Prohibition on the Use in Stock-Farming of Substances having a Hormonal or Thyrostatic Action and of Betaagonists Rules, 2005 (L.N. 96 of 2005)

B 1363 A.L. 96 ta’ l-2005 ATT DWAR IS-SERVIZZI VETERINARJI (KAP. 437) Regoli tal-2005 dwar Projbizzjoni ta’ l-U]u ta’ Sustanzi li G[andhom Azzjoni Ormonali jew Tirostatika u ta’ Betaagnosti fit-Trobbija ta’ l-Annimali BIS-SA{{A tas-setg[a mog[tija bl-artikolu 13(a) ta’ l-Att dwar is-Servizzi Veterinarji, il-Ministru g[all-Affarijiet Rurali u l-Ambjent g[amel dawn ir-regoli li ;ejjin> 1. (1) It-titolu ta’ dawn ir-regoli huwa Regoli ta’ l-2004 dwar il-Projbizzjoni ta’ l-U]u ta’ Sustanzi li G[andhom Azzjoni Ormonali jew Tirostatika u ta’ Betaagnosti fit-Trobbija ta’ l-Annimali. (2) L-iskop ta’ dawn ir-regoli hu l-implimetazzjoni tar-regoli mni]]la ta[t id-Direttiva tal-Kunsill ta’ l-Unjoni Ewropea 96#22#KEE dwar il-Projbizzjoni ta’ l-U]u ta’ Sustanzi li G[andhom Azzjoni Ormonali jew Tirostatika u ta’ Betaagnosti fit-Trobbija ta’ l-Annimali. 2. G[all-finijiet ta’ dawn ir-regoli, u kemm-il darba r-rabta tal kliem ma tkunx te[tie; mod ie[or – “annimali ta’ l-irziezet” tfisser annimali domestiçi ta’ l-ispeçi bovina, porçina, ovina u kaprina, annimali domestiçi li g[andhom difrejhom sodi (solipeds), tjur u fniek, kif ukoll annimali selva;;i ta’ dawk l-ispeçi u ruminanti selva;;i li jkunu ;ew imrobbija f’razzett< “l-awtorità kompetenti” tfisser is-Servizzi Veterinarji kif provdut ta[t artikolu 2 ta’ l-Att dwar is-Servizzi Veterinarji< “il-Komunità” tfisser il-Komunità Ewropea kif stabbilita mit Trattat li jistabilixxi l-Komunità Ewropea< “il-Kummissjoni” tfisser il-Kummissjoni Ewropea< “Stat Membru” tfisser Stat li huwa Membru fil-Komunità Ewropea< Titolu u skop. Tifsir. Suppliment tal-Gazzetta tal-Gvern ta’ Malta, Nru. 17,752, 8 ta’ April, 2005 Taqsima B –––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– B 1364 “trattament illegali” tfisser l-u]u ta’ sustanzi jew prodotti mhux awtorizzati jew l-u]u ta’ sustanzi jew prodotti awtorizzati minn kull li;i o[ra ghal ra;unijet jew ta[t kundizzjonijet differenti minn dawk stipulati f’kull li;i o[ra< “trattament terapewtiku” tfisser l-amministrazzjoni, stipulata fir-regola 4 ta’ dawn ir-regoli, lil annimal ta’ razzett individwali, ta’ sustanza awtorizzata sabiex tikkura, wara e]ami minn veterinarju, problema ta’ fertilità inklu]a t-terminazzjoni ta’ ;estazzjoni mhux mixtieqa u, fil-ka] ta’ betaagonisti, sabiex tikka;una tokolosi f’baqar tqal u sabiex tikkura problemi respiratorji u sabiex jikka;unaw tokolosi f’equidae mrobbija g[al ra;unijiet o[ra barra minn dawk ta’ produzzjoni tal-la[am< “trattament zootekniku” tfisser l-amministrazzjoni> (a) lill-annimal tar-razzett individwali ta’ kull sustanza awtorizza kif stipulat fir-regola 6 ta’ dawn ir-regoli g[as sinkronizzar taç-çiklu sesswali u l-preparazzjoni ta’ donaturi u reçipjenti g[all-implantazzjoni tal-embrijoni, wara e]ami ta’ l-annimal minn veterinarju jew, skond it-tieni paragrafu tar-regola 6, ta[t ir-responsabbiltà tieg[u< (b) fil-ka] ta’ annimali akwatici, lil grupp ta’ annimali mrobbija g[at-tnissil g[all-inver]joni tas-sess, fuq preskrizzjoni tal-veterinarju u ta[t ir-responsabbilità tieg[u. 3. F’Malta, dan li ;ej ikun projbit (i) it-tqeg[id fis-suq ta’ stilbenes, derivattivi ta’ l-istilbene, il-mel[ u esters tag[hom u sustanzi tirostatiçi biex ji;u amministrati lill-annimali ta’ kull speçi< (ii) it-tqeg[id fis-suq ta’ betaagonisti biex ji;u amministrati lill-annimali, meta dak il-la[am u prodotti huma inti]i g[all konsum mill-bniedem, g[al ra;unijiet o[ra barra minn dawk stipulati fis-sub-paragrafu (ii) tar-regola 5. 