natgillin/translations-raw huggingface dataset:
Where there is concern that a pharmaceutical substance could pose serious risk to the environment, it may be appropriate to examine that substance in the context of Union environmental legislation.
Kadar obstaja zaskrbljenost, da bi farmacevtska snov lahko predstavljala resno tveganje za okolje, bi jo bilo morda primerno pregledati v okviru okoljske zakonodaje Unije.
In particular, under Directive 2000/60/EC of the European Parliament and of the Council, it may be appropriate to identify whether that substance is a substance for inclusion in the surface water watch list, in order to gather monitoring data on it.
Zlasti bi lahko bilo primerno, da se v skladu z Direktivo 2000/60/ES Evropskega parlamenta in Sveta ugotovi, ali je to snov, ki jo je treba vključiti na nadzorni seznam površinskih voda, da se zberejo podatki o spremljanju te snovi.
It may be appropriate to include it in the list of priority substances and to set an environmental quality standard for it, as well as to identify measures to reduce its emissions to the environment.
Primerno bi jo bilo vključiti na seznam prednostnih snovi in zanjo določiti standard kakovosti okolja, pa tudi ukrepe za zmanjšanje njenih emisij v okolje.
Those measures could include measures to reduce emissions from manufacturing by following Best Available Techniques (BAT) under Directive 2010/75/EU of the European Parliament and of the Council, particularly if the emission of active pharmaceutical ingredients have been identified as a key environmental issue during the drafting or revision of relevant Best Available Technique Reference Documents (BREFs) and their accompanying BAT conclusions.
Ti ukrepi bi lahko vključevali ukrepe za zmanjšanje emisij iz proizvodnje, pri čemer bi uporabili najboljše razpoložljive tehnike v skladu z Direktivo 2010/75/EU Evropskega parlamenta in Sveta, zlasti če so bile emisije aktivnih farmacevtskih sestavin med pripravo ali revizijo ustreznih referenčnih dokumentov o najboljših razpoložljivih tehnikah in priloženih zaključkov o najboljših razpoložljivih tehnikah prepoznane kot ključno okoljsko vprašanje.
Tests, pre-clinical studies and clinical trials represent a major investment for companies which they need to make in order to submit the necessary data with the application for a marketing authorisation or to establish a maximum residue limit for pharmacologically active substances of the veterinary medicinal product.
Testi, predklinične študije in klinična preskušanja predstavljajo velike naložbe za podjetja, ki so zanje nujna, da lahko predložijo potrebne podatke z vlogo za pridobitev dovoljenja za promet ali določijo mejne vrednosti ostankov za farmakološke učinkovine zdravil za uporabo v veterinarski medicini.
That investment should be protected in order to stimulate research and innovation, in particular on veterinary medicinal products for minor species and antimicrobials, so that it is ensured that the necessary veterinary medicinal products are available in the Union.
Navedene naložbe bi bilo treba zaščititi za spodbuditev raziskav in inovacij, zlasti na področju zdravil za uporabo v veterinarski medicini za manj pomembne vrste in protimikrobnih snovi, tako da se zagotovi razpoložljivost nujnih zdravil za uporabo v veterinarski medicini v Uniji.
For that reason, data submitted to a competent authority or the Agency should be protected against use by other applicants.
Zato bi bilo treba podatke, ki se predložijo pristojnemu organu ali Agenciji, zaščititi, da jih ne bi uporabljali drugi predlagatelji.
That protection, however, should be limited in time in order to allow for competition.
Vendar pa bi navedena zaščita morala biti časovno omejena, da se omogoči konkurenca.
Similar protection of investments should be applied to studies supporting a new pharmaceutical form, administration route or dosage that reduces the antimicrobial or antiparasitic resistance or improves the benefit-risk balance.
Podobno zaščito naložb bi bilo treba uporabiti tudi za študije, ki podpirajo novo farmacevtsko obliko, nov način dajanja ali odmerjanje, s katerimi se zmanjša mikrobna odpornost ali odpornost proti antiparazitikom ali izboljša razmerje med koristjo in tveganjem.
Certain particulars and documents that are normally to be submitted with an application for a marketing authorisation should not be required if a veterinary medicinal product is a generic medicinal product of a veterinary medicinal product that is authorised or has been authorised in the Union.
Nekaterih podatkov in dokumentov, ki jih je treba običajno predložiti z vlogo za pridobitev dovoljenja za promet, ne bi bilo treba zahtevati, če je zdravilo za uporabo v veterinarski medicini generično zdravilo za uporabo v veterinarski medicini, za katerega je bilo v Uniji izdano dovoljenje za promet.
