FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: Where immunological veterinary medicinal products consist of live organisms, especially those which could be shed by vaccinated animals, the potential risk to unvaccinated animals of the same or of any other potentially exposed species shall be evaluated.
Slovenian: Kadar imunološka zdravila za uporabo v veterinarski medicini vsebujejo žive organizme, posebno tiste, ki bi se lahko razširili prek cepljenih živali, je treba oceniti možna tveganja za necepljene živali iste živalske vrste ali za druge morebitno izpostavljene živalske vrste.
English: The particulars and documents which shall accompany the application for marketing authorization pursuant to Article 12(3)(j) and 13(1) shall be submitted in accordance with the requirements of section B.
Slovenian: Podrobne podatke ter dokumentacijo, ki spremlja vlogo za pridobitev dovoljenja za promet z zdravilom v skladu s členom 12(3)(j) ter 13(1) je treba predložiti v skladu z zahtevami oddelka B.
English: Member States shall ensure that the laboratory tests are carried out in conformity with the principles of good laboratory practice laid down in Council Directives 87/18/EEC and 88/320/EEC.
Slovenian: Države članice morajo zagotoviti, da bodo laboratorijski preskusi izvedeni v skladu z načeli dobre laboratorijske prakse, kakor to določata direktivi Sveta 87/18/EGS ter 88/320/EGS.
English: GENERAL REQUIREMENTS
Slovenian: SPLOŠNE ZAHTEVE
English: The safety tests shall be carried out in the target species.
Slovenian: Preskusi varnosti se morajo izvesti na ciljni živalski vrsti.
English: The dose to be used shall be that quantity of the product to be recommended for use and containing the maximum titre or potency for which the application is submitted.
Slovenian: Odmerek mora biti tista količina zdravila, ki je predlagana za uporabo ter mora vsebovati najvišji titer ali potenco, na katero se vloga nanaša.
English: The sample used for safety testing shall be taken from a batch or batches produced according to the manufacturing process described in the application for marketing authorization.
Slovenian: Vzorec za preskušanje varnosti mora biti vzet iz serije ali serij, izdelanih v skladu s procesom izdelave, opisanim v vlogi za pridobitev dovoljenja za promet z zdravilom.
English: LABORATORY TESTS
Slovenian: LABORATORIJSKI PRESKUSI
English: Safety of the administration of one dose
Slovenian: Varnost dajanja enega odmerka
English: The immunological veterinary medicinal product shall be administered at the recommended dose and by each recommended route of administration to animals of each species and category in which it is intended for use, including animals of the minimum age of administration.
Slovenian: Imunološko zdravilo za uporabo v veterinarski medicini je treba dajati v priporočenem odmerku ter na vsak predlagan način za vsako živalsko vrsto in kategorijo, ki ji je zdravilo namenjeno z, vključno z živalmi z najmanjšo starostjo, še primerno za dajanje zdravila.
English: The animals shall be observed and examined for signs of systemic and local reactions.
Slovenian: Živali je treba opazovati ter pregledovati na znake sistemskih ali lokalnih reakcij.
English: Where appropriate, these studies shall include detailed post-mortem macroscopic and microscopic examinations of the injection site.
Slovenian: Kjer je to ustrezno, morajo te študije vključevati podrobne post-mortem makroskopske in mikroskopske preiskave mesta injiciranja.
English: Other objective criteria shall be recorded, such as rectal temperature and performance measurements.
Slovenian: Zabeležiti je treba tudi ostala objektivna merila, kot so na primer rektalna temperatura ter meritve proizvodnosti.
English: The animals shall be observed and examined until reactions may no longer be expected, but in all cases, the observation and examination period shall be at least 14 days after administration.
Slovenian: Živali je treba opazovati in pregledovati dokler reakcij ni moč več pričakovati, vendar mora biti v vseh primerih doba opazovanja in pregledovanja najmanj 14 dni po dajanju zdravila.
English: Safety of one administration of an overdose
Slovenian: Varnost enkratnega dajanja zdravila v prekomernem odmerku
English: An overdose of the immunological veterinary medicinal product shall be administered by each recommended route of administration to animals of the most sensitive categories of the target species.
Slovenian: Prekomerni odmerek imunološkega zdravila za uporabo v veterinarski medicini je treba na priporočen način dajati živalim iz najbolj občutljivih kategorij ciljne živalske vrste.
English: The animals shall be observed and examined for signs of systemic and local reactions.
Slovenian: Živali je treba opazovati ter pregledovati na znake sistemskih in lokalnih reakcij.
English: Other objective criteria shall be recorded, such as rectal temperature and performance measurements.
