FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: Where the health situation so requires, a Member State may authorise the marketing or administration to animals of veterinary medicinal products which have been authorized by another Member State in accordance with this Directive.
Slovenian: V primeru, da zdravstvene razmere tako zahtevajo, lahko država članica dovoli promet ali dajanje živalim zdravilo za uporabo v veterinarski medicini, ki je pridobilo dovoljenje za promet v drugi državi članici v skladu s to direktivo.
English: In the event of serious disease epidemic, Member States may provisionally allow the use of immunological veterinary medicinal products without an authorization for placing on the market, in the absence of a suitable medicinal product and after informing the Commission of the detailed conditions of use.
Slovenian: V primeru resne epidemije bolezni, lahko države članice začasno dovolijo uporabo imunoloških zdravil za uporabo v veterinarski medicini brez dovoljenja za promet, če ni na voljo ustreznega zdravila, pri čemer mora biti Komisija predhodno obveščena o podrobnih pogojih uporabe.
English: No veterinary medicinal product may be administered to animals unless the marketing authorization has been issued, except for the tests of veterinary medicinal products referred to in Article 12(3)(j) which have been accepted by the competent national authorities, following notification or authorization, in accordance with the national rules in force.
Slovenian: Živalim se ne sme dajati nikakršnih zdravil za uporabo v veterinarski medicini brez izdanega dovoljenja za promet z zdravilom, razen v primeru preskušanj zdravil za uporabo v veterinarski medicini iz člena 21(3)(j), ki so jih sprejeli pristojni organi po prijavi ali odobritvi, v skladu z veljavnimi nacionalnimi predpisi.
English: Where there is no authorized medicinal product for a condition, Member States may exceptionally, in particular in order to avoid causing unacceptable suffering to the animals concerned, permit the administration by a veterinarian or under his/her direct personal responsibility to an animal or to a small number of animals on a particular holding:
Slovenian: Kjer za neko zdravstveno stanje ni zdravila z dovoljenjem za promet, lahko države članice izjemoma, posebno zato, da bi preprečile nesprejemljivo trpljenje zadevnih živali, dovolijo, da veterinar(ka) ali oseba, za katero je veterinar(ka) neposredno osebno odgovoren(na), za živali, ali manjše število živali na določenem posestvu, uporabi:
English: of a veterinary medicinal product authorized in the Member State concerned under this Directive or under Regulation (EEC) No 2309/93 for use in another animal species, or for another condition in the same species;
Slovenian: zdravilo za uporabo v veterinarski medicini, ki je pridobilo dovoljenje za promet v zadevni državi članici v skladu s to direktivo ali z Uredbo (EGS) št. 2309/93, in je namenjeno za uporabo pri drugih živalskih vrstah, ali za drugo stanje pri isti vrsti;
English: if there is no product as referred to in point (a), of a medicinal product authorized for use in the Member State concerned in human beings in accordance with Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code relating to medicinal products for human use(12) or under Regulation (EEC) No 2309/93;
Slovenian: če ni nobenega zdravila, kot ga navaja točka (a), zdravilo, ki ima v zadevni državi članici dovoljenje za promet za uporabo pri ljudeh v skladu z Direktivo 2001/83/ES Evropskega Parlamenta ter Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini [12] ali z Uredbo (EGS) št. 2309/93;
English: if there is no product as referred to in point (b) and within the limits of the law of the Member State concerned, of a veterinary medicinal product prepared extemporaneously by a person authorized to do so under national legislation in accordance with the terms of a veterinary prescription.
Slovenian: če ni nobenega zdravila, kot ga navaja točka (b) in v zakonskih okvirih zadevne države članice, zdravilo za uporabo v veterinarski medicini, ki ga, v skladu s pogoji veterinarskega recepta, za vsak primer posebej, pripravijo osebe, ki so za tako dejavnost pooblaščene v skladu z nacionalno zakonodajo.
English: For the purposes of this paragraph, the phrase "an animal or a small number of animals on a particular holding" also covers pets, and shall be interpreted more flexibly for minor or exotic animal species which do not produce food.
Slovenian: Za potrebe tega odstavka, izraz "žival ali manjše število živali na določenem posestvu" vključuje tudi hišne živali, in jo je treba prožneje razlagati pri manj pomembnih ali eksotičnih živalskih vrstah, ki niso namenjene za proizvodnjo živil.
English: The provisions of paragraph 1 shall apply provided that the medicinal product, where administered to food-producing animals, contains only substances to be found in a veterinary medicinal product authorized for such animals in the Member State concerned and that in the case of food-producing animals the veterinarian responsible specifies an appropriate withdrawal period.
