natgillin/translations-raw huggingface dataset:
Furthermore, the supply of veterinary medicinal products by veterinarians should be restricted to the amount required for treatment of the animals under their care.
Dobavo protimikrobnih zdravil za uporabo v veterinarski medicini, ki jih izdajo veterinarji, bi bilo treba omejiti na količino, potrebno za zdravljenje živali, ki so v njihovi oskrbi.
The prudent use of antimicrobials is a cornerstone in addressing antimicrobial resistance.
Za preprečevanje mikrobne odpornosti je bistvena preudarna uporaba protimikrobnih snovi.
All the stakeholders concerned should together promote prudent use of antimicrobials.
Vsi zadevni deležniki bi morali skupno spodbujati preudarno rabo protimikrobnih snovi.
It is therefore important that guidance on the prudent use of antimicrobials in veterinary medicine be taken into account and further elaborated.
Zato je pomembno, da se upoštevajo in dodatno oblikujejo smernice za preudarno rabo protimikrobnih snovi v veterinarski medicini.
The identification of risk factors and the development of criteria for the initiation of administration of antimicrobials, as well as the identification of alternative measures, could help in avoiding the unnecessary use of antimicrobial medicinal products, including through metaphylaxis.
Opredelitev dejavnikov tveganja in razvoj meril za začetek uporabe protimikrobnih snovi ter določitev alternativnih ukrepov bi lahko pripomogli k preprečevanju nepotrebne uporabe protimikrobnih zdravil, tudi v primeru metafilakse.
In addition, Member States should be allowed to take further restrictive measures to implement national policy on the prudent use of antimicrobials, provided that those measures do not unduly restrict the functioning of the internal market.
Poleg tega bi državam članicam moralo biti omogočeno, da sprejmejo nadaljnje omejevalne ukrepe za izvajanje nacionalne politike o preudarni rabi protimikrobnih snovi, pod pogojem, da ti ukrepi ne omejujejo neupravičeno delovanja notranjega trga.
It is important to consider the international dimension of the development of antimicrobial resistance when assessing the benefit-risk balance of certain veterinary antimicrobials in the Union.
Pomembno je upoštevati mednarodne razsežnosti razvoja mikrobne odpornosti pri ocenjevanju razmerja med tveganji in koristmi nekaterih protimikrobnih snovi za uporabo v veterinarski medicini v Uniji.
Antimicrobial resistant organisms can spread to humans and animals in the Union and third countries through consumption of products of animal origin from the Union or from third countries, from direct contact with animals or humans or by other means.
Organizmi, odporni na protimikrobne snovi, se lahko razširijo na ljudi in živali v Uniji in tretjih državah z uživanjem proizvodov živalskega izvora, uvoženih iz Unije ali iz tretjih držav, neposrednim stikom z živaljo ali ljudmi ali na druge načine.
Therefore, measures restricting the use of veterinary antimicrobials in the Union should be based on scientific advice and should be considered in the context of cooperation with third countries and international organisations.
Zato bi morali ukrepi, ki omejujejo uporabo protimikrobnih zdravil za uporabo v veterinarski medicini v Uniji, temeljiti na znanstvenih mnenjih in bi jih bilo treba preučiti v okviru sodelovanja s tretjimi državami in mednarodnimi organizacijami.
For those reasons, it should also be ensured, in a non-discriminatory and proportionate manner, that operators in third countries respect certain basic conditions relating to antimicrobial resistance for animals and products of animal origin exported to the Union.
Zato bi bilo treba na nediskriminatoren in sorazmeren način zagotoviti, da izvajalci dejavnosti v tretjih državah spoštujejo nekatere osnovne pogoje v zvezi z mikrobno odpornostjo za živali in proizvode živalskega izvora, ki se izvažajo v Unijo.
Any such action should respect Union obligations under relevant international agreements.
Vsak tak ukrep bi moral spoštovati obveznosti Unije iz ustreznih mednarodnih sporazumov.
This should contribute to the international fight against antimicrobial resistance, in particular in line with the WHO Global Action Plan and the OIE Strategy on Antimicrobial Resistance and the Prudent Use of Antimicrobials.
To bi moralo prispevati k mednarodnemu boju proti mikrobni odpornosti, zlasti v skladu z globalnim akcijskim načrtom SZO in strategijo OIE o mikrobni odpornosti in preudarni rabi protimikrobnih snovi.
There is still a lack of sufficiently detailed and comparable data at Union level to determine the trends and identify possible risk factors that could lead to the development of measures to limit the risk from antimicrobial resistance and to monitor the effect of measures already introduced.
