FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: It is advisable to stipulate more precisely the cases in which the results of pharmacological and toxicological tests or clinical trials do not have to be provided with a view to obtaining authorization for a veterinary medicinal product which is essentially similar to an innovative product, while ensuring that innovative forms are not placed at a disadvantage.
Slovenian: Zaželeno je točneje predpisati primere, v katerih za pridobitev dovoljenja za promet z zdravili za uporabo v veterinarski medicini, ki je bistveno podobno inovativnemu zdravilu rezultati farmakoloških in toksikoloških preskusov ali kliničnih preskušanj niso potrebni, pri tem pa je treba zagotoviti, da inovativne oblike niso postavljene v slabši položaj.
English: However, there are reasons of public policy for not repeating tests carried out on animals without overriding cause.
Slovenian: V interesu javnega reda je, da se preskušanja na živalih ne ponavljajo brez izrecnega razloga.
English: Following the establishment of the internal market, specific controls to guarantee the quality of veterinary medicinal products imported from third countries can be waived only if appropriate arrangements have been made by the Community to ensure that the necessary controls are carried out in the exporting country.
Slovenian: Po ustanovitvi notranjega trga se lahko opustijo specifične kontrole, ki zagotavljajo kakovost zdravil za uporabo v veterinarski medicini uvoženih iz tretjih držav samo, če je Skupnost dosegla ustrezne dogovore, ki zagotavljajo, da se potrebne kontrole opravljene v državi izvoznici.
English: In order to ensure the continued safety of veterinary medicinal products in use, it is necessary to ensure that pharmacovigilance systems in the Community are continually adapted to take account of scientific and technical progress.
Slovenian: Da bi zagotovili trajno varnost zdravil za uporabo v veterinarski medicini, ki se že uporabljajo, je treba zagotoviti, da se sistem farmakovigilance v Skupnosti nenehno prilagaja in se upošteva sprotni znanstveni in tehnološki napredek.
English: For public health protection, relevant data on adverse effects in humans related to the use of veterinary medicines should be collected and evaluated.
Slovenian: Za varovanje javnega zdravja je treba zbirati in ovrednotiti ustrezne podatke o različnih učinkih zdravil za uporabo v veterinarski medicini pri ljudeh.
English: The pharmacovigilance systems should consider the available data on lack of efficacy.
Slovenian: Sistem farmakovigilance mora upoštevati razpoložljive podatke glede izostanka učinkovitosti.
English: In addition, collection of information on adverse reactions due to off-label use, investigations of the validity of the withdrawal period and on potential environmental problems may contribute to improve regular monitoring of good usage of veterinary medicines.
Slovenian: Poleg tega zbiranje informacij o neželenih škodljivih učinkih zaradi izjemne uporabe, raziskave o veljavnosti karence ter o potencialnih okoljevarstvenih problemih lahko pripomore k izboljšanju rednega nadzora pravilne uporabe zdravil za uporabo v veterinarski medicini.
English: 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.
Slovenian: Treba je upoštevati spremembe, ki nastajajo kot rezultat notranjega usklajevanja opredelitev pojmov, terminologije in tehnološkega razvoja na področju farmakovigilance.
English: The increasing use of electronic means of communication of information on adverse reactions to veterinary medicinal products marketed in the Community is intended to allow a single reporting point for adverse reactions, at the same time ensuring that this information is shared with the competent authorities in all Member States.
Slovenian: Vse večja uporaba elektronskih sredstev izmenjave informacij o neželenih škodljivih učinkih zdravil za uporabo v veterinarski medicini, ki so v prometu znotraj Skupnosti ima za cilj omogočiti enotne točke obveščanja o neželenih škodljivih učinkih, hkrati pa zagotoviti, da so te informacije na voljo vsem državam članicam.
English: It is the interest of the Community to ensure that the veterinary pharmacovigilance systems for centrally authorised medicinal products and those authorised by other procedures are consistent.
Slovenian: V interesu Skupnosti je, da se zagotovi dosleden sistem farmakovigilance za zdravila za uporabo v veterinarski medicini z dovoljenjem za promet, pridobljenim po centraliziranem postopku ter za tista zdravila, ki so pridobila dovoljenje za promet po drugih postopkih.
English: Holders of marketing authorisations should be proactively responsible for ongoing pharmacovigilance of the veterinary medicinal products they place on the market.
Slovenian: Imetniki dovoljenja za promet z zdravilom morajo biti proaktivno odgovorni za stalno farmakovigilanco za zdravila za uporabo v veterinarski medicini, ki jih dajejo v promet.
English: The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(8).
