FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: Where the manufacturer is not in possession of an authorization to place the product on the market, he shall provide the authorities responsible for establishing the certificate referred to in the first paragraph with a declaration explaining why such authorization is not available.
Slovenian: Če izdelovalec nima dovoljenja za promet z zdravilom, mora predložiti izjavo pristojnim organom za izdajo potrdila iz prvega odstavka in obrazložiti zakaj takega dovoljenja nima.
English: Article 94
Slovenian: Člen 94
English: Any decision referred to in this Directive, taken by the competent authorities of the Member States, may only be taken on the grounds set out in this Directive and shall state in detail the reasons on which it is based.
Slovenian: Vsaka odločitev iz te direktive, ki jo sprejmejo pristojni organi držav članic, se lahko sprejme le na temeljih, ki jih določa ta direktiva in mora vsebovati podrobne razloge na katerih odločitev temelji.
English: Such a decision shall be notified to the party concerned who shall at the same time be informed of the remedies available to him under current legislation and the time allowed for seeking such remedies.
Slovenian: Odločitev se mora posredovati zadevni stranki, ki mora biti istočasno obveščena o pravnih sredstvih, ki so na voljo v skladu z veljavno zakonodajo ter potreben čas za uveljavljanje razpoložljivih pravnih sredstev.
English: Marketing authorizations and revocations of such authorizations shall be published by each Member State in its official gazette.
Slovenian: Dovoljenja za promet z zdravilom in preklic le-teh je treba objaviti v uradnem listu posamezne države članice.
English: Article 95
Slovenian: Člen 95
English: The Member States shall not permit foodstuffs for human consumption to be taken from test animals unless maximum residue limits have been established by the Community in accordance with the provisions of Regulation (EEC) No 2377/90 and an appropriate withdrawal period has been established to ensure that this maximum limit will not be exceeded in the foodstuffs.
Slovenian: Države članice ne smejo dovoliti, da bi živila za prehrano ljudi izvirala iz poskusnih živali razen v primeru, če je Skupnost določila najvišje dovoljene količine zaostankov v skladu z določili Uredbe (EGS) št. 2377/90 in če je bila določena ustrezna karenca, ki zagotavlja, da najvišja dovoljena količina zaostankov v živilih ne bo presežena.
English: TITLE XI
Slovenian: NASLOV XI
English: FINAL MEASURES
Slovenian: KONČNE DOLOČBE
English: Article 96
Slovenian: Člen 96
English: Directives 81/851/EEC, 81/852/EEC, 90/677/EEC and 92/74/EEC referred to in Annex II, Part A are repealed, without prejudice to the obligations of the Member States in respect of the deadline for transposition laid down in Annex II, Part B.
Slovenian: Direktive 81/851/EGS, 81/852/EGS, 90/677/EGS ter 92/74/EGS iz dela A Priloge II se razveljavijo, brez poseganja v dolžnosti držav članic glede rokov za prenos, kakor je določeno v delu B Priloge II.
English: The reference made to the said Repealed Directives shall be construed as references to this Directive and should be read in accordance with the correlation table set out in Annex III.
Slovenian: Sklicevanja na navedene razveljavljene direktive se razumejo kakor sklicevanja na to direktivo in jih je treba brati v povezavi s korelacijsko tabelo iz Priloge III:
English: Article 97
Slovenian: Člen 97
English: This Directive enters into force on the 20th day following that of its publication in the Official Journal of the European Communities.
Slovenian: Ta direktiva začne veljati dvajseti dan po objavi v Uradnem listu Evropskih skupnosti.
English: Article 98
Slovenian: Člen 98
English: Done at Brussels, 6 November 2001.
Slovenian: V Bruslju, 6. novembra 2001
English: Opinion of the European Parliament of 3 July 2001 (not yet published in the Official Journal) and Council Decision of 27 September 2001.