Še vedno primanjkuje dovolj podrobnih in primerljivih podatkov na ravni Unije za določitev trendov in opredelitev možnih dejavnikov tveganja, ki bi lahko privedli do oblikovanja ukrepov za omejitev tveganja zaradi mikrobne odpornosti in spremljanje učinkov že sprejetih ukrepov.
It is therefore important to continue the collection of such data and further develop it in line with a stepwise approach.
Zato je pomembno nadaljevati z zbiranjem podatkov in ga postopno razvijati.
That data, when available, should be analysed with data on the use of antimicrobials in humans and data on antimicrobial resistant organisms found in animals, humans and food.
Ko bodo ti podatki na razpolago, bi jih bilo treba analizirati s podatki o uporabi protimikrobnih snovi pri ljudeh ter podatki o organizmih, odpornih na protimikrobne snovi in najdenih pri ljudeh, živalih in v živilih.
To ensure that the data collected can be used effectively, appropriate technical rules should be laid down concerning the collection and the exchange of data.
Za zagotovitev učinkovite uporabe zbranih podatkov bi bilo treba določiti ustrezna tehnična pravila o zbiranju in izmenjavi podatkov.
The Member States should be responsible for collecting data on the sales and use of antimicrobials used in animals under the coordination of the Agency.
Države članice bi morale biti odgovorne za zbiranje podatkov o prodaji in uporabi protimikrobnih snovi, ki se uporabljajo pri živalih, pod vodstvom Agencije.
It should be possible to make further adjustments to the obligations on data collection when the procedures in the Member States for the collection of data on sales and use of antimicrobials are sufficiently reliable.
Omogočiti bi bilo treba nadaljnje prilagajanje obveznosti zbiranja podatkov, kadar so postopki v državah članicah za zbiranje podatkov o prodaji in uporabi protimikrobnih snovi dovolj zanesljivi.
The majority of the veterinary medicinal products on the market have been authorised under national procedures.
Za večino zdravil za uporabo v veterinarski medicini v prometu so bila izdana dovoljenja v okviru nacionalnih postopkov.
The lack of harmonisation of summary of product characteristics for veterinary medicinal products authorised nationally in more than one Member State creates additional and unnecessary barriers for the circulation of veterinary medicinal products within the Union.
Neharmonizacija povzetkov glavnih značilnosti zdravil za uporabo v veterinarski medicini, za katera so izdana dovoljenja na nacionalni ravni v več kot eni državi članici, ustvarja dodatne in nepotrebne ovire za promet zdravil za uporabo v veterinarski medicini znotraj Unije.
It is necessary to harmonise those summaries of product characteristics at least in regard to dosage, uses and warnings of the veterinary medicinal products.
Treba je harmonizirati navedene povzetke glavnih značilnosti zdravil vsaj glede odmerjanja, uporabe in opozoril zdravil za uporabo v veterinarski medicini.
In order to reduce administrative burden and maximise the availability of veterinary medicinal products in the Member States, simplified rules should be laid down as to how their packaging and labelling are to be presented.
Za zmanjšanje upravnega bremena in izboljšanje razpoložljivosti zdravil za uporabo v veterinarski medicini v državah članicah bi bilo treba določiti poenostavljena pravila za njihove ovojnine in označevanje.
The textual information provided should be reduced and, if possible, pictograms and abbreviations could be developed and used as an alternative to such textual information.
Predložene besedilne informacije bi bilo treba omejiti, piktograme in okrajšave pa bi se lahko po možnosti razvilo in jih uporabljalo kot alternativo za ubesedene informacije.
Pictograms and abbreviations should be standardised across the Union.
Piktograme in okrajšave bi bilo treba standardizirati po vsej Uniji.
Care should be taken so that those rules do not jeopardise public or animal health or environmental safety.
Paziti bi bilo treba, da navedena pravila ne ogrožajo javnega zdravja ali zdravja živali ali varstva okolja.
In addition, Member States should be able to choose the language of the text used in the summary of product characteristics, labelling and package leaflet of veterinary medicinal products authorised in their territory.
Poleg tega bi morale države članice imeti možnost, da izberejo jezik besedila, ki se uporablja za povzetke glavnih značilnosti zdravila, označevanja in navodila za uporabo zdravil za uporabo v veterinarski medicini, za katera so bila izdana dovoljenja na njihovem ozemlju.
With a view to increasing availability of veterinary medicinal products in the Union, it should be possible to grant more than one marketing authorisation for a specific veterinary medicinal product to the same marketing authorisation holder in the same Member State.