Slovenian: Ukrepi, potrebni za izvajanje te direktive morajo biti sprejeti v skladu z Sklepom Komisije 1999/468/ES z dne 28. junija 1999o določitvi postopkov za uresničevanje Komisiji podeljenih izvedbenih pooblastil [8].
English: In order to improve the protection of public health, it is necessary to specify that foodstuffs for human consumption may not be taken from animals which have been used in clinical trials of veterinary medicinal products unless a maximum residue limit has been laid down for residues of the veterinary medicinal product concerned in accordance with the provisions of Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin(9).
Slovenian: Za izboljšanje zaščite javnega zdravja je treba jasno navesti, da živila za prehrano ljudi ne smejo izvirati iz živali, ki so bile uporabljene v kliničnih preskušanjih zdravil za uporabo v veterinarski medicini, razen če so najvišje dovoljene količine zaostankov za zaostanke zadevnega zdravila za uporabo v veterinarski medicini določene v skladu z določili Uredbe Sveta (EGS) št. 2377/90 z dne 26. junija 1990 o določitvi postopka Skupnosti za določanje najvišjih dovoljenih količin zaostankov zdravil za uporabo v veterinarski medicini v živilih živalskega izvora [9].
English: The Commission should be empowered to adopt the changes necessary in order to adapt Annex I to scientific and technical progress.
Slovenian: Komisija mora biti pooblaščena, da sprejeme spremembe, potrebne za uskladitev Priloge I z znanstvenim in tehnološkim napredkom,.
English: This Directive should be without prejudice to the obligations of the Member States concerning the time-limits for transposition of the Directives set out in Annex II, Part B,
Slovenian: Ta direktiva ne sme posegati v obveznosti držav članic glede rokov za prenos direktiv, določenih v delu B Priloge II –
English: TITLE I
Slovenian: NASLOV I
English: DEFINITIONS
Slovenian: OPREDELITEV POJMOV
English: For the purposes of this Directive, the following terms shall bear the following meanings:
Slovenian: V tej direktivi imajo izrazi naslednji pomeni:
English: Proprietary medicinal product:
Slovenian: Lastniško zdravilo :
English: Any ready-prepared medicinal product placed on the market under a special name and in a special pack.
Slovenian: katero koli zdravilo, pripravljeno za uporabo, ki je dano v promet pod določenim imenom in v posebni ovojnini.
English: Veterinary medicinal product:
Slovenian: Zdravilo za uporabo v veterinarski medicini :
English: Any substance or combination of substances presented for treating or preventing disease in animals.
Slovenian: katera koli snov ali kombinacija snovi, ki so namenjene za zdravljenje ali preprečevanje bolezni pri živalih.
English: Any substance or combination of substances which may be administered to animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in animals is likewise considered a veterinary medicinal product.
Slovenian: Prav tako se šteje za zdravilo za uporabo v veterinarski medicini katera koli snov ali kombinacija snovi, ki se jih daje živalim z namenom, da bi se določila medicinska diagnoza ali ponovno vzpostavile, izboljšale ali spremenile fiziološke funkcij pri živalih.
English: Ready-made veterinary medicinal product:
Slovenian: Pripravljeno zdravilo za uporabo v veterinarski medicini :
English: Any veterinary medicinal product prepared in advance which does not comply with the definition of proprietary medicinal products and which is marketed in a pharmaceutical form which may be used without further processing. 4. Substance:
Slovenian: katero koli zdravilo za uporabo v veterinarski medicini, pripravljeno vnaprej, ki se ne sklada z opredelitvijo lastniškega zdravila ter se trži v farmacevtski obliki, ki se lahko uporablja brez nadaljnje predelave.
English: Any matter irrespective of origin which may be:
Slovenian: Snov - človeškega izvora, npr.:
English: human, e.g. human blood and human blood products;
Slovenian: človeška kri in pripravki in izdelki iz človeške krvi;
English: animal, e.g.
Slovenian: živalskega izvora, npr.:
English: micro-organisms, whole animals, parts of organs, animal secretions, toxins, extracts, blood products;
Slovenian: mikroorganizmi, cele živali, deli organov, živalski izločki, strupi, izvlečki, krvni izdelki;
English: vegetable, e.g.
Slovenian: rastlinskega izvora, npr.:
English: micro-organisms, plants, parts of plants, vegetable secretions, extracts;
Slovenian: mikroorganizmi, rastline, deli rastlin, rastlinski izločki, izvlečki;
English: chemical, e.g.
Slovenian: kemičnega izvora:
English: elements, naturally occurring chemical materials and chemical products obtained by chemical change or synthesis.
