Conditions governing the preparation, placing on the market and use of medicated feedingstuffs Rules, 2005 (L.N. 225 of 2005)

B 3527 A.L. 225 ta’ l-2005 ATT DWAR IS-SERVIZZI VETERINARJI (KAP. 437) Regoli ta’ l-2005 dwar Kondizzjonijiet li Jirregolaw il-Preparazzjoni, t-Tpo;;ieg[ fis-Suq u l-U]u ta’ G[alf Medikat BIS-SA{{A tas-setg[a mog[tija bl-artikolu 26 ta’ l-Att dwar is Servizzi Veterinarji, il-Ministru ta’ l-Affarijiet Rurali u l-Ambjent g[amel dawn ir-regoli li ;ejjin> 1. (1) It-titolu ta’ dawn ir-regoli huwa Regoli ta’ l-2005 dwar Kondizzjonijiet li Jirregolaw il-Preparazzjoni, t-Tpo;;ieg[ fis-Suq u l U]u ta’ G[alf Medikat. (2) Ming[ajr pre;udizzju g[all-adozzjoni tal-lista mni]]la fl-Artikolu 3 punt 1, it-tieni sub-paragrafu tad-Direttiva ta’ l-Unjoni Ewropea 2001#82#KE, dawn ir-regoli jni]]lu il-kondizzjonijiet barra dawk tas-sa[[a ta’ l-annimali, li jirregolaw il-preparazzjoni, t-tpo;;ieg[ fis-suq u u]u ta’ g[alf medikat fit-territorju ta’ Malta. (3) Dawn ir-regoli ma g[andhomx jaffetwaw ir-regoli tal Komunità ta’ l-Unjoni Ewropea applikabbli g[all-adittivi w]ati fl-g[alf, jew regoli nazzjonali adottati skond ir-regoli msemmija, u b’mod partikolari dawk applikabbli g[all-adittivi msemmija fl-Artikolu 1 tat tieni sub-paragrafu tad-Direttiva tal-Kunsill ta’ l-Unjoni Ewropea 90#167#KE. (4) L-iskop ta’ dawn ir-regoli hu l-implimentazzjoni tar regoli mni]]la ta[t id-Direttiva tal-Kunsill ta’ l-Unjoni Ewropea tas-26 ta’ Marzu, 1990 li tni]]el il-kondizzjonijiet li jirregolaw il-praparazzjoni, t-tpo;;ieg[ fis-suq u l-u]u ta’ g[alf medikat fil-Komunità ta’ l-Unjoni Ewropea. 2. (1) G[all-g[an ta’ dawn ir-regoli d-definizzjonijiet li jidhru fl-Artikolu 1 tad-Direttiva ta’ l-Unjoni Ewropea 2001#82#KE tal Parlament ta’ l-Unjoni Ewropea u tal-Kunsill tas-6 ta’ Novembru, 2001, fuq il-kodiçi tal-Komunità relatati g[all-prodotti mediçinali veterinarji u Artikolu 2 tad-Direttiva tal-Kunsill ta’ l-Unjoni Ewropea 79#373#KEE tat-2 ta’ April, 1979, fuq il-[ru; fis-suq ta’ g[alf kompost, kif l-a[[ar Titolu u skop. Tifsir. Suppliment tal-Gazzetta tal-Gvern ta’ Malta, Nru. 17,780, 17 ta’ :unju, 2005 Taqsima B –––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– B 3528 emendat bid-Direttiva 2000#16#KE tal-Parlament ta’ l-Unjoni Ewropea u tal-Kunsill ta’ l-10 ta’ April, 2000, g[andhom japplikaw kif neçessarjament. (2) G[all-g[an ta’ dawn ir-regoli, id-definizzjonijiet li ;ejjin g[andhom japplikaw ukoll> “il-Kummissjoni” tfisser il-Kummissjoni ta’ l-Unjoni Ewropea< “il-Komunità” tfisser il-Komunità Ewropea< “pajji] tat-tielet dinja” tfisser pajji] illi mhux membru tal Komunità Ewropea< “Servizzi Veterinarji” tfisser l-awtorità kompetenti fit territorju ta’ Malta kif stabbilit ta[t l-artikolu 2 ta’ l-Att dwar is Servizzi Veterinarji< “Stat Membru” tfisser Stat li huwa membru fil-Komunità Ewropea< “ta[lita lesta medikata awtorizzata” tfisser kull ta[lita lesta g[all-manifattura ta’ g[alf medikat kif definit fl-Artikolu 1 punt 5 tad-Direttiva ta’ l-Unjoni Ewropea 2001#82#KE li ;iet mog[tija awtorizazzjoni skond l-Artikoli 5, 6, 7, 8, 9, 10 u 11, ta’ dik id Direttiva< “tqeg[id fis-suq” tfisser l-azjenda fit-territorju tal-Komunità Ewropea g[all-bejg[ jew rimi fi kwalunkwe g[amla o[ra jkun x’ikun lill-partijiet terzi, sew jekk g[all-konsiderazzjoni sew jekk le, u l-bejg[ jew rimi attwali. 3. (1) Is-Servizzi Veterinarji g[andha tippreskrivi illi, fir rigward ta’ komponent mediçinali, g[alf medikat jista’ jkun manifatturat minn ta[lit lest medikat awtorizzat biss. (2) B’deroga mill-ewwel subparagrafu, is-Servizzi Veterinarji tista’, sakemm ikunu konformi mar-rekwi]iti ta’ l-Artikolu 6 tad-Direttiva tal-Kunsill ta’ l-Unjoni Ewropea 2001#82#KE> (a) bla [sara g[al kwalunkwe kondizzjonijiet speçifiçi mni]]la f’awtorizzazzjonijiet biex jitpo;;ew ta[lit lesti medikati awtorizzati fis-suq, tawtorizza l-prodotti ntermedjarji li huma preparati minn dawk it-ta[lit lesti medikati awtorizzati skond l Artikoli 6, 7, 8, 9, 10, u 11 tad-Direttiva ta’ l-Unjoni Ewropea G[alf medikat li g[andu jkun manifatturat minn ta[lit lest medikat awtorizzat. B 3529 2001#82#KE u minn wie[ed jew aktar mill-g[alf u li huma ma[suba g[all-manifattura sussegwenti ta’ g[alf medikat lest g[all-u]u. (b) Is-Servizzi Veterinarji g[andha tie[u l-mi]uri neçessarji biex ti]gura illi prodotti intermedjarji huma manifatturati minn stabbilimenti awtorizzati biss skond regola 4 u li huma so;;etti g[al dikjarazzjoni g[as-Servizzi Veterinarji, tawtorizza l veterinarju li kien immanifattura ta[t il-kondizzjonijiet mni]]la fl-Artikolu 4 (3) tad-Direttiva 81#851#KEE, u ta[t ir-responsabbilita tieg[u u fuq preskrizzjoni, g[alf medikat minn bosta ta[lit medikat minn qabel awtorizzat, provvdut illi m’hemmx a;ent terapewtiku awtorizzat speçifikament f’forma ta’ ta[lita lesta biex ikun trattat jew g[all-ispeçi konçernata. (ç) Sad-data meta s-Servizzi Veterinarji g[andha tkun konformi mar-regoli l-;odda mni]]la fl-Artikolu 9 tad-Direttiva ta’ l-Unjoni Ewropea 2001#82#KE, regoli nazzjonali li jirregolaw il-kondizzjonijiet mni]]la hawn fuq g[andhom jibqg[u applikabbli, bir-rigward ikun mag[mul g[ad-disposizzjonijiet ;enerali tat Trattat. (3) Prodotti awtorizzati skond is-sub-regola (1) g[andhom ikunu so;;etti g[ar-regoli mni]]la fl-Artikoli 44 sa 63 tad-Direttiva ta’ l-Unjoni Ewropea 2001#82#KE. 4. (1) Is-Servizzi Veterinarji g[andha tie[u l-mi]uri neçessarji biex ti]gura illi g[alf medikat huwa manifatturat ta[t il-kondizzjonijiet mni]]la hawn ta[t biss> (a) il-manifattur g[andu jkollu postijiet li jkunu ;ew approvati minn qabel mill-awtorità kompetenti nazzjonali, apparat tekniku u adattat u ma[]en adekwat u façilitajiet ta’ ispezzjoni< (b) l-impjant li jimmanifattura l-g[alf medikat g[andu jkun mag[mul minn impjegati li t-tag[rif u kwalifikazzjonijiet tag[hom fit-teknolo;ija tat-ta[lit huwa adegwat< (ç) il-produttur g[andu jkun responsabbli biex ji]gura illi> (i) jkun u]at g[alf biss jew kombinazzjonijiet mill g[alf li huma konformi mad-disposizzjonijiet tal-Komunità Ewropea fuq l-g[alf, (ii) l-g[alf u]at jipproduçi ta[lita omo;enja u stabbli bit-ta[lita lesta medikata awtorizzata, Kondizzjonijiet g[all-manifattura ta’ g[alf medikat. B 3530 (iii) it-ta[lita lesta medikata awtorizzata hija u]ata matul il-proçess ta’ manifattura skond il-kondizzjonijiet mni]]la meta awtorizazzjoni g[at-tqeg[id fis-suq tkun ing[atat u, b’mod partikolari, illi> (1) m’hemmx possibilita ta’ interazzjoni mhux mixtieqa bejn prodotti mediçinali veterinarji, adittivi u g[alf< (2) l-g[alf medikat jibqa’ tajjeb g[all-perjodu stipulat< (3) l-g[alf li g[andu jintu]a biex jipproduçi g[alf medikat ma jikkontenix l-istess antibijotiku jew l-istess coccidiostat b[al dawk u]ati b[ala sustanza attiva fit ta[lita lesta medikata< (iv) id-do]a ta’ kuljum tal-prodott mediçinali hija mi]muma fi kwantità ta’ g[alf li tikkorrispondi g[al ta’ lanqas ir-razzjon ta’ ikel ta’ kuljum ta’ l-annimali trattati jew, fil ka] ta’ ruminanti, li tikkorrispondi g[al ta’ lanqas nofs il [tie;a ta’ kuljum ta’ g[alf supplimentari mhux minerali< (d) postijiet, impjegati u apparat u]at u li jipparteçipaw fil proçess kollu ta’ manifattura g[andhom ikunu konformi mar-regoli ta’ i;ene ta’ manifattura u prinçipji ta’ l-Istati Membri fil-kwistjoni< il-proçess ta’ manifattura g[andu jkun konformi mar-regoli ta’ prattiçità tajba ta’ manifattura< (e) l-g[alf medikat manifatturat g[andu jg[addi minn kontrolli regolari, inklu] it-testijiet fil-laboratorju approprjati ta’ omo;enita mill-istabbilimenti ta’ manifattura, ta[t is-supervi]joni u kontroll perjodiku tad-dipartiment uffiçjali, biex ji]gura illi l g[alf medikat huwa skond il-[ti;ijiet ta’ dawn ir-regoli, speçjalment fir-rispett ta’ l-omo;enjita tag[hom, stabilità u [a]na< (f) manifatturi g[andhom ikunu obbligati j]ommu re;istri ta’ kuljum tat-tipi u kwantitajiet tat-ta[lit lest medikat awtorizzat u g[alf u]at u ta’ l-g[alf medikat manifatturat, mi]mum jew mibg[ut, flimkien ma l-ismijiet u l-indirizzi ta’ min irabbi jew min i]omm l-annimali, u fil-ka] mni]]el f’regola 19(2), l-isem u l-indirizz tad-distributur awtorizzat u, fejn approprjat, l-isem u l indirizz tal-veterinarju li jippreskrivi. Dawn ir-re;istri, li g[andhom jil[qu r-rekwi]iti ta’ l-Artikolu 12 u Artikolu 13 (1) tad-Direttiva ta’ l-Unjoni Ewropea 2001#82#KE, g[andhom jin]ammu g[al ta’ B 3531 lanqas tlett snin wara d-data ta’ l-a[[ar entratura u g[andhom ikunu disponibbli kull [in lill-awtoritajiet kompetenti fil-ka] ta’ kontrolli< (;) ta[lit lest u g[alf medikat g[andu jkun ma[]un fi kmamar adatti, separati u siguri jew f’kontenituri ermetiki li huma desinjati speçifikament g[all-[a]na ta’ dawn il-prodotti. (2) Is-Servizzi Veterinarji tista’, b’deroga minn paragrafu 1, u so;;ett g[all-garanziji addizzjonali approprjati, tawtorizza l manifattura ta’ g[alf medikat fuq irziezet sakemm ikunu konformi ma’ l-isetss paragrafu. 5. (1) Is-Servizzi Veterinarji g[andha tippreskrivi illi g[alf medikat jista’ jitpo;;a fis-suq f’pakketti jew kontenituri ssi;illati b’tali mod illi, meta l-pakkett jinfeta[, l-g[eluq jew is-si;ill jinkiser u ma jkunux jistg[u jer;g[u jintu]aw. (2) Fejn tankijiet tat-triq jew kontenituri simili huma w]ati biex jitpo;;a g[alf medikat fis-suq, dawn g[andhom jitnaddfu qabel kull u]u mill-;did sabiex tippreveni kull interazzjoni mhux mixtieqa sussegwenti jew kontaminazzjoni. 6. (1) Is-Servizzi Veterinarji g[andha tie[u l-mi]uri neçessarji biex ti]gura illi l-g[alf medikat ma jitpo;;iex fiç-çirkolazzjoni sakemm it-tikettar ma jkunx konformi mad-disposizzjonijiet fis-se[[ ta’ l-Unjoni Ewropea. Barra minn dan, il-pakketti jew kontenituri msemmija f’regola 5(1) g[andhom ikunu çarament immarkati bil-marka “G[alf Medikat”. (2) Fejn it-tankijiet tat-triq jew kontenituri simili huma w]ati biex jitqieg[ed g[alf medikat fis-suq, ikun suffiçenti li l-informazzjoni msemmija f’paragrafu 1 tkun mi]muma fid-dokumenti li jakkompanjawhom. 7. (1) Is-Servizzi Veterinarji g[andha tie[u l-mi]uri kollha neçessarji biex ti]gura illi g[alf medikat ma jin]ammx, jitpo;;a fis-suq jew ji;i w]at sakemm ma kienx immanifatturat skond dawn ir-regoli. (2) Su;;ett g[ar-rekwi]iti ta’ l-Artikolu 6 tad-Direttiva ta’ l-Unjoni Ewropea 2001#82#KE fir-rigward tat-testijiet li g[andhom isiru fuq il-prodotti mediçinali veterinarji, madankollu is-Servizzi Veterinarji tista g[al skopijiet xjentifiçi, tipprovdi g[all-derogi minn dawn ir-regoli, sakemm hemm kontroll uffiçjali adekwat. 8. (1) Is-Servizzi Veterinarji g[andha ti]gura illi g[alf medikat ma jkunx issuplixxit lill-irziezet li jistukkjaw jew lil min i]omm l Tpo;;ieg[ fis-suq ta’ g[alf medikat. Tikketjar ta’ g[alf medikat. Rekwi]iti o[ra. Preskrizzjonijiet ta’ g[alf medikat. B 3532 annimali bl-eççezzjoni fuq pre]entazzjoni ta’ preskrizzjoni tal veterinarju re;istrat fuq it-termini li ;ejjin> (a) il-preskrizzjoni tal-veterinarju g[andha ssir fuq forma murija fuq il-kampjun fi Skeda I< il-forma ori;inali g[andha tkun g[all-manifattur jew, fejn approprjat, distributur approvat mill awtorità kompetenti ta’ l-Istat Membru tad-destinazzjoni ta’ l-g[alf medikat< (b) il-veterinarju g[andu jimla Parti A tal-preskrizzjoni li ;ejja u kopji tal-preskrizzjoni murija fi Skeda I> (i) L-ori;inal tal-manifattur jew tad-distributur awtorizzati, li g[andhom jin]ammu mill-manifattur jew distributur awtorizzat g[all-perjodu ta’ mhux inqas minn tlett snin mid-data meta l-preskrizzjoni hija mimlija mill veterinarju. Il-veterinarju g[andu j[alli barra d-dettalji tal marda g[al liema t-trattament huwa preskritt f’Parti A ta’ dan l-ori;inal. Il-manifattur jew distributur awtorizzat g[andu jimla Parti B ta’ dan l-ori;inal. Din il-preskrizzjoni g[andha tin]amm disponibbli kull mument lis-Servizzi Veterinarji matul l-ispezzjonijiet uffiçjali< (ii) Kopja tad-Divisjoni tar-Regolament ta’ l-Ikel u l Veterinarji g[andha tintbag[at mill-manifattur jew distributur awtorizzat lis-Servizzi Veterinarji fi ]mien [amest ijiem mill pre]entazzjoni tal-preskrizzjoni. Il-veterinarju g[andu j[alli barra d-dettalji tal-marda g[al liema t-trattament huwa preskritt f’Parti A ta’ din il-kopja. Il-manifattur jew distributur awtorizzat g[andu jimla Parti B ta’ din il-kopja< (iii) Il-kopja tal-veterinarju li g[andha tin]amm mill veterinarju g[all-perjodu ta’ mhux anqas minn tlett snin mid data meta l-preskrizzjoni tkun saret minnu. Il-marda li g[andha tkun trattata g[andha tkun indikata biss f’Parti A ta’ din il-kopja. Il-kopja tal-preskrizzjoni g[andha tin]amm disponibbli kull mument lis-Servizzi Veterinarji matul l ispezzjonijiet uffiçjali. (ç) g[alf medikat ma jistax jintu]a g[al aktar minn trattament wie[ed ta[t l-istess preskrizzjoni< (d) il-preskrizzjoni veterinarja g[andha tkun valida biss g[al perjodu determinat mis-Servizzi Veterinarji li ma tistax tkun iktar minn tlett xhur mid-data meta ssir il-preskrizzjoni mill-veterinarju< B 3533 (e) il-preskrizzjoni tal-veterinarju tista’ tintu]a biss g[all annimali trattati minnu. Il-veterinarju g[andu l-ewwel ikun sodisfatt illi> (i) l-u]u ta’ din il-medikazzjoni hija ;ustifikata g[all ispeçi konçernata fuq ra;unijiet veterinarji< (ii) amministrazzjoni tal-prodott mediçinali ma jkunx inkompatibbli ma trattament preçedenti jew u]u u illi ma jkollux kontra-indikazzjoni jew interazzjoni bejn bosta ta[lit lesti li huma w]ati< (f) il-veterinarju g[andu> (i) jippreskrivi l-g[alf medikat f’dawk il-kwantitajiet biss kif, fil-limiti massimi mni]]la mill-awtorizzazzjoni nazzjonali g[at-tpo;;ieg[ fis-suq ta’ ta[lit medikat minn qabel, huma neçessarji g[all-iskop tat-trattament< (ii) jkun sodisfatt illi l-g[alf medikat u l-g[alf li jkun qieg[ed ji;i w]at biex annimali trattati ji;u mitmug[a ma jkunx fih l-istess antibijotiku jew l-istess coccidiostat b[ala sustanzi attivi. (2) B’danakollu, fil-ka] ta’ prodotti mediçinali anthelmintic (vermifuges), is-Servizzi Veterinarji tista’, sakemm issir revi]joni li g[andha ssir ta[t id-Direttiva ta’ l-Unjoni Ewropea 2001#82#KE tar riskji assoçjati