Za povečanje razpoložljivosti zdravil za uporabo v veterinarski medicini v Uniji bi moralo biti mogoče istemu imetniku dovoljenja za promet v isti državi članici odobriti več kot eno dovoljenje za promet za specifično zdravilo za uporabo v veterinarski medicini.
In that case, all product-related characteristics of the veterinary medicinal product and data in support of the applications for the veterinary medicinal product should be identical.
V navedenem primeru bi morale biti vse značilnosti zdravila za uporabo v veterinarski medicini in podatki v podporo vlogam za zdravilo za uporabo v veterinarski medicini enaki.
However, multiple applications for a specific veterinary medicinal product should not be used to circumvent the principles of mutual recognition, and therefore this type of applications in different Member States should take place within the procedural framework for mutual recognition.
Vendar pa se ne bi smelo uporabljati več vlog za specifično zdravilo za uporabo v veterinarski medicini za izogibanje načelom vzajemnega priznavanja, zato bi morale biti te vrste vlog v različnih državah članicah predložene v okviru postopka za vzajemno priznavanje.
Pharmacovigilance rules are necessary for the protection of public and animal health and of the environment.
Pravila o farmakovigilanci so potrebna za varovanje javnega zdravja in zdravja živali ter okolja.
Collection of information on suspected adverse events should contribute to the good usage of veterinary medicinal products.
Zbiranje informacij o domnevnih neželenih dogodkih bi moralo prispevati k smiselni uporabi zdravil za uporabo v veterinarski medicini.
Environmental incidents that are observed following the administration of a veterinary medicinal product to an animal should also be reported as suspected adverse events.
Okoljske nesreče, ki se opazijo po uporabi zdravila za uporabo v veterinarski medicini pri živali, bi tudi bilo treba prijaviti kot domnevne neželene dogodke.
Such incidents may consist, for example, in a significant increase of soil contamination by a substance to levels considered harmful for the environment or in high concentrations of veterinary medicinal products in drinking water produced from surface water.
Take nesreče lahko na primer vključujejo znatno povečanje onesnaženosti tal s snovjo do ravni, ki veljajo za škodljive za okolje, ali visoke koncentracije zdravil za uporabo v veterinarski medicini v pitni vodi, ki se proizvede iz površinskih voda.
The competent authorities, the Agency and marketing authorisation holders should encourage and facilitate the reporting of suspected adverse events, in particular by veterinarians and other health care professionals, where such events occur during the conduct of their duties, as well as facilitate that veterinarians receive appropriate feedback on reporting made.
Pristojni organi, Agencija in imetniki dovoljenj za promet bi morali zlasti veterinarje in druge zdravstvene delavce spodbujati k poročanju o domnevnih neželenih dogodkih in jim ga olajševati, ko do takih dogodkov pride med izvajanjem njihovih dolžnosti, pa tudi omogočiti, da veterinarji po poročanju prejmejo ustrezno povratno informacijo.
In the light of experience, it has become clear that it is necessary to take measures to improve the operation of the pharmacovigilance system.
Glede na izkušnje je postalo jasno, da je treba sprejeti ukrepe za izboljšanje delovanja sistema farmakovigilance.
That system should integrate and monitor data at Union level.
Ta sistem bi moral vključevati in spremljati podatke na ravni Unije.
It is in the interest of the Union to ensure that the veterinary pharmacovigilance systems for all authorised veterinary medicinal products are consistent.
V interesu Unije je zagotoviti, da so vsi veterinarski sistemi farmakovigilance za vsa zdravila za uporabo v veterinarski medicini z dovoljenjem za promet dosledni.
At the same time, it is necessary to take account of changes arising as a result of international harmonisation of definitions, terminology and technological developments in the field of pharmacovigilance.
Hkrati je treba upoštevati spremembe, ki izhajajo iz mednarodne harmonizacije opredelitev pojmov, terminologije in tehnološkega razvoja na področju farmakovigilance.
Holders of marketing authorisations should be responsible for continuously carrying out pharmacovigilance in order to ensure the continuous evaluation of the benefit-risk balance of the veterinary medicinal products they place on the market.
Imetniki dovoljenj za promet z zdravilom bi morali biti odgovorni za stalno izvajanje farmakovigilance, da se zagotovi stalno ocenjevanje razmerja med tveganjem in koristjo za zdravila za uporabo v veterinarski medicini, ki jih dajejo v promet.
They should collect reports on suspected adverse events relating to their veterinary medicinal products, including those concerning use outside the terms of the granted marketing authorisation.
