natgillin/translations-raw huggingface dataset:
In spite of the measures that farmers and other operators are obliged to take on the basis of rules adopted at Union level regarding health of kept animals, good animal husbandry, good hygiene, feed, management and biosecurity, animals can suffer from a broad range of diseases which need to be prevented or treated by veterinary medicinal products for both animal health and welfare reasons.
Živali lahko kljub ukrepom, ki jih morajo kmeti in drugi nosilci dejavnosti sprejeti na podlagi pravil, sprejetih na ravni Unije, glede zdravja gojenih živali, dobre reje živali, dobre higiene, krme, upravljanja in biološke varnosti, zbolijo za številnimi boleznimi, ki jih je treba preprečiti ali zdraviti z zdravili za uporabo v veterinarski medicini, da bi se zagotovila zdravje in dobrobit živali.
The impact of animal diseases and the measures necessary to control them can be devastating for individual animals, animal populations, animal keepers and the economy.
Učinek živalskih bolezni in ukrepi, potrebni za njihov nadzor, imajo lahko uničujoče posledice za posamezne živali, živalske populacije, imetnike živali in gospodarstvo.
Animal diseases transmissible to humans can also have a significant impact on public health.
Živalske bolezni, ki se prenašajo na ljudi, lahko tudi znatno vplivajo na javno zdravje.
Therefore sufficient and effective veterinary medicinal products should be available in the Union in order to ensure high standards of public and animal health, and for the development of the agriculture and aquaculture sectors.
Zato bi morala biti v Uniji na voljo zadostna in učinkovita zdravila za uporabo v veterinarski medicini za zagotovitev visokih standardov javnega zdravja in zdravja živali ter za razvoj sektorjev kmetijstva in akvakulture.
This Regulation should set high standards of quality, safety and efficacy for veterinary medicinal products in order to meet common concerns as regards the protection of public and animal health and of the environment.
Ta uredba bi morala določati visoke standarde kakovosti, varnosti in učinkovitosti zdravil za uporabo v veterinarski medicini, da se obravnavajo pogosta vprašanja v zvezi z varovanjem javnega zdravja, zdravja živali in okolja.
At the same time, this Regulation should harmonise the rules for the authorisation of veterinary medicinal products and the placing of them on the Union market.
Hkrati bi morala ta uredba harmonizirati pravila za pridobitev dovoljenja za promet z zdravili za uporabo v veterinarski medicini in njihovim dajanjem v promet v Uniji.
This Regulation should not apply to veterinary medicinal products which have not undergone an industrial process such as, for example, non-processed blood.
Ta uredba se ne bi smela uporabljati za zdravila za uporabo v veterinarski medicini, ki niso bila podvržena industrijskemu postopku, kot velja na primer za nepredelano kri.
Antiparasitics include also substances with repelling activity that are presented for use as veterinary medicinal products.
Antiparazitiki vključujejo tudi snovi z repelentnim delovanjem, ki se uporabljajo kot zdravila za uporabo v veterinarski medicini.
There is insufficient information to date on traditional herbal products used to treat animals in order to allow the setting up of a simplified system.
O tradicionalnih zdravilih rastlinskega izvora, ki se uporabljajo za zdravljenje živali, do zdaj ni bilo dovolj informacij, da bi lahko oblikovali poenostavljen sistem.
Therefore, the possibility of introducing such a simplified system should be examined by the Commission based on the information provided by the Member States on the use of such products on their territory.
Zato bi morala Komisija na podlagi informacij držav članic o uporabi takih proizvodov na njihovem ozemlju preučiti možnost uvedbe poenostavljenega sistema.
This Regulation applies to veterinary medicinal products, including those products which Directive 2001/82/EC referred to as ‘pre-mixes’ and which in this Regulation are considered to be a pharmaceutical form of a veterinary medicinal product, until such time as those products are included in medicated feed or intermediate products, after which Regulation (EU) 2019/4 of the European Parliament and of the Council applies to the exclusion of this Regulation.
Ta uredba se uporablja za zdravila za uporabo v veterinarski medicini vključno za zdravila, ki so v Direktivi 2001/82/ES navedena kot „premiks“ in ki se v tej uredbi obravnavajo kot farmacevtska oblika zdravila za uporabo v veterinarski medicini, dokler ta zdravila ne bodo vključena v medicirano krmo ali vmesne proizvode, po čemer se bo Uredba (EU) 2019/4 Evropskega parlamenta in Sveta uporabljala namesto te uredbe.
