Ministerial Joint Decree No. 313314 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products

495 E<DHMEPII THI KYBEPNHIEQI THI: EMHNIKHr dHMOKPATIAr TEYXO.I: dEYTEPO nEPIEXOMENA YnOYPrlKEJ: AnOG>AIEII: KAI ErKPIIEII: 8&0nlOTJ VE:vlK(a)V OPX(a)V KOi KOH:U8UVOECalV VLO TTJV na paOKEUT) (l)apµOKOOV npoop1~oµtvwv y10 KlT]V!OTPlKl'] XPl'IOTJ, OE 0Ul,1µ6pq>WOTJ npoc; Tl'lV OZiTJViO 91 / 412/ EOK n1c; Emtponnc;. . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Ap. Cl>ullou 52 28 lavouapiou 1994 500 EcJ>HMEPII: THI: KYBEPNHEEQt {TEYXOI A.EVTEPO) ApI0 313314 (3) etomori VEVIKWI/ apxwv Krn Kan:uBuvOE:wv yI0 n1v napa OKEUr) q,apµOKWV npoop1~oµtvwv YIO KTf)VlOTPIKT] xpnori, 0£ ouµµop<.pwon npo½ 1rIv Oorivlo 91 /412/EOK Tl)t; Ennponr']c;. OI YnOYPrOI E8NIKHI: OIKONOMIAI KAI rEQPrlAI ·Exovta½ uno4-1ri: 1. Tic; i51ata~£t½: a) Tau 6p8pou 2 nap 1 m:pim. 1 10u N. 1338/1983 «Ecpopµoyri rnu Ko1vo11Kou /'.l1Kalou» 1:A 34). 13) Tou ap8pou 1 nap. 2 Kat 5 co. S wu N. 1965/1991 «Tpononoirion Kat ouµn>..rn1wor, rwv 01ma~Ewv rou E8v1 KOU Opyav1oµou ©ap~16Kwv (E.O.<l>.l Km 6>..A£C; 01or6~t:u;» (A" 146). y) Tou ap0pou 29A mu N. 1558/1985 «Ku~tpvrion Kai Ku~epvl)ltKO 'Opyava» (A' 137). onwc; auto npoort917K£ µi:: 10 ap8po 27 TOU N. 2081 /92 (A" 154), 15) Tnc; Un' ap18µ. 184/1993 OTTO(f)OOr,c; TOU npw0u TTOlJP\fOU KOi TOU Ynoupyou ru0pyioc; «Av68i:OT7 apµOOLO TT]TWV Ynoupyou rewpyiac; cnov Yqiunoupyo rcwpyim;» (ff 836). 2. Triv un· ap18µ. 0415/6/5 .5.93 cIoriv11017 rnu ~.L. rnu E8v1Kou Opyav1oµou (!)apµ6Kwv (E.0.¢>.). 3. To yr.yov6½, on an6 rn:; 01ma~rn:; n1c; nopouoac; on6 (l)OOl1<;; i5e;v npoKaAc:ital oano.vri oc l36poc; 'TOU KPOltKOU npoun0Aoy1oµou, anocpaoi~ouµs: KE(])A/\AIO I 'Ap9po 1 LKOn6½ (ap8po 1 1ric; Oi'\rwiac; 91 /412/EOK) LKon6<; 117c; napoiJooc; an6cpaaric; f.iva1 o K□8op10µ6c; lWV OPXWV Kat 1WV KOTEU8UVT\lPiWV ypoµµ(i)v '{10 H]V KG/Ir'] nopooK£Ull K1l')v1mp1Kwv lJ)apµo.Kwv, Twv onoiwv Tl napo Y(;)Vfl □nOITt:"i 1T]V 00£10, nou OVO(f)tpcTOl OTO 6p8po 23 n7<; Ynoupy1KTic; Ano((>aoric; 378812/1992 (B' 491 ). oe ouµ µ6pcpwo11 npoc; u1v Oonvia 91 /412/EOK 