rr anpeca 1-rn coITcrne I-111 KoT HJIIT o .urrrenyBa 0roT Ha )KlfBOTHHTe; H 9) BIT,[(, paca, H l(OKOJIKY e ITpmreHJi liBO, H)leHTH<pHKa­ UHOHeH 6poj Ha )KllBOTHOTO H.TIH rpy narn )KlfBOTHH KOH ce TPeTHpaHH. (2) EBnneHUIIjarn on crnB (1) Ha oBoj •rneH TPe 6a na e l(OCTaITHa 33 1rncneKunja Oil CTPaHa Ha AreHunjarn 33 x pa­ Ha II BeTep1rnapcTBO BO nepnon on HaJMarrKy neT rom rnw. lJ:rreH l 0 BeTep1rnapmue anTeKn TPe 6a na B0!laT nernrrHa emr­ neHUIIJa 3a npenapanue KOH ce IB!laBaaT Ha BeTep1rnapeH peuenT KaKo IIIT0 e HaBeneHo BO •rneH 7 II 8 on ITpamrnmr­ K0T 33 no6mICKIITe )'CJI0BII no 0l(H0C Ha npocTopoT, onpe­ Marn II KanapoT UIT0 TPe6a na rn ncnorrnyBa BeTepnHapHa­ Ta aITTeKa II Ha0mH0T Ha pa6orn . lJ:rreH 11 ( ) ) ConCTBeHIIUIITe mm onn1enyBa0rnTe Ha )KlIB0THII TPe6a na o6e36enaT noKa3 3a KynyBaH,e, nocenyBaH,e n npm1eHa Ha npenapanr Ha )KIIB0THIITe BO nepnon o.u neT fO,[(HHH, BKJiycrnTeJIH0 H 33 )KllB0THIITe KOH 6nrre 33KJI3HII BO TeK0T Ha neTrol(IIUIHII0T nepII0)l. (2) gOKTOpOT no BeTepHHapHa Mel(IIUIIHa m m onr rre­ .il)'B3°IOT, BO eBH)leHUHJaTa K0Ja Ja B0)lII onr rrenyBa0IOT, BO CJI)TLiaJ Kora .il0KTopoT no BeTepnHapHa ~remrwrna ro an­ MIIHIICTPIIPa npenaparnT, TPe6a na rrr emr.ueHnrpa crre.u­ HHTe nonaT0UH: 1) m ,re Ha l(0KT0p0T no BeTepnHapHa Mel(IIUIIHa co 6poj Ha BeTepHHapHa JIHUeHua; 2) IIMe Ha npenaparnT II cepncKn 6poj; 3) .uaTyM Ha nprrMeHa Ha npenaparnT; 4) KOJTWIITHa Ha ynoTPe6eH npenapaT; 5) KapeHua, l(0K0JIKY e npnMeHJiliB0 ; II 6) II)leHTmjmKaUIIOHeH 6poj Ha )KlfB0TH0TO H.iIH rpy na­ Ta )KlfB0THII KOH ce TPen1pam1, .il0K0ITKY e npmvremnrno. ( 3) Bo cnycraj Kora npenaparnT e y noTPe6eH on onrne­ nyBa0roT Ha )Kl!B0THIITe, TPe 6a )la rn eBII)leHTIIpa HajMaJIKY CJiel(HIITe nonaT0UU: 1) IIMe Ha npenaparnT II cepncKn 6poj ; 2) )l3T)'M Ha Ha6aByBaH,e; 3) K0JIWIIIHa Ha Ha6aBeH npenapaT; 4) m1e II anpeca Ha no6aByBa0roT Ha npenapaToT, II Ka­ KO UIT0 e C00l(BeTH0, 6poj Ha BeTepnHapeH peuenT; 5) naTyM Ha npnMeHa Ha npenapaToT; CTp 12 - Ep. 70 Gpcka k,Hn£ 7 j y 1111 2012 { ea Peny6nuKa MaKeAOHHja 6) KOJlWIHHa Ha y r10Tpe6eH npenap aT; 7) Kapem-1a, JlOKOJlKY e rrp11MeHmmo ; H 8) H) \eHTl1cjJl1K3U110HeH 6 poj Ha )KHBOTHOTO HJ!H rpy rra­ Ta )KHBOTHII KOH ce rpeTHpaHII, )lOKOrrKy e rrpHMeHrrHBO . 