It is recognised that the potential effect of a product on the environment may depend on the volume used and the resulting amount of the pharmaceutical substance that may reach the environment.
Priznava se, da je morebiten učinek zdravila na okolje lahko odvisen od porabljene količine in posledične količine farmacevtske snovi, ki lahko vstopi v okolje.
Therefore, where there is evidence that a constituent of a medicinal product, for which an application for a marketing authorisation for a generic veterinary medicinal product has been submitted, is a hazard for the environment, it is appropriate to require data on the potential effect on the environment in order to protect the environment.
Zato je, kadar obstajajo dokazi, da sestavina zdravila, za katerega je bila predložena vloga za pridobitev dovoljenja za promet za generično zdravilo za uporabo v veterinarski medicini, pomeni tveganje za okolje, primerno zahtevati podatke o možnem vplivu na okolje, da se zavaruje okolje.
In such cases, applicants should endeavour to join efforts in generating such data in order to reduce costs and to reduce testing on vertebrate animals.
V takih primerih bi si predlagatelji morali prizadevati, da združijo moči pri pripravi takšnih podatkov, da bi omejili stroške in testiranja na vretenčarjih.
The establishment of a single Union assessment of the environmental properties of active substances for veterinary use by means of an active substance-based review (‘monograph’) system could be a potential alternative.
Alternativna možnost bi lahko bila vzpostavitev enotnega ocenjevanja okoljskih lastnosti učinkovin za uporabo v veterinarski medicini v Uniji s sistemom za pregledovanje posameznih učinkovin (v nadaljnjem besedilu: monografija).
The Commission should therefore submit a report to the European Parliament and the Council which examines the feasibility of such a monograph system and other potential alternatives for environmental risk assessment of veterinary medicinal products, accompanied, if appropriate, by a legislative proposal.
Komisija bi morala zato Evropskemu parlamentu in Svetu predložiti poročilo, ki preuči izvedljivost take monografije in druge morebitne alternative za oceno okoljskega tveganja pri zdravilih za uporabo v veterinarski medicini ter mu po potrebi priložiti zakonodajni predlog.
The protection of technical documentation should be applied to new veterinary medicinal products, as well as to data developed for supporting innovations of products with or referring to an existing marketing authorisation.
Pri novih zdravilih za uporabo v veterinarski medicini je nujno varstvo tehnične dokumentacije in podatkov, pripravljenih v podporo inovacijam zdravil z obstoječim dovoljenjem za promet ali s sklicevanjem na tako dovoljenje.
In that case, the variation or marketing authorisation application may refer partly to data submitted in a former marketing authorisation or variation applications, and should include new data specifically developed to support the required innovation of the existing product.
V tem primeru se vloga za spremembo ali pridobitev dovoljenja za promet lahko delno nanaša na podatke, predložene za prejšnjo vlogo za pridobitev dovoljenja za promet ali spremembo, in bi morala vključevati nove podatke, posebej pripravljene v podporo potrebnim inovacijam obstoječega zdravila.
Differences in the manufacturing process of biological products or a change in the excipient used may lead to differences in the generic product characteristics.
Razlike v proizvodnem postopku za biološka zdravila ali sprememba v uporabljeni pomožni snovi bi lahko privedle do razlik v značilnostih generičnega zdravila.
In an application for a marketing authorisation for a generic biological veterinary medicinal product, the bioequivalence should therefore be demonstrated in order to ensure, based on the existing knowledge, that quality, safety and efficacy are similar.
V vlogi za pridobitev dovoljenja za promet za generično biološko zdravilo za uporabo v veterinarski medicini bi bilo zato treba dokazati bioekvivalenco, da se na podlagi obstoječega znanja zagotovijo podobna kakovost, varnost in učinkovitost.
In order to avoid unnecessary administrative and financial burdens both for the competent authorities and for the pharmaceutical industry, as a general rule a marketing authorisation for a veterinary medicinal product should be granted for an unlimited period of time.
Za preprečitev nepotrebnega upravnega in finančnega bremena za pristojne organe in farmacevtsko industrijo bi na splošno bilo treba dovoljenje za promet z zdravilom za uporabo v veterinarski medicini odobriti za nedoločen čas.
Conditions for renewing the approval of a marketing authorisation should be imposed only exceptionally and should be duly justified.
Pogoje za podaljšanje dovoljenja za promet bi bilo treba uvesti le izjemoma in bi jih bilo treba ustrezno utemeljiti.
It is recognised that, in some cases, a scientific risk assessment alone cannot provide all the information on which a risk management decision should be based, and other relevant factors, including societal, economical, ethical, environmental and welfare factors and the feasibility of controls, should also be taken into account.