Slovenian: Mnenje Evropskega parlamenta z dne 3. julija 2001 (še ni objavljeno v Uradnem listu) ter Sklepa Sveta z dne 27. Septembra 2001.
English: REQUIREMENTS AND ANALYTICAL PROTOCOL, SAFETY TESTS, PRE-CLINICAL AND CLINICAL FOR TESTS OF VETERINARY MEDICINAL PRODUCTS
Slovenian: ZAHTEVE IN ANALITSKI PROTOKOL, VARNOSTNI PRESKUSI, PREDKLINIČNI IN KLINIČNI PRESKUSI ZA PRESKUŠANJE ZDRAVIL ZA UPORABO V VETERINARSKI MEDICINI
English: The particulars and documents accompanying an application for marketing authorization pursuant to Articles 12 and 13(1) shall be presented in accordance with the requirements set out in this Annex and taking account of the guidance contained in the "Notice to applicants for marketing authorizations for veterinary medicinal products in the Member States of the European Community", published by the Commission in The rules governing medicinal products in the European Community, volume V:
Slovenian: Podrobne podatke in dokumente, ki spremljajo vlogo za pridobitev dovoljenja za promet z zdravilom v skladu s členi 12 in 13(1), je treba predložiti v skladu z zahtevami, ki jih določa ta priloga ter ob upoštevanju navodil, ki jih vsebuje "Obvestilo predlagateljem za pridobitev dovoljena za promet z zdravili za uporabo v veterinarski medicini v državah članicah Evropske skupnosti", ki ga je objavila Komisija v Pravilih, ki urejajo zdravila v Evropski Skupnosti, Zvezek V:
English: Veterinary Medicinal Products.
Slovenian: Zdravila za uporabo v veterinarski medicini.
English: In assembling the dossier for application for marketing authorization, applicants shall take into account the Community guidelines relating to the quality, safety and efficacy of veterinary medicinal products published by the Commission in The rules governing medicinal products in the European Community.
Slovenian: Pri zbiranju dokumentacije za vlogo za pridobitev dovoljenja za promet z zdravilom morajo predlagatelji upoštevati navodila Skupnosti v pogledu kakovosti, varnosti ter učinkovitosti zdravil za uporabo v veterinarski medicini, ki jih je objavila Komisija v Pravilih, ki urejajo zdravila v Evropski skupnosti.
English: All information which is relevant to the evaluation of the medicinal product concerned shall be included in the application, whether favourable or unfavourable to the product.
Slovenian: V vlogo morajo biti vključene vse informacije, ki so pomembne za ovrednotenje zadevnega zdravila, bodisi da so ugodne ali neugodne za zdravilo.
English: In particular, all relevant details shall be given of any incomplete or abandoned test or trial relating to the veterinary medicinal product.
Slovenian: Še posebno morajo biti podani vsi pomembni podatki za vsak nedokončan ali opuščen preskus ali preskušanje, ki zadeva zdravilo za uporabo v veterinarski medicini.
English: Moreover, after marketing authorization, any information not in the original application, pertinent to the benefit/risk assessment, shall be submitted forthwith to the competent authority.
Slovenian: Poleg tega je potrebno po pridobitvi dovoljenja za promet pristojnemu organu nemudoma dostaviti vse informacije, ki niso bile priložene k vlogi in ki zadevajo oceno koristi/tveganja.
English: Member States ensure that all experiments on animals are conducted in accordance with Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes(1).
Slovenian: Države članice zagotovijo, da bodo vsi poskusi na živalih izvedeni v skladu z Direktivo Sveta 86/609/EGS z dne 24. novembra 1986 o prilagajanju zakonov in drugih predpisov držav članic glede zaščite živali, ki se uporabljajo za eksperimentalne ali druge znanstvene namene [1].
English: The provisions of Title I of this Annex shall apply to veterinary medicinal products other than immunological veterinary medicinal products.
Slovenian: Določila naslova I te priloge, se nanašajo na zdravila za uporabo v veterinarski medicini razen na imunološka zdravila za uporabo v veterinarski medicini,.
