natgillin/translations-raw huggingface dataset:
Although inactivated immunological veterinary medicinal products referred to in Article 2(3) should be manufactured in accordance with the principles of good manufacturing practice, detailed guidelines of good manufacturing practice should specifically be prepared for those products since they are manufactured in a way that is different from industrially prepared products.
Čeprav bi bilo treba inaktivirana imunološka zdravila za uporabo v veterinarski medicini iz člena 2(3) proizvajati v skladu z načeli dobre proizvodne prakse, bi bilo treba posebej za ta zdravila pripraviti podrobne smernice dobre proizvodne prakse, saj se proizvajajo na drugačen način kot industrijsko pripravljena zdravila.
That would preserve their quality without hindering their manufacturing and availability.
Tako bi ohranili njihovo kakovost, njihova proizvodnja in razpoložljivost pa ne bi bili ovirani.
Companies should hold an authorisation to be able to distribute wholesale veterinary medicinal products and should comply with the principles of good distribution practice, so as to guarantee that such medicinal products are appropriately stored, transported and handled.
Podjetja bi morala imeti dovoljenje za promet z zdravili za uporabo v veterinarski medicini na debelo in upoštevati načela dobre distribucijske prakse, s čimer se zagotovi, da se taka zdravila ustrezno skladiščijo in prevažajo ter da se z njimi ustrezno ravna.
It should be the responsibility of the Member States to ensure that those conditions are met.
Za zagotavljanje izpolnjevanja navedenih pogojev bi morale biti odgovorne države članice.
Those authorisations should be valid throughout the Union and should also be required in the case of parallel trade in veterinary medicinal products.
Navedena dovoljenja bi morala veljati po vsej Uniji in bi jih bilo treba zahtevati tudi v primeru vzporednega prometa z zdravili za uporabo v veterinarski medicini.
In order to ensure transparency, a database should be established at Union level for the purpose of publishing a list of wholesale distributors who have been found to comply with applicable Union legislation following an inspection by the competent authorities of a Member State.
Za zagotovitev preglednosti bi bilo treba vzpostaviti zbirko podatkov na ravni Unije za namen objavljanja seznama veletrgovcev, za katere je bilo na podlagi inšpekcijskih pregledov, ki jih izvajajo pristojni organi države članice, ugotovljeno, da upoštevajo veljavno zakonodajo Unije.
The conditions governing the supply of veterinary medicinal products to the public should be harmonised in the Union.
Pogoje, ki urejajo dobavo zdravil za uporabo v veterinarski medicini javnosti, bi bilo treba harmonizirati na ravni Unije.
Veterinary medicinal products should only be supplied by persons authorised to do so by the Member State in which they are established.
Zdravila za uporabo v veterinarski medicini bi morale dobavljati samo osebe, ki jih za to pooblasti država članica, v kateri imajo sedež.
At the same time, in order to improve access to veterinary medicinal products in the Union, retailers that are authorised to supply veterinary medicinal products by the competent authority in the Member State in which they are established should be allowed to sell veterinary medicinal products not subject to a veterinary prescription at a distance to buyers in other Member States.
Za izboljšane dostopnosti zdravil za uporabo v veterinarski medicini v Uniji bi bilo treba trgovcem na drobno, ki jih pristojni organ v državi članici, v kateri imajo sedež, pooblasti za dobavo zdravil za uporabo v veterinarski medicini, dovoliti, da zdravila za uporabo v veterinarski medicini brez veterinarskega recepta prodajajo na daljavo kupcem v drugih državah članicah.
However, taking into account that in some Member States it is current practice to sell at a distance also those veterinary medicinal products which are subject to prescription, Member States should be allowed to continue such practice under certain conditions and within their territory only.
Vendar bi morale ob upoštevanju dejstva, da je v nekaterih državah članicah prodaja na daljavo zdravil za uporabo v veterinarski medicini na recept običajna praksa, države članice imeti možnost, da pod določenimi pogoji na svojem ozemlju nadaljujejo takšno prakso.
In such cases, those Member States should take appropriate measures to avoid unintended consequences of such supply and establish rules on appropriate penalties.
V takih primerih bi morale te države članice sprejeti ustrezne ukrepe, da bi se izognile nenamernim posledicam takšne dobave, in določiti pravila o ustreznih kaznih.
Veterinarians should always issue a veterinary prescription when supplying a veterinary medicinal product subject to a veterinary prescription only and not administering it themselves.