ma’ l-u]u ta’ dawn il-gruppi ta’ sustanzi, tag[mel deroga g[all-[ames snin wara l-addozzjoni ta’ dawn ir-regoli mill-obbligazzjoni mni]]la f’sub-regola (1) sabiex ma jkun suplixxit g[alf medikat mi;jub minn ta[lit lest medikat awtorizzat bl-eççezzjoni fuq il-pre]entazzjoni tal-preskrizzjoni veterinarja, provdut illi> (a) it-ta[lit lest medikat u]at ma fihx sustanzi li huma fil gruppi kemikali u]ati, fit-territorju ta’ Malta, fuq preskrizzjoni medikali g[all-mediçina tal-bnedmin, (b) l-g[alf medikat li jkun akkordat dik l-awtorizzazzjoni huma w]ati fit-territorju tag[hom huma biss prophylactically u fid-do]i neçessarji g[all-iskop fil-kwistjoni. (3) Is-Servizzi Veterinarji g[andha tinforma lill Kummissjoni ta’ l-Unjoni Ewropea u lill-Istati Membri fl-iStanding Veterinary Committee bl-applikazzjoni ta’ din id-deroga, u tispeçifika partikolarment in-natura tal-prodotti mediçinali u l-ispeçi ta’ l-annimali li tkopri. B 3534 (4) Fejn g[alf medikat huwa amministrat lill-annimali li l la[am, ;ilda, offal jew prodotti tag[hom huma ma[suba g[all-konsum tal-bniedem, ir-ra[[al jew dak li j]omm l-annimali konçernati g[andu ji]gura illi l-annimali trattati ma jkunux maqtula biex ikunu offruti g[all konsum qabel ma jispiçça l-perjodu tat-tne[[ija mhumiex mormija bl iskop li jkunu offruti g[all-konsum tal-bniedem. 9. (1) Is-Servizzi Veterinarji g[andha tie[u l-mi]uri kollha neçessarji biex ti]gura illi l-g[alf medikat huwa mog[ti dirett lir-ra[[al jew lil min i]omm l-annimali biss mill-manifattur jew distributor approvati speçjali mill-awtorità kompetenti ta’ l-Istat Membru tad destinazzjoni. (2) Barra minn hekk, g[alf medikat g[at-trattament ta’ l annimali li l-la[am, ;ilda, offal jew prodotti tag[hom huma ma[suba g[all-konsum tal-bniedem ma jistawx jin[ar;u, sakemm> (a) huma ma jeççedux il-kwantitajiet preskritti g[at trattament, skond il-preskrizzjoni veterinarja fejn dan huwa provdut g[alih, (b) huma m’humiex ma[ru;a fi kwantitajiet ikbar mir rekwi]iti ta’ xhar wie[ed kif stabbilit skond l-istipulazzjonijiet ta’ l-ewwel inçi]. (3) B’danakollu, minkejja sub-regola (1), is-Servizzi Veterinarji tista’ f’ka]ijiet speçjali tawtorizza distributuri speçifikament approvati g[al dak l-iskop biex jo[or;u, a ba]i tal-preskrizzjoni veterinarja, g[alf medikat fi kwantitajiet ]g[ar, pakkettati minn qabel u lesti g[all-u]u, u preparati, ming[ajr pre;udizzju g[all-regola 8(2) skond ir-rekwi]iti ta’ dawn ir-regoli, provdut illi dawn id-distributuri> (a) i[arsu l-istess kondizzjonijiet b[all-manifattur fir rigward li j]ommu re;istri u l-[a]na, transport u l-[ru; tal-prodotti konçernati, (b) huma so;;etti g[all-kontrolli speçjali g[all-iskop, ta[t is-supervi]joni ta’ l-awtorità veterinarja kompetenti, (ç) jistg[u jissuplixxu biss g[alf medikat li jkun pakketat jew pakke;jat minn qabel lesti g[all-u]u minn min i]omm jew mill-bidwi li g[andhom fuq il-pakketti jew kontenituri istruzzjonijiet g[all-u]u ta’ l-istess g[alf medikat u, b’mod partikolari, indikazzjoni tal-perjodu ta’ tne[[ija. {ru; ta’ g[alf medikat g[all bdiewa u min i]omm l-annimali. B 3535 (4) Id-disposizzjonijiet ta’ sub-regola (2) ma g[andhomx jaffetwaw ir-regoli nazzjonali fuq il-proprjetarju legali ta’ l-g[alf medikali. 10. (1) Is-Servizzi Veterinarji g[andha ti]gura li, ming[ajr pre;udizzju g[ar-regoli dwar is-sa[[a ta’ l-annimali, ma jkunx hemm projbizzjonijiet, limitazzjonijiet jew ostakoli fir-rispett ta’ kummerç intra-komunitarju> (a) Fl-g[alf medikat li kien immanifatturat skond ir rekwi]iti ta’ dawn ir-regolamenti, u b’mod partikolari regola 4, b’ta[lit lest awtorizzat li g[andhom l-istess sustanzi attivi b[al dawk ta’ ta[lit lest awtorizzat mill-Istat Membru tad-destinazzjoni, skond il-kriteja tad-Direttiva ta’ l-Unjoni Ewropea 2001#82#KE, u komposizzjoni kwantitattiva u kwalittativa simili g[alihom, (b) so;;ett g[ad-disposizzjonijiet speçifiçi tad-Direttiva tal Kunsill ta’ l-Unjoni Ewropea 96#23#KE tad-29 ta’ April, 1996 fuq mi]uri ta’ monitera;; ta’ çertu sustanzi u residwi tag[hom f’annimali [ajjin u prodotti ta’ l-animali u li t[assar id-Direttivi 85#358#KEE u 86#469#KEE u Deçi]jonijiet 89#187#KEE u 91#664#KEE u Direttiva tal-Kunsill 96#22#KE tad-29 ta’ April, 1996 li jikkonçernaw il-projbizzjoni ta’ l-u]u f’biedja bl-istokk ta’ çerti sustanzi li g[andhom azzjoni ormonali jew tirostatika u ta’ ß agonists, u li t[assar Direttivi 81#602#KEE, 88#146#KEE kif imsemmi f’Artikolu 7(1) tad-Direttiva tal-Kunsill 96#22#KE, f’annimali li g[alihom dawk l-g[alf medikat bl-eççezzjoni ta’ dawk prodotti skond regola 3(2), kienu ;ew amministrati, jew fil-la[am, ;ilda, offal jew prodotti tag[hom minn dawk l-annimali. (2) Fejn l-applikazzjoni f’sub-regola (1) tag[ti lok g[al kwistjoni, b’mod partikolari li jikkonçernaw ir-rikonoxximent in-natura simila tat-ta[lita lesta, l-Istat Membru konçernat jew il-Kummissjoni tista’ tpo;;i l-kwistjoni biex tkun assessjata minn espert li jidher fuq il lista ta’ l-esperti tal-Komunità Ewropea li g[andha ssir mill Kummissjoni fuq proponiment ta’ l-Istati Membri. Jekk i]-]ew; Stati Membri hekk jiftehmu minn qabel, il-partijiet g[andhom jintrabtu ma’ l-opinjoni ta’ l-espert, skond il-legislazzjoni tal-Komunità Ewropea. (3) L-Istat Membru ta’ destinazzjoni jista’ je[tie; illi kull konsinja ta’ g[alf medikat tkun akkompanjatha b’çertifikat ma[ru; mill awtorità kompetenti, li jikkorrispondi mal-kampjun fi Skeda II. 11. (1) Il-mi]uri ta’ salvagwardja mni]]la mid-Direttiva tal Kunsill ta’ l-Unjoni Ewropea 89#662#KEE g[andhom japplikaw g[all kummerç ta’ ta[lit medikat lest u awtorizzat jew g[alf medikat. Kummerç Intra komunitarju ta’ l g[alf medikat. Mi]uri ta’ Salvagwardja. B 3536 (2) Ir-regoli mni]]la li jikkonçernaw il-kontroll veterinarju u, b’mod partikolari, il-[ti;ijiet mni]]la fl-Artikolu 5 (2) u Artikolu 20 tad-Direttiva tal-Kunsill ta’ l-Unjoni Ewropea 89#662#KEE g[andhom japplikaw g[all-kummerç ta’ ta[lit medikat lest u awtorizzat jew g[alf medikat sakemm huma so;;etti g[all-kontroll veterinarju. 