4. F’Malta, dawn li ;ejjin g[andhom ji;u wkoll projbiti (i) l-amministrazzjoni lill-annimali tar-razzett jew akwatiku, permezz ta’ kull metodu, ta’ sustanzi li g[andhom azzjoni tirostatika, ostro;enika, andro;enika jew ;esta;enika u ta’ betaagonisti< Projbizzjonijiet f’Malta. Projbizzjonijiet o[ra f’Malta. B 1365 (ii) i]-]amma, minbarra ta[t kontroll uffiçjali, ta’ annimali msemmija f’paragrafu (i) fir-razzett, it-tqeg[id fis-suq jew qatla g[al konsum mill-bniedem ta’ annimali tar-razzett jew annimali akwatici li jkollhom sustanzi msemmija f’paragrafu (i) jew fejn il pre]enza ta’ sustanzi b[al dawn tkun ;iet stabbilita, sakemm ma ting[atax prova illi l-annimali in kwistjoni ;ew ikkurati skond ir regoli 5 jew 6< (iii) it-tqeg[id fis-suq g[al konsum mill-bniedem ta’ annimali akwatici li ;ew amministrati b’sustanzi msemmija f’paragrafu (i) u ta’ prodotti proçessati derivanti minn annimali b[al dawn< (iv) it-tqeg[id fis-suq ta’ la[am ta’ annimali msemmija f’paragrafu (b) < (v) l-ipproçessar ta’ la[am imsemmi f’paragrafu (iv). 5. Minkejja d-dispo]izzjonijiet f’regoli 3 u 4, g[andu jkun awtorizzat dan li ;ej> (i) l-amministrazzjoni lill-annimali tar-razzett, g[al ra;unijiet terapewtici, ta’ ßoestradiol 17, testosterone u progesterone u derivattivi li jirrilaxxaw f’[in qasir il-kompost prinçipali ma’ l-idrolisi wara li ji;i assorbit fil-lok ta’ applikazzjoni> I]da prodotti mediçinali veterinarji w]ati g[at-trattament terapewtiku g[andhom jaqblu mar-rekwi]iti g[at-tqeg[id fis-suq stabbiliti fid-direttiva tal-Unjoni Ewropea 81#851#EEC u ji;u amministratti minn veterinarju biss, permezz ta’ injezzjoni jew g[at-trattament ta’ malfunzjoni ta’ l-ovarji permezz ta’ spirali va;inali, i]da mhux permezz ta’ implant, lill-annimali tar-razzett li jkunu ;ew identifikati b’mod çar. Trattament ta’ annimali identifikati g[andu ji;i re;istrat mill-veterinarju responsabbli. Dan ta’ l-a[[ar g[andu jni]]el g[all-inqas dawn id-dettalji li ;ejjin f’re;istru, li jista’ jkun dak stabbilit fid-direttiva tal-Unjoni Ewropea 81#851#EEC – (a) it-tip ta’ trattament< (b) it-tip ta’ prodotti awtorizzati< (ç) id-data tat-trattament< (d) l-identità ta’ l-annimali kkurati. E]enzjonijiet minn projbizzjonijiet. B 1366 I]da wkoll ir-re;istru g[andu jkun disponnibli g[as-Servizzi Veterinarji meta dawn jitolbuh< (ii) l-amministrazzjoni g[al ra;unijiet terapewtiçi ta’ prodotti mediçinali veterinarji awtorizzati li g[andu jkun fihom> (a) allyl trenbolone, amministrat oralment, jew betaagonisti g[al equidae u annimali domestiçi mansi, sakemm dawn huma w]ati skond l-istruzzjonijiet pprovduti mill-manifattur< (b) betaagonisti, fl-g[amla ta’ injezzjoni sabiex jikka;unaw tokolosi fil-baqar tqal. Sustanzi b[al dawn g[andhom ji;u amministrati minn veterinarju jew, fil-ka] tal-prodotti mediçinali veterinarji msemmija f’paragrafu (a) hawn qabel, ta[t ir-responsabbiltà diretta tieg[u< trattament g[andu ji;i re;istrat mill-veterinarju responsabbli, li g[andu jni]]el g[all-inqas id-dettalji msemmija f’paragrafu (i). Il-bdiewa g[andhom ikunu pprojbiti milli j]ommu prodotti medeçinali veterinarji li jkollhom betaagonisti li jistg[u ji;u w]ati g[al ra;unijiet ta’ induzzjoni fit-trattament tat-tokolosi. Madankollu, ming[ajr pre;udizzju g[all-ewwel subparagrafu tal-punt (b) ta’ dan il-paragrafu, it-trattament terapewtiku ta’ annimali g[all-produzzjoni, inklu] annimali g[at-tnissil fl-a[[ar tal-[ajja riproduttiva tag[hom, huwa projbit. 6. (1) Minkejja regola 4(i) u ming[ajr pre;udizzju g[ar-regola 3, l-amministrazzjoni lill-annimali tar-razzett hija awtorizzata, g[al ra;unijiet ta’ trattament zootekniku, ta’ prodotti mediçinali veterinarji li g[andhom azzjoni estro;enika, andro;enika jew ;esta;enika li huma awtorizzata skond id-direttiva ta’ l-Unjoni Ewropea 81#851#EEC u 81#852#EEC. Prodotti mediçinali veterinarji b[al dawn g[andhom ji;u amministrati minn veterinarju lill-annimali identifikati b’mod çar< it trattament g[andu jigi mni]]el mill-veterinarju responsabbli skond ir regola 5 (i)> I]da s-Servizzi Veterinarji jistg[u jippermettu s-sinkronizazzjoni taç-çiklu sesswali u preparazzjoni ta’ donaturi u reçipjenti biex isir impjant ta’ embrijuni li ma jkunux se jsiru mill-veterinarju direttament, i]da ta[t ir-responsabbilita tieg[u. (2) Fir-rigward ta’ l-annimali fl-akwakultura, [ut li g[adu ]g[ir jista’ ji;i kkurat g[all-ewwel tlett xhur g[ar-ra;uni ta’ inversjoni ?ertu trattamenti permessi. B 1367 ta’ sess permezz ta’ prodotti mediçinali veterinarji li g[andhom azzjoni andro;ena u li huma awtorizzati skond id-direttiva tal-Unjoni Ewropea 81#851#EEC u 81#852#EEC. (3) Fil-ka]ijiet stipulati f’din ir-regola, il-veterinarju g[andu jag[mel riçetta li ma tistax ti;i m;edda, u jispeçifika l-kura in kwistjoni u l-kwantita’ tal-prodott neçessarju u g[andu jni]]el il-prodotti preskritti> I]da trattament zootekniku ta’ annimali tal-produzzjoni, inklu] matul il-perjodu ta’ t[axxin g[all-annimali tat-tnissil fl-a[[ar tal-[ajja riproduttiva tag[hom, huwa projbit. 