Slovenian: Zabeležiti je treba tudi ostala objektivna merila, kot so rektalna temperatura ter meritve proizvodnosti.
English: The animals shall be observed and examined for at least 14 days after administration.
Slovenian: Živali je treba opazovati in pregledovati še najmanj 14 dni po dajanju zdravila.
English: Safety of the repeated administration of one dose
Slovenian: Varnost pri ponovljenem dajanju enega odmerka
English: Repeated administration of one dose may be required to reveal any adverse effects induced by such administration.
Slovenian: Možno je zahtevati ponovljeno dajanje enega odmerka zdravila, da se ugotovijo škodljivi učinki, ki jih povzroča tovrstno dajanje zdravila.
English: These tests shall be carried out on the most sensitive categories of the target species, using the recommended route of administration.
Slovenian: Te preskuse je treba izvesti pri najbolj občutljivih kategorijah ciljne živalske vrste, zdravilo pa je treba dajati na priporočeni način.
English: The animals shall be observed and examined for at least 14 days after the last administration for signs of systemic and local reactions.
Slovenian: Živali je treba opazovati in pregledovati najmanj 14 dni od zadnjega dne dajanja zdravila na znake sistemskih ali lokalnih reakcij.
English: Examination of reproductive performance
Slovenian: Pregled reproduktivnega delovanja
English: Examination of reproductive performance shall be considered when data suggest that the starting material from which the product is derived may be a potential risk factor.
Slovenian: Pregled reproduktivnga delovanja je treba izvesti takrat, kadar podatki nakazujejo, da bi lahko vhodna snov iz katere se zdravilo izdeluje, lahko predstavljala rizični faktor.
English: Reproductive performance of males and non-pregnant and pregnant females shall be investigated with the recommended dose and by each of the recommended routes of administration.
Slovenian: Reproduktivno sposobnost samcev ter brejih in nebrejih samic je treba preiskati tako, da se uporabi priporočen odmerek za vsak priporočen način dajanja zdravila.
English: In addition, harmful effects on the progeny, as well as teratogenic and abortifacient effects, shall be investigated.
Slovenian: Poleg tega je treba preučiti škodljive učinke na potomstvo, kot tudi teratogene in abortivne učinke.
English: These studies may form part of the safety studies described in paragraph 1.
Slovenian: Te študije so lahko del varnostnih študij, opisane v odstavku 1.
English: Examination of immunological functions
Slovenian: Pregled imunoloških funkcij
English: Where the immunological veterinary medicinal product might adversely affect the immune response of the vaccinated animal or of its progeny, suitable tests on the immunological functions shall be carried out.
Slovenian: V primeru, da bi imunološko zdravilo za uporabo v veterinarski medicini lahko imelo škodljivi učinek na imunski odziv cepljene živali ali vpliv na potomstvo, je treba izvesti ustrezne preskuse imunoloških funkcij.
English: Special requirements for live vaccines:
Slovenian: Posebne zahteve za živa cepiva:
English: Spread of the vaccine strain
Slovenian: Širjenje vakcinalnega seva
English: Spread of the vaccine strain from vaccinated to unvaccinated target animals shall be investigated, using the recommended route of administration most likely to result in the spread.
Slovenian: Preučiti je treba širjenje vakcinalnega seva iz cepljene na necepljeno ciljno žival, kadar se zdravilo daje na tisti priporočen način, pri katerem bi najverjetneje prišlo do širjenja.
English: Moreover, it may be necessary to investigate the spread to non target species which could be highly susceptible to a live vaccine strain.
Slovenian: Poleg tega je morda treba preučiti razširitev na neciljno živalsko vrsto, ki bi lahko bila močno dovzetna za živi vakcinalni sev.
English: Dissemination in the vaccinated animal
Slovenian: Diseminacija v cepljeni živali
English: Faeces, urine, milk, eggs, oral, nasal and other secretions shall be tested for the presence of the organism.
Slovenian: Blato, urin, mleko, jajca, izločki iz nosu in ust ter druge izločke je treba preskusiti na prisotnost organizmov.
English: Moreover, studies may be required of the dissemination of the vaccine strain in the body, with particular attention being paid to the predilection sites for replication of the organism.
Slovenian: Poleg tega se lahko zahtevajo študije diseminacije vakcinalnega seva v telesu, s posebno pozornostjo na predilekcijska mesta za replikacijo organizmov.
English: In the case of live vaccines for well established zoonotic diseases for food producing animals, these studies must be undertaken.
Slovenian: V primeru živega cepiva proti dobro znanim zoonoznim boleznim pri živalih za proizvodnjo hrane je izvedba teh študij potrebna.