111c; ErnTpon17c; 1ric; 23rJc; louAiou 1991 «oxr.nK6 w:: 10v Ka8op10µ61wv ap xwv KOi Kme;u8uvtqpiwv ypaµµwv nou acpopouv 10uc; Ka vove;c; KoAf'1c ; napOOKl::U11C: cpopµQKWV nou TTpoopi~OVTOI \,'lO · Kn1v1mp1KI') xpiJcrri» IEE op18p. L 22s tnc; 17.8 .91, □£A. 70). "Ap9po 2 (apepo 21nc; Oorwioc; 91 /412/EOKi ria TOU<; OKOTTOU<; lll½ napouooc; onocpaonc; lOXUOUV 0 op10µ6c ; twv qmpµ6KWV. 6nc,x; i'\tQTUTTWVf:10! OTO ap0po 2 n1c; Ynoupyu<!'Jc; Anor.paoric; 9392/1992 (B- 233) KOi o o pI aµ6c; TOU KTriv1mp1Kou q.apµaKou, 6nwc; 01munwvern1 ow op8po 2 nap. 1 m:pim. ~) n1c; Ynoupy1Kric ; Anoqiaoric; 378812/ 1992 cnmAtov v0Eito1 wc; «nopo0Ke;uoo111c;»: K60e; Koroxoc; 111-c;; 615c:1ac; nou avo <ptpe,m 010 6p8po 23 Tll½ UTTOUPYIKJic;' anO(f)OO f'1 C: 37881 2/ 1992. «€1<"'S1Kwµtvo np6owno»: 10 npoowno to onoio avoc.pt petal, 010 6p0po 28 u1c; we; av1.,) on6r.poo11c;. «01oocp6;\1ori no16n1rnc; (papµOKWV": TO ouvo>..o 1wv pu9 µio£wv µto(,) TWV onoiwv sn101WKS"{OI VO f.~OO(j)OAI08Si, CTI TO KTflVlOTPIKCl cpapµaKSUTIKO npo16vrn txouv TflV noI6 Tfll0 nou OTTQITEilOI yia 10 OKOTTO y Ia TOV onoio npoopi~o VTOl. · .. Kavovec; KoAl')c; napaoKE:UTl½": 01 Kov6v.;c; µt:: mu,; onoiouc; emi31wK8T01 vo 8~aor.pa>.108ci, 6T1 ta npo'i6vra no payovrn1 Kat ,:Myxovrn1 ouµcpwva µ£ 10 npotuna n o161ri rnc; nou £ivm KotollA.ri>.a via TO oKon6 via 10v onoio npoo pi~ovrn1. 'Ap0po 3 (ap0po 3 111c; Oi3rwiac; 911412/EOK) Me H\ l3oi]8i::1a rwv rnava>.aµl3avoµtvwv £1\tyxwv . nou avacptpov101 010 6p9po 33 n1c; YnoupytKf\c; an6cpaoni:; 378812/92, 0 EQ(Il µ8p1µv6, WOH'. 01 napooKSUOOttc; VO haµ~6vouv un64,111 Kot va oKoAou8ouv 1Ic; apxtc; KOi rn; KO n:u8uv1i]p1£c; ypa~1µtc; oxn1Ka µe rnuc; Kav6v£c; Ka,\r']c:; TTOPOOKt:ui]c;. 01 onoiu; K08opi~OVTOl OTO 6.p8pa 6-14 1nc; napouoac; Ynoupy1Ki]c; on6cpaoric; ' r,a TT'JV spµrivsio OIJ"{WV TWV apxwv KOi TWV KOTE:U0UVTT) piwv ypaµµwv OX£TIK6 µs rnuc; Kav6vsc; Kor,.!'Ji:; napa OK8Uli½, 01 napaoK£UQOTEc; KOi 01 c:Knpoownot 1WV apxwv avmptxouv 011c; M:moµqJ£ic; K01eueuv1i]p1£c; ypaµµtc; TTOU avacptpov101 OTO ap0po 26 111c; Ynoupy1Ki]c; OTTO(p0 011c; 37881 2/92. 