Zbirati bi morali poročila o domnevnih neželenih dogodkih v zvezi z njihovimi zdravili za uporabo v veterinarski medicini, vključno s tistimi, ki se nanašajo na uporabo, ki ni v okviru pogojev izdanega dovoljenja za promet.
It is necessary to increase the shared use of resources among authorities and to enhance efficiency of the pharmacovigilance system.
Povečati je treba skupno uporabo virov med organi ter izboljšati učinkovitost sistema farmakovigilance.
Data collected should be uploaded to a single reporting point to ensure that the information is shared.
Zbrani podatki bi morali biti naloženi na enotni točki obveščanja, da se zagotovi izmenjava informacij.
The competent authorities should use those data to ensure the continuous assessment of the benefit-risk balance of the veterinary medicinal products that are on the market.
Pristojni organi bi morali uporabljati navedene podatke, da se zagotovita stalno ocenjevanje razmerja med tveganjem in koristjo zdravil za uporabo v veterinarski medicini, ki so v prometu.
In specific cases, or from a public or animal health or environment perspective, it is necessary to complement the safety and efficacy data available at the time of authorisation with additional information following the placing of the veterinary medicinal product on the market.
V posebnih primerih ali z vidika javnega zdravja, zdravja živali ali okolja je treba podatke o varnosti in učinkovitosti, ki so na voljo ob pridobitvi dovoljenja za promet, dopolniti z dodatnimi informacijami po tem, ko je zdravilo za uporabo v veterinarski medicini dano v promet.
It should be possible, therefore, to impose the obligation to conduct post-authorisation studies on the marketing authorisation holder.
Zato bi moralo biti mogoče, da se za imetnika dovoljenja za promet z zdravilom uvede obveznost izvajanja študij po pridobitvi dovoljenja za promet.
A pharmacovigilance database at Union level should be established to record and integrate information of suspected adverse events for all veterinary medicinal products authorised in the Union.
Vzpostaviti bi bilo treba zbirko podatkov za farmakovigilanco na ravni Unije, da se evidentirajo in vključijo informacije o domnevnih neželenih dogodkih za vsa zdravila za uporabo v veterinarski medicini z dovoljenjem za promet v Uniji.
That database should improve detection of suspected adverse events and should allow and facilitate the pharmacovigilance surveillance and work-sharing between the competent authorities.
Navedena zbirka podatkov bi morala izboljšati odkrivanje domnevnih neželenih dogodkov ter omogočati in olajšati farmakovigilanco in delitev dela med pristojnimi organi.
That database should include mechanisms for exchanging data with the existing national pharmacovigilance databases.
Ta zbirka podatkov bi morala vključevati mehanizme za izmenjavo podatkov z obstoječimi nacionalnimi zbirkami podatkov o farmakovigilanci.
The procedures that competent authorities and the Agency will adopt in order to evaluate the information on suspected adverse events that they receive should comply with the measures on good pharmacovigilance practice which should be adopted by the Commission and, as appropriate, be based on a common standard derived from the current Commission guidelines on pharmacovigilance for veterinary medicinal products.
Postopki, ki jih bodo pristojni organi in Agencija sprejeli za oceno informacij o domnevnih neželenih dogodkih, ki jih prejmejo, bi morali biti skladni z ukrepi v zvezi z dobro farmakovigilančno prakso, ki bi jih morala sprejeti Komisija, in bi morali po potrebi temeljiti na skupnem standardu, ki bi izhajal iz veljavnih smernic Komisije o farmakovigilanci za zdravila za uporabo v veterinarski medicini.
The evaluation performed by the competent authority or the Agency in that way may be one of the means by which it is determined whether there is any change to the benefit-risk balance of those veterinary medicinal products.
Ocena, ki jo na ta način opravi pristojni organ ali Agencija, je lahko eden od načinov ugotavljanja, ali je prišlo do kakršne koli spremembe razmerja med tveganji in koristmi navedenih zdravil za uporabo v veterinarski medicini.
It is, however, emphasised that the signal management process is the ‘gold standard’ for that purpose and proper attention should be given to it.
Vendar se poudarja, da je „postopek obravnave signala“ za ta namen „zlati standard“ in bi mu bilo treba posvetiti ustrezno pozornost.
That signal management process consists of tasks of signal detection, validation, confirmation, analysis and prioritisation, assessment and recommendation for action.
Ta postopek obravnave signala sestavljajo naloge zaznavanja signala, vrednotenja, potrjevanja, preučevanja in določanja prednostnih nalog, ocenjevanja in priporočanja za ukrepanje.
