FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: According to their particular qualifications, the role of the experts shall be:
Slovenian: Glede na določeno usposobljenost strokovnjakov, mora biti vloga strokovnjakov naslednja:
English: to carry out such work as falls within their particular discipline (analysis, pharmacology and similar experimental sciences, clinical trials) and to describe objectively the results obtained in both quantitative and qualitative terms;
Slovenian: da izvajajo dela, ki sodijo v njihovo strokovno področje (analiza, farmakologija ter sorodne eksperimentalne vede, klinično preskušanje) ter da objektivno opišejo dobljene rezultate tako v kakovostnem kot količinskem pogledu;
English: to describe their findings in accordance with Annex I and in particular to state:
Slovenian: da opišejo svoja opažanja v skladu s Prilogo I ter še posebno, da navedejo, če gre za:
English: in the case of analysts, whether the medicinal product conforms with the stated composition, providing any reasons for the control testing methods which the manufacturer is to use;
Slovenian: analitika, ali je zdravilo v skladu z navedeno sestavo, ter da navede razloge za kontrolne preskusne metode, ki jih mora uporabiti izdelovalec;
English: in the case of pharmacologists and appropriately qualified specialists:
Slovenian: farmakologa in ustrezno usposobljenih specialistov:
English: the toxicity of the medicinal product and the pharmacological properties observed,
Slovenian: toksičnost zdravila ter opažene farmakološke lastnosti,
English: whether, after administration of the veterinary medicinal product under normal conditions of use and observance of the recommended withdrawal period, foodstuffs obtained from the treated animals contain residues which might constitute a health hazard to the consumer;
Slovenian: če po dajanju zdravila za uporabo v veterinarski medicini pod normalnimi pogoji uporabe ter upoštevanju priporočene karence živila, pridobljena iz zdravljenih živali vsebujejo zaostanke, ki bi lahko predstavljali tveganje za zdravje potrošnika;
English: in the case of clinicians, whether they have found in animals treated with the medicinal product effects corresponding to the information furnished by the manufacturer pursuant to Articles 12 and 13(1), whether the medicinal product is well tolerated, what dosage they recommend and what are the contra-indications and adverse reactions, if any;
Slovenian: klinika, ali so pri živalih, zdravljenih z zdravili, ugotovljeni učinki, skladni s podatki, ki jih je predložil proizvajalec v skladu s členi 12 in 13(1), ali je toleranca na zdravilo dobra, kakšen je priporočeni odmerek ter kakšne so kontraindikacije in škodljivi učinki, če te obstajajo;
English: to give reasons for the use of the references to published data referred to in point (a)(ii) of Article 13(1).
Slovenian: da podajo razloge za uporabo navedb objavljenih podatkov iz točke (a)(ii) člena 13(1).
English: The experts' detailed reports shall form part of the documentation which the applicant shall lodge with the competent authorities.
Slovenian: Podrobna izvedenska poročila morajo biti sestavni del dokumentacije, ki jo predlagatelj vloži pri pristojnih organih.
English: A brief curriculum vitae of the expert shall be appended to each report.
Slovenian: K vsakemu poročilu je treba dodati kratek življenjepis strokovnjaka.
English: CHAPTER 2
Slovenian: POGLAVJE 2
English: Particular provisions applicable to homeopathic veterinary medicinal products
Slovenian: Posebna določila, ki se nanašajo na homeopatska zdravila za uporabo v veterinarski medicini
English: Member States shall ensure that homeopathic veterinary medicinal products manufactured and marketed within the Community are registered or authorized in accordance with the provisions of Articles 17(1) and (2), 18 and 19.
Slovenian: Države članice morajo zagotoviti, da so homeopatska zdravila za uporabo v veterinarski medicini, ki se izdelujejo in dajejo v promet znotraj Skupnosti, registrirana ali imajo dovoljenje za promet v skladu z določili členov 17(1) in (2), 18 in 19.
English: Each Member State shall take due account of registrations and authorizations previously granted by another Member State.
Slovenian: Vsaka država članica mora upoštevati poprejšnje registracije in dovoljenja, ki jih je izdala druga država članica.
English: A Member State may refrain from establishing a special, simplified registration procedure for the homeopathic veterinary medicinal products referred to in Article 17(1) and (2).
Slovenian: Država članica lahko odstopi od uvajanja posebnega, poenostavljenega postopka registracije homeopatskega zdravila za uporabo v veterinarski medicini iz člena 17(1) in (2).
English: A Member State applying this provision shall inform the Commission accordingly.
Slovenian: Država članica, ki bo uporabila to določilo, mora o tem obvestiti Komisijo.
English: The Member State concerned shall, by 31 December 1995 at the latest, allow use in its territory of homeopathic veterinary medicinal products registered by other Member States in accordance with Article 17(1) and (2) and Article 18.