Slovenian: Določila odstavka 1 se lahko uporabljajo pod pogojem, da zdravilo, ki se ga daje živalim za proizvodnjo živil, vsebuje samo snovi, ki se jih najde v zdravilu za uporabo v veterinarski medicini z dovoljenjem za promet za te živali v zadevni državi članici ter da v primeru živali za proizvodnjo živil, odgovorni veterinar odredi ustrezno karenco. Če uporabljeno zdravilo ne navaja karence za zadevno živalsko vrsto, karenca ne sme biti krajša od: 7 dni za jajca
English: Unless the medicinal product used indicates a withdrawal period for the species concerned, the specified withdrawal period shall not be less than:
Slovenian: 7 dni za mleko 28 dni za meso perutnine in sesalcev, vključno z maščobo in drobovino
English: With regard to homeopathic veterinary medicinal products in which the level of active principles is equal to or less than one part per million, the withdrawal period referred to in the first and second subparagraphs is reduced to zero.
Slovenian: 500 dnevnih stopinj za meso rib Pri homeopatskih zdravilih za uporabo v veterinarski medicini, pri katerih je raven učinkovin enaka ali manjša kot en del na milijon, je karenca iz prvega in drugega pododstavka, ničelna.
English: When a veterinarian has recourse to the provisions of Article 10, he shall keep adequate records of the date of examination of the animals, details of the owner, the number of animals treated, the diagnosis, the medicinal products prescribed, the dosages administered, the duration of treatment and the withdrawal periods recommended, and make these records available for inspection by the competent authorities for a period of at least three years.
Slovenian: V primeru, da veterinar uporabi določila člena 10, mora hraniti ustrezne evidence o datumu pregleda živali, o lastniku, o številu zdravljenih živali, o diagnozi, o predpisanih zdravilih, o odmerkih danih zdravil, o trajanju zdravljenja ter o priporočeni karenci. Ti podatki morajo biti na razpolago inšpektorjem pristojnih organov najmanj tri leta.
English: This requirement may be extended by the Member States to non food-producing animals.
Slovenian: To zahtevo lahko države članice razširijo na živali, ki niso namenjene za proizvodnjo živil.
English: For the purposes of obtaining a marketing authorization in respect of a veterinary medicinal product, other than under the procedure established by Regulation (EEC) No 2309/93, an application shall be lodged with the competent authority of the Member State concerned.
Slovenian: za pridobitev dovoljenja za promet z zdravilom za uporabo v veterinarski medicini, razen po postopku, ki ga določa Uredba (EGS) št. 2309/93, je treba vložiti vlogo pri pristojnem organu zadevne države članice.
English: A marketing authorization may only be granted to an applicant established in the Community.
Slovenian: Dovoljenje za promet z zdravilom se lahko izda samo predlagatelju, ki je ustanovljen v Skupnosti.
English: The following particulars and documents shall accompany an application in accordance with Annex I:
Slovenian: K vlogi je treba priložiti naslednje podatke in dokumente v skladu s Prilogo I:
English: name or business name and permanent address or registered place of business of the person responsible for placing the product on the market and, if different, of the manufacturer or manufacturers involved and of the sites of manufacture;
Slovenian: ime ali poslovni naziv ter stalni naslov ali prijavljeno mesto poslovanja osebe, odgovorne za dajanje zdravila v promet, in če ne gre za isto osebo, izdelovalca ali izdelovalcev, ki so vključeni ter mesta izdelave;
English: name of the veterinary medicinal product (brand name, non-proprietary name, with or without a trademark, or name of the manufacturer or scientific name or formula, with or without a trademark, or the name of the manufacturer);
Slovenian: ime zdravila za uporabo v veterinarski medicini (ime blagovne znamke, nelastniško ime, z ali brez blagovne znamke, ali ime izdelovalca ali znanstveno ime ali formula, z ali brez blagovne znamke, ali ime izdelovalca);
English: qualitative and quantitative particulars of all the constituents of the veterinary medicinal product, using the usual terminology, but not empirical chemical formulae and giving the international non-proprietary name recommended by the World Health Organization, where such a name exists;
Slovenian: podrobnosti o kakovostni in količinski sestavi zdravila za uporabo v veterinarski medicini, izraženo v običajni terminologiji, toda ne empirične kemijske formule ter z navedbo mednarodnega nelastniškega imena, ki ga priporoča Svetovna zdravstvena organizacija, kjer tako ime obstaja;
English: description of the method of manufacture;
Slovenian: opis postopka izdelave;
English: therapeutic indications, contra indications and adverse reactions;
Slovenian: terapevtske indikacije, kontraindikacije ali neželeni škodljivi učinki;
English: dosage for the various species of animal for which the veterinary medicinal product is intended, its pharmaceutical form, method and route of administration and proposed shelf life;
Slovenian: odmerki za različne živalske vrste, ki jim je zdravilo za uporabo v veterinarski medicini namenjeno, farmacevtska oblika, način dajanja zdravila ter predlagani rok uporabnosti;
English: if applicable, explanations of the precautionary and safety measures to be taken when the product is stored, when it is administered to animals and when waste therefrom is disposed of, together with an indication of any potential risks the medicinal product might pose to the environment and the health of humans, animals or plants;
Slovenian: če je treba, pojasnilo o previdnostnih ter varnostnih ukrepih pri shranjevanju zdravila, pri dajanju živalim in pri odstranjevanju odpadkov, skupaj z navedbo kakršnih koli možnih tveganj, ki jih zdravilo lahko predstavlja za okolje in za zdravje ljudi, živali ali rastlin;
English: indication of the withdrawal period.