Priznava se, da znanstvena ocena tveganja sama v nekaterih primerih ne more zagotoviti vseh informacij, na katerih naj bi temeljila odločitev glede obvladovanja tveganja, in da bi bilo treba upoštevati tudi druge pomembne dejavnike, vključno z družbenimi, gospodarskimi, etičnimi in okoljskimi dejavniki ter dejavniki v zvezi z dobrobitjo živali in izvedljivostjo nadzora.
In certain circumstances where a significant public or animal health concern exists but scientific uncertainty persists, appropriate measures can be adopted taking into account Article 5(7) of the WTO Agreement on the Application of Sanitary and Phytosanitary Measures which has been interpreted for the Union in the communication from the Commission of 2 February 2000 on the precautionary principle.
V nekaterih okoliščinah, kadar gre za bistveno vprašanje javnega zdravja ali zdravja živali, a še vedno obstaja znanstvena negotovost, se lahko sprejmejo ustrezni ukrepi ob upoštevanju člena 5(7) sporazuma Svetovne trgovinske organizacije (STO) o uporabi sanitarnih in fitosanitarnih ukrepov, ki je bil za Unijo razložen v sporočilu Komisije z dne 2. februarja 2000 o previdnostnem načelu.
In such circumstances, Member States or the Commission should seek to obtain additional information necessary for a more objective assessment of the particular concern and should review the measure accordingly within a reasonable period of time.
V takih okoliščinah bi morale države članice ali Komisija poskušati pridobiti dodatne informacije, potrebne za objektivnejšo oceno posameznega vprašanja, in ustrezno preučiti ukrep v razumnem roku.
Antimicrobial resistance to medicinal products for human use and veterinary medicinal products is a growing health problem in the Union and worldwide.
Mikrobna odpornost na zdravila za uporabo v humani medicini in zdravila za uporabo v veterinarski medicini postaja vse večji zdravstveni problem v Uniji in po svetu.
Due to the complexity of the problem, its cross-border dimension and the high economic burden, its impact goes beyond its severe consequences for human and animal health and has become a global public health concern that affects the whole of society and requires urgent and coordinated intersectoral action in accordance with the ‘One Health’ approach.
Zaradi kompleksnosti vprašanja, njegove čezmejne razsežnosti in velikega gospodarskega bremena njegov vpliv presega posledice za zdravje ljudi in živali, saj je protimikrobna odpornost postala svetovni problem javnega zdravja, ki vpliva na celotno družbo ter zahteva nujne in usklajene medsektorske ukrepe, ki bodo skladni s pristopom „eno zdravje“.
Such action includes strengthening of the prudent use of antimicrobials, avoiding their routine prophylactic and metaphylactic use, actions to restrict the use in animals of antimicrobials that are of critical importance for preventing or treating life-threatening infections in humans and encouraging and incentivising the development of new antimicrobials.
Ti ukrepi vključujejo bolj preudarno rabo protimikrobnih snovi, izogibanje rutinski preventivni in metafilaktični uporabi, ukrepe za omejitev uporabe protimikrobnih snovi, ki so bistvenega pomena za preprečevanje ali zdravljenje življenjsko nevarnih okužb pri ljudeh, pri živalih ter spodbujanje razvoja novih protimikrobnih snovi.
It also needs to be ensured that appropriate warnings and guidance are included on the labels of veterinary antimicrobials.
Zagotoviti je treba tudi, da so na oznakah na protimikrobnih snoveh za uporabo v veterinarski medicini vključena ustrezna opozorila in navodila.
Use that is not covered by the terms of the marketing authorisation of certain new or critically important antimicrobials for humans should be restricted in the veterinary sector.
Uporabo, ki ni zajeta v pogojih dovoljenja za promet za nekatere nove ali bistvene protimikrobne snovi za ljudi, bi bilo treba v veterinarskem sektorju omejiti.
The rules for advertising veterinary antimicrobials should be tightened, and the authorisation requirements should sufficiently address the risks and benefits of antimicrobial veterinary medicinal products.
Pravila za oglaševanje protimikrobnih zdravil za uporabo v veterinarski medicini morajo biti strožje opredeljena, zahteve za pridobitev dovoljenja pa bi morale zadostno obravnavati tveganja in koristi protimikrobnih zdravil za uporabo v veterinarski medicini.
It is necessary to mitigate the risk of development of antimicrobial resistance to medicinal products for human use and veterinary medicinal products.
Zmanjšati je treba tveganje za razvoj mikrobne odpornosti na zdravila za uporabo v humani medicini in zdravila za uporabo v veterinarski medicini.