Slovenian: Zadevna država članica mora najpozneje do 31. decembra 1995 na svojem ozemlju dovoliti uporabo homeopatskih zdravil za uporabo v veterinarski medicini, registriranih v drugih državah članicah v skladu s členom 17(1) in (2) ter členom 18.
English: Only homeopathic veterinary medicinal products which satisfy all of the following conditions may be subject to authorization by means of a special, simplified registration procedure:
Slovenian: Samo homeopatska zdravila za uporabo v veterinarski medicini, ki izpolnjujejo vse naslednje pogoje, lahko pridobijo dovoljenje za promet po posebnem, poenostavljenem postopku:
English: they are intended for administration to pet animals or exotic species which are non food-producing,
Slovenian: če so namenjena hišnim živalim ali eksotičnim vrstam, ki niso namenjene za proizvodnjo živil ,
English: they are administered by a route described in the European Pharmacopoeia or, in absence thereof, by the pharmacopoeias currently used officially in the Member States,
Slovenian: če se dajejo na način, ki ga opisuje Evropska farmakopeja, ali če tega ni, farmakopeje, ki so trenutno uradno v uporabi v državah članicah,
English: no specific therapeutic indication appears on the labelling of the veterinary medicinal product or in any information relating thereto,
Slovenian: če na ovojnini ali v drugi informaciji, povezani z zdravilom za uporabo v veterinarski medicini ni navedena nobena terapevtska indikacija.
English: there is a sufficient degree of dilution to guarantee the safety of the medicinal product;
Slovenian: če je stopnja razredčitve zadostna, da je zajamčena varnost zdravila;
English: in particular, the medicinal product may not contain either more than one part per 10000 of the mother tincture or more than 1/100th of the smallest dose used in allopathy with regard to active principles whose presence in an allopathic medicinal product results in the obligation to submit a veterinary prescription.
Slovenian: še posebno zdravilo ne sme vsebovati več kot en del na 10000 pratinkture ali več kot 1/100 najmanjšega odmerka zdravilne učinkovine, ki se uporablja v alopatiji, katerih prisotnost v alopatskem zdravilu zahteva predložitev veterinarskega recepta.
English: At the time of registration, Member States shall determine the classification for the dispensing of the medicinal product.
Slovenian: Ob registraciji morajo države članice določiti razvrstitev glede izdajanja zdravila.
English: The criteria and rules of procedure provided for in Chapter 3, with the exception of Article 25, shall apply by analogy to the special, simplified registration procedure for homeopathic veterinary medicinal products referred to in paragraph 1, with the exception of the proof of therapeutic effect.
Slovenian: Merila ter pravila za postopek, opisan v Poglavju 3, z izjemo člena 25, se smiselno nanašajo na poseben, poenostavljen postopek registracije homeopatskih zdravil za uporabo v veterinarski medicini iz odstavka 1, razen glede dokazila o terapevtskem učinku.
English: The proof of therapeutic effect shall not be required for homeopathic veterinary medicinal products registered in accordance with paragraph 1 of this Article or, where appropriate, admitted in accordance with Article 16(2).
Slovenian: Dokazilo o terapevtskem učinku ni potrebno za homeopatska zdravila za uporabo v veterinarski medicini, ki so bila registrirana v skladu z odstavkom 1 tega člena, ali kjer je to smiselno, so bili priznani v skladu s členom 16(2).
English: A special, simplified application for registration may cover a series of medicinal products derived from the same homeopathic stock or stocks.
Slovenian: Poseben, poenostavljen postopek za registracijo se lahko nanaša na celo serijo zdravil, ki izhajajo iz iste homeopatske surovine ali surovin.
English: The following documents shall be included with the application in order to demonstrate, in particular, the pharmaceutical quality and the batch-to-batch homogeneity of the products concerned:
Slovenian: K vlogi je treba priložiti naslednje dokumente, ki dokazujejo zlasti farmacevtsko kakovost in homogenost serij zadevnega zdravila:
English: scientific name or other name given in a pharmacopoeia of the homeopathic stock or stocks, together with a statement of the various routes of administration, pharmaceutical forms and degree of dilution to be registered,
Slovenian: znanstveno ime ali drugo ime iz farmakopeje za homeopatsko surovino ali surovine, skupaj z navedbo različnih načinov dajanja zdravila, farmacevtskih obliki ter stopenj razredčenja, ki naj se registrira,
English: dossier describing how the homeopathic stock or stocks is/are obtained and controlled, and justifying its/their homeopathic nature, on the basis of an adequate bibliography;
Slovenian: dokumentacijo z opisom kako se homeopatska surovina ali surovine pridobiva in kontrolira, ter obrazložitev homeopatske narave na osnovi ustrezne bibliografije;
English: in the case of homeopathic veterinary medicinal products containing biological substances, a description of the measures taken to ensure the absence of pathogens,
Slovenian: v primeru homeopatskega zdravila za uporabo v veterinarski medicini, ki vsebuje biološke snovi, je potreben opis ukrepov za zagotovitev odsotnosti povzročiteljev bolezni,
English: manufacturing and control file for each pharmaceutical form and a description of the method of dilution and potentiation,
Slovenian: dokumentacija o izdelavi in kontroli za vsako farmacevtsko obliko ter opis metode redčenja in potenciranja,
English: manufacturing authorization for the medicinal products concerned,
Slovenian: dovoljenje za izdelavo zadevnih zdravil,
English: copies of any registrations or authorizations obtained for the same medicinal products in other Member States,
Slovenian: kopije registracije ali pridobljenih dovoljenj za ista zdravila v drugih državah članicah,
English: one or more specimens or mock-ups of the outer packaging and immediate packaging of the medicinal products to be registered,
Slovenian: enega ali več vzorcev ali osnutkov zunanje ovojnine in primarne ovojnine zdravila, ki naj se registrira,
English: data concerning the stability of the medicinal product.