7. (1) Prodotti ormonali u Betaagonisti li huma awtorizzati skond ir-regoli 5 u 6 sabiex ji;u amministrati lill-annimali f’razzett, g[andhom ikunu skond il-[ti;ijiet stabbiliti fid-direttivi tal-Unjoni Ewropea 81#851#EEC u 81#852#EEC. (2) Madankollu is-segwenti mhumiex awtorizzati skond is subregola (1) (a) dawn il-prodotti ormonali> (i) prodotti li ja;ixxu ta’ depositi< (ii) prodotti b’withdrawal period ta’ iktar minn 15-il ;urnata wara t-tmiem tat-trattament< (iii) prodotti> (1) li huma awtorizzati ta[t regoli li jippreçedu xi li;i nazzjonali li tistabbilixxi proçeduri in konformita’ ma’ ftehim internazzjonali g[all-awtorizazzjoni u s supervi]joni ta’ prodotti mediçinali g[all-u]u mill bniedem u dak veterinarju, (2) li l-kundizzjonijiet ta’ u]u tag[hom mhumiex mag[rufa, (3) jew fejn ma je]istux rea;enti jew apparat g[all-u]u fit-tekniçi analitiçi sabiex tinstab il-pre]enza ta’ residwi li jeççedu l-limiti permessi, (b) prodotti mediçinali veterinarji li fihom betaagonisti li g[andhom withdrawal period ta’ iktar minn 28 ;urnata wara t tmiem tat-trattament. Awtorizazzjoni ta’ amministrazzjoni ta’ prodotti ormonali u Betaagonisti. B 1368 8. (1) G[all-fini ta’ kummerç, huwa permess, it-tqeg[id fis suq ta’ annimali g[at-tnissil u annimali g[at-tnissil fl-a[[ar tal-[ajja riproduttiva tag[hom illi, matul dak il-perjodu ta’ l-a[[ar, ikunu [adu trattament msemmi fir-regoli 5 u 6 biex jista’ ji;i awtorizzat l-affissjoni ta’ marki ta’ sa[[a ta’ Skeda I, Kapitolu XI, (50) tad-direttivi ta’ l Unjoni Ewropea 64#433#EEC fuq la[am minn annimali b[al dawn fejn il-kundizzjonijiet stipulati fir-regoli 5 u 6 u l-withdrawal periods minimi stipulati f’regola 7(2), ta[t l-paragrafu (a) (ii) jew (b) rispettivament jew il-withdrawal periods stipulati fl-awtorizazzjoni g[at-tqeg[id fis suq, ji;u m[arsa> I]da l-kummerç fi ]wiemel ta’ valur g[oli, u b’mod partikolari ]wiemel tal-;iri, ]wiemel tal-kompetizzjonijiet, ]wiemel taç-çirku u ]wiemel intenzjonati g[at-tnissil jew g[all-esibizzjonijiet, inklu]i equidae re;istrati li ;ew amministrati bi prodotti mediçinali veterinarji li fihom allyl trenbolone jew betaagonisti g[ar-ra;unijiet imsemmija f’regola 5, jista’ jsir qabel it-tmiem tal-withdrawal period, sakemm il kundizzjonijiet marbuta ma’ l-amministrazzjoni jkunu m[arsa u t-tip u d-data tal-kura huma mni]]la fiç-çertifikat jew fil-passaport li jakkumpanja dawn l-annimali. (2) La[am jew prodotti minn annimali li ;ew amministrati b’sustanzi li g[andhom azzjoni estro;enika, andro;enika jew ;esta;enika jew betaagonisti skond il-provvedimenti ta’ dispensa ta’ dawn ir-regoli ma jistg[ux jitqeg[du fis-suq g[all-konsum mill-bniedem, [lief meta l-annimali in kwistjoni ;ew ikkurati minn prodotti mediçinali veterinarji li j[arsu l-[ti;ijiet f’regola 7 u sakemm il-withdrawal period stipulat ikun ;ie osservat qabel ma l-annimali jkunu ;ew maqtula. 9. F’Malta (i) fil-perjodu ta’ l-importazzjoni, manifattura, [a]na, distribuzzjoni, bejg[ u u]u tas-sustanzi msemmija f’regoli 3 u 4 (i), il-pussess tag[hom huwa ristrett g[all-persuni awtorizzati minn kull li;i o[ra skond l-Artiklu 1 (5) tad-direttiva tal-Unjoni Ewropea 81#851#EEC< (ii) flimkien mal-kontrolli stipulati fl-Ordnijiet li jirregolaw it-tqeg[id fis-suq tad-diversi prodotti in kwistjoni, il-kontrolli uffiçjali stipulati fl-Artiklu 11 tad-direttiva ta’ l-Unjoni Ewropea 96#23#EEC isiru mill-awtoritajiet kompetenti nazzjonali ming[ajr preavviz, bil-[sieb li ji;i zgurat> (a) il-pusses jew pre]enza ta’ sustanzi jew prodotti projbiti ta[t ir-regola 3, inti]i biex ji;u amministrati lill annimali sabiex jit[axxnu< Kummerç, tnissil u marki ta’ sa[[a relattivi. Pusses u u]u ta’ sustanzi minn persuni awtorizzati. B 