English: The provisions of Title II of this Annex shall apply to immunological veterinary medicinal products.
Slovenian: Določila naslova II te priloge se morajo nanašati na imunološka zdravila za uporabo v veterinarski medicini.
English: Requirements for veterinary medicinal products other than immunological veterinary medicinal products
Slovenian: Zahteve za zdravila za uporabo v veterinarski medicini razen za imunološka zdravila za uporabo v veterinarski medicini
English: PART 1
Slovenian: DEL 1
English: Summary of the dossier
Slovenian: Povzetek dokumentacije
English: ADMINISTRATIVE DATA
Slovenian: ADMINISTRATIVNI PODATKI
English: The veterinary medicinal product which is the subject of the application shall be identified by name and by name of the active substance(s), together with the strength and pharmaceutical form, the method and route of administration and a description of the final sales presentation of the product.
Slovenian: Zdravilo za uporabo v veterinarski medicini, ki je predmet vloge, je treba opredeliti z imenom ter z imenom zdravilne(ih) učinkovin, skupaj z jakostjo in farmacevtsko obliko, načinom dajanja zdravila ter z opisom končne oblike pakiranja in ovojnine zdravila.
English: The name and address of the applicant shall be given, together with the name and address of the manufacturers and the sites involved in the different stages of the manufacture (including the manufacturer of the finished product and the manufacturer(s) of the active substance(s)), and where relevant the name and address of the importer.
Slovenian: Treba je podati ime in naslov predlagatelja, ime in naslov izdelovalcev in mest vključenih v različne fazah izdelave (vključno z izdelovalcem končnega zdravila ter izdelovalcem(i) zdravilne(ih) učinkovin(e)), in kjer je to potrebno, ime in naslov uvoznika.
English: The applicant shall identify the number and titles of volumes of documentation submitted in support of the application and indicate what samples, if any, are also provided.
Slovenian: Predlagatelj mora navesti število in naslove zvezkov dokumentacije, ki je priloga k vlogi ter navesti, kateri vzorci, če ti obstajajo, so priloženi.
English: Annexed to the administrative data shall be a document showing that the manufacturer is authorized to produce the veterinary medicinal products concerned, as defined in Article 44, together with a list of countries in which authorization has been granted, copies of all the summaries of product characteristics in accordance with Article 14 as approved by Member States and a list of countries in which an application has been submitted.
Slovenian: K administrativnim podatkom je treba priložiti dokument, ki dokazuje, da ima izdelovalec dovoljenje za izdelavo zadevnih zdravil za uporabo v veterinarski medicini, opredeljenih v členu 44, skupaj s seznamom držav, v katerih je bilo dovoljenje za promet izdano, kopije povzetkov glavnih značilnosti zdravila v skladu s členom 14, kot so ga odobrile države članice ter seznam držav, v katerih je bila vložena vloga.
English: The applicant shall propose a summary of the product characteristics, in accordance with Article 14 of this Directive.
Slovenian: Predlagatelj mora predložiti povzetek glavnih značilnosti zdravila v skladu s členom 14 te direktive.
English: In addition the applicant shall provide one or more specimens or mock-ups of the sales presentation of the veterinary medicinal product, together with a package insert where one is required.
Slovenian: Poleg tega mora predlagatelj predložiti enega ali več vzorcev ali predlogov ovojnine zdravila za uporabo v veterinarski medicini, skupaj z navodilom za uporabo, če se le-ta zahteva.
English: EXPERT REPORTS
Slovenian: IZVEDENSKA POROČILA
English: In accordance with Article 15(2) and (3), expert reports must be provided on the analytical documentation, the pharmacotoxicological documentation, the residues documentation and the clinical documentation.
Slovenian: V skladu s členom 15(2) ter (3), je treba podati izvedenska poročila o analitski dokumentaciji, o farmakološko-toksikološki dokumentaciji, o dokumentaciji o zaostankih ter o klinični dokumentaciji.