Veterinarji bi morali vedno izdati veterinarski recept, ko dobavljajo zdravilo za uporabo v veterinarski medicini, ki ga je mogoče dobiti samo na recept in ki ga ne dajejo sami.
Whenever the veterinarians administer such medicinal products themselves it should be left up to national provisions to specify whether a veterinary prescription needs to be issued.
Kadar veterinarji sami dajejo taka zdravila, bi v nacionalni zakonodaji moralo biti določeno, ali mora veterinar izdati veterinarski recept ali ne.
However, veterinarians should always keep records of the medicinal products that they have administered.
Ne glede ne to bi veterinarji vedno morali voditi evidenco zdravil, ki so jih dali živalim.
The illegal sale of veterinary medicinal products to the public at a distance may represent a threat to public and animal health, as falsified or substandard medicines may reach the public in this way.
Nezakonita prodaja zdravil za uporabo v veterinarski medicini javnosti na daljavo lahko predstavlja tveganje za javno zdravje in zdravje živali, saj lahko na ta način javnost dosežejo ponarejena ali podstandardna zdravila.
It is necessary to address that threat.
To nevarnost je treba obravnavati.
Account should be taken of the fact that specific conditions for supply of medicinal products to the public have not been harmonised at Union level and, therefore, Member States can impose conditions for supplying medicinal products to the public within the limits of the Treaty on the Functioning of the European Union (TFEU).
Upoštevati bi bilo treba dejstvo, da posebni pogoji za dobavo zdravil javnosti niso bili harmonizirani na ravni Unije, zato lahko države članice uvedejo pogoje za dobavo zdravil javnosti v mejah Pogodbe o delovanju Evropske unije (PDEU).
When examining the compatibility with Union law of the conditions for the supply of medicinal products, the Court of Justice has recognised, in the context of medicinal products for human use, the very particular nature of medicinal products whose therapeutic effects distinguish them substantially from other goods.
Pri preučevanju skladnosti pogojev za dobavo zdravil s pravom Unije je Sodišče v okviru zdravil za uporabo v humani medicini priznalo zelo posebno naravo zdravil, ki se po svojih zdravilnih učinkih bistveno razlikujejo od drugega blaga.
The Court of Justice has also held that health and life of humans rank foremost among the assets and interests protected by the TFEU and that it is for Member States to determine the level of protection which they wish to afford to public health and the way in which that level has to be achieved.
Sodišče je tudi menilo, da sta zdravje in življenje ljudi na prvem mestu med sredstvi in interesi, ki jih ščiti PDEU, ter da morajo države članice določiti raven varovanja, ki jo želijo zagotoviti javnemu zdravju, ter način, na katerega je navedeno raven treba doseči.
Since that level may vary from one Member State to another, Member States are to be allowed some discretion as regards the conditions for the supply on their territory of medicinal products to the public.
Ker se navedena raven med državami članicami lahko razlikuje, je treba državam članicam dopustiti diskrecijsko pravico glede pogojev za dobavo zdravil javnosti na njihovem ozemlju.
Member States should be able, therefore, to subject the supply of medicinal products offered for sale at a distance by means of information society services to conditions justified by the protection of public or animal health.
Zato bi države članice morale imeti možnost, da za dobavo zdravil, ki se prodajajo na daljavo prek storitev informacijske družbe, uvedejo pogoje, utemeljene z varovanjem javnega zdravja ali zdravja živali.
Such conditions should not unduly restrict the functioning of the internal market.
Taki pogoji ne bi smeli po nepotrebnem omejevati delovanja notranjega trga.
In that context, Member States should be able to subject the supply of veterinary medicinal products offered for retail to stricter conditions justified by the protection of public or animal health or of environment, provided that those conditions are proportionate to the risk and do not unduly restrict the functioning of the internal market.
Države članice bi morale imeti možnost, da na podlagi razlogov, utemeljenih z varovanjem javnega zdravja, zdravja živali ali okolja, določijo strožje pogoje za promet zdravil za uporabo v veterinarski medicini na drobno, če so ti pogoji sorazmerni s tveganjem in po nepotrebnem ne omejujejo delovanja notranjega trga.
In order to ensure high standards and safety of the veterinary medicinal products offered for sale at a distance, the public should be assisted in identifying websites which are legally offering such medicinal products.
Za zagotavljanje visokih standardov in varnosti zdravil za uporabo v veterinarski medicini, ki se prodajajo na daljavo, bi bilo treba javnosti pomagati pri prepoznavanju spletnih mest, ki zakonito ponujajo taka zdravila.