1369 (b) it-trattament illegali ta’ l-annimali< (c) in-nuqqas ta’ osservazzjoni tal-withdrawal periods stipulati f’regola 7< (d) in-nuqqas ta’ osservazzjoni tar-restrizzjonijiet fuq l-u]u ta’ çertu sustanzi jew prodotti stipulati f’regoli 5 u 6< (iii) l-e]amijiet g[all-pre]enza ta’ (a) sustanzi msemmija f’punt (i) fl-annimali, fl-ilma tax-xorb ta’ l-annimali u fil-postijiet kollha fejn jitrabbew jew jin]ammu l-annimali< (b) residwi tas-sustanzi msemmija hawn qabel f’annimali [ajjin, fil-[mie; u fil-fluwidi tag[hom u fit-tessuti u fil-prodotti ta’ l-annimali isiru skond l-Iskedi III u IV tad direttiva 96#23#EEC< (iv) fejn il-kontrolli stipulati f’punti (ii) u (iii) juru> (a) il-pre]enza ta’ sustanzi jew prodotti li l-u]u jew pussess tag[hom huwa projbit, jew il-pre]enza ta’ residwi ta’ sustanzi li l-amministrazzjoni tag[hom taqa’ ta[t il-kap ta’ trattament illegali, dawn is-sustanzi jew prodotti huma konfiskati, filwaqt illi kull annimal ikkurat jew il-la[am tag[hom jitqieg[ed ta[t supervi]joni uffiçjali sakemm ji;u applikati l-penali neçessarji< (b) nuqqas ta’ [arsien mar-rekwi]iti ta paragrafi (ii) (b) u (c) is-Servizzi Veterinarji g[andhom jie[du l-mi]uri adatti konsistenti mal-gravita’ tal-ksur ta’ li;i. 10. (1) Ming[ajr pre;udizzju g[ad-direttiva 81#851#KEE, persuni fi s[ab li jixtru jew jipproduçu sustanzi li g[andhom azzjoni tirostatika, estro;enika, andro;enika jew ;esta;enika u betaagonisti, persuni bi s[ab awtorizzati fi kwalunkwe kapaçità li jqeg[du fis-suq sustanzi b[al dawk u persuni fi s[ab li jixtru jew jipproduçu prodotti mediçinali veterinarji u farmaçewtiçi minn sustanzi b[al dawn, g[andhom i]ommu re;istri li jkollhom dettalji, f’ordni kronolo;iku, tal-kwantitajiet prodotti jew akwistati u dawk mibjug[in jew u]ati g[all produzzjoni ta’ prodotti mediçinali veterinarji u farmaçewtiçi u l-ismijiet tal-persuni li lilhom ikunu ;ew mibjug[a dawn il-kwantitajiet jew ming[and min inxtraw. }amma ta’ re;istri ta’ sustanzi. B 1370 (2) L-informazzjoni f’sub-regola (1) hawn fuq g[andha tkun disponnibli g[all-awtorita’ kompetenti meta din titlobhom u, fil-ka] ta’ informazzjoni li tin]amm f’kompjuter, fil-forma ta’ karta stampata. 11. Meta r-ri]ultati ta’ kontrolli li saru f’Malta juru nuqqas ta’ [arsien tar-rekwi]iti ta’ dawn ir-regoli fil-pajji] ta’ ori;ini ta’ l-annimali jew prodotti, l-awtorita’ kompetenti g[andha tirrikorri g[all provvedimenti me[uda skond il-proçedura stipulata f’Artiklu RE1 ta’ l-Att dwar is-Servizzi Veterinarji dwar l-assistenza reçiproka bejn awtoritajiet amministrattivi ta’ Malta u ta’ l-Istati Membri sabiex ti;i ]gurata l-applikazzjoni korretta tal-le;islazzjoni f’materji veterinarji u zootekniçi. 12. (1) Pajji]i terzi li g[andhom le;islazzjoni li tawtorizza it tpo;;ija fis-suq u l-amministrazzjoni ta’ stilbenes, derivattivi ta’ stilbene, il-mel[ u esters tag[hom, jew ta’ sustanzi tirostatiçi biex ji;u amministrati lill-annimali ta’ kull speçje jista’ ma jidher fuq l-ebda wa[da mil-listi ta’ pajji]i stabbiliti bil-le;islazzjoni veterinarja li minnhom Malta tawtorizza l-importazzjoni ta’ annimali tar-razzett jew ta’ l-akwakultura jew la[am jew prodotti ;ejjin minn dawn l-annimali. (2) Hija projbita l-importazzjoni ;ewwa Malta minn terzi pajji]i fuq xi lista minn dawk imsemmija f’sub-regola (1)> (a) fil-ka] ta’ annimali tar-razzett jew ta’ l-akwakultura (i) li jkunu ;ew lilhom amministrati b’kull mezz prodotti jew sustanzi msemmija f’punt (i) ta’ regola 3< (ii) li jkunu ;ew lilhom amministrati sustanzi jew prodotti msemmija f’punt (i) tar-regola 4, [lief jekk dawk is sustanzi jew prodotti ;ew amministrati konformement mad dispo]izzjonijiet u mar-rekwi]iti stipulati f’regoli 5, 6 u 8 u l-withdrawal periods aççettati skond rakkomandazzjonijiet internazzjonali jkunu ;ew im[arsa< (b) la[am jew prodotti li ;ejjin minn annimali li l importazzjoni tag[hom hija projbita ta[t il-paragrafu (a). (3) Madankollu, annimali inti]i g[at-tnissil, annimali tat tnissil fl-a[[ar tal-[ajja riproduttiva tag[hom, jew la[am tag[hom, minn pajji]i terzi jistg[u ji;u impurtati jekk dawn jag[tu garanzija mill-inqas ekwikalenti