12. Is-Servizzi Veterinarji g[andha tie[u dawk il-mi]uri kollha neçessarji biex ti]gura konformita ma dawn ir-regoli> (a) billi tag[mel kontrolli ta’ kampjuni f’kull stadji ta’ produzzjoni u marketing tal-prodotti msemmija f’dawn ir-regoli, biex ti]gura illi d-disposizzjonijiet ta’ dawn ir-regoli ikunu m[arsa< (b) partikolarment, billi tag[mel kontrolli tal-kampjuni fuq irziezet u biççeriji, biex ti]gura illi g[alf medikat huwa u]at skond il-kondizzjonijiet ta’ l-u]u, u li l-perjofi ta’ tne[[ija ;ew im[arsa. 13. Sakemm ikunu mplimentati l-mi]uri tal-Komunità Ewropea relatati ma’l-importazzjoni ta’ g[alf medikat minn pajji]i terzi, is Servizzi Veterinarji g[andha tapplika dawk il-mi]uri ta’ importazzjoni li huma ta’ lanqas ekwivalenti ma dawk ta’ dawn ir-regoli. Kontroll b’iççekkjar ta’ kampjuni. G[alf medikat minn Pajji]i Terzi. B 3537 Skeda I No: MINISTERU GHALL-AFFARIJIET RURAL! U L-AMBJENT MINISTRY FOR RURAL AFFAIRS AND THE ENVIRONMENT Taqsima ,a · I-Ike/ 11 A11ivi1a · Ve1eri1u11ja MA LTA Food mu/ VeterinmJ1 Regulation Division PARTI A : TRIO TINTELA MILL•VETERINARJU LI QED JGRAMEL IL·PRESKRIZZJONI KunJom u lsem tal-veterlnarju lsem tad-dar jew klinika I Triq Ral\al I Kodici Postali lsem tan-negozju u lndlrlzz tal-produttur Jew dlstrlbutur awtorltiat ta' I• gflalf medlkat Triq I I Rahal Kodici Postali I lsem tar-raflflal Jew pussessur tal-annlmall I I nru tal-garra ltlmbrul nru ta' 1-stalla. Triq I I Ral\al I Kodici Postali I Numru u ldentlflkazzjonl tal-annlmal Timbru / Tag/ Numru Speci Tattoo I Razza Sess Kategorija Microchip ,. • ~ Mard II Jrld JIOI ttratat 141 DeslgnazzJonl talpre-m/x medlkat awtorlzzat Kwantlta fkllogramml ta' feedlngstuff medlkat lstruzzJonlJlet spetJall gflar-raflflal Jew 11 pussesur ta' 1-annlmall PertentaOO tal- Frekwenza tat- Dewmlen tat- Perjodu ta' dlastakk feedlngstuff frazzJon trattament trattament ta' kuljum fOranet BaJd Laflam ftallb '· • ,. Data meta lntllet II• Flnna personal tal• Numruta' Tlmbru preskrlzzjonl Veterlnarju reglstrazzjonl Jum I Xhar Sena I PARTI B : TRIO TINTELA MILL-PRODUTTUR JEW MID-DISTRIBUTUR TA' L-GKALF AWTORIZZAT Jum tal-kunslnna Oum-xhar-sena) I Trld t101 wtata Oum-xhar-sena) I Jum meta 11-preskrlzzjonl Flnna tal-produttur 1- dlstrlbutur Tlmbru tal-produttur Jew dlstrlbutur Olet lppretentata awtorltiat awtorltiat Jum I Xhar I Sena I I <11 Trid tintela skond ir-regola 8 (1) (b). 121 Din il-preskrizzjoni hi valida gl\al perjodu Ii ma je¢¢edix tlett xhur u gl\anda tintlea darba biss. 1' 1 Din il-preskrizzjoni gl\anda tiniamm gnal perjodu ta' mhux anqas min tlett snin mid-data min liema 1-preskrizzjoni intliet mill -veterinarju . <•I 11-mard Ii qed jigi ittratat gl'landu Jinkiteb biss fil-kopja tal-veterlnarju. Ori(1inal tal-produttur iew distributur awtoriilat B 3538 MINISTERU GHALL-AFFARIJIET RURALI U L-AMBJENT Taqsima ta ' I-Ike/ 11 Allivita · Ve1eri11a,ja MALTA No: MINISTRY FOR RURAL AFFAIRS AND THE ENVIRONMENT Food a11d Veterinary Regulation Division PARTI A: TRIO TINTELA MILL-VETERINARJU LI QED JGRAMEL IL-PRESKRIZZJONI KunJom u 1-lsem tal-veterlnarju lsem tad-dar jew klinika I Triq Ral'lal I Kodicl Postali lsem tan-negozju u lndlrlzz tal-produttur Jew dlstrlbutur awtorlliat ta' 1 gflalf medlkat Triq I I Rahal Kodici Postali I lsem u lndlrlzz tar-raflflal Jew pussesur tal I annlmall / nru tal {larra/tlmbru / nru ta' 1-lstalla. Triq I I Ral'lal I Kodici Postali I ldentlflkazzjonl u numru tal-annlmall Timbru/ Misluta Numru Speci Tattoo/ Razza Sess Kategorija Microchip 1. 2. 3. Mard lttrattat 131 DeslgnJazzjonl ta' 1-pre-m/x awtorlzzat Kwantlta' ta' 1-gflalf medlkat fkllogramml lstruzzjonlJlet spetJall gflar-raflflal Jew pussesur tal-annlmall Pertenta{l{I ta' gflalf Frekwenza tat- Dewmlen tat- Perjodu ta' dlstakk fl {lranet medlkat flr-razzJon ta' trattament trattament fl kulJum {lranet BaJd Laflam Rallb , . . ~ Jum meta 1-preskrtzzjonl Flnna personal Ital- Numruta' Tlmbru ntllet veterlnarju Ra(ilstrazzjonl Jum I Xhar Sena I PARTI B: TRIO TIGI TINTELA MILL-PRODUTTUR JEW MID-DISTRIBUTUR TA' L-GRALF AWTORIZZAT Jum tal-kunslnna (lum-xhar-sena) I Trld tl{II vdata (lum-xhar-sena) I Jum meta 11-preskrtzzjonl Flnna tal-produttur Jew dlstrlbutur Tlmbru tal-produttur J- dlstrlbutur Olet lppreientata awtortttat awtorlttat Jum Xhar Sena !•J Trld tlntela skond lr-regola 8 (1) {b). <2J Din il-preskrizzjoni ghanda t intbghat mill-produttur jew distributur awtoriizat lit Taqsima ta' 1-lkel u Attivita ' Veterinarja fi :i:mien hamest ijiem mid-data meta tigi ppre:i:entata din il-preskrizzjoni <•J 11-mard Ii qed j igi ittratat ghandu jinkiteb biss fil-kopja tal-veterinarju. Kopja tat-Taqsima ta ' 1-lkel u Attivita ' Veterinarja B 3539 No: ~ ... MINISTERU GHALL-AFFARIJIET RURALI U ~~ MINISTRY FOR RURAL AFFAIRS AND L-AMBJENT THE ENVIRONMENT Taqsima ta ' I-Ike/ 11 Anivita' Veterinmja MALTA Faod and Veterinmy Regulation Division PARTI A: TRID TINTELA MILL-VETERINARJU LI QED JGffAMEL IL-PRESKRIZZJONI KunJom u 1-lsem tal-veterlnarju lsem tad-dar jew klinika Triq Ralial Kodici Postali lsem tan-negozJu u lndlrlzz tal-produttur Jew dlstrlbutur awtorl:lzat ta' 1 gflalf medlkat Triq I Rahal Kodici Postali I lsem u lndlrlzz tar-raflflal Jew pussesur tal I annlmall / chum no. /tlmbru / nru ta' 1-lstalla. Triq I Rahal I Kodlci Postali I ldentlflkazzJonl u numru tal-annlmall Timbru/ Tag/ Numru Speci Tattoo/ Razza Sess Kategorija Microchip 1, • ,. Mardll Jrld Jl(II ttrattat 131 DeslgnJazzJonl tal-pre-mlx awtorlzzat Kwantlta' ta' 1-gflalf medlkat fkllogramml lstruzzJonlJlet spetJall gflar-raflflal Jew pussesur tal-annlmall Percenta(l(I ta' gflalf Frekwenza tat- Dewmlen tat- Perjodu ta' dlstakk fl (lranet medlkat flr-razzJon ta' trattament trattament fl kulJum (lranet BaJd Laflam ffallb , . • ,. Jum meta 1-preskrfzzjonl Flnna personal Ital- Numruta' Tlmbru ntllet veterlnarju Ret,lstrazzjonl Jum I Xhar Sena I PARTI B: TRIO TIGI TINTELA MILL-PRODUTTUR TA' L-GffALF JEW MID-DISTRIBUTUR AWTORIZZAT Jum tal-kunslnna 0um-xhar-sena) I Trld tl(II wzata 0um-xhar-sena) I Jum meta 11-preskrlzzjonl Flnna tal-produttur Jew dlstrlbutur Tlmbru tal-produttur J- dlstrlbutur (!let lppreientata awtorltiat awtorltiat Jum I Xhar I Sena I I 1' 1 Trid tintela skond ir-regola 8 (1) (b), <21 1 Din il-preskrizzjoni glianda tinzamm glial perjodu ta ' mhux anqas min tlett snin mid-data min liema 1-preskrizzjoni intliet mill-veterinarju , <'111-mard Ii qed j igi ittratat gliandu jinkiteb biss fil-kopja tal-veterinarju, Kopja tal-Veterinarju B 3540 Skeda II ~ERTIFIKAT T’ AKKOMPANJAZZJONI FIR-RISPETT TA’ G}ALF MEDIKAT G}ALL-ANNIMALI MA}SUBA G}ALL-KUMMER~ Isem u indirizz tal-manifattur jew distributur approvat: ……………………………….................... ………………………………………………………………………………………………………. ………………………………………………………………………………………………………. ………………………………………………………………………………………………………. Isem ta’ l-g]alf medikat: …………………………………………………………………................ ………………………………………………………………………………………………………. Tip ta’ animal g]al liema l-g]alf medikat hu ma]sub: …………………………………………….. Isem u kompo\izzjoni tat-ta]lita lesta medikata awtorizzata: ……………………………............... ………………………………………………………………………………………………………. Do\a tat-ta]lita lesta medikata awtorizzata fl-g]alf medikat: ……………………………............... ………………………………………………………………………………………………………. Kwantità ta’ g]alf medikat: ………………………………………………………………............... Isem u indirizz tar-re`ipjent: ……………………………………………………………………….. ………………………………………………………………………………………………………. ………………………………………………………………………………………………………. Huwa hawn hekk `ertifikat illi l-g]alf medikat kif deskritt hawn fuq [ie manifatturat minn persuna awtorizzata skond id-Direttiva 90/167/KEE. Mag]mul ……………………………………………………., fil-………………………………… (post) (data) Timbru ta’ l-awtorità veterinarja jew awtorità kompetenti o]ra (Firma) (isem u posizzjoni) B 3541 L.N. 225 of 2005 VETERINARY SERVICES ACT, 2001 (ACT NO. XXIII OF 2001) Conditions governing the preparation, placing on the market and use of medicated feedingstuffs Rules, 2005 IN exercise of the powers conferred by article 26 