Slovenian: navedba karence.
English: Where necessary, the applicant shall propose and justify a tolerance level for residues which may be accepted in foodstuffs without risk for the consumer, together with routine analysis methods which could be used by the competent authorities to trace residues;
Slovenian: Kjer je treba, mora predlagatelj predlagati in utemeljiti stopnjo tolerance za zaostanke v živilih, ki so brez tveganja za potrošnika sprejemljivi, skupaj z rutinskimi analitskimi metodami, ki jih lahko uporabijo pristojne organi za odkrivanje zaostankov;
English: description of the control testing methods employed by the manufacturer (qualitative and quantitative analysis of the constituents and the finished product, specific tests e.g. sterility tests, test for the presence of pyrogens, for the presence of heavy metals, stability tests, biological and toxicity tests, tests on intermediate products);
Slovenian: opis kontrolnih preskusnih metod, ki jih uporablja izdelovalec (kakovostna in količinska analiza sestavin in končnega izdelka; posebni preskusi, npr. preskusi sterilnosti, preskusi za odkrivanje prisotnosti pirogenih snovi, prisotnosti težkih kovin, preskusi stabilnosti, biološki preskusi in preskusi toksičnosti, preskusi na vmesnih proizvodih);
English: results of:
Slovenian: rezultati:
English: physico-chemical, biological or microbiological tests,
Slovenian: fizikalno-kemijskih, bioloških ali mikrobioloških preskusov,
English: toxicological and pharmacological tests,
Slovenian: toksikoloških in farmakoloških preskusov,
English: clinical trials.
Slovenian: kliničnih preskušanj;
English: a summary in accordance with Article 14 of the product characteristics, one or more specimens or mock-ups of the sales presentation of the veterinary medicinal product together with the package insert;
Slovenian: v skladu s členom 14 povzetek glavnih značilnostih zdravila, en ali več vzorcev ovojnine ali osnutkov zunanje in stične ovojnine novega zdravila za uporabo v veterinarski medicini, skupaj z navodilom za uporabo;
English: a document showing that the manufacturer is authorized in his own country to produce veterinary medicinal products;
Slovenian: dokument, ki dokazuje, da ima izdelovalec v svoji državi dovoljenje za izdelavo zdravil za uporabo v veterinarski medicini;
English: copies of any marketing authorization obtained in another Member State or in a third country for the relevant veterinary medicinal product, together with a list of those Member States in which an application for authorization submitted in accordance with this Directive is under examination.
Slovenian: kopije vseh dovoljenja za promet z zdravilom, pridobljenih v drugih državah članicah ali v tretji državi za ustrezno zdravilo za uporabo v veterinarski medicini, skupaj s seznamom držav članic, v katerih je bila vloga za pridobitev dovoljenja za promet vložena v skladu s to direktivo in je v obravnavi.
English: Copies of the summary of the product characteristics proposed by the applicant in accordance with Article 14 or approved by the competent authority of the Member State in accordance with Article 25 and copies of the package insert proposed, details of any decision to refuse authorization, whether in the Community or a third country and the reasons for that decision.
Slovenian: Kopije povzetka glavnih značilnosti zdravila, ki ga predlaga predlagatelj v skladu s členom 14, ali ki ga je odobril pristojni organ države članice v skladu s členom 25 ter kopije predloga navodila za uporabo, podatki o morebitni odločbi o zavrnitvi izdaje dovoljenja za promet, bodisi znotraj Skupnosti ali v tretji državi ter razloge za tako odločitev.