g[al dawk stipulati f’dawn ir-regoli jew li jew li jkunu ;ew stabbiliti g[all-implimentazzjoni u l-inforzar tal-Kapitolu V tad-direttiva ta’ l-Unjoni Ewropea 96#23#KEE fuq mi]uri li g[andhom jittie[du fil ka] ta’ ksur ta’ li;i. (4) Kontrolli fuq importazzjoni minn terzi pajjizi ghandhom isiru skond l-Artiklu 17 (2) and (3) ta’ l-Att dwar is-Servizzi Veterinarji. Nuqqas ta’ [arsien tar-rekwiziti ta’ dawn ir-regoli. Limitazzjoni ta’ importazzjoni. B 1371 L.N. 96 of 2005 VETERINARY SERVICES ACT, 2001 (CAP. 437) Prohibition on the Use in Stock-Farming of Substances having a Hormonal or Thyrostatic Action and of Betaagonists Rules, 2005 IN exercise of the powers conferred under article 13(a) 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 Prohibition on the Use in Stock Farming of Substances having a Hormonal or Thyrostatic Action and of Betaagonists Rules, 2005. (2) The scope of these regulations is to implement the rules found under European Union Council Directive 96#22#EEC on the Prohibition on the Use in Stock-Farming of Certain Substances having a Hormonal or Thyrostatic Action and of Betaagonists. 2. For the purpose of these rules, and unless the context otherwise requires – “the Commission” means the European Commission< “the Community” means the European Community as established under the Treaty establishing the European Community< “Competent authority” means the Veterinary Services within the territory of Malta as provided under article 2 of the Veterinary Services Act< “farm animals” shall mean domestic animals of the bovine, porcine, ovine and caprine species, domestic solipeds, poultry and rabbits, as well as wild animals of those species and wild ruminants which have been raised on a holding< “illegal treatment” shall mean the use of unauthorised substances or products or the use of substances or products authorised under national legislation for purposes or under conditions other than those laid down in national legislation< “Member State” means a State which is a Member within the European Community< Title and scope and applicability. Definitions. B 1372 “therapeutic treatment” shall mean the administering under rule 4 of these rules to an individual farm animal of an authorised substance to treat, after examination by a veterinarian, a fertility problem including the termination of unwanted gestation and, in the case of betaagonists, to induce tocolysis in cows when calving and to treat respiratory problems and to induce tocolysis in equidae raised for purposes other than meat production< “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. “zootechnical treatment” shall mean the administering> (a) to an individual farm animal of any substance authorised under rule 6 of these rules for synchronising oestrus and preparing donors and recipients for the implantation of embryos, after examination of the animal by a veterinarian or, in accordance with the second paragraph of rule 6, under his responsibility< (b) in the case of aquaculture animals, to a group of breeding animals for sex inversion, on a veterinarian’s prescription and under his responsibility. 3. In the territory of Malta, the following shall be prohibited (i) the placing on the market of stilbenes, stilbene derivatives, their salts and esters and thyrostatic substances for administering to animals of all species< (ii) the placing on the market of betaagonists for administering to animals the flesh and products of which are intended for human consumption for purposes other than those provided for in sub-paragraph (ii) of rule 5. 