of the Veterinary Services Act, the Minister for Rural Affairs and the Environment has made the following rules> 1. (1) The title of these rules is Conditions governing the preparation, placing on the market and use of medicated feedingstuffs Rules, 2005. (2) These rules lay down, without prejudice to the adoption of the list laid down in Article 3 point 1, second sub-paragraph to European Union Directive 2001#82#EC, the conditions other than those of animal health, governing the preparation, placing on the market and use of medicated feedingstuffs within the territory of Malta. (3) These rules shall not affect European Community rules applicable to additives used in feedingstuffs, or national rules adopted pursuant to the said rules, and in particular those applicable to the additives referred to in Article 1 second sub-paragraph to European Union Council Directive 90#167#EC (4) The scope of these rules is to implement the rules found under the European Union Council Directive of the 26th March, 1990 laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the Community 2. (1) For the purposes of these rules the definitions appearing in Article 1 of European Union Directive 2001#82#EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products and Article 2 of Council Directive 79#373#EEC of 2 April 1979 on the marketing of compound feedingstuffs, as last amended by Directive 2000#16#EC of the European Parliament and the Council of 10 April 2000 shall apply as necessary. (2) For the purposes of these rules, the following definitions shall also apply> “authorized medicated pre-mix” means any pre-mix for the manufacture of medicated feedingstuffs as defined in Article 1 Title and scope. Definitions. B 3542 point 5 of European Union Directive 2001#82#EC which has been granted an authorization in accordance with Articles 5,6,7,8,9,10,and 11, of that Directive< “Member State” means a State which is a Member within the European Community< “placing on the market” means the holding in the territory of the Community for sale or disposal in any other form whatever to third parties, whether or not for consideration, and actual sale or disposal< “the Commission” means the European Union Commission< “the Community” means the European Community< “Third Country” means a State which is not a Member within the European Community< “Veterinary Services” means the competent authority within the territory of Malta as established under article 2 of the Veterinary Services Act. 3. (1) The Veterinary Services shall prescribe that, as regards the medicinal component, medicated feedingstuffs may be manufactured from authorized medicated pre-mixes only. (2) By way of derogation from the first subparagraph, the Veterinary Services may, provided they comply with the requirements of Article 6 of European Union Directive 2001#82#EC> (a) subject to any specific conditions laid down in authorizations to place authorized medicated pre-mixes on the market, authorize intermediate products which are prepared from such medicated pre-mixes authorized in accordance with Article 6, 7, 8, 9,10, and 11 of Directive European Union Directive 2001#82#EC and from one or more feedingstuffs and which are intended for the subsequent manufacture of medicated feedingstuffs ready for use. (b) The Veterinary Services shall take all necessary steps to ensure that intermediate products are manufactured only by establishments authorized in accordance with rule 4 and that they are the subject of a declaration to the Veterinary Services, authorize the veterinarian to have manufactured under the conditions laid down in Article 4 (3) of Directive 81#851#EEC, and under his Medicated feedingstuffs to be manufactured from authorised medicated pre mixes. B 3543 responsibility and on prescription, medicated feedingstuffs from several authorized medicated pre-mixes, provided that there is no specific authorized therapeutic agent in pre-mix form for the disease to be treated or for the species concerned. (c) Until the date on which the Veterinary Services has to comply with the new rules laid down in Article 9 of European Union Directive 2001#82#EC, national rules governing the above conditions shall remain applicable, with due regard for the general provisions of the Treaty. (3) Products authorized pursuant to sub-rule (1) shall be subject to the rules laid down in Articles 44 to 63 of European Union Directive 2001#82#EC. 4. (1) The Veterinary Services shall take all necessary measures to ensure that medicated feedingstuffs are manufactured only under the conditions set out below> (a) the manufacturer shall have premises which have been previously approved by the competent national authority, technical equipment and suitable and adequate storage and inspection facilities< (b) the medicated feedingstuffs manufacturing plant shall be manned by staff whose knowledge of and qualifications in mixing technology are adequate< (c) the producer shall be responsible for ensuring that> (i) only feedingstuffs or combinations thereof which comply with Community provisions on feedingstuffs are used, (ii) the feedingstuff used produces a homogeneous and stable mix with the authorized medicated pre-mix, (iii) the authorized medicated pre-mix is used during the manufacturing process in accordance with the conditions laid down when authorization for placing on the market was given and, in particular, that> (1) there is no possibility of any undesirable interaction between veterinary medicinal products, additives and feedingstuffs< Conditions for the manufacture of medicated feedingstuffs. B 3544 (2) the medicated feedingstuff will keep for the stipulated period< (3) the feedingstuff to be used for producing the medicated feedingstuff does not contain the same antibiotic or the same coccidiostat as those used as an active substance in the medicated pre-mix< (iv) the daily dose of medicinal product is contained in a quantity of feedingstuff corresponding to at least half the daily feed ration of the animals treated or, in the case of ruminants, corresponding to at least half the daily requirement of nonmineral supplementary feedingstuffs< (d) premises, staff and equipment used and participating in the entire manufacturing process must comply with the manufacturing hygiene rules and principles of the Member State in question< the manufacturing process must conform to the rules of good manufacturing practice< (e) the medicated feedingstuffs manufactured shall undergo regular checks, including appropriate laboratory tests of homogeneity by the manufacturing establishments, under the supervision and periodic control of the official department, to ensure that the medicated feedingstuff complies with the requirements of these rules, especially in respect of its homogeneity, stability and storability< (f) manufacturers shall be obliged to keep daily records of the types and quantities of the authorized medicated pre-mixes and