To ensure the proper administration and appropriate dosing of certain veterinary medicinal products which are to be administered orally in feed or drinking water to animals, especially in the case of treatment of groups of animals, such administration should be properly described in the product information.
Da se zagotovita ustrezno dajanje in odmerjanje nekaterih zdravil za uporabo v veterinarski medicini, ki jih je treba živalim dati peroralno prek krme ali v vodi za pitje, zlasti v primeru zdravljenja skupin živali, se način dajanja ustrezno opiše v informacijah o zdravilu.
Additional instructions for cleaning the equipment used for administration of those products should be set out to avoid cross-contamination and reduce antimicrobial resistance.
Zagotoviti bi bilo treba tudi dodatne informacije o čiščenju opreme, ki se uporablja za dajanje teh zdravil, da se prepreči navzkrižna kontaminacija in zmanjša odpornost mikrobov proti protimikrobnim snovem (v nadaljnjem besedilu: mikrobna odpornost).
In order to improve the effective and safe use of veterinary medicinal products authorised and prescribed for oral administration via routes other than medicated feed, such as mixing of water for drinking with a veterinary medicinal product or manual mixing of a veterinary medicinal product into feed and administered by the animal keeper to food-producing animals, the Commission should, where necessary, adopt delegated acts.
Komisija bi morala po potrebi sprejeti delegirane akte, da se izboljša učinkovita in varna uporaba zdravil za uporabo v veterinarski medicini, ki so odobrena in predpisana za peroralno dajanje na način, ki ni medicirana krma, kot je mešanje vode za pitje z zdravilom za uporabo v veterinarski medicini ali ročno mešanje zdravil za uporabo v veterinarski medicini v krmo, ki jo živalim, namenjenim za proizvodnjo hrane, daje njihov imetnik.
The Commission should take into account scientific recommendations of the European Medicines Agency, established by Regulation (EC) No 726/2004 (‘the Agency’), for example concerning measures to minimise over-dosage or under-dosage, unintended administration to non-target animals, the risk of cross-contamination and dissemination of those products in the environment.
Komisija bi morala upoštevati znanstvena priporočila Evropske agencije za zdravila, ustanovljene z Uredbo (ES) št. 726/2004 (v nadaljnjem besedilu: Agencija), na primer v zvezi z ukrepi za čim večje zmanjšanje prevelikega ali premajhnega odmerjanja, nenamerno uporabo zdravila pri neciljnih živalih, tveganjem navzkrižne kontaminacije in razširjenjem teh zdravil v okolju.
With a view to harmonising the internal market for veterinary medicinal products in the Union and improving their free movement, rules should be established concerning the procedures for authorisation of such products that ensure the same conditions for all applications and a transparent framework for all interested parties.
Z namenom harmonizacije notranjega trga za zdravila za uporabo v veterinarski medicini v Uniji in izboljšanja njihovega prostega pretoka bi bilo treba določiti pravila v zvezi s postopki za pridobitev dovoljenja za promet s takšnimi zdravili, ki zagotavljajo enake pogoje za vse vloge in pregleden okvir za vse zainteresirane strani.
The scope of the mandatory use of a centralised authorisation procedure under which the authorisations are valid throughout the Union should cover, inter alia, products containing new active substances and products which contain or consist of engineered tissues or cells, including novel therapy veterinary medicinal products with the exclusion of blood components, such as plasma, platelet concentrates or red cells.
Področje obvezne uporabe centraliziranega postopka za pridobitev dovoljenja, v skladu s katerim so dovoljenja za promet z zdravili veljavna po vsej Uniji, bi moralo med drugim zajemati zdravila, ki vsebujejo nove učinkovine, in zdravila, ki vsebujejo inženirsko obdelana tkiva ali celice ali so iz njih sestavljena, vključno z zdravili za uporabo v veterinarski medicini za nove terapije, z izjemo krvnih komponent, kot so krvna plazma, koncentrati trombocitov in rdeče krvničke.
At the same time, in order to ensure the widest possible availability of veterinary medicinal products in the Union, the access of small and medium-sized enterprises (SMEs) to the centralised authorisation procedure should be facilitated by all appropriate means, and its use should be extended to allow for applications for authorisations under that procedure to be submitted for any veterinary medicinal product, including for generics of nationally authorised veterinary medicinal products.