English: This information shall be updated on a regular basis;
Slovenian: Te podatke je treba redno posodabljati;
English: in the case of medicinal products containing new active substances which are not mentioned in Annex I, II or III to Regulation (EEC) No 2377/90, a copy of the documents submitted to the Commission in accordance with Annex V to that Regulation.
Slovenian: v primeru, da zdravila vsebujejo nove zdravilne učinkovine, ki niso navedene v prilogah I, II, ali III k Uredbi (EGS) št. 2377/90, kopijo dokumentov, predloženih Komisiji v skladu s Prilogo V k navedeni uredbi.
English: By way of derogation from point (j) of Article 12(3), and without prejudice to the law relating to the protection of industrial and commercial property:
Slovenian: Z odstopanjem od točke (j) člena 12(3) ter brez poseganja v zakonodajo, ki se nanaša na varovanje industrijske in komercialne lastnine:
English: the applicant shall not be required to provide the results of toxicological and pharmacological tests and clinical trials if he can demonstrate:
Slovenian: predlagatelju ni treba predložiti rezultatov toksikoloških in farmakoloških preskusov ter kliničnih preskušanj, v primeru, če lahko dokaže, da:
English: either that the veterinary medicinal product is essentially similar to a medicinal product authorized in the Member State concerned by the application and that the marketing authorization holder has agreed that the toxicological, pharmacological and/or clinical references contained in the file on the original veterinary medicinal product may be used for the purpose of examining the application in question;
Slovenian: je zdravilo za uporabo v veterinarski medicini bistveno podobno zdravilu, ki ima dovoljenje za promet v zadevni državi članici ter da se imetnik dovoljenja za promet z zdravilom strinja z navedbo sklica na toksikološke, farmakološke in/ali klinične navedbe, ki jih vsebuje dokumentacija originalnega zdravila za uporabo v veterinarski medicini, za potrebe preverjanja zadevne vloge;
English: or that the constituent or constituents of the veterinary medicinal product have a well-established medicinal use, with recognized efficacy and an acceptable level of safety, by means of detailed references to scientific literature;
Slovenian: ali da ima sestavina ali sestavine zdravila za uporabo v veterinarski medicini že dobro znano medicinsko uporabo, z dobro znano učinkovitostjo, s sprejemljivo stopnjo varnosti, z natančnimi navedki znanstvene literature;
English: or that the veterinary medicinal product is essentially similar to a medicinal product which has been authorized within the Community, in accordance with Community provisions in force, for not less than six years and is marketed in the Member State for which the application is made;
Slovenian: ali da je zdravilo za uporabo v veterinarski medicini bistveno podobno zdravilu, ki ima, v skladu z veljavnimi določili, dovoljenje za promet znotraj Skupnosti najmanj šest let ter je v prometu v državi članici, v kateri je bila vložena vloga;
English: this period shall be extended to 10 years in the case of high-technology medicinal products having been authorized in pursuance of the procedure established by Article 2(5) of Council Directive 87/22/EEC(13).
Slovenian: to obdobje se mora podaljšati na 10 let v primeru visoko tehnološkega zdravila, ki je dovoljenje za promet pridobilo v skladu s postopkom iz člena 2(5) Direktive Sveta 87/22/EGS [13].
English: Furthermore, a Member State may also extend this period to 10 years by a single Decision covering all the medicinal products marketed in its territory where it considers this necessary in the interest of public health.
Slovenian: Poleg tega lahko država članica podaljša to dobo na 10 let z enotno odločbo, ki velja za vsa zdravila, ki so v prometu na njenem območju, če meni, da je to v interesu javnega zdravja.
English: Member States are at liberty not to apply the six-year period beyond the date of expiry of a patent protecting the original medicinal product;
Slovenian: Države članice imajo na razpolago, da ne uveljavijo šestletnega obdobja po datuma izteka patenta, ki ščiti originalno zdravilo;
English: in the case of new veterinary medicinal products containing known constituents not hitherto used in combination for therapeutic purposes, the results of toxicological and pharmacological tests and of clinical trials relating to that combination must be provided, but it shall not be necessary to provide the relevant documentation for each individual constituent.
Slovenian: v primeru novih zdravil za uporabo v veterinarski medicini, ki vsebujejo znane sestavine, ki dotlej v predlagani kombinaciji še niso bile uporabljane za terapevtske namene, je treba predložiti rezultate toksikoloških in farmakoloških preskusov ter kliničnih preskušanj, ki se nanašajo na zadevno kombinacijo, ni pa jih treba predložiti za vsako sestavino posebej.