English: Each expert report shall consist of a critical evaluation of the various tests and/or trials which have been carried out in accordance with this Directive, and bring out all the data relevant for evaluation.
Slovenian: Vsako izvedensko poročilo mora vsebovati kritično oceno različnih preskusov in/ali preskušanj, ki so bili izvedeni v skladu s to direktivo, izpostavljeni morajo biti vsi podatki, ki so potrebni za ovrednotenje.
English: The expert shall give his opinion as to whether sufficient guarantees have been provided as to the quality, safety and efficacy of the product concerned.
Slovenian: Izvedenec mora podati svoje mnenje ali je podano zadostno zagotovilo glede kakovosti, varnosti in učinkovitosti zadevnega zdravila.
English: A factual summary is not sufficient.
Slovenian: Faktografski povzetek ne zadošča.
English: All important data shall be summarized in an appendix to the expert report, whenever possible in tabular or graphic form.
Slovenian: Vsi pomembni podatki morajo biti povzeti v prilogi k izvedenskemu poročilu, v tabelarni ali grafični obliki, če je to le mogoče.
English: The expert report and the summaries shall contain precise cross references to the information contained in the main documentation.
Slovenian: Izvedensko poročilo ter povzetki morajo vsebovati natančna sklicevanja na podatke, ki jih vsebuje glavna dokumentacija.
English: Each expert report shall be prepared by a suitably qualified and experienced person.
Slovenian: Vsako izvedensko poročilo mora pripraviti primerno usposobljena in izkušena oseba.
English: It shall be signed and dated by the expert, and attached to the report shall be brief information about the educational background, training and occupational experience of the expert.
Slovenian: Poročilo mora izvedenec podpisati in navesti datum, k poročilu pa mora biti priložena kratka informacija o izobrazbi, usposabljanju ter strokovnih izkušnjah izvedenca.
English: The professional relationship of the expert to the applicant shall be declared.
Slovenian: Treba je navesti, v kakšnem poslovnem odnosu sta izvedenec in predlagatelj.
English: PART 2
Slovenian: DEL 2
English: Analytical (physico-chemical, biological or microbiological) tests of veterinary medicinal products other than immunological veterinary medicinal products
Slovenian: Analitski (fizikalno-kemijski, biološki ali mikrobiološki) preskusi zdravil za uporabo v veterinarski medicini razen imunoloških zdravil za uporabo v veterinarski medicini
English: All test procedures shall correspond to the state of scientific progress at the time and shall be validated procedures;
Slovenian: Vsi postopki preskušanja morajo ustrezati stanju trenutnega znanstvenega napredka in morajo biti validirani;
English: results of the validation studies shall be provided.
Slovenian: treba je predložiti rezultate validacijskih študij.
English: All the test procedure(s) shall be described in sufficiently precise detail so as to be reproducible in control tests, carried out at the request of the competent authority;
Slovenian: Vse postopke preskušanja je treba opisati dovolj natančno, da jih je mogoče ponoviti v kontrolnih preskusih, ki jih lahko zahteva pristojni organ;
English: any special apparatus and equipment which may be used shall be described in adequate detail, possibly accompanied by a diagram.
Slovenian: ustrezno podrobno je treba opisati vse posebne naprave ali opremo za preskušanje, po možnosti je treba priložiti shemo.
English: The formulae of the laboratory reagents shall be supplemented, if necessary, by the method of preparation.
Slovenian: Treba je dodati formule laboratorijskih reagentov in če je potrebno, tudi postopek priprave.
English: In the case of test procedures included in the European Pharmacopoeia or the pharmacopoeia of a Member State, this description may be replaced by a detailed reference to the pharmacopoeia in question.
Slovenian: V primeru postopkov preskušanja, ki so vključeni v Evropski farmakopeji, ali farmakopeji države članice, se ta opis lahko nadomesti s podrobnim sklicem na zadevno farmakopejo.