A common logo should be established, recognisable throughout the Union, while allowing for the identification of the Member State in which the person offering veterinary medicinal products for sale at a distance is established.
Oblikovati bi bilo treba skupen logotip, prepoznaven po vsej Uniji, pri tem pa omogočiti identifikacijo države članice, v kateri ima sedež oseba, ki ponuja zdravila za uporabo v veterinarski medicini za prodajo na daljavo.
The Commission should develop the design for such a common logo.
Komisija bi morala pripraviti zasnovo takega skupnega logotipa.
Websites offering veterinary medicinal products for sale at a distance to the public should be linked to the website of the competent authority concerned.
Spletna mesta, ki javnosti ponujajo zdravila za uporabo v veterinarski medicini za prodajo na daljavo, bi morala biti povezana s spletnim mestom zadevnega pristojnega organa.
The websites of the competent authorities of Member States, as well as that of the Agency, should give an explanation of the use of that common logo.
Uporaba skupnega logotipa bi morala biti pojasnjena na spletnih mestih pristojnih organov držav članic, pa tudi na spletnem mestu Agencije.
All those websites should be linked in order to provide comprehensive information to the public.
Vsa ta spletna mesta bi morala biti povezana, da se javnosti zagotovijo obsežne informacije.
Collection systems for the disposal of waste veterinary medicinal products should continue to be in place in the Member States in order to control any risk that such products might raise with regard to the protection of human and animal health or the environment.
Sisteme zbiranja za odstranjevanje odpadnih zdravil za uporabo v veterinarski medicini bi bilo treba še naprej uporabljati v državah članicah za namene nadzora morebitnega tveganja, ki bi ga taka zdravila lahko povzročila v zvezi z varovanjem zdravja ljudi in živali ali okolja.
Advertising, even of medicinal products not subject to a veterinary prescription, could affect public and animal health and distort competition.
Oglaševanje, tudi oglaševanje zdravil brez veterinarskega recepta, bi lahko vplivalo na javno zdravje in zdravje živali ter izkrivljalo konkurenco.
Therefore, advertising of veterinary medicinal products should meet certain criteria.
Zato bi moralo oglaševanje zdravil za uporabo v veterinarski medicini izpolnjevati nekatera merila.
Persons qualified to prescribe or supply veterinary medicinal products can properly evaluate the information available in advertising because of their knowledge, training and experience in animal health.
Osebe, usposobljene za predpisovanje ali dobavljanje zdravil za uporabo v veterinarski medicini, lahko zaradi svojega znanja, usposabljanja in izkušenj na področju zdravja živali ustrezno ocenijo informacije, ki so na voljo pri oglaševanju.
The advertising of veterinary medicinal products to persons who cannot properly assess the risk associated with their use may lead to medicinal product misuse or overconsumption which is liable to harm public or animal health, or the environment.
Oglaševanje zdravil za uporabo v veterinarski medicini za osebe, ki ne morejo ustrezno razumeti tveganja, povezanega z njihovo uporabo, lahko privede do zlorabe ali prekomerne uporabe zdravil, kar lahko ogrozi javno zdravje, zdravje živali ali okolje.
However, in order to preserve the animal health status in their territory, Member States should be able under restricted conditions to allow advertising of immunological veterinary medicinal products also to professional animal keepers.
Da bi ohranile zdravstveni status živali na svojem ozemlju, bi državam članicam moralo biti omogočeno, da pod omejenimi pogoji dovolijo oglaševanje imunoloških zdravil za uporabo v veterinarski medicini tudi za poklicne rejce živali.
With regard to the advertising of veterinary medicinal products, Member States’ experience has shown that it is necessary to put emphasis on the distinction between feed and biocidal products, on the one hand, and veterinary medicinal products, on the other, because that distinction is often misrepresented in advertising.
Ko gre za oglaševanje zdravil za uporabo v veterinarski medicini, so izkušnje držav članic pokazale, da je treba poudariti razliko med krmo in biocidnimi proizvodi na eni strani ter zdravili za uporabo v veterinarski medicini na drugi strani, ker je ta razlika v oglaševanju pogosto napačno predstavljena.
The rules of advertisement in this Regulation are to be seen as specific rules that complement the general rules in Directive 2006/114/EC of the European Parliament and of the Council.
Pravila o oglaševanju v tej uredbi je treba obravnavati kot posebna pravila, ki dopolnjujejo splošna pravila iz Direktive 2006/114/ES Evropskega parlamenta in Sveta.