English: Annex I shall apply in like manner where, pursuant to point (a)(ii) of paragraph 1, references to published data are submitted.
Slovenian: Priloga I se v skladu s točko (a)(ii) odstavka 1, uporabi na podoben način, kjer so predložene reference o objavljenih rezultatih.
English: The summary of the product characteristics shall contain the following information:
Slovenian: Povzetek glavnih značilnosti zdravila mora vsebovati naslednje podatke:
English: Name of the veterinary medicinal products;
Slovenian: Ime zdravila za uporabo v veterinarski medicini;
English: Qualitative and quantitative composition in terms of the active substances and constituents of the excipient, knowledge of which is essential for proper administration of the medicinal product;
Slovenian: Kakovostno in količinsko sestavo zdravilnih učinkovin in pomožnih snovi, poznavanje katerih je potrebno za ustrezno dajanje zdravila;
English: the international non-proprietary names recommended by the World Health Organization shall be used, where such names exist, or failing this, the usual non-proprietary name or chemical description;
Slovenian: uporabljati se morajo mednarodna nelastniška imena, ki jih priporoča Svetovna zdravstvena organizacija če taka imena obstajajo, v nasprotnem primeru pa je treba uporabiti običajno nelastniško ime ali kemijski opis;
English: Pharmaceutical form;
Slovenian: Farmacevtska oblika;
English: Pharmacological properties and, in so far as this information is useful for the therapeutic purposes, pharmacokinetic particulars;
Slovenian: Farmakološke lastnosti ter, če je ta informacija koristna za terapevtske namene, tudi farmakokinetični podatki;
English: Clinical particulars;
Slovenian: Klinični podatki:
English: indications for use, specifying the target species,
Slovenian: indikacije za uporabo za posamezne ciljne živalske vrste,
English: contra-indications,
Slovenian: kontraindikacije,
English: undesirable effects (frequency and seriousness),
Slovenian: neželeni učinki (pogostost in resnost),
English: special precautions for use,
Slovenian: posebni previdnostni ukrepi za uporabo,
English: use during pregnancy and lactation,
Slovenian: uporaba v obdobju brejosti in laktacije,
English: interaction with other medicaments and other forms of interaction,
Slovenian: medsebojno delovanje z drugimi zdravili ter druge oblike interakcij,
English: posology and method of administration,
Slovenian: odmerjanje in načini uporabe,
English: overdose (symptoms, emergency procedures, antidotes) (if necessary),
Slovenian: preveliko odmerjanje (simptomi, ukrepanje, antidoti) (če je potrebno),
English: special warnings for each target species,
Slovenian: posebna opozorila za vsako ciljno živalsko vrsto,
English: withdrawal periods,
Slovenian: karenca,
English: special precautions to be taken by the person administering the medicinal product to animals;
Slovenian: posebni varnostni ukrepi, ki jih mora izvajati oseba, ki daje zdravilo živalim;
English: Pharmaceutical particulars:
Slovenian: Farmacevtski podatki:
English: major incompatibilities,
Slovenian: glavne inkompatibilnosti
English: shelf life, when necessary after reconstitution of the medicinal product or when the container is opened for the first time,
Slovenian: rok uporabnosti zdravila, če je to treba tudi rok uporabe po rekonstituciji zdravila ali po prvem odprtju originalnega vsebnika,
English: special precautions for storage,
Slovenian: posebna navodila za shranjevanje,
English: nature and contents of container,
Slovenian: vrsta in vsebina vsebnika,
English: special precautions for the disposal of unused medicinal product or waste materials, if any;
Slovenian: posebni varnosti ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi, če obstajajo;
English: Name or corporate name and address or registered place of business of the authorization holder.
Slovenian: Naziv ali ime podjetja ter naslov ali registrirani kraj poslovanja imetnika dovoljenja za promet.
English: Member States shall make all necessary arrangements to ensure that the documents and particulars listed in Article 12(3)(h), (i), (j) and Article 13(1) are drafted by experts with the requisite technical or professional qualifications before being submitted to the competent authorities.
Slovenian: Države članice morajo opraviti vse potrebne dogovore, da bi zagotovile, da predloge dokumente in podrobne podatke, naštete v členu 12(3)(h), (i), (j) in členu 13(1) pripravijo strokovnjaki z ustrezno tehnično ali strokovno usposobljenostjo, preden se podatke predloži pristojnim organom.
English: These documents and particulars shall be signed by the experts in question.
Slovenian: Te dokumente in podatke morajo podpisati zadevni strokovnjaki.