Slovenian: elementi, kemične snovi, ki se pojavljajo v določeni obliki v naravi, kemični izdelki, pridobljeni s kemično substitucijo ali sintezo.
English: Pre-mix for medicated feedingstuffs:
Slovenian: Premiks za izdelavo medicinirane krme :
English: Any veterinary medicinal product prepared in advance with a view to the subsequent manufacture of medicated feedingstuffs.
Slovenian: katera koli vnaprej pripravljena zdravila za uporabo v veterinarski medicini namenjena poznejši izdelavi medicinirane krme.
English: Medicated feedingstuffs:
Slovenian: Medicirana krma :
English: Any mixture of a veterinary medicinal product or products and feed or feeds which is ready prepared for marketing and intended to be fed to animals without further processing, because of its curative or preventive properties or other properties as a medicinal product covered by point 2.
Slovenian: vsaka mešanica zdravila ali zdravil za uporabo v veterinarski medicini in krme ali krme, ki je pripravljena za prodajo in namenjena krmljenju živali brez nadaljnje predelave, zaradi kurativnih ali preventivnih lastnosti ali drugih lastnosti zdravil, zajetih pod točko 2.
English: Immunological veterinary medicinal product:
Slovenian: Imunološka zdravila za uporabo v veterinarski medicini :
English: A veterinary medicinal product administered to animals in order to produce active or passive immunity or to diagnose the state of immunity.
Slovenian: izdelki, ki, dani živalim, povzročijo nastanek aktivne ali pasivne imunosti ali so namenjeni diagnosticiranju stanja imunosti.
English: Homeopathic veterinary medicinal product:
Slovenian: Homeopatsko zdravilo za uporabo v veterinarski medicini :
English: Any veterinary medicinal product prepared from products, substances or compositions called homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias currently used officially in the Member States.
Slovenian: katero koli zdravilo za uporabo v veterinarski medicini, pripravljeno iz snovi ali sestavin, ki se imenujejo homeopatske surovine, v skladu s homeopatskim postopkom izdelave po določilih Evropske farmakopeje ali, če Evropska farmakopeja tega ne določa, po določilih drugih veljavnih farmakopej, ki se trenutno uradno uporablja v državah članicah.
English: A homeopathic veterinary medicinal product may also contain a number of principles.
Slovenian: Homeopatsko zdravilo za uporabo v veterinarski medicini lahko vsebuje tudi več učinkovin.
English: Withdrawal period:
Slovenian: Karenca :
English: Period necessary between the last administration of the veterinary medicinal product to animals under normal conditions of use and the production of foodstuffs from such animals, in order to ensure that such foodstuffs do not contain residues in quantities in excess of the maximum limits laid down in application of Regulation (EEC) No 2377/90.
Slovenian: časovno obdobje, ki mora preteči od zadnjega dajanja zdravila živali ob normalni uporabi pa do trenutka proizvodnje živil iz takih živali, da bi zagotovili, da ta živila ne vsebujejo zaostankov zdravil nad najvišjimi dovoljenimi količinami zaostankov določenih z izvajanjem Uredbe (EGS) št. 2377/90.
English: Adverse reaction:
Slovenian: Neželen škodljiv učinek :
English: A reaction which is harmful and unintended and which occurs at doses normally used in animals for the prophylaxis, diagnosis or treatment of disease or the modification of physiological function.
Slovenian: škodljiva in nenamerna reakcija, do katere prihaja v odmerkih, ki jih normalno uporabljamo pri živalih za preprečevanje, diagnozo ali zdravljenje bolezni, ali za spreminjanje fiziološke funkcije.
English: Human adverse reaction:
Slovenian: Neželen škodljiv učinek pri človeku :
English: A reaction which is noxious and unintended and which occurs in a human being following exposure to a veterinary medicine.
Slovenian: reakcija, ki je zdravju škodljiva in nenamerna in ki se pojavlja pri človeku, ki je izpostavljen zdravilu za uporabo v veterinarski medicini.
English: Serious adverse reaction:
Slovenian: Resen neželen škodljiv učinek :
English: An adverse reaction which results in death, is life-threatening, results in significant disability or incapacity, is a congenital anomaly/birth defect, or which results in permanent or prolonged signs in the animals treated.
Slovenian: škodljiva reakcija, ki se konča s poginom, ogroža življenje, ima za posledico znatno prizadetost ali nesposobnost, je prirojena anomalija ali napaka pri rojstvu, ali pa ima za posledico trajne ali dolgotrajnejše znake pri zdravljenih živalih.
English: Unexpected adverse reaction:
Slovenian: Nepričakovan neželen škodljiv učinek :
English: An adverse reaction, the nature, severity or outcome of which is not consistent with the summary of the product characteristics.