4. In Malta, the following shall also be prohibited (i) the administering to a farm or aquaculture animal, by any means whatsoever, of substances having a thyrostatic, oestrogenic, androgenic or gestagenic action and of betaagonists< Prohibitions within Malta. Further prohibitions within Malta. B 1373 (ii) the holding, except under official control, of animals referred to in paragraph (i) on a farm, the placing on the market or slaughter for human consumption of farm animals or of aquaculture animals which contain the substances referred to in paragraph (i) or in which the presence of such substances has been established, unless proof can be given that the animals in question have been treated in accordance with rules 5 or 6< (iii) the placing on the market for human consumption of aquaculture animals to which substances referred to in paragraph (i) have been administered and of processed products derived from such animals< (iv) the placing on the market of meat of the animals referred to in paragraph (ii) < (v) the processing of the meat referred to in paragraph (iv). 5. Notwithstanding rules 3 and 4, in Malta, the following is authorised> (i) the administering to farm animals, for therapeutic purposes, of floestradiol 17, testosterone and progesterone and derivatives which readily yield the parent compound on hydrolysis after absorption at the site of application. Veterinary medicinal products used for therapeutic treatment must comply with the requirements for placing on the market laid down in Order (81#851) and be administered only by a veterinarian, by injection or for the treatment of ovarian dysfunction in the form of vaginal spirals, but not by implant, to farm animals which have been clearly identified. Treatment of identified animals must be registered by the veterinarian responsible. The latter must record at least the following details in a register, which may be the one provided for in Directive 81#851#EEC – (a) type of treatment< (b) the type of products authorised< (c) the date of treatment< (d) the identity of the animals treated. The register must be made available to the Veterinary Services at its request< Exemptions to prohibitions. B 1374 (ii) the administering for therapeutic purposes of authorised veterinary medicinal products containing> (a) allyl trenbolone, administered orally, or betaagonists to equidae and pets, provided they are used in accordance with the manufacturer’s instructions< (b) betaagonists, in the form of an injection to induce tocolysis in cows when calving. Such substances must be administered by a veterinarian or, in the case of the veterinary medicinal products referred to in paragraph (a) hereof, under his direct responsibility< treatment must be registered by the veterinarian responsible, who shall record at least the details referred to in point (i). Farmers shall be prohibited from holding veterinary medicinal products containing betaagonists which may be used for induction purposes in the treatment of tocolysis. However, without prejudice to the first subparagraph of point ii (b), therapeutic treatment of production animals, including breeding animals at the end of their reproductive life, shall be prohibited. 6. (1) Notwithstanding rule 4 (i) and without prejudice to rule 3, in Malta the administering to farm animals is authorised, for the purpose of zootechnical treatment, of veterinary medicinal products having an oestrogenic, androgenic or gestagenic action which are authorised in accordance with Orders (81#851) and (81#852). Such veterinary medicinal products must be administered by a veterinarian to clearly identified animals< the treatment must be recorded by the veterinarian responsible in accordance with rule 5 (i)> Provided that Veterinary Services may allow the synchronisation of oestrus and the preparation of donors and recipients for the implantation of embryos to be effected not by the veterinarian direct, but under his responsibility. (2) With regard to aquaculture animals, young fish may be treated for the first three months for the purpose of sex inversion with veterinary medicinal products that have an androgenous action and are authorised in accordance with Directives 81#851#EEC and 81#852#EEC. (3) In the cases provided for in this rule, the veterinarian shall make out a non-renewable prescription, specifying the treatment Certain treatments permitted within the Maltese territory. B 1375 in question and the quantity of the product required and shall record the products prescribed> Provided that zootechnical treatment of production animals, including during the fattening period for breeding animals at the end of their reproductive life, shall be prohibited. 