Za zagotovitev najširše možne razpoložljivosti zdravil za uporabo v veterinarski medicini v Uniji bi morali malim in srednjim podjetjem z vsemi ustreznimi sredstvi olajšati dostop do centraliziranega postopka, njegovo uporabo pa bi hkrati bilo treba razširiti, da se lahko vloge za pridobitev dovoljenja za promet v okviru tega postopka predložijo za vsako zdravilo za uporabo v veterinarski medicini, tudi za generična zdravila za uporabo v veterinarski medicini z nacionalnim dovoljenjem za promet.
The replacement or the addition of a new antigen or a new strain in the case of already authorised immunological veterinary medicinal products against, for example, avian influenza, bluetongue, foot and mouth disease or equine influenza should not be considered as adding a new active substance.
Nadomestitev ali dodatek novega antigena ali novega seva v primeru že odobrenih imunoloških zdravil za uporabo v veterinarski medicini, na primer proti aviarni influenci, bolezni modrikastega jezika, slinavki in parkljevki ali influenci konj, se ne bi smela šteti kot dodatek nove učinkovine.
The national procedure for authorising veterinary medicinal products should be maintained because of varying needs in different geographical areas of the Union as well as the business models of SMEs.
Nacionalni postopek za pridobitev dovoljenj za promet z zdravili za uporabo v veterinarski medicini bi bilo treba ohraniti zaradi različnih potreb na različnih geografskih območjih Unije ter poslovnih modelov MSP.
It should be ensured that marketing authorisations granted in one Member State are recognised in other Member States.
Zagotoviti bi bilo treba, da se dovoljenja za promet, izdana v eni državi članici, priznajo v drugih državah članicah.
In order to help applicants, and in particular SMEs, to comply with the requirements of this Regulation, Member States should provide advice to the applicants.
Da bi države članice pomagale predlagateljem, zlasti MSP, pri izpolnjevanju zahtev iz te uredbe, bi jim morale zagotoviti svetovanje.
That advice should be provided in addition to the operational guidance documents and other advice and assistance provided by the Agency.
To svetovanje bi moralo biti zagotovljeno poleg operativnih smernic ter drugih svetovanj in pomoči, ki jih zagotavlja Agencija.
In order to avoid unnecessary administrative and financial burdens for applicants and competent authorities, a full in-depth assessment of an application for the authorisation of a veterinary medicinal product should be carried out only once.
V izogib nepotrebnim upravnim in finančnim bremenom za predlagatelje in pristojne organe bi bilo treba celovito poglobljeno oceno vloge za pridobitev dovoljenja za promet z zdravilom za uporabo v veterinarski medicini izvesti samo enkrat.
It is appropriate therefore to lay down special procedures for the mutual recognition of national authorisations.
Zato je primerno določiti posebne postopke za vzajemno priznavanje nacionalnih dovoljenj za promet.
Moreover, rules should be established under the mutual recognition procedure to resolve any disagreements between competent authorities in a coordination group for mutual recognition and decentralised procedures for veterinary medicinal products (‘the coordination group’) without undue delay.
Poleg tega bi bilo treba določiti pravila v skladu s postopkom vzajemnega priznavanja za reševanje morebitnih sporov med pristojnimi organi v usklajevalni skupini za postopek vzajemnega priznavanja in decentralizirani postopek za zdravila za uporabo v veterinarski medicini (v nadaljnjem besedilu: usklajevalna skupina) brez nepotrebnega odlašanja.
This Regulation also lays down new tasks for the coordination group, including the drawing up an annual list of reference veterinary medicinal products which are to be subject to harmonisation of the summary of product characteristics, the issuing of recommendations on pharmacovigilance and its involvement in the signal management process.
Ta uredba določa tudi nove naloge za usklajevalno skupino, vključno s pripravo letnega seznama referenčnih zdravil za uporabo v veterinarski medicini, katerih povzetek glavnih značilnosti je treba harmonizirati, izdajanjem priporočil o farmakovigilanci in sodelovanjem v postopku obravnave signala.
Where a Member State, the Commission or the marketing authorisation holder considers that there are reasons to believe that a veterinary medicinal product could present a potential serious risk to human or animal health or to the environment, a scientific evaluation of the product should be undertaken at Union level, leading to a single decision on the area of disagreement, binding on the relevant Member States, and taken on the basis of an overall benefit-risk assessment.
Kadar država članica, Komisija ali imetnik dovoljenja za promet meni, da obstajajo razlogi za domnevo, da bi lahko zdravila za uporabo v veterinarski medicini predstavljala potencialno resno tveganje za zdravje ljudi ali živali ali za okolje, bi bilo treba znanstveno vrednotenje zdravila izvesti na ravni Unije, kar bi privedlo do enotne odločitve na spornem področju, ki bi bila zavezujoča za relevantne države članice, na podlagi celovite ocene razmerja med tveganji in koristmi.