'Ap8po 4 {6p8po 4 n1c; Ooriyiac; 91 /412 /EOKl Ot napOOKEUOOTtc; µep1µvouv' WOT£ 6Acc; 0 1 01ai31Kao iec; napaywyl']c; va 151e;~avov101 o uµcpwva µe rouc; Kavovr.c; Ko Mc; napaoKsunc; KOl µ£ lflV 6i5£I0 napaywync; Touc;. LTl'jV nepimwori TWV KTl"]VIOij)IKWV cpapµ6KWV , nou f.100 yovrm ano 1pi1Ec; xwp£c;, 01 8locywytc; 01aoq>□,\ i ~ouv 6n ta r.papµoKa txouv napaxBt:i ano napaaKEuao1tc; 01 ono(rn i'\m8trnuv Tr) OX€TIK17 00€10 KOi ll7POUV KOVOVf. t;' K0 1\Tlt;' TTOpOOK€Ull<:; TOUAOXIOTOV IOOOUVOµOuc ; µ8 TG np6HJ TTQ nou lOXUOUV y1a TO napOOK£UO~Oµt:va c:nriv Ei'IAaoa. 'Ap8po 5 (6p8po 5 111c; Ooriyia½ 91 / 41 2/EOK) 1. Ot napa0Kwa01tc; i'\1aor.paAi~ouv, OT1 6Asc; 0 1 napa ywy1Ktc; i51ao1Kaoi£c;, □ 1 onoit:i::; nsp11\aµf3avovrn1 0117v Cl08(0 KLIKflOq>Opioc;, OIE~OVOVTOI ouµcpwva µs TO 0£00 µtvo TO onoia nep1txov101 on1v oi117017 yto niv 60£10 KU KJ\o(j)opioc; K□I rn onoio txouv yivs1 onoi5£:K'T6 an6 r ov EO<D. 2. 01 napaOK€UOOTtc; snove~CTO~OUV 0€ 10KTO XPOVIKQ 0100111µ010 Tic; µe;86oouc; nopovwvtic; rnuc;; un6 TO cpwc; i:ric; £mOTflµov1Kt')c; KOi 1r.xvol\oy1Kiic; npo6oou. ·ornv e ivrn avayKaio va 1ponono1110ouv to ot:i3oµtva no1J nspItxovrn1 010 q,aKcl\o yI0 1riv ooc:10 KUK?locpopiac;, ri np-ornori Tpono noirioric; unof3aMnrn 010v EOlll . KE(l)A/\AIO II APXEE KAI KATEY8YNTHPIE[ rPAMME[ noY AlllOPOYN TOYE KANONEE KAAHE nAPArKEYHI: 'Ap8po 6 (opepo 6 n-1c; Oorwiac; 91 / 412/ EOK) L'l.I□x2ip1ori no101nrnc; Ka8€ TTOPOOK£UOOT17<; i::Xt:I TflV unoxptWOI) VO Of1!110Up yei KOi V□ Ecpopµo~€1 tvo QTTOTE:1\£.aµotlKO OUOTl')µO 1510 ocpci,l,.1oqc; 1 fl½ n o1cnnrnc; 1wv cpapµoKEUTIKWV npo16vn,>v, E<t>HMEPII THI KYBEPNHI:EQI (TEYXOI .dEYTEPO) 501 010 onoio ovµµe1txouv evrpyo K0I 10 npoowmK6 mu EO<l>. Ap8po 7 (op9po 7 nIc; Oonviac; 91 /412/EOK) npoowmK6 1 . re Ka0e µovaba napaywyl']c;, o napa0Keuoa1iic; O(llei Ae, vo 0I08tn:I IKov6 KOi KmaMrilla rn51KE:Uµtvo npoow rnK6 10 onoio nptns1 vo sivrn KOi op18µn11Ka enopKtc; , Wdle VO eiva1OUVQTT711 E:niTfU~l") TWV a16xwv 111c; 6100<p6A1 oric; 111c; TTOIOTrJTOC: TWV (j)OPµOK£U11KWV npoi6vrwv. 2 . Ta Ka81']KOVTO TOU OIOIK"1TIKOU npoowmKOU KOi lOU npoowmKou nou np0To10101 ouµm:p1Aaµl3avoµtvou KOi 1ou 1;;161Keuµtvou npoownou 1:ri rwv e101Keuµtvwv npoow nwv), 10 ormio eivm uneu8uvo yI0 niv Ecpapµoyi] rwv KO vovwv KOA!lc; nopooKeur,c;, nptne1 VO Ka8opi~OVlOI OtrJV ne;p1ypocpti K08T7KOVTWV. 