English: Reversion to virulence of attenuated vaccines
Slovenian: Vračanje virulence atenuirani vakcini
English: Reversion to virulence shall be investigated with material from the passage level which is least attenuated between the master seed and the final product.
Slovenian: Vračanje virulence je treba raziskati z materialom iz stopnje prehoda med matično kulturo in končnim izdelkom, ki je najmanj oslabljen.
English: The initial vaccination shall be carried out using the recommended route of administration most likely to lead to reversion to virulence.
Slovenian: Začetno cepljenje je treba opraviti s priporočenim načinom dajanja zdravila, pri katerem bi najverjetneje prišlo do vračanje virulence.
English: At least five serial passages through animals of the target species shall be undertaken.
Slovenian: Treba je najmanj pet zaporednih prehodov skozi živali iz ciljne vrste.
English: Where this is not technically possible due to failure of the organism to replicate adequately, as many passages as possible shall be carried out in the target species.
Slovenian: Tam, kjer to tehnično ni izvedljivo zaradi nesposobnosti organizma, da bi se lahko ustrezno repliciral, je treba pri ciljni živalski vrsti izvesti največ možnih prehodov.
English: If necessary, in vitro propagation of the organism may be carried out between passages in vivo.
Slovenian: Po potrebi je treba izvesti in vitro razmnoževanje organizma med dvema in vivo prehodoma.
English: The passages shall be undertaken by the route of administration most likely to lead to reversion to virulence.
Slovenian: Prehode je treba izvesti s takim načinom dajanja zdravila, ki bi najverjetneje lahko privedel do vračanja virulence.
English: Biological properties of the vaccine strain
Slovenian: Biološke lastnosti vakcinalnega seva
English: Other tests may be necessary to determine as precisely as possible the intrinsic biological properties of the vaccine strain (e.g. neurotropism).
Slovenian: Potrebni bodo morda še drugi testi za določanje čim natančnejših bioloških lastnosti vakcinalnega seva (npr. nevrotropizem).
English: Recombination or genomic reassortment of strains
Slovenian: Rekombinacija ali genomske preureditve sevov
English: The probability of recombination or genomic reassortment with field or other strains shall be discussed.
Slovenian: Treba je podati obrazložitev verjetnosti rekombinacije genomske preureditve z divjimi ali drugimi sevi.
English: Study of residues
Slovenian: Študije zaostankov
English: For immunological veterinary medicinal products, it will normally not be necessary to undertake a study of residues.
Slovenian: Običajno pri imunoloških zdravilih za uporabo v veterinarski medicini ni treba izvajati študij zaostankov.
English: However, where adjuvants and/or preservatives are used in the manufacture of immunological veterinary medicinal products, consideration shall be given to the possibility of any residue remaining in the foodstuffs.
Slovenian: Vendar pa v primerih, ko se pri izdelavi imunoloških zdravil uporabljajo dodatki in/ali konzervansi, je treba upoštevati možnost zaostankov v živilih.
English: If necessary, the effects of such residues shall be investigated.
Slovenian: Po potrebi je treba preučiti učinke teh zaostankov.
English: Moreover, in the case of live vaccines for zoonotic diseases, the determination of residues at the injection site may be required in addition to the studies described in paragraph 6.2.
Slovenian: Poleg tega je v primeru živega cepiva proti zoonoznim boleznim možno zahtevati poleg študij, opisanih v odstavku 6.2, določitev zaostankov na mestu injiciranja.
English: A proposal for a withdrawal period shall be made and its adequacy shall be discussed in relation to any residue studies which have been undertaken.
Slovenian: Predlog karence zdravila je treba izdelati ter njeno ustreznost obrazložiti v povezavi z drugimi predhodno opravljenimi študijami o zaostankih.
English: Any known interactions with other products shall be indicated.
Slovenian: Treba je prikazati vse znane interakcije z drugimi zdravili.
English: FIELD STUDIES
Slovenian: TERENSKE ŠTUDIJE
English: Unless justified, results from laboratory studies shall be supplemented with supportive data from field studies.
Slovenian: Razen v primeru ko je to upravičeno, je treba rezultate laboratorijskih študij dopolniti s podatki iz študij na terenu.
English: ECOTOXICITY
Slovenian: EKOTOKSIČNOST
English: The purpose of the study of the ecotoxicity of an immunological veterinary medicinal product is to assess the potential harmful effects which the use of the product may cause to the environment and to identify any precautionary measures which may be necessary to reduce such risks.