feedingstuffs used and of the medicated feedingstuffs manufactured, held or dispatched, together with the names and addresses of the breeders or holders of the animals, and in the case provided for in rule 10 (2), the name and address of the authorized distributor and, where appropriate, the name and address of the prescribing veterinarian. The records, which must meet the requirements of Article 12 and Article 13 (1) of European Union Directive 2001#82#EC, must be kept for at least three years after the date of the last entry and must be made available at any time to the competent authorities in case of checking< (g) pre-mixes and medicated feedingstuffs shall be stored in suitable separate and secured rooms or hermetic containers which are specially designed for the storage of such products. B 3545 (2) The Veterinary Services may, by way of derogation from paragraph 1, subject to any additional guarantees appropriate, authorize the manufacture of medicated feedingstuffs on farms provided that the said paragraph is complied with. 5. (1) The Veterinary Services shall prescribe that medicated feedingstuffs may be placed on the market only in packages or containers sealed in such a way that, when the package is opened, the closure or seal is damaged and they cannot be re-used. (2) Where road tankers or similar containers are used to place medicated feedingstuffs on the market, these must be cleaned before any re-use in order to prevent any subsequent undesirable interaction or contamination. 6. (1) The Veterinary Services shall take all necessary measures to ensure that medicated feedingstuffs are not put into circulation unless the labelling complies with the European Community provisions in force. Furthermore, the packages or containers referred to in rule 5 (1) shall be clearly marked “Medicated Feedingstuffs”. (2) Where road tankers or similar containers are used to place medicated feedingstuffs on the market, it shall be sufficient for the information referred to in paragraph 1 to be contained in the accompanying documents. 7. (1) The Veterinary Services shall take all necessary measures to ensure that a medicated feedingstuff cannot be held, placed on the market or used unless it has been manufactured in accordance with these rules. (2) Subject to the requirements of Article 6 of European Union Directive 2001#82#EC with regard to the tests to be carried out on veterinary medicinal products, the Veterinary Services may, however, for scientific purposes, provide for derogations from these rules, provided there is adequate official control. 8. (1) The Veterinary Services shall ensure that medicated feedingstuffs are not supplied to stockfarmers or holders of animals except on presentation of a prescription from a registered veterinarian on the following terms> (a) the veterinarian’s prescription shall be made out on a form shown on the specimen in Schedule I< the original form shall be for the manufacturer or, where appropriate, a distributor Placing on the market of medicated feedingstuffs. Labelling of medicated feedingstuffs. Further requirements. Medicated feedingstuff prescriptions. B 3546 approved by the competent authority of the Member State of destination of the medicated feedingstuffs< (b) the veterinarian shall fill Part A of the following prescription and copies of prescription shown in Schedule I> (i) Manufacturer’s or authorised distributors original, which shall be retained by the manufacturer or authorised distributor for a period which is not less than three years from date when the prescription was filled by the veterinarian. The veterinarian shall omit the details of the disease for which the treatment is prescribed in Part A of this original. The manufacturer or authorised distributor shall fill Part B of this original. This prescription shall be made available at all times to the Veterinary Services during official inspections< (ii) Food and Veterinary Regulation Division copy which shall be sent by the manufacturer or authorised distributor to the Veterinary Services within five days of the presentation of the prescription. The veterinarian shall omit the disease for which the treatment is prescribed in Part A of this copy. The manufacturer or authorised distributor shall fill Part B of this copy< (iii) The veterinarian’s copy which shall be retained by the veterinarian for a period of not less than three years from the date the prescription was made by him. The disease to be treated shall only be indicated in Part A of this copy. This prescription copy shall be made available at all times to the Veterinary Services during official inspections. (c) medicated feedingstuffs may not be used for more than one treatment under the same prescription< (d) the veterinary prescription shall be valid only for a period determined by the Veterinary Services which shall not exceed three months from the date on which the prescription is made by the veterinarian< (e) the veterinarian’s prescription may be used only for animals treated by him. The veterinarian must first satisfy himself that> (i) the use of this medication is justified for the species concerned on veterinary grounds< B 3547 (ii) administration of the medicinal product is not incompatible with a previous treatment or use and that there is no contra-indication or interaction where several pre-mixes are used< (f) the veterinarian must> (i) prescribe the medicated feedingstuffs only in such quantities as, within the maximum limits laid down by the national authorization for placing medicated pre-mixes on the market, are necessary for the purpose of the treatment< (ii) satisfy himself that the medicated feedingstuff and the feedingstuff currently used to feed treated animals do not contain the same antibiotic or the same coccidiostat as active substances. (2) However, in the case of anthelmintic medicinal products (vermifuges), the Veterinary Services may, pending the review to be carried out under European Union Directive 2001#82#EC of the risks associated with the use of these groups of substances, derogate for five years after the adoption of these rules from the obligation laid down in sub-rule (1) not to supply medicated feedingstuffs obtained from authorized medicated pre-mixes except on presentation of a veterinary prescription, provided that> (a) the medicated pre-mixes used do not contain active substances which belong to the chemical groups used, in the territory of Malta, on medical prescription for human medicine, (b) the medicated feedingstuffs accorded such authorization are used in their territory only prophylactically and in the dosages necessary for the purpose in question. (3) The Veterinary Services shall inform the European Union Commission and the other Member States within the Standing Veterinary Committee of the application of such a derogation, specifying in particular the nature of the medicinal products and animal species that it covers. (4) Where medicated feedingstuffs are administered to animals whose meat, flesh, offal or products are intended for human consumption, the stockfarmer or holder of the animals concerned must ensure that treated animals are not slaughtered in order to be offered for consumption before the end of the withdrawal period and that products obtained from a treated animal before the end of such a withdrawal B 3548 period are not disposed of with a view to their being offered for human consumption. 