01 1epapx11<tc; oxtoe1c; nptne1 vo 1<08opi~ov1m oe tva opyavoypaµµa . Ta opyovoypa µµarn KOi ri m;pIypacpi] 1<a8riK6v1wv npt neI VO EVKPiVOVlOI o uµcpwva µE nc; c:ow1ep1Ktc; 010011<0 oiec; nIc; en1xe1pfioewc; mu napaywyou. 3. To npoowmK6 nou npo1010101 KOi TO onoio avaqitpe 101 OTTJV nporiyouµc:vri napaypmpo nptne1 vo 0108tre1 1;;nopKtc; KUPOC: yI0 n1vop8T7 0.0KT]OT) iWV K09rJKOVTWV iOU. 4. rrn npoowmK6 nptne1 va naptXETO\ ~OOIKTJ KOi ouvs )(i]c; e:KTTaioeuor, 011w onoio va m:p1>.a (1Pavov1m ri ecwpio KOi e;cpapµoyl'J TT7(; OPXTlC: iWV KOVOVWV HlC: OIQO(pCIAlOTl<; n1c; nOIOTrJ'lOC: KOi Ka>-.r)c; napOOKEUf]c;. 5. nptne Iva K01ap1i~ov10I npoypoµµaro uy1£1vr,c; npo oapµooµtvo OTl<; opaotf]plCJlllTE<; TOU npooWntKOU KOi va napaK0Aou6cirn1 ri e,:papµov11 1ouc;. Ta npoypaµµmQ au1a nptm:I va m :p1Aaµf36.vouv 0 1ao1Kao iec; nou acpopouv ,riv uye: ia. 1nv uv1e1vn Kai nw e:vouµooia r ou npoowm K OLJ. ·Ap6po 8 (ap8po 8 TrJc; oorivioc; 91 /412 / EOK) Xwpo1 napaywyr,c; Kat el;onA10µ6c; 1. 01 xwpo, napaywvric: oxeoIa~ov1m, Kora0Ke:uo~ov101 KOi OUVTl')POUVTOI KOi O E~onA10 µ6c; yto Tl')V napaywyr; TO no9£TEiTOI, npooopµ6~£Trn KOi ouvn1pe:irn1, WOT£ va eivm K016Mri.\01 y10 rn; A£:1toul)Viu; yIa rn; onoiE<; npoopi~o vta1. 2. H 01610/;i) 1ouc;, o oxeo1aoµ6c; 10uc;, o rp6noc; xprionc; nptm:I vo □nol3.\tn£1 o n1v eAoxm10noiTJO'l 1wv K1vouvwv O(j)OAµarnc; KQI VO ETT11Ptn s1 10V onoTEAEOµOTIKO K06ap1 0µ6 Km Tr\ auvrtipriori, wme: va anoq>cuvern1, 11 6µ€:0ll KOi n t µµrnri emµ6Auvori, ri 01oornupouµevr, smµoi\uvori KOi ycvIK6 K6.8.1c ovem8uµrirri eniopoori ornv noI6n1rn Twv nporovTwv. 3. 01 xwpo1 Krn o c~on.