Slovenian: Namen študije ekotoksičnosti imunološkega zdravila za uporabo v veterinarski medicini je ocena možnih škodljivih učinkov, ki bi jih uporaba zdravila lahko povzročila v okolju ter določitev previdnostnih ukrepov, potrebnih za zmanjševanje takih tveganj.
English: An assessment of ecotoxicity shall be compulsory for any application for marketing authorization for an immunological veterinary medicinal product other than applications submitted in accordance with Article 12(3)(j) and 13(1).
Slovenian: Ocena ekotoksičnosti je obvezna pri vsaki vlogi za izdajo dovoljenja za promet z imunološkim zdravilom za uporabo v veterinarski medicini, razen pri vlogah, ki so bile vložene v skladu s členoma 12(3)(j) in 13(l).
English: This assessment shall normally be conducted in two phases.
Slovenian: Oceno je treba izvesti v dveh fazah.
English: The first phase of the assessment shall always be carried out:
Slovenian: Prva faza ocene je vedno obvezna:
English: the investigator shall assess the potential extent of exposure of the environment to the product, its active substances, or relevant metabolites, taking into account:
Slovenian: preiskovalec mora oceniti potencialni obseg izpostavljenosti okolja zadevnemu zdravilu, njegovim zdravilnim učinkovinam ali ustreznim metabolitom, pri tem pa mora upoštevati:
English: the target species and the proposed pattern of use (e.g. mass medication or individual animal medication),
Slovenian: ciljne živalske vrste ter predlagano shemo uporabe (npr. masovno ali individualno zdravljenje živali),
English: the method of administration, in particular the likely extent to which the product will enter directly into environmental system,
Slovenian: način dajanja zdravila, še posebno obseg možnega prehajanja zdravila v okoljske sisteme,
English: the possible excretion of the product, its active substances or relevant metabolites into the environment by treated animals, persistence in such excretia,
Slovenian: možno izločanje zdravila, njegovih zdravilnih učinkovin ali ustreznih metabolitov iz zdravljenih živalih v okolje ter obstojnost teh izločkov,
English: the disposal of unused or waste product.
Slovenian: odlaganje neporabljenih ali odpadnih snovi.
English: Where the conclusions of the first phase indicate potential exposure of the environment to the product, the applicant shall proceed to the second phase and evaluate the potential ecotoxicity of the product.
Slovenian: V primeru, da zaključki iz prve faze nakazujejo potencialno izpostavljenost okolja zdravilu, mora predlagatelj izvesti še drugo fazo ter oceniti potencialno ekotoksičnost.
English: For this purpose, he shall consider the extent and duration of exposure of the environment to the product, and the information about the physical/chemical, pharmacological and/or toxicological properties of the compound obtained during the conduct of the other tests and trials required by this Directive.
Slovenian: V ta namen mora upoštevati obseg ter trajanje izpostavljenosti okolja zdravilu ter informacije, pridobljene med izvajanjem ostalih preskusov in preskušanj, ki jih zahteva ta direktiva, o fizikalno-kemijskih, farmakoloških in/ali toksikoloških lastnostih spojine.
English: Where necessary, further investigations on the impact of the product (soil, water, air, aquatic systems, non-target organisms) shall be carried out.
Slovenian: Kadar je to potrebno, je treba izvesti nadaljnje študije o vplivih zdravila (zemlja, voda, zrak, vodni sistemi, ne-ciljni organizmi).
English: These further investigations shall be carried out in accordance with the test protocols laid down in Annex V to Council Directive 67/548/EEC or where an end point is not adequately covered by these protocols, in accordance with other internationally recognized protocols on the immunological veterinary medicinal product and/or the active substances and/or the excreted metabolites as appropriate.
Slovenian: Te nadaljnje študije je treba izvesti v skladu s protokoli preskušanj, ki jih določa Priloga V k Direktivi Sveta 67/548/EGS, ali, kjer končni cilj v protokolih ni ustrezno zajet, v skladu z drugimi mednarodno priznanimi protokoli o imunoloških zdravilih za uporabo v veterinarski medicini in/ali zdravilnih učinkovinah in/ali izločenih metabolitih, kakor je ustrezno.
English: The number and types of tests and the criteria for their evaluation shall depend upon the state of scientific knowledge at the time the application is submitted.
Slovenian: Število in vrste preskusov ter merila za vrednotenje so odvisni od stopnje znanstvenega napredka v času, ko je bila vloga vložena.
English: PART 8
Slovenian: DEL 8
English: Efficacy trials
Slovenian: Preskušanje učinkovitosti
English: The purpose of the trials described in this Part is to demonstrate or to confirm the efficacy of the immunological veterinary medicinal product.
Slovenian: Namen preskušanj, ki jih opisuje ta del, je dokazati ali potrditi učinkovitost imunoloških zdravil za uporabo v veterinarski medicini.