Slovenian: podatke o stabilnosti zdravila.
English: Homeopathic veterinary medicinal products other than those referred to in Article 17(1) shall be authorized in accordance with the provisions of Articles 12 to 15 and Chapter 3.
Slovenian: Homeopatska zdravila za uporabo v veterinarski medicini razen tistih iz člena 17(1), morajo pridobiti dovoljenje v skladu z določili členov 12 do 15 ter poglavja 3.
English: A Member State may introduce or retain in its territory specific rules for the pharmacological and toxicological tests and clinical trials of homeopathic veterinary medicinal products intended for pet animals and exotic species which are non food-producing other than those referred to in Article 17(1), in accordance with the principles and characteristics of homeopathy as practised in that Member State.
Slovenian: Država članica lahko uvede ali zadrži na svojem ozemlju posebna pravila za farmakološke in toksikološke preskuse ter klinično preskušanje za homeopatska zdravila za uporabo v veterinarski medicini, namenjena hišnim živalim in eksotičnim vrstam, ki niso namenjene za proizvodnjo živil, razen tistih iz člena 17(1), v skladu z načeli in značilnostmi homeopatije, ki se izvajajo v tej državi članici.
English: In this case, the Member State concerned shall notify the Commission of the specific rules in force.
Slovenian: V tem primeru mora zadevna država članica obvestiti Komisijo o posebnih veljavnih pravilih.
English: This Chapter shall not apply to immunological homeopathic veterinary medicinal products.
Slovenian: To poglavje se ne uporablja za imunološka homeopatska zdravila za uporabo v veterinarski medicini.
English: The provisions of titles VI and VII shall apply to homeopathic veterinary medicinal products.
Slovenian: Določila naslovov VI in VII se morajo upoštevati pri homeopatskih zdravilih za uporabo v veterinarski medicini.
English: CHAPTER 3
Slovenian: POGLAVJE 3
English: Procedure for marketing authorization
Slovenian: Postopek za pridobitev dovoljenja za promet z zdravilom
English: Member States shall take all appropriate measures to ensure that the procedure for granting an authorization to place a veterinary medicinal product on the market is completed within 210 days of the submission of a valid application.
Slovenian: Države članice morajo uvesti ustrezne ukrepe, da bi zagotovile, da bo postopek za pridobitev dovoljenja za promet z zdravilom za uporabo v veterinarski medicini končan v 210 dneh od vložitve veljavne vloge.
English: Where a Member State notes that an application for authorization submitted is already under active examination in another Member State in respect of that veterinary medicinal product, the Member State concerned may decide to suspend the detailed examination of the application in order to await the assessment report prepared by the other Member State in accordance with Article 25(4).
Slovenian: V primeru, da država članica ugotovi, da je vloga za pridobitev dovoljenja za promet z zadevnim zdravilom za uporabo v veterinarski medicini že v obravnavi v drugi državi članici, se lahko zadevna država članica odloči, da opusti podroben pregled vloge zato, da bi počakala na poročilo o oceni zdravila druge države članice v skladu s členom 25(4).
English: The Member State concerned shall inform the other Member State and the applicant of its decision to suspend detailed examination of the application in question.
Slovenian: O odločitvi glede opustitve podrobnega pregleda mora država članica obvestiti drugo državo članico ter zadevnega predlagatelja.
English: As soon as it has completed the examination of the application and reached a decision, the other Member State shall forward a copy of its assessment report to the Member State concerned.
Slovenian: Kakor hitro se opravi pregled vloge in sprejme odločitev, mora druga država članica posredovati kopijo poročila zadevni državi članici.
English: Where a Member State is informed in accordance with Article 12(3)(m), that another Member State has authorized a veterinary medicinal product which is the subject of an application for authorization in the Member State concerned, that Member State shall forthwith request the authorities of the Member State which has granted the authorization to forward to it the assessment report referred to in Article 25(4).
Slovenian: Če je država članica obveščena v skladu s členom12(3)(m) o tem, da je druga država članica izdala dovoljenje za promet z zdravilom za uporabo v veterinarski medicini, ki