No veterinary medicinal product should be allowed to be placed on the market in the Union unless it has been authorised, and its quality, safety and efficacy have been demonstrated.
Nobeno zdravilo za uporabo v veterinarski medicini se ne bi smelo dati v promet v Uniji, razen če je bilo zanj izdano dovoljenje in je bilo dokazano, da je kakovostno, varno in učinkovito.
Where a veterinary medicinal product is intended for food-producing animal species, a marketing authorisation should only be granted if the pharmacologically active substances which the product contains are allowed in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council and any acts adopted on the basis thereof for the animal species for which the veterinary medicinal product is intended.
Kadar je zdravilo za uporabo v veterinarski medicini namenjeno za živali za proizvodnjo živil, se dovoljenje za promet sme izdati samo, če so farmakološke učinkovine, ki jih zdravilo vsebuje, odobrene v skladu z Uredbo (ES) št. 470/2009 Evropskega parlamenta in Sveta in vsemi akti, sprejetimi na tej podlagi, za živalske vrste, ki jim je zdravilo za uporabo v veterinarski medicini namenjeno.
There may be, however, situations where no suitable authorised veterinary medicinal product is available.
Vendar pa lahko obstajajo primeri, v katerih ni na voljo nobenega primernega zdravila za uporabo v veterinarski medicini.
In those situations, by way of exception, veterinarians should be allowed to prescribe other medicinal products to the animals under their responsibility in conformity with strict rules and only in the interest of animal health or animal welfare.
V navedenih primerih bi moralo biti veterinarjem izjemoma dovoljeno, da predpišejo druga zdravila za živali, za katere so odgovorni, v skladu s strogimi pravili in zgolj v interesu zdravja ali dobrobiti živali.
In the case of food-producing animals, veterinarians should ensure that an appropriate withdrawal period is prescribed, so that harmful residues of those medicinal products do not enter the food chain, and particular care should therefore be taken when administering antimicrobials.
V primeru živali za proizvodnjo živil bi morali veterinarji zagotoviti, da je predpisana ustrezna karenca, tako da škodljivi ostanki navedenih zdravil ne vstopijo v prehransko verigo, še posebna skrbnost pa bi bila potrebna pri dajanju protimikrobnih snovi.
Member States should be able to allow the exceptional use of veterinary medicinal products without a marketing authorisation where it is necessary to respond to Union-listed diseases or emerging diseases and where the health situation in a Member State so requires.
Države članice bi morale imeti možnost dovoliti izjemno uporabo zdravil za uporabo v veterinarski medicini brez dovoljenja za promet, kadar je to potrebno za odzivanje na bolezni ali izbruhe bolezni s seznama Unije in kadar zdravstvene razmere v državi članici tako zahtevajo.
Taking into account the need for simple rules on changes to the marketing authorisations of veterinary medicinal products, only changes that can affect public or animal health or the environment should require a scientific assessment.
Ob upoštevanju potrebe po preprostih pravilih glede sprememb dovoljenj za promet z zdravili za uporabo v veterinarski medicini bi bila potrebna samo znanstvena ocena sprememb, ki bi lahko vplivale na javno zdravje ali zdravje živali ali okolje.
Directive 2010/63/EU of the European Parliament and of the Council lays down provisions on the protection of animals used for scientific purposes based on the principles of replacement, reduction and refinement.
Direktiva 2010/63/EU Evropskega parlamenta in Sveta določa določbe o zaščiti živali, ki se uporabljajo v znanstvene namene, na podlagi načel zamenjave, zmanjšanja in izboljšanja.
Clinical trials for veterinary medicinal products are exempted from the scope of that Directive.
Klinična preskušanja zdravil za uporabo v veterinarski medicini so izvzeta iz področja uporabe navedene direktive.
The design and performance of clinical trials, which provide essential information on the safety and efficacy of a veterinary medicinal product, should take into account those principles of replacement, reduction and refinement, where they concern the care and use of live animals for scientific purposes, and should be optimised in order to provide the most satisfactory results whilst using the minimum number of animals.
Zasnova in izvedba kliničnih preskušanj, ki zagotavljajo bistvene informacije o varnosti in učinkovitosti zdravil za uporabo v veterinarski medicini, bi morali upoštevati načela zamenjave, zmanjšanja in izboljšanja v zvezi z oskrbo in uporabo živih živali v znanstvene namene ter bi morali biti optimizirani, da se zagotovijo najbolj zadovoljivi rezultati ob uporabi najmanjšega števila živali.