English: All claims made by the applicant with regard to the properties, effects and use of the product, shall be fully supported by results of specific trials contained in the application for marketing authorization.
Slovenian: Vse trditve predlagatelja glede lastnosti, učinkov ter uporabe zdravila morajo biti podprte z rezultati specifičnih preskušanj, in jih mora vsebovati vloga za pridobitev dovoljenja za promet z zdravilom.
English: The particulars and documents which shall accompany applications for marketing authorizations pursuant to Article 12(3)(j) and 13(1) shall be submitted in accordance with the provisions below.
Slovenian: Podrobni podatki ter dokumentacija, ki spremlja vlogo za pridobitev dovoljenja za promet z zdravilom v skladu s členom 12(3)(j) ter 13(1) mora biti vložena v skladu s spodaj navedenimi določili.
English: All veterinary clinical trials shall be conducted in accordance with a fully considered detailed trial protocol which shall be recorded in writing prior to commencement of the trial.
Slovenian: Vsa veterinarska klinična preskušanja je treba izvesti v skladu v točno določenim protokolom preskušanja, ki mora biti pisno dokumentiran pred začetkom preskušanja.
English: The welfare of the trial animals shall be subject to veterinary supervision and shall be taken fully into consideration during the elaboration of any trial protocol and throughout the conduct of the trial.
Slovenian: Zaščita poskusnih živali mora biti pod veterinarskim nadzorom ter jo je treba v celoti upoštevati med izvajanjem katerega koli protokola preskušanja ter skozi celotno izvajanje preskušanja.
English: Pre-established systematic written procedures for the organization, conduct, data collection, documentation and verification of clinical trials shall be required.
Slovenian: Potrebni so predhodno določeni sistematični pisni postopki organizacije, izvajanja, zbiranja podatkov, dokumentiranja ter preverjanja kliničnih preskušanj.
English: Before the commencement of any trial, the informed consent of the owner of the animals to be used in the trial shall be obtained and documented.
Slovenian: Pred začetkom vsakega preskušanja je za uporabo živali v preskušanju treba pridobiti in dokumentirati soglasje lastnika.
English: A copy of this notification, countersigned and dated by the animal owner, shall be included in the trial documentation.
Slovenian: Kopijo tega obvestila, podpisano in datirano s strani lastnika živali, je treba vključiti v dokumentacijo o preskušanju
English: Unless the trial is conducted with a blind design, the provisions of Articles 58, 59 and 60 shall apply by analogy to the labelling of formulations intended for use in veterinary clinical trials.
Slovenian: Razen v primeru, če je bilo preskušanje izvedeno s slepim testom, se morajo določila členov 58, 59 in 60 glede označevanja analogno nanašati na označevanje formulacij, namenjenih za uporabo v veterinarskih kliničnih preskušanjih.
English: In all cases, the words "for veterinary clinical trial use only" shall appear prominently and indelibly upon the labelling.
Slovenian: V vseh primerih mora biti na nalepki jasen in neizbrisljiv napis "samo za uporabo v veterinarskem kliničnem preskušanju".
English: The choice of vaccine strains shall be justified on the basis of epizoological data.
Slovenian: Izbor seva vakcin je treba upravičiti glede na epizoološke podatke.
English: Efficacy trials carried out in the laboratory shall be controlled trials, including untreated control animals.
Slovenian: Preskušanje učinkovitosti, izvedeno v laboratoriju, morajo biti kontrolirani preskusi in vključevati nezdravljene kontrolne živali.
English: In general, these trails shall be supported by trials carried out in field conditions, including untreated control animals.
Slovenian: Na splošno morajo biti ta preskušanja podprta s preskušanji, izvedenimi v terenskih pogojih, vključno z nezdravljenimi kontrolnimi živalmi.
English: All trials shall be described in sufficiently precise details so as to be reproducible in control trials, carried out at the request of the competent authorities.
Slovenian: Vsa preskušanja je treba opisati dovolj podrobno, da bi jih bilo možno ponoviti v kontrolnih preskušanjih, ki se opravljajo na zahtevo pristojnih organov.
English: The investigator shall demonstrate the validity of all the techniques involved.
Slovenian: Preiskovalec mora izkazati veljavnost vseh uporabljenih tehnik.
English: All results shall be presented as precisely as possible.
Slovenian: Vse rezultate je treba predstaviti karseda natančno.
English: All results obtained, whether favourable or unfavourable, shall be reported.
Slovenian: Poročati je treba o vseh dobljenih rezultatih, bodisi ugodnih ali neugodnih.