It is necessary to exercise control over the entire chain of distribution of veterinary medicinal products, from manufacture or import into the Union through supply to the end-user.
Nadzorovati je treba celotno verigo distribucije zdravil za uporabo v veterinarski medicini, od proizvodnje ali uvoza v Unijo prek dobave do končnega uporabnika.
Veterinary medicinal products from third countries should comply with the same requirements which apply to veterinary medicinal products manufactured in the Union, or with requirements which are recognised to be at least equivalent thereto.
Zdravila za uporabo v veterinarski medicini iz tretjih držav bi morala izpolnjevati iste zahteve, ki se uporabljajo za zdravila za uporabo v veterinarski medicini, proizvedena v Uniji, ali zahteve, ki so priznane vsaj kot enakovredne navedenim zahtevam.
The parallel trade in veterinary medicinal products concerns veterinary medicinal products traded from one Member State to another and is distinct from imports in that the latter are products coming from third countries into the Union.
Vzporedni promet se nanaša na proizvode, s katerimi se trguje iz ene države članice v drugo, in se razlikuje od uvoza, pri katerem proizvodi prihajajo v Unijo iz tretjih držav.
The parallel trade in veterinary medicinal products authorised under national, decentralised, mutual recognition or subsequent recognition procedure should be regulated to ensure that the principles of the free movement of goods are restricted only for the purpose of safeguarding public and animal health in a harmonised manner, and respecting the case law of the Court of Justice of the European Union (‘the Court of Justice’).
Vzporedni promet z zdravili za uporabo v veterinarski medicini, ki so odobrena v skladu z nacionalnim ali decentraliziranim postopkom priznavanja, postopkom z medsebojnim priznavanjem ali naknadnim postopkom priznavanja, bi bilo treba urediti tako, da se zagotovi, da se načela prostega pretoka blaga omejijo le za namen harmoniziranega varovanja zdravja ljudi in živali, pri čemer se upošteva sodna praksa Sodišča Evropske unije (v nadaljnjem besedilu: Sodišče).
Any administrative procedures put in place in that context should not introduce an excessive burden.
Upravni postopki, vzpostavljeni v tej zvezi, ne bi smeli predstavljati prekomernega bremena.
In particular, any approval of a licence for such parallel trade should be based on a simplified procedure.
Zlasti bi morala vsaka odobritev dovoljenja za tak vzporedni promet temeljiti na poenostavljenem postopku.
In order to facilitate the movement of veterinary medicinal products and to prevent checks carried out in one Member State being repeated in others, minimum requirements should be applied to veterinary medicinal products manufactured in, or imported from, third countries.
Za olajšanje pretoka zdravil za uporabo v veterinarski medicini ter za preprečevanje podvajanja kontrol, ki se izvajajo v eni državi članici, v drugih državah članicah, bi bilo treba uporabljati minimalne zahteve za zdravila za uporabo v veterinarski medicini, proizvedena v tretjih državah ali uvožena iz njih.
The quality of veterinary medicinal products manufactured within the Union should be guaranteed by requiring compliance with the principles of good manufacturing practice for medicinal products irrespective of their final destination.
Kakovost zdravil za uporabo v veterinarski medicini, proizvedenih v Uniji, bi morala biti zajamčena z zahtevo po skladnosti z načeli dobre prakse v proizvodnji zdravil, ne glede na njihov končni namembni kraj.
The good manufacturing practice for the purpose of this Regulation should take into account the Union and international standards of animal welfare when active substances are prepared from animals.
Dobra proizvodna praksa za namen te uredbe bi morala upoštevati standarde Unije in mednarodne standarde dobrobiti živali, kadar so učinkovine pripravljene iz živali.
Measures to prevent or minimise discharge of active substances into the environment should be also taken into account.
Upoštevati je treba tudi ukrepe za preprečevanje ali čim večje zmanjšanje izpusta učinkovin v okolje.
Any such measures should only be adopted following an evaluation of their impact.
Navedeni ukrepi bi morali biti sprejeti šele po oceni njihovega učinka.
In order to ensure the uniform application of principles of good manufacturing practice and good distribution practice, the compilation of Union procedures for inspections and exchange of information should serve as a basis for competent authorities when performing controls on manufacturers and wholesale distributors.
Da bi zagotovili enotno uporabo načel dobre proizvodne in distribucijske prakse, bi se morali pristojni organi, ko izvajajo nadzor nad proizvajalci in veletrgovci, zgledovati po postopkih Unije za inšpekcijske preglede in izmenjavo informacij.