1IrreH 12 (1) CneunjarrmHpaHHTe npOJl3BHHUH OJl '-IJieH 3 CTaB (2) TO'-IKa 1 Ha OBOj npaBHrrHHK KOH BpIIIaT MarronpOJl3)1(6a Ha npenapanr so crro6oJleH npoMeT rpe6a Tpe6a ) \a o6e3 6eJlaT Jl0Ka3 33 KyrryBafue, noce) \yBaH,e II npOJl3)1(6a Ha npenapanr II ) \a BOJl3T eBH) \eHUHJa H3JMarrKy 33 crre) \HHTe no) \aTOUII: 2) HMe Ha npenapaTOT H cepHCKH 6poj; 3) Jl3TYM Ha Ha6aByBallie; 4) KOrrll'-IHHa Ha Ha6aBeH npenapaT; II 5) IIMe II a) (peca Ha Jl06aByBa'-!oT Ha npenapaToT. (2) EBH) \eHUHjarn OJl CTaBOT (1) Ha OBOj '-lrreH rpe6a ) \a e JlOCTanHa 33 HHCneKUHja OJl CTpaHa Ha AreHUHjarn 33 xpaHa II BeTepHHapCTBO BO nepHOJl OJl H3JMarrKy neT ro) \H­ HII. 1IrreH 13 (1) IIpenapaTHTe KOII ce pacnopeJlyBaaT BO KaTeropH­ jaTa HaBe) \eHa BO '-lrreHOBHTe 3 II 4 Ha OBOj npaBHrrHHK ce H3JlaBaaT 6e3 npenHIIIYBafue Ha BeTepHHapeH peuenT. (2) IIpenapaTHTe KOH ce pacnope!lyBaaT BO KaTeropH­ jarn HaBe) \eHa BO '-lrreHOBHTe 6, 7 II 8 Ha OBOj npaBHrrHHK JlHpeKTHO ce 3) \MHHHCTµHpaaT OJl JlOKTOpH no BeTepHHap­ Ha Me)lHUHHa HrrH O,[( BeTepHHapHrr TexHwrapH. (3) IIpenapaTHTe KOII ce pacnopeJleyBaaT BO KaTeropH­ jarn HaBe) \eHa BO qrreH 5 OJl OBOj npaBHrrHHK MO)Ke ce H3 Jl3B33T Ha BeTepHHapeH peuenT npenHIIIaH BO corrracHocT co '-lrreHOBHTe 14 rr 15 O)l OBOj rrpaBHrrHHK. ( 4) KorrH'-IHHarn Koja e npenHIIIaHa H Ha6aBeHa 3a npe­ napaTHTe OJl CTaB (3) Ha OBOj qrreH rpe6a ) \a 6H) \e MHHH­ MarrHaTa norpe6Ha 33 COO) \BeTHHOT rpeTMaH HrrH TepanHja. 1IrreH 14 (1) BeTepHHapHHOT peuenT ro npenHIIIYBa JlOKTOp no BeTepHHapHa Me)lHUHHa. (2) BeTepHHapHHOT peuenT rpe6a ) \a e '-IHTrrHB, 6e3 npHCYCTBO Ha H36pHIII3HH Mecrn H BH) \rrHBH KOpeKUHH. (3) CneuHjarrHHOT ) \err OJl BeTepHHapHHOT ) \err Tpe6a ) \a e HanHIIIaH Ha rraTHHCKIIJa3HK. ( 4) BeTepHHapHHOT peuenT ce H3Jl3Ba BO ) \Be KOnHH, OJl KOII e) \Ha e HaMeHeTa 33 conCTBeHHKOT HrrH O) \rrre) \y Ba­ '-IOT Ha )KHBOTHOTO (KyrryBa'-IOT), a Jlpyrarn e HaMeHeTa 33 apxHBarn Ha BeTepHHapHaTa anTeKa/BeTepHHapHo JlPYIII­ TBO. (5) E n e11 BeTepmrapeH peuerrT ce H3!laBa 3a e)le11 rrpe­ napaT KOj e I-IaMe I-IeT 33 em -IO HJlH ITOBeJ(e )KJ-lBOTI-111 O)l 1-lCT BH)l KOH ce conCTBeJ-l OCT I-Ia HCT con crneJ-lHK IU!H O)lrJie)ly (6) BeTepm rnp1rnoT peuerrr e co B3)1(!