English: QUALITATIVE AND QUANTITATIVE PARTICULARS OF THE CONSTITUENTS
Slovenian: PODROBNI PODATKI O KAKOVOSTNI IN KOLIČINSKI SESTAVI ZDRAVILA
English: The particulars and documents which must accompany applications for marketing authorization, pursuant to Article 12(3)(c), shall be submitted in accordance with the following requirements.
Slovenian: Podrobne podatke in dokumentacijo, ki morajo spremljati vlogo za pridobitev dovoljena za promet z zdravilom v skladu s členom 12(3)(c), je treba predložiti v skladu z naslednjimi zahtevami.
English: Qualitative particulars
Slovenian: Podrobni podatki o kakovosti
English: "Qualitative particulars" of all the constituents of the medicinal product shall mean the designation or description of:
Slovenian: "Podrobni podatki o kakovosti" vseh sestavin zdravila pomenijo navedbo ali opis:
English: the active substance(s),
Slovenian: zdravilne(ih) učinkovin(e),
English: the constituent(s) of the excipients, whatever their nature or the quantity used, including colouring matter, preservatives, adjuvants, stabilisers, thickeners, emulsifiers, flavouring and aromatic substances, etc,
Slovenian: sestavin pomožnih snovi, ne glede na lastnosti ali uporabljeno količino, vključno z barvili, konzervansi, dodatki, stabilizatorji, zgoščevalci, emulgatorji, snovmi za izboljšanje okusa in aromami itd.,
English: the constituents, intended to be ingested or otherwise administered to animals, of the outer covering of the medicinal products-capsules, gelatine capsules, etc.
Slovenian: sestavin, ki jih žival zaužije ali se kako drugače dajejo živalim, ki jih vsebuje zunanji del zdravil-kapsul, želatinskih kapsul, itd.
English: These particulars shall be supplemented by any relevant data concerning the container and, where appropriate, its manner of closure, together with details of devices with which the medicinal product will be used or administered and which will be delivered with the medicinal product.
Slovenian: Te podrobne podatke morajo spremljati vsi potrebni podatki o vsebniku in, kjer je to potrebno, načinu zapiranja vsebnika, skupaj s podatki o pripomočkih, s katerimi se bo zdravilo uporabljalo ali se dajalo in bo izdano skupaj zdravilom
English: The "usual terminology", to be used in describing the constituents of medicinal products, shall mean, notwithstanding the application of the other provisions of Article 12(3)(c):
Slovenian: "Običajna terminologija", ki se bo uporabljala pri opisovanju sestavin zdravil, mora pomeniti, ne glede na uporabo drugih določil člena 12(3)(c):
English: in respect of substances which appear in the European Pharmacopoeia or, failing this, in the national pharmacopoeia of one of the Member States, the main title at the head of the monograph in question, with reference to the pharmacopoeia concerned,
Slovenian: pri snoveh, ki so navedene v Evropski farmakopeji, ali, v odsotnosti le-te, v nacionalni farmakopeji ene od držav članic, glavni naslov v glavi zadevne monografije, s sklicem na zadevno farmakopejo,
English: in respect of other substances, the international non-proprietary name recommended by the World Health Organization (WHO), which may be accompanied by another non-proprietary name, or, failing these, the exact scientific designation;
Slovenian: pri ostalih snoveh, mednarodno nelastniško ime, ki ga priporoča Svetovna zdravstvena organizacija, ki ga lahko spremlja drugo nelastniško ime, ali če tega ni, natančna znanstvena oznaka;
English: substances not having an international non-proprietary name or an exact scientific designation shall be described by a statement of how and from what they were prepared, supplemented, where appropriate, by any other relevant details,
Slovenian: snovi, ki nimajo mednarodnega nelastniškega imena ali natančne znanstvene oznake, je treba opisati z navedbo o načinu priprave in sestavinah, iz katerih so bile pripravljene, dopolnjeno, kjer je to potrebno, z drugimi relevantnimi podatki,
English: in respect of colouring matter, designation by the "E" code assigned to them in Council Directive 78/25/EEC of 12 December 1977 on the approximation of the rules of the Member States concerning the colouring matters authorized for use in medicinal products(2).