7. (1) Hormonal products and Betaagonists the administration of which to farm animals is authorised in accordance with rules 5 and 6 must meet the requirements of Directives 81#851#EEC and 81#852#EEC. (2) The following are not, however, authorised in accordance with sub-rule (1) (a) the following hormonal products> (i) products acting as a deposit< (ii) products with a withdrawal period of more than 15 days after the end of treatment< (iii) products> (1) which were authorised under rules that preceded the national legislation laying down procedures in conformity with international agreement for the authorisation and supervision of medicinal products for human and veterinary use, (2) whose conditions of use are not known, (3) or which no reagents or equipment exist for use in the analytical techniques for detecting the presence of residues in excess of the permitted limits, (b) veterinary medicinal products containing betaagonists which have a withdrawal period of more than 28 days after the end of treatment. 8. (1) For the purpose of trade, it is permitted in Malta, the placing on the market of animals for breeding and breeding animals at the end of their reproductive life which, during the latter period, have undergone a treatment referred to in rules 5 and 6 and may authorise the affixing of the health mark of Annex I, Chapter XI, (50) of Directive 64#433#EEC to meat from such animals where the conditions laid down in rules 5 and 6 and the minimum withdrawal periods laid down in rule Authorisation of administration of hormonal products and Betaagonists. Trade, breeding and relative health marks. B 1376 7 (2), under paragraph (a) (ii) or (b) respectively or the withdrawal periods provided for in the authorisation to place on the market are complied with. However, trade in highvalue horses, and in particular racehorses, competition horses, circus horses or horses intended for stud purposes or for exhibitions, including registered equidae to which veterinary medicinal products containing allyl trenbolone or betaagonists have been administered for the purposes referred to in rule 5, may take place before the end of the withdrawal period, provided that the conditions governing administration are fulfilled and that the type and date of treatment are entered on the certificate or passport accompanying these animals. (2) Meat or products from animals to which substances having an oestrogenic, androgenic or gestagenic action or betaagonists have been administered in accordance with the dispensatory provisions of these regulations may not be placed on the market for human consumption unless the animals in question have been treated with veterinary medicinal products complying with the requirements of rule 7 and in so far as the withdrawal period laid down was observed before the animals were slaughtered. 9. Within the territory of Malta (i) at the time of the import, manufacture, storage, distribution, sale and use of the substances referred to in rules 3 and 4 (i), their possession is restricted to the persons authorised by national legislation in accordance with Article 1 (5) of Order (81#851)< (ii) in addition to the checks provided for in the Orders governing the placing on the market of the various products in question, the official checks provided for in Article 11 of Directive 96#23#EEC are carried out by the competent national authorities without prior notice, with a view to ascertaining> (a) the possession or presence of substances or products prohibited under rule 3, intended to be administered to animals for the purpose of fattening< (b) the illegal treatment of animals< (c) failure to observe the withdrawal periods provided for in regulation 7< Possession and use of substances by authorised persons. B 1377 (d) failure to observe the restrictions on the use of certain substances or products laid down in rules 5 and 6< (iii) the tests for the presence of> (a) the substances referred to in point (i) in animals, in the drinking water of