-IOCT O!l e)leH Jv1e­ ceu HrrH ITOKpaTOK nepHO)l K3KO IIITO e HaBe)leHO BO BeTe­ pmrnpHllOT peuenT. (7) )loKorrKy seTeprrnapHHOT peuenT e Ha~1e1-1eT 3a no­ sekeKpaTHa Ha6 asKa, Tpe6a )la ro co)lp)Kl-1 6pojoT 1-1a npeJl­ BllJleHir Ha6aBKll KOll MO)K3T )lace OCTBapaT co peuenTOT. 1In eH 15 (1) Be-rep1rnapmmT peuen-r rpe6 a )la nr co)lp)KII c n eJl­ HIITe nOJl3TOUII: 1) 6poj Ha peuem; 2) TI0Jl3TOUII 33 BeTep1rnapHOTO LlPYIIITBO ( n M e, a)lpeca II TerrecjJOHCKII 6poj Ha 0 Jl06peHOTO BeTepnHapHO LlPYIIITBO BO Koe e Bpa6oTeH JlOKTOpOT no BeTepnHapHa M e)lIIUirna); 3) IIITeM6IIJI Ha BeTep1rnapHOTO LlPYIIITBO ; 4) IIMe II npe3IIM e Ha COTICTBeHIIKOT IIJlII O)lr.Tie)ly Ba­ ~-IOT~ 5) 3Jlpeca Ha COTICTBeHifKOT IIJIII 0 JlL Tie)ly Ba'-IOT ; 6) 3Jlpeca Ha o 6jeKn-ITe BO KOH ce '-l)'B33T )KHBOTHIITe (JlOKOrrKy ce pa3.1IIFIHII 0)l a)lpecarn Ha conCTBeHIIKOT ILTIII 0 JlrJieJlyBa '-IOT); 7) IIJleHTmjmKaunja Ha )KlillOTHOTO IIJlII rpy narn Ha )KlIBOTHII KOH Tpe6 a ) \3 ce rpenrpaaT ( BKJl)"-IIITeJlHO II BIIJl, paca , norr, crnpocT H HJleHTIICjlllK3UllOHeH 6 poj Ha )KllBOT­ H0T0 HrrH rpy nara )KHBOTHH) ; 8) cneunjarreH Jlerr Koj ce coc-ron 0Jl : KpaTeHKaTa Rp.; IIMe Ha npennIIIaHIIOT npenapa-r (KpaeH npenapa-r HrrH KOMTIOHeHTIITe Ha Marnc-rpaJlHIIOT npenapa-r); cpapMaueBTCKa cpop Ma II CllJlllHa Ha rrperrllIII3Hll0T npenapa-r; H BK)'TIHa KorrwrnHa Koja ce II3Jl3Ba II IIHCTp)'KUIIII 33 npnMeHa; 9) KapeHua, JlOKOrrKy e npnMeHJlHBO; 10) MepKH Ha nperna3JlHB0CT ; 11 ) IIMe, n oTTIIIC II cpaKCIIMI-1.11 Ha )lOKTOpOT no BeTepn HapHa M eJlIIUIIHa KOJ ro npem-rIIIy Ba npenapa-ro-r; 12) Jl3T)'M Ha II3Jl3B3H,e; II 13) 6poj Ha Be-repnHapHa m-rueHua. (2) <PopMarn II CO)lp)KI-!Harn Ha BeTepIIHapHll0T peuerrT ce Jl3JleHn BO Ilp1rnoro-r Koj e cocrnBeH )lerr Ha 0BOJ npa­ BIIJlHIIK. 1IrreH 16 OBoj npaBirnHIIK B.Tiery Ba Ha CIIJla 0CM IIOT )leH 0)l )le­ HOT Ha o6jaBy BafueTO BO " C rry )l(6 eH BeCHIIK Ha Perry6nnKa MaKeJlom-rja". Ep. 21-1327/3 3 M aj 2012 romrna CKonje )lnpeKTop, ,Uej aH Pytt-reBrnH, c.p. 7 jy,111 2012 Ep. 70 - C rp. 13 CTp 14 - Ep. 70 7 j y 1111 2012