The procedures of such clinical trials should be designed to avoid causing pain, suffering or distress to animals and should take into account the principles laid down in Directive 2010/63/EU, including the use of alternative test methods wherever possible, and the guidelines of the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (‘VICH’).
Postopki takih kliničnih preskušanj bi morali biti zasnovani tako, da ne bi povzročali bolečine, trpljenja ali stiske živali, ter bi upoštevali načela iz Direktive 2010/63/EU, vključno z uporabo alternativnih testnih metod, ko je to mogoče, in smernic, določenih v okviru Mednarodnega sodelovanja pri harmonizaciji tehničnih zahtev za registracijo zdravil za uporabo v veterinarski medicini (v nadaljnjem besedilu: VICH).
It is recognised that improved access to information contributes to public awareness, gives the public the opportunity to express its observations and enables authorities to take due account of those observations.
Priznava se, da izboljšani dostop do informacij prispeva k ozaveščenosti javnosti, daje javnosti možnost, da izrazi svoje pripombe, organom pa omogoča, da upoštevajo navedene pripombe.
The general public should therefore have access to information in the product database, the pharmacovigilance database and the manufacturing and wholesale distribution database, after the deletion of any commercially confidential information by the competent authority.
Splošna javnost bi morala zato imeti dostop do informacij iz zbirke podatkov o zdravilih, zbirke podatkov o farmakovigilanci in zbirke podatkov o proizvodnji in prometu na debelo, potem ko pristojni organ izbriše vse poslovno zaupne informacije.
Regulation (EC) No 1049/2001 of the European Parliament and of the Council gives the fullest possible effect to the right of public access to documents and lays down the general principles and limits on such access.
Uredba Evropskega parlamenta in Sveta (ES) št. 1049/2001 zagotavlja čim boljšo uresničitev pravice dostopa javnosti do dokumentov ter določa splošna načela in omejitve takega dostopa.
The Agency should therefore give the widest possible access to the documents while carefully balancing the right for information with existing data protection requirements.
Zato bi morala Agencija omogočiti čim širši dostop do dokumentov, pri tem pa skrbno zagotoviti ravnotežje med pravico do obveščenosti in veljavnimi zahtevami glede varstva podatkov.
Certain public and private interests, such as personal data and commercially confidential information, should be protected by way of exceptions in accordance with Regulation (EC) No 1049/2001.
Nekatere javne in zasebne interese, kot so interesi v zvezi z osebnimi podatki in poslovno zaupnimi informacijami, bi bilo treba zaščititi z izjemami v skladu z Uredbo (ES) št. 1049/2001.
Companies have less interest in developing veterinary medicinal products for markets of a limited size.
Podjetja so manj zainteresirana za razvoj zdravil za uporabo v veterinarski medicini za trge z omejeno velikostjo.
In order to promote the availability of veterinary medicinal products within the Union for those markets, in some cases it should be possible to grant marketing authorisations without a complete application dossier having been submitted, on the basis of a benefit-risk assessment of the situation and, where necessary, subject to specific obligations.
Zaradi spodbujanja razpoložljivosti zdravil za uporabo v veterinarski medicini znotraj Unije za navedene trge bi bilo treba v nekaterih primerih izdati dovoljenja za promet brez predložitve popolne vloge na podlagi ocene razmerja med tveganji in koristmi ter po potrebi ob upoštevanju posebnih obveznosti.
In particular, the grant of such marketing authorisations should be possible in the case of veterinary medicinal products for use in minor species or for the treatment or prevention of diseases that occur infrequently or in limited geographical areas.
Izdaja takih dovoljenj za promet bi zlasti morala biti mogoča v primeru zdravil za uporabo v veterinarski medicini za manj pomembne vrste živali ali za zdravljenje ali preprečevanje bolezni, ki se pojavljajo redko ali na omejenih geografskih območjih.
For all new applications for a marketing authorisation, environmental risk assessments should be mandatory and should consist of two phases.
Ocene tveganja za okolje bi morale biti obvezne za vse nove vloge za pridobitev dovoljenj za promet in bi morale biti sestavljene iz dveh faz.
In the first phase the extent of environmental exposure to the product, its active substances and other constituent should be estimated, while in the second phase the effects of the active residue should be assessed.
V prvi fazi bi bilo treba oceniti obseg okoljske izpostavljenosti zdravilu, njegovim učinkovinam in drugim sestavinam, v drugi fazi pa učinke aktivnih ostankov.