Therefore, an application for an antimicrobial veterinary medicinal product should contain information about the potential risks that use of that medicinal product may lead to the development of antimicrobial resistance in humans or animals or in organisms associated with them.
Zato bi bilo treba v vlogo za protimikrobno zdravilo za uporabo v veterinarski medicini vključiti informacije o morebitnih tveganjih pri uporabi tega zdravila za razvoj mikrobne odpornosti pri ljudeh ali živalih ali organizmih, ki so z njimi povezani.
In order to ensure a high level of public and animal health, antimicrobial veterinary medicinal products should only be authorised following a careful scientific benefit-risk assessment.
Za zagotovitev visoke ravni javnega zdravja in zdravja živali bi se protimikrobna zdravila za uporabo v veterinarski medicini smela odobriti šele po temeljiti znanstveni oceni razmerja med tveganji in koristmi.
If necessary, conditions should be laid down in the marketing authorisation in order to restrict the use of the veterinary medicinal product.
Po potrebi bi bilo treba določiti pogoje v dovoljenju za promet, da se omeji uporaba zdravila za uporabo v veterinarski medicini.
Such conditions should include restrictions on the use of the veterinary medicinal product that is not in accordance with the terms of the marketing authorisation, in particular with the summary of product characteristics.
Taki pogoji bi morali vključevati omejitve uporabe zdravila za uporabo v veterinarski medicini, ki ni v skladu s pogoji dovoljenja za promet, zlasti s povzetkom glavnih značilnosti zdravila.
The combined use of several antimicrobial active substances may represent a particular risk with respect to the development of antimicrobial resistance.
Kombinirana uporaba več protimikrobnih učinkovin lahko pomeni posebno tveganje za razvoj mikrobne odpornosti.
Such combined use should be taken into account, therefore, when assessing whether to authorise a veterinary medicinal product.
Taka kombinirana uporaba bi se morala zato upoštevati pri oceni, ali se zdravilo za uporabo v veterinarski medicini odobri.
The development of new antimicrobials has not kept pace with the increase of resistance to existing antimicrobials.
Razvoj novih protimikrobnih snovi zaostaja za povečanjem odpornosti obstoječih protimikrobnih snovi.
Given the limited innovation in developing new antimicrobials, it is essential that the efficacy of existing antimicrobials be maintained for as long as possible.
Glede na omejene inovacije pri razvoju novih protimikrobnih snovi je bistveno, da se učinkovitost obstoječih protimikrobnih snovi ohrani čim dlje.
The use of antimicrobials in medicinal products that are used in animals may accelerate the emergence and spread of resistant micro-organisms and may compromise the effective use of the already limited number of existing antimicrobials to treat human infections.
Uporaba protimikrobnih snovi v zdravilih, ki se uporabljajo pri živalih, lahko pospeši pojav in širjenje odpornih mikroorganizmov ter ogrozi učinkovito uporabo že tako omejenega števila obstoječih protimikrobnih snovi za zdravljenje okužb pri ljudeh.
Therefore, the misuse of antimicrobials should not be allowed.
Zato zloraba protimikrobnih snovi ne bi smela biti dovoljena.
Antimicrobial medicinal products should not be used for prophylaxis other than in well-defined cases for the administration to an individual animal or restricted number of animals when the risk for infection is very high or its consequences are likely to be severe.
Protimikrobna zdravila se ne bi smela uporabljati za profilakso, razen v dobro določenih primerih, ko se dajo posamezni živali ali omejenemu številu živali, kadar je tveganje za okužbo zelo veliko ali je verjetno, da bodo posledice resne.
Antibiotic medicinal products should not be used for prophylaxis other than in exceptional cases only for the administration to an individual animal.
Antibiotiki se ne bi smeli uporabljati za profilakso, razen v izjemnih primerih, ko se dajo posamezni živali.
Antimicrobial medicinal products should be used for metaphylaxis only when the risk of spread of an infection or of an infectious disease in a group of animals is high and where no appropriate alternatives are available.
Protimikrobna zdravila bi se morala uporabljati za metafilakso le, kadar je tveganje za širjenje okužbe ali nalezljive bolezni v skupini živali veliko in kadar ni na voljo drugih ustreznih možnosti.
Such restrictions should allow the decrease of prophylactic and metaphylactic use in animals towards representing a smaller proportion of the total use of antimicrobials in animals.
Takšne omejitve bi morale omogočiti zmanjšanje preventivne in metafilaktične uporabe pri živalih, da bi ta predstavljala manjši delež skupne uporabe protimikrobnih snovi pri živalih.