9. (1) The Veterinary Services shall take all necessary measures to ensure that medicated feedingstuffs are issued directly to the stockfarmer or holder of the animals only by the manufacturer or distributor specially approved by the competent authority of the Member State of destination. (2) Furthermore, medicated feedingstuffs for the treatment of animals whose meat, flesh, offal or products are intended for human consumption may not be issued unless> (a) they do not exceed the quantities prescribed for the treatment, in accordance with the veterinary prescription where this is provided for, (b) they are not issued in quantities greater than one month’s requirements as established in accordance with the stipulations of the first indent. (3) However, notwithstanding sub-rule (1), the Veterinary Services may in special cases authorize distributors specifically approved for that purpose to issue, on the basis of a veterinary prescription, medicated feedingstuffs in small quantities, prepacked and ready for use, and prepared, without prejudice to rule 8 (2) in accordance with the requirements of these rules, provided that these distributors> (a) comply with the same conditions as the manufacturer regarding the keeping of registers and the storage, transport and issue of the products concerned, (b) are subject to special checking for the purpose, under the supervision of the competent veterinary authority, (c) may supply only prepacked or prepackaged medicated feedingstuffs ready for use by the holder or stockfarmer that have on the packaging or containers instructions for the use of the said medicated feedingstuffs and, in particular, an indication of the withdrawal period. (4) The provisions of sub-rule (2) shall not affect national rules on the legal ownership of the medicated feedingstuffs. Issuing of medicated feedingstuffs to stockfarmers or holder of the animals. B 3549 10. (1) The Veterinary Services shall ensure that, without prejudice to animal-health rules, there are no prohibitions, limitations or obstacles in respect of intra-Community trade> (a) in medicated feedingstuffs which have been manufactured in accordance with the requirements of these regulations, and in particular rule 4 thereof, with authorized pre mixes which have the same active substances as pre-mixes authorized by the Member State of destination, in accordance with the criteria of European Union Directive 2001#82#EC, and a quantitative and qualitative composition similar thereto, (b) subject to the specific provisions of European Union Council Directive 96#23#EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85#358#EEC and 86#469#EEC and Decisions 89#187#EEC and 91#664#EEC and Council Directive 96#22#EC of 29 April 1996 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of b-agonists, and repealing Directives 81#602#EEC, 88#146#EEC and 88#299#EEC as referred to in Article 7 (1) of Council Directive 96#22#EC, in animals to which those medicated feedingstuffs except those produced pursuant to rule 3 (2), have been administered, or in meat, flesh, offal or their products from such animals. (2) Where the application of sub-rule (1) gives rise to dispute, in particular as concerns recognition of the similar nature of the pre-mix, the Member States concerned or the Commission may submit the dispute to assessment by an expert appearing on a list of Community experts to be drawn up by the Commission on a proposal from the Member States. If the two Member States so agree beforehand, the parties shall abide by the opinion of the expert, in compliance with Community legislation. (3) The Member State of destination may require that each consignment of a medicated feedingstuff be accompanied by a certificate issued by the competent authority, corresponding to the specimen form in Schedule II. 11. (1) The safeguard measures laid down by European Union Council Directive 89#662#EEC shall apply to trade in authorized medicated pre-mixes or medicated feedingstuffs. (2) The rules laid down concerning veterinary control and, in particular, the requirements laid down in Article 5 (2) and Article 20 Intra-Community Trade of medicated feedingstuffs. Safeguard Measures. B 3550 of European Union Council Directive 89#662#EEC shall apply to trade in authorized pre-mixes or medicated feedingstuffs to the extent that they are subject to veterinary control. 12. The Veterinary Services shall take all necessary measures to ensure compliance to these rules> (a) by making sampling checks at all stages of the production and marketing of the products referred to by these rules, to ensure that the provisions of these rules are complied with< (b) in particular, by making sampling checks on farms and slaughterhouses, to ensure that medicated feedingstuffs are used in compliance with the conditions of use, and that withdrawal periods have been complied with. 13. Pending the implementation of Community measures relating to imports of medicated feedingstuffs from third countries, the Veterinary Services shall apply to those imports measures which are at least equivalent to those of these rules. Control by sampling checks. Medicated feedingstuffs from Third Countries. B 3551 Schedule I No: ~ "' MINISTERU GHALL-AFFARIJIET RURALI U ~, MINISTRY FOR RURAL AFFAIRS AND L-AMBJENT THE ENVIRONMENT Taqs ima ta' I-Ike/ 11 A11ivita ' Veterina,ja MALTA Food and Veterinary Reg11/ation Division PART A: TO BE COMPLETED BY THE PRESCRIBING VETERINARIAN Surname and forename of veterinarian Name of house or cllnlc Street Village Postal Code Name or business name and address of manufacturer or supplier of the medicated feedlngstuff Street Village Postal code Name and address of stockfarmer or holder of animals / chum no. /stamp / stable no. Street Village Postal Code Identification and number of animals Number Species Stamp/Tag Breed Sex Category Tattoo/ Microchip 1. 2. 3. Disease to be treated 141 Designation of authorised medicated pre-mixes Quantity of medicated feedlngstuff In kilograms Special Instructions for the stockfarmer or holder of the animals Percentage of medicated Frequency of Duration of Withdrawal time In days feedlngstuff In the dally treatment treatment In days Eggs Meat MIik ration 1. 2. 3. Date when prescription was Personal signature of Registration Stamp filled veterinarian Number Day I Month I Year I I PART B: TO BE COMPLETED BY THE MANUFACTURER OR AUTHORISED DISTRIBUTOR Date of delivery Day I Month I Year I To be used before Day I Month I Year I Date when prescription was Signature of manufacturer or suppller Stamp of manufacturer or suppller presented Day I Month I Year I I 1' 1 To be filled in accordance with sub-rule 8 (1) (b). 