Slovenian: škodljiva reakcija, katere narava, resnost ali izid ni v skladu s povzetkom glavnih značilnosti zdravila.
English: Periodic safety update reports:
Slovenian: Periodično posodobljeno varnostno poročilo :
English: The periodical reports containing the records referred to in Article 75.
Slovenian: občasna poročila, ki vsebujejo zapise iz člena 75.
English: Post-marketing surveillance studies:
Slovenian: Študija o varnosti zdravila po pridobitvi dovoljenja za promet :
English: Pharmacoepidemiological study or a clinical trial carried out in accordance with the terms of the marketing authorization, conducted with the aim of identifying and investigating a safety hazard relating to an authorized veterinary medicinal product.
Slovenian: farmakoepidemiološka študija ali klinično preskušanje, ki se izvede v skladu s pogoji dovoljenja za promet z zdravilom, da bi se odkrila in raziskala morebitna tveganja glede varnosti zdravila za uporabo v veterinarski medicini, ki že ima dovoljenje za promet.
English: Off-label use:
Slovenian: Izjemna uporaba :
English: The use of a veterinary medicinal product that is not in accordance with the summary of the product characteristics, including the misuse and serious abuse of the product. 17. Wholesale dealing in veterinary medicinal products:
Slovenian: uporaba zdravila za uporabo v veterinarski medicini, ki ni v skladu s povzetkom glavnih značilnosti zdravila, vključno z napačno uporabo in resno zlorabo proizvoda.
English: Any activity which includes the purchase, sale, import, export, or any other commercial transaction in veterinary medicinal products, whether or not for profit, except for: - the supply by a manufacturer of veterinary medicinal products manufactured by himself,
Slovenian: Promet z zdravili za uporabo v veterinarski medicini na debelo - dobave izdelovalca zdravil za uporabo v veterinarski medicini, ki jih izdeluje sam
English: retail supplies of veterinary medicinal products by persons entitled to carry out such supplies in accordance with Article 66.
Slovenian: maloprodajne dobave zdravil za uporabo v veterinarski medicini preko oseb, ki so upravičene za izvajanje tovrstnih dobav v skladu s členom 66.
English: Agency:
Slovenian: Agencija :
English: European Agency for the Evaluation of Medicinal Products established by Regulation (EEC) No 2309/93.
Slovenian: Evropska agencija za vrednotenje zdravil, ustanovljena z Uredbo (EGS) št. 2309/93.
English: Risk to human or animal health or the environment:
Slovenian: Tveganje za zdravje ljudi ali živali ali za okolje :
English: Any risk relating to the quality, safety and efficacy of the veterinary medicinal product.
Slovenian: vsako tveganje, ki se nanaša na kakovost, varnost in učinkovitost zdravila za uporabo v veterinarski medicini.
English: TITLE II
Slovenian: NASLOV II
English: SCOPE
Slovenian: OBSEG UPORABE
English: The provisions of this Directive shall apply to veterinary medicinal products intended to be placed on the market inter alia in the form of medicinal products, ready-made veterinary medicinal products or pre-mixes for medicated feeedingstuffs.
Slovenian: Določila te direktive se nanašajo na zdravila za uporabo v veterinarski medicini namenjene dajanju v promet, med drugim v obliki zdravil, pripravljenih zdravil za uporabo v veterinarski medicini ali premiksov za izdelavo medicirane krme.
English: Medicated feedingstuffs as defined in Council Directive 90/167/EEC of 26 March 1990 laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the Community(10);
Slovenian: Medicirano krmo, opredeljeno z Direktivo Sveta 90/167/EGS z dne 26. marca 1990 o pogojih za proizvodnjo, dajanje na trg in uporabo medicirane krme v Skupnosti [10];
English: However, medicated feedingstuffs may be prepared only from pre-mixes which have been authorized under this Directive;
Slovenian: Vendar pa sme biti medicirana krma pripravljena le iz premiksov, ki so pridobili dovoljenje za promet v skladu s to direktivo;
English: Inactivated immunological veterinary medicinal products which are manufactured from pathogens and antigens obtained from an animal or animals from a holding and used for the treatment of that animal or the animals of that holding in the same locality;
Slovenian: Inaktivirana imunološka zdravila za uporabo v veterinarski medicini, izdelana iz patogenih organizmov in antigenov, pridobljenih iz ene ali več živali s posestva in ki se uporabljajo za zdravljenje te ali teh živali s tega posestva na isti lokaciji;
English: Any medicinal product prepared in a pharmacy in accordance with a prescription for an individual animal (commonly known as the magistral formula);
Slovenian: Katero koli zdravilo, pripravljeno v lekarni po receptu za posamezno žival (splošno znano kot magistralni pripravek);
English: Any medicinal product prepared in a pharmacy in accordance with the prescriptions of a pharmacopoeia and is intended to be supplied directly to the end-user (commonly known as the officinal formula);
Slovenian: Katero koli zdravilo, pripravljeno v lekarni po recepturi iz farmakopeje in ki je neposredno namenjeno končnemu uporabniku (splošno znano kot galensko zdravilo);
English: Veterinary medicinal products based on radio-active isotopes;
Slovenian: Zdravila za uporabo v veterinarski medicini, ki temeljijo na radioaktivnih izotopih;
English: Any additives covered by Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs(11), where they are incorporated in animal feedingstuffs and supplementary animal feedingstuffs in accordance with that Directive.