In order to strengthen Member States’ national policies on the prudent use of antimicrobials, especially those antimicrobials which are important for the treatment of infections in humans, but which are also necessary for the use in the veterinary medicine, it may be necessary to restrict or prohibit their use.
Da bi se okrepile nacionalne politike držav članic o preudarni uporabi protimikrobnih snovi, zlasti tistih, ki so pomembna za zdravljenje okužb pri ljudeh, pa tudi za uporabo v veterinarski medicini, je morda treba omejiti ali prepovedati njihovo uporabo.
Member States should be allowed, therefore, following scientific recommendations, to define restrictive conditions for their use, for example conditioning their prescription to the realisation of antimicrobial susceptibility testing to ensure that there is no other antimicrobials available that are sufficiently effective or appropriate to treat diagnosed disease.
Državam članicam bi zato moralo biti dovoljeno, da na podlagi znanstvenih priporočil določijo stroge pogoje za njihovo uporabo, npr. da je predpisovanje pogojeno z izvedbo testiranja protimikrobne občutljivosti, da se potrdi, da nobena druga razpoložljiva protimikrobna snovni dovolj učinkovita ali ustrezna za zdravljenje diagnosticirane bolezni.
In order to preserve as long as possible the efficacy of certain antimicrobials in the treatment of infections in humans, it may be necessary to reserve those antimicrobials for humans only.
Da bi čim dlje ohranili učinkovitost nekaterih protimikrobnih snovi za zdravljenje okužb pri ljudeh, je morda treba navedene protimikrobne snovi rezervirati samo za ljudi.
It should be possible, therefore, to decide that certain antimicrobials, following the scientific recommendations of the Agency, should not be available on the market in the veterinary sector.
Zato bi bilo treba omogočiti, da se na podlagi znanstvenih priporočil Agencije sprejme odločitev, da nekatere protimikrobne snovi ne bi smele biti na voljo na trgu v veterinarskem sektorju.
When making such decisions on antimicrobials, the Commission should also take into account available recommendations on the matter provided for by the European Food Safety Authority (EFSA) and other relevant Union agencies, which in turn also take into account any relevant recommendations from international organisations, such as the World Health Organization (WHO), the World Organisation for Animal Health (OIE), and the Codex Alimentarius.
Komisija bi morala pri odločanju o protimikrobnih snoveh upoštevati tudi razpoložljiva priporočila o zadevi, ki so jih pripravile Evropska agencija za varnost hrane (EFSA) in druge ustrezne agencije Unije, v katerih se upoštevajo vsa ustrezna priporočila mednarodnih organizacij, kot so Svetovna zdravstvena organizacija (SZO), Svetovna organizacija za zdravje živali (OIE) in Codex Alimentarius.
If an antimicrobial is administered or used incorrectly, this presents a risk to public or animal health.
Če se protimikrobna snov ne daje ali uporablja pravilno, lahko pomeni tveganje za javno zdravje ali zdravje živali.
Therefore, antimicrobial veterinary medicinal products should only be available on veterinary prescription.
Zato bi morala biti protimikrobna zdravila za uporabo v veterinarski medicini na voljo samo na veterinarski recept.
Veterinarians have a key role in ensuring prudent use of antimicrobials and consequently they should prescribe the antimicrobial medicinal products based on their knowledge of antimicrobial resistance, their epidemiological and clinical knowledge and their understanding of the risk factors for the individual animal or group of animals.
Veterinarji imajo ključno vlogo pri zagotavljanju preudarne uporabe protimikrobnih snovi, zato bi protimikrobna zdravila morali predpisovati na podlagi njihovega poznavanja mikrobne odpornosti, njihovega epidemiološkega in kliničnega znanja in njihovega razumevanja dejavnikov tveganja za posamezno žival ali skupino živali.
In addition, the veterinarians should respect their professional code of conduct.
Poleg tega bi veterinarji morali spoštovati svoj kodeks poklicnega ravnanja.
Veterinarians should ensure that they are not in a situation of conflict of interest when prescribing medicinal products, while recognising their legitimate activity of retail in accordance with national law.
Veterinarji bi pri predpisovanju zdravil morali zagotoviti, da nimajo navzkrižnih interesov, svojo zakonito dejavnost prometa na drobno pa bi morali izvajati skladno z nacionalnim pravom.
In particular, veterinarians should not to be influenced, directly or indirectly, by economic incentives when prescribing those medicinal products.
Zlasti pa na veterinarje pri predpisovanju teh zdravil ne bi smele neposredno ali posredno vplivati gospodarske spodbude.