Where medicinal products are authorised within a Member State and have been prescribed in that Member State by a veterinarian for an individual animal or group of animals, it should in principle be possible for that veterinary prescription to be recognised and for the medicinal product to be dispensed in another Member State.
Kadar je za zdravila izdano dovoljenje v eni državi članici in jih je v navedeni državi članici predpisal veterinar za posamezno žival ali skupino živali, bi moralo biti načeloma mogoče, da se navedeni veterinarski recept prizna in zdravilo izda v drugi državi članici.
The removal of regulatory and administrative barriers to such recognition should not affect any professional or ethical duty for veterinarians to refuse to dispense the medicinal product stated in the prescription.
Odstranitev regulativnih in upravnih ovir za tako priznavanje receptov ne bi smela vplivati na poklicno ali etično dolžnost veterinarjev, da zavrnejo izdajo zdravila iz recepta.
The implementation of the principle of recognition of veterinary prescriptions should be facilitated by the adoption of a model format for veterinary prescription, listing the essential information necessary to ensure the safe and efficacious use of the medicinal product.
Izvajanje načela priznavanja veterinarskih receptov bi moralo olajšati sprejetje vzorca obrazca za veterinarski recept s seznamom bistvenih informacij, potrebnih za zagotovitev varne in učinkovite uporabe zdravila.
Nothing should prevent Member States from having further elements in their veterinary prescriptions, as long as this does not prevent veterinary prescriptions from other Member States from being recognised.
Državam članicam ne bi smelo nič preprečiti, da v svoje veterinarske recepte vključijo dodatne elemente, če to ne preprečuje priznavanja veterinarskih receptov iz drugih držav članic.
Information on veterinary medicinal products is essential in order to enable health professionals, authorities and companies make informed decisions.
Informacije za zdravila za uporabo v veterinarski medicini so bistvenega pomena, da zdravstvenim delavcem, organom in podjetjem omogočajo sprejemanje ozaveščenih odločitev.
A key aspect is the creation of a Union database that should collate information on marketing authorisations granted in the Union.
Ključni vidik je vzpostavitev zbirke podatkov v Uniji, ki bi morala združevati informacije o dovoljenjih za promet, izdanih v Uniji.
That database should enhance overall transparency, streamline and facilitate the flow of information between authorities, and prevent multiple reporting requirements.
Ta zbirka podatkov bi morala izboljšati splošno preglednost ter racionalizirati in olajšati pretok informacij med organi ter preprečiti podvajanje zahtev za poročanje.
The verification of compliance with the legal requirements through controls is of fundamental importance to ensure that the objectives of this Regulation are effectively achieved across the Union.
Preverjanje skladnosti s pravnimi zahtevami prek nadzora je bistvenega pomena za zagotovitev učinkovitega doseganja ciljev te uredbe po vsej Uniji.
Therefore, the competent authorities of the Member States should have the power to perform inspections at all stages of production, distribution and use of veterinary medicinal products.
Zato bi pristojni organi držav članic morali biti pooblaščeni za izvajanje inšpekcijskih pregledov v vseh fazah proizvodnje, distribucije in uporabe zdravil za uporabo v veterinarski medicini.
In order to preserve the effectiveness of the inspections, the competent authorities should have the possibility to perform unannounced inspections.
Za ohranitev učinkovitosti inšpekcijskih pregledov bi pristojni organi morali imeti možnost izvesti nenapovedane inšpekcijske preglede.
The frequency of controls should be established by the competent authorities having regard to the risk and to the level of compliance expected in the different situations.
Pogostost nadzora bi morali določiti pristojni organi ob upoštevanju tveganja in pričakovane ravni skladnosti v različnih razmerah.
That approach should allow those competent authorities to allocate resources where the risk is the highest.
Ta pristop bi moral tem pristojnim organom omogočiti, da sredstva dodelijo področjem, na katerih je tveganje največje.
In some cases, however, controls should be performed irrespective of the level of risk or expected non-compliance, for example prior to granting manufacturing authorisations.
V nekaterih primerih je treba nadzor izvajati ne glede na raven tveganja ali pričakovano neskladnost, na primer pred izdajo dovoljenja za proizvodnjo.
In certain cases, failures in Member States’ control system can substantially hinder the achievement of the objectives of this Regulation and may lead to the emergence of risks to public and animal health and the environment.
V nekaterih primerih pomanjkljivosti nadzornega sistema držav članic lahko znatno ovirajo doseganje ciljev te uredbe in lahko privedejo do tveganj za javno zdravje in zdravje živali ter okolje.