\10µ6c; nou npoopi{ovwt yta na poywy1Ktc; 01o<'i1Kaoiec;, 01 onoie: c; c:ivai Kpio1µec; yIa HJV no16n1To TWV npoI6v1wv. nptne1 VO 0108tTOUV TTJV KOlCI/\ AflArJU £m[3£:[3oiwon. Ap6po 9 (op8po 9 1ric; Oonvioc; 91 /412/EOK) TeKµT]piwori 1 . K68e nopo0Keuoo1iic; nptns1 va t xeI t vo ouo1nµo 1sKµ11piworic; f3ooi{6~1evo orn; npoo,aypa,:ptc; . m; µE96 Oouc; nopaywyl')c; KOi nc; oonvic:c; yI0 Tnv nopaoKeuii Kot 1 • · OUOKEUaoia. TL<; O\OOLKOOiEc; nopoywytic; KOi Ta OTOIX£IG nou KOAumouv nc; 01oq>opec; napoywyIKtc; 01001Kaoie:c;. To tyypar.pa nptnc1 vo i=.:iva, Ka8apci, xwpic; Aci9ri KOi r.vri pr. pwµtva. npornnwµt vo tyypaqia yI0 1Ic; napaywy1Ktc; om t51Kooiec; KOi rn; ouv9tiKsc; nopoywytic; nptncI vo civo, 010 Stmµa µo~i µ£ £1011<6 tyypaq>a yIa 1riv nopaywyf) Ka8c: napTiom:;. To ouvoAo autwv H,.>v cyypacpwv nptnc1 va em 1ptnE1 111v avaopoµri 010 101op1K6 rr1c; napoywytic; y10 Ko8c: napTioa. H TEKµrJpiwon nou acpopa rn:: napTioec; nptTTEI VO OIOTT]peiTOI cni tvo XPOVO µ£TO i rJV riµepoµrivio Ai)~e:wc; Twv nap1iowv Km rnuMxI010v ntv,e xpovIa µe1a 1r,v mo10noiri ori nou ovmptpEta l 010 ap8po 29 1nc; Ynoupy1Kiic; an6q>ooric; 378812/92. 2. ·ornv XPno1µono1ouvrnt l1A£KTpOVIKO, (j)WTOVPO(jllKO ii oMo ouaniµorn rnc~c:pyaoiac; O£i5oµtvwv avTi 'lwv ypo nrwv eyypaq>wv, o nopaywy6c; ocpciAe1 vo £na>..necue110 ouo1riµo KOi va ano6£1Kvuc:1. 611 rn bcooµtva ano011Kcuo v1m µe 10v KOTaMri>.o 1p6no yI0 niv n pof3Arn6µcvn n e: piooo. Ta oc6oµtva nou ano6rtK£uovi:m ono 10 oua1ti µo rn auto nptm:I vo 0Ia ri8ev101 aµ t owc:; KOi va eivm euo- vayvworn, Ta oE15oµtva nou ano0nKeuovt01 rJA£Krpov1K6. nptnEL VO npooTOTEUOVTOI ano TOV Kivouvo VO onwAc oeouv ii VO q)6apouv (ov11ypoq:>fi I'] BACK -UP KOi µern q>opa oc: tva 6Mo o uorriµa ano817K1::uoric;) . ·Ap9po 10 (6p9po 10 Tll C: Oo11yioc; 91 / 41 2/ EOK) nopoywy17 1 . Ot 0Iocpopec; e:pyaoicc; napaywyi]c; n ptneI va ~Ic~ayo vtoI ouµq:,wvo µe np0Ka8op1oµtvcc; ooriyic<; KOi ~1001Ko oiec; µ£ TOU<; Kavovec; K□Mc; TTOj)OOKEUtic;. Kara>.linAo KOi E:napKii µtoo npt m::1 vo c:ivm 0108t oiµa, worn vo <'S1c~ayo v1rn tAevxo, KOT□ Tr\ ?imotKooia TrJc; nopaywyl')c;. KaraA>,r,Aa 1sxvIKo l']/Kai opyavw11K6 µt1pa nptm :1 va AOµ~GVOVTOl, WOTE VO OTTO(l)EUyETOl l7 01aornupouµcvri KO! ovcrn8uµri1ri ovaµeI~n. 2. 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