animals and in all places where animals are bred or kept< (b) residues of the aforementioned substances in live animals, their excrement and body fluids and in animal tissues and products, are carried out in accordance with Annexes III and IV to Directive 96#23#EEC< (iv) where the checks provided for in points (ii) and (iii) reveal> (a) the presence of substances or products the use or possession of which is prohibited, or the presence of residues of substances the administering of which comes under the heading of illegal treatment, such substances or products are confiscated, while any animals treated or the meat therefrom is placed under official supervision until the requisite penalties have been applied< (b) failure to comply with the requirements of points (ii) (b) and (c), the Veterinary Services takes appropriate measures consistent with the gravity of the infringement. 10. (1) Without prejudice to Directive 81#851#EEC, undertakings buying or producing substances having a thyrostatic, oestrogenic, androgenic or gestagenic action and betaagonists, undertakings authorised in any capacity to market such substances and undertakings buying or producing pharmaceutical and veterinary medicinal products from such substances shall be required to keep registers detailing, in chronological order, quantities produced or acquired and those sold or used for the production of pharmaceutical and veterinary medicinal products and the names of the persons to whom such quantities were sold or from whom they were purchased. (2) The information in sub-rule (1) hereof shall be made available to the Veterinary Services at its request and, in the case of computerised records, in the form of a print-out. Keeping of registers of substances. B 1378 11. Where the results of checks carried out in the territory of Malta show failure to comply with the requirements of these regulations in the country of origin of the animals or products, the Veterinary Services shall have recourse to provisions taken according to the procedure laid down in Article RE1 of the Veterinary Framework Act on mutual assistance between the administrative authorities of Malta and of the Member States to ensure the correct application of legislation on veterinary and zootechnical matters. 12. (1) Third countries whose legislation authorizes the placing on the market and administration of stilbenes, stilbene derivatives, their salts and esters, or of thyrostatic substances for administering to animals of all species may not appear on any of the lists of countries provided for under veterinary legislation from which Malta authorizes to import farm or aquaculture animals or meat or products obtained from such animals. (2) In Malta, it is prohibited to import from third countries on any of the lists referred to in sub-rule (1) of> (a) farm or aquaculture animals (i) to which products or substances referred to in point (i) of rule 3 have been administered by any means whatsoever< (ii) to which substances or products referred to in point (i) of rule 4 have been administered, unless those substances or products were administered in compliance with the provisions and requirements laid down in rules 5, 6 and 8 and the withdrawal periods allowed in international recommendations have been observed< (b) meat or products obtained from animals the importation of which is prohibited under point (a). (3) However, animals intended for breeding, breeding animals at the end of their reproductive life, or meat there from, from third countries may be imported subject to their affording guarantees at least equivalent to those laid down in these regulations or which have been established for the implementation and enforcement of Chapter V of Directive 96#23#EEC on measures to be taken in the event of infringement. (4) Checks on imports from third countries shall be carried out in accordance with Article 17 (2) and (3) of the Veterinary Framework Act. Failure to comply with the requirements of these rules. Limitation of importation. 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 32ç – Price 32c