To ensure a harmonised approach to controls throughout the Union, the Commission should be able to carry out audits in the Member States to verify the functioning of national control systems.
Za zagotovitev harmoniziranega pristopa za nadzor po vsej Uniji bi morala Komisija imeti možnost izvedbe revizij v državah članicah, da preveri delovanje nacionalnih nadzornih sistemov.
Those audits should be carried out so as to avoid any unnecessary administrative burden and, as far as possible, be coordinated with Member States and with any other Commission audits to be carried out under Regulation (EU) 2017/625 of the European Parliament and of the Council.
Te revizije bi bilo treba izvesti tako, da se prepreči kakršno koli nepotrebno upravno breme, po možnosti pa bi morale biti kar se da usklajene z državami članicami ter z vsemi drugimi revizijami Komisije, ki se bodo izvajale v skladu z Uredbo (EU) 2017/625 Evropskega parlamenta in Sveta.
In order to ensure transparency, impartiality and consistency in the level of enforcement activities by Member States, it is necessary for Member States to set up an appropriate framework for penalties with a view to imposing effective, proportionate and dissuasive penalties for non-compliance with this Regulation, as non-compliance can result in damage to public and animal health and the environment.
Za zagotovitev preglednosti, nepristranskosti in doslednosti dejavnosti izvrševanja v državah članicah je nujno, da države članice vzpostavijo ustrezen okvir za kazni, v okviru katerega se naložijo učinkovite, sorazmerne in odvračilne kazni za neskladnost s to uredbo, saj ima lahko neskladnost škodljive posledice za javno zdravje in zdravje živali ter okolje.
Companies and authorities are frequently confronted with the need to distinguish between veterinary medicinal products, feed additives, biocidal products and other products.
Podjetja in organi so pogosto soočeni s potrebo po razlikovanju med zdravili za uporabo v veterinarski medicini, krmnimi dodatki, biocidnimi proizvodi in drugimi proizvodi.
In order to avoid inconsistencies in the treatment of such products, to increase legal certainty, and to facilitate the decision-making process by Member States, a coordination group of Member States should be established, and among other tasks it should provide on a case-by-case basis a recommendation as to whether a product falls within the definition of a veterinary medicinal product.
V izogib nedoslednostim pri obravnavi takih proizvodov ter za povečanje pravne varnosti in olajšanje sprejemanja odločitev v državah članicah bi bilo treba vzpostaviti usklajevalno skupino držav članic, med drugim pa bi ta skupina za vsak primer posebej morala zagotavljati priporočilo, ali proizvod spada v opredelitev zdravila za uporabo v veterinarski medicini.
In order to ensure legal certainty, the Commission may decide whether a specific product is a veterinary medicinal product.
Za zagotovitev pravne varnosti lahko Komisija odloči, ali je specifični proizvod dejansko zdravilo za uporabo v veterinarski medicini.
Having regard to the special characteristics of homeopathic veterinary medicinal products, especially the constituents of those products, it is desirable to establish a special, simplified registration procedure and to provide specific provisions for package leaflets for certain homeopathic veterinary medicinal products which are placed on the market without indications.
Ob upoštevanju posebnih značilnosti homeopatskih zdravil za uporabo v veterinarski medicini, zlasti sestavin teh zdravil, je zaželeno, da se določi poseben poenostavljen postopek registracije in zagotovijo posebne določbe za navodila za uporabo nekaterih homeopatskih zdravil za uporabo v veterinarski medicini, ki se dajejo v promet brez indikacij.
The quality aspect of homeopathic medicinal products is independent of their use, so no specific provisions should apply to such products with regard to the necessary quality requirements and rules.
Kakovostni vidik homeopatskih zdravil je neodvisen od njihove uporabe, zato ne bi bilo treba uporabljati posebnih določb za ta zdravila v zvezi z zahtevami in pravili glede potrebne kakovosti.
Moreover, while the use of homeopathic veterinary medicinal products authorised under this Regulation is regulated in the same way as other authorised veterinary medicinal products, it does not regulate the use of registered homeopathic veterinary medicinal products.
Medtem ko je uporaba homeopatskih zdravil za uporabo v veterinarski medicini, odobrenih s to uredbo, urejena na isti način kot druga odobrena zdravila za uporabo v veterinarski medicini, pa uredba ne ureja uporabe registriranih homeopatskih zdravil za uporabo v veterinarski medicini.