121 This prescription is valid for a period not exceeding 3 months and shall be used only once. 1' 1 This prescription shall be kept for a period of not less than three years from the date from which the prescription is filled by the veterinarian. 1' 1 Disease to be treated shall be entered only on Veterinarian's copy. Manufactu rer's or Authorised Distributor's Original B 3552 No: MINISTERU GHALL-AFFARIJIET RURALI U ~, MINISTRY FOR RURAL AFFAIRS AND L-AMBJENT THE ENVIRONMENT Taqsimt, w · I-Ike/ u Auivita · Veterina,ja MALTA Food and Veterinary Regulation Di,iision PART A: TO BE COMPLETED BY THE PRESCRIBING VETERINARIAN Surname and forename of veterinarian Name of house or clinic Street Village Postal Code Name or business name and address of manufacturer and supplier of the medicated feedlngstuff Street Village Postal code Name and address of stockfarmer or holder of animals / chum no. /stamp / stable no. Street Village Postal Code Identification and number of animals Number Species Stamp /Tag Breed Sex Category Tattoo I Microchip 1. 2. 3. Disease to be treated 131 Designation of authorised medicated pre-mixes Quantity of medicated feedlngstuff In kilograms Special Instructions for the stockfarmer or holder of the animals Percentage of medicated Frequency of Duration of Withdrawal time In days feedlngstuff In the dally treatment treatment In days Eggs Meat MIik ration 1. 2. 3. Date when prescription was Personal signature of Registration Number Stamp filled veterinarian Day I Month I Year I I PART B: TO BE COMPLETED BY THE MANUFACTURER OR AUTHORISED DISTRIBUTOR Date of delivery Day I Month I Year I To be used before Day I Month I Year I Date when prescription was Signature of manufacturer or suppller Stamp of manufacturer or suppller presented Day I Month I Year I I 11> To be filled in accordance with sub-rule 8 (1) (b). 12> This prescription shall be sent by manufacturer or authorised distributor to the Food and Veterinary Regulation Division within 5 days of presentation of this prescription. l'J Disease to be treated shall be entered only on Veterinarian's copy. Food and Veterinary Regulation Division Copy B 3553 No: ~ MINISTERU GHALL-AFFARIJIET RURALI U ~, MINISTRY FOR RURAL AFFAIRS AND L-AMBJENT THE ENVIRONMENT Taqsima la ' I-Ike/ 11 A11ivila ' Ve1eri11arja MALTA Food and Ve1erinary Reg11/a1ion Division PART A: TO BE COMPLETED BY THE PRESCRIBING VETERINARIAN Surname and forename of veterinarian Name of house or clinic Street VIiiage Postal Code Name or business name and address of manufacturer or supplier of the medicated feedlngstuff Street Village Postal code Name and address of stockfarmer or holder of animals / chum no. I stamp I stable no. Street Village Postal Code Identification and number of animals Number Species Stamp /Tag Breed Sex Category Tattoo/ Microchip 1, 2, 3, Disease to be treated 131 Designation of authorised medicated pre-mixes Quantity of medicated feedlngstuff In kilograms Special Instructions for the stockfarmer or holder of the animals Percentage of medicated Frequency of Duration of Withdrawal time In days feedlngstuff In the dally treatment treatment In days Eggs Meat MIik ration 1, 2, 3, Date when prescription was Personal signature of Registration Number Stamp filled veterinarian Day I Month I Year I I PART B: TO BE COMPLETED BY THE MANUFACTURER OR AUTHORISED DISTRIBUTOR Date of delivery Day I Month I Year I To be used before Day I Month I Year I Date when prescription was Signature of manufacturer or supplier Stamp of manufacturer or supplier presented Day I Month I Year I I 1' 1 To be filled in accordance with sub-rule 8 (1) (b), 121 This prescription shall be kept for a period of not less than three years from the date when the prescription is filled by the veterinarian, 131 Disease to be treated shall be entered only on Veterinarian's copy. Veterinarian's Copy B 3554 Ippubblikat mid-Dipartiment ta’ l-Informazzjoni (doi.gov.mt) — Valletta — Published by the Department of Information (doi.gov.mt) — Valletta Mitbug[ fl-Istamperija tal-Gvern — Printed at the Government Printing Press Prezz 56ç – Price 56c Schedule II ACCOMPANYING CERTIFICATE IN RESPECT OF MEDICATED FEEDINGSTUFFS FOR ANIMALS INTENDED FOR TRADE Name and address of the manufacturer or approved distributor: ……………………………….. …………………………………………................................................................................................. ........................................................................................................................................................... ........................................................................................................................................................... Name of the medicated feedingstuff: ............................................................................................ ........................................................................................................................................................... Type of animal for which the medicated feedingstuff is intended: ............................................ Name and composition of the authorised medicated pre-mix: .................................................. ........................................................................................................................................................... Dosage of the medicated pre-mix authorised in the medicated feedingstuff: .......................... ........................................................................................................................................................... Quantity of medicated feedingstuff: ............................................................................................. Name and address of the recipient: .............................................................................................. ........................................................................................................................................................... ........................................................................................................................................................... It is hereby certified that the medicated feedingstuff as described above has been manufactured by an authorised person in accordance with Directive 90/167/EEC. Done at ..................................................................., on .................................................................. (place) (date) Stamp of the veterinary authority or other competent authority ........................................................................................ (Signature) (Name and position) ·····.... . ... ····· ···············