Slovenian: pri barvilih, število "E" kode, ki jim je določena z Direktivo Sveta 78/25/EGS z dne 12. decembra 1977 o prilagajanju pravil držav članic o barvilih, dovoljenih za uporabo v zdravilih [2].
English: Quantitative particulars
Slovenian: Podrobni podatki o količinski sestavi
English: In order to give "quantitative particulars" of all the active substances of the medicinal products, it is necessary, depending on the pharmaceutical form concerned, to specify the mass, or the number of units of biological activity, either per dosage-unit or per unit of mass or volume, of each active substance.
Slovenian: Za "podrobne podatke o količinski sestavi" vseh zdravilnih učinkovin v zdravilu je treba, glede na zadevno farmacevtsko obliko, specificirati maso, ali število enot biološke aktivnosti, bodisi na odmerno enoto ali na enoto mase ali volumna za vsako zdravilno učinkovino.
English: Units of biological activity shall be used for substances which cannot be defined chemically.
Slovenian: Enote biološke aktivnosti se morajo uporabljati za snovi, ki jih ni mogoče kemijsko opredeliti.
English: Where an International Unit of biological activity has been defined by the World Health Organization, this shall be used.
Slovenian: Če obstaja mednarodna enota za biološko aktivnost, ki jo je določila Svetovna zdravstvena organizacija, se mora uporabiti le-ta.
English: Where no International Unit has been defined, the units of biological activity shall be expressed in such a way as to provide unambiguous information on the activity of the substances.
Slovenian: Če mednarodna enota ni bila opredeljena, se morajo enote za biološko aktivnost izraziti tako, da dajejo nedvomno informacijo o aktivnosti snovi.
English: Whenever possible, biological activity per units of mass or volume shall be indicated.
Slovenian: Kadar koli je možno, je treba označiti biološko aktivnost na enoto mase ali volumna.
English: This information shall be supplemented:
Slovenian: Te podatke je treba dopolniti v primerih:
English: in respect of injectable preparations, by the mass or units of biological activity of each active substance in the unit container, taking into account the usable volume of the product, after reconstitution, where appropriate,
Slovenian: injekcijskih pripravkov z maso ali z enotami biološke aktivnosti za vsako zdravilno učinkovino v enem vsebniku, ob upoštevanju uporabnega volumna zdravila po rekonstituciji, če je to ustrezno,
English: in respect of medicinal products to be administered by drops, by the mass or units of biological activity of each active substance contained in the number of drops corresponding to 1 ml or 1 g of the preparation,
Slovenian: zdravil, ki se dajejo po kapljicah, z maso ali enotami biološke aktivnosti za vsako zdravilno učinkovino, ki jo vsebuje tako število kapljic, ki ustreza 1 ml ali 1g zdravila,
English: in respect of syrups, emulsions, granular preparations and other pharmaceutical forms to be administered in measured quantities, by the mass or units of biological activity of each active substance per measured quantity.
Slovenian: sirupov, emulzij, granulatov ter drugih farmacevtskih oblik, ki se dajejo v odmerjenih količinah, z maso ali enotami biološke aktivnosti za vsako zdravilno učinkovino na odmerjeno količino.
English: Active substances present in the form of compounds or derivatives shall be described quantitatively by their total mass, and if necessary or relevant, by the mass of the active entity or entities of the molecule.
Slovenian: Zdravilne učinkovine, ki so prisotne v obliki spojin ali derivatov, se morajo navesti količinsko s celotno maso, in če je potrebno ali primerno, z maso učinkovitega dela ali delov v molekuli.