Slovenian: Kateri koli dodatki, vključeni v Direktivo Sveta 70/524/EGS z dne 23. novembra 1970 o dodatkih v krmi [11], če so vključeni v živalsko krmo ter nadomestno krmo v skladu s to direktivo.
English: Nevertheless, Member States may, when implementing Articles 10(1)(c) and(2) take acount of the medicinal products referred to in points 3 and 4 of the first paragraph.
Slovenian: Vendar pa lahko države članice, pri izvajanju člena 10(1)c ter (2) upoštevajo zdravila iz točk 3 in 4 prvega odstavka.
English: Nonetheless, Member States may, when implementing Article 10(1)(c) and (2) take account of the medicinal products referred to in points 3 and 4 of the first paragraph.
Slovenian: Vendar države članice pri izvajanju členov 10(1)(c) ter (2) upoštevajo zdravila iz točk 3 in 4 prvega odstavka.
English: Member States may provide that this Directive shall not apply to non-inactivated immunological veterinary medicinal products which are manufactured from pathogens and antigens obtained from an animal or animals from a holding and used for the treatment of that animal or the animals of that holding in the same locality.
Slovenian: Države članice lahko določijo, da se ta direktiva ne uporablja za ne-inaktivirana imunološka zdravila za uporabo v veterinarski medicini, izdelana iz patogenih organizmov in antigenov, pridobljenih iz živali s posestva in ki se uporabljajo za zdravljenje teh živali s tega posestva na isti lokaciji.
English: Member States may permit exemptions on their territory in respect of veterinary medicinal products intended solely for aquarium fish, cage birds, homing pigeons, terrarium animals and small rodents, from the provisions in Articles 5, 7 and 8, provided that such products do not contain substances the use of which requires veterinary control and that all possible measures have been taken to prevent unauthorized use of the products for other animals.
Slovenian: Države članice lahko na svojem ozemlju dovolijo izjeme za zdravila za uporabo v veterinarski medicini, namenjene izključno za akvarijske ribice, ptice v kletkah, domače golobe, terarijske živali ter majhne glodalce, glede določil iz členov 5, 7, in 8, pod pogojem da taki proizvodi ne vsebujejo snovi, katerih uporaba zahteva veterinarski nadzor ter da so bili izvedeni vsi možni ukrepi za preprečitev nedovoljene uporabe zdravil za druge živali.
English: TITLE III
Slovenian: NASLOV III
English: MARKETING
Slovenian: PROMET
English: CHAPTER 1
Slovenian: POGLAVJE 1
English: Marketing authorization
Slovenian: Dovoljenje za promet
English: No veterinary medicinal product may be placed on the market of a Member State unless a marketing authorization has been issued by the competent authorities of that Member State in accordance with this Directive or a marketing authorization has been granted in accordance with Regulation (EEC) No 2309/93.
Slovenian: V promet v državi članici ni dovoljeno dajati nobenega zdravila za uporabo v veterinarski medicini brez izdanega dovoljenja za promet z zdravilom, ki ga izda pristojni organ te države članice v skladu s to direktivo, ali pa če je bilo dovoljenje za promet z zdravilom izdano v skladu z Uredbo (EGS) št. 2309/93.
English: In order that a veterinary medicinal product may be the subject of a marketing authorization for the purpose of administering it to food-producing animals, the active substances which it contains must be shown in Annexes I, II or III of Regulation (EEC) No 2377/90.
Slovenian: Da bi zdravilo za uporabo v veterinarski medicini, namenjeno živalim za proizvodnjo živil, lahko pridobilo dovoljenja za promet morajo biti zdravilne učinkovine, ki jih to zdravilo vsebuje, navedene v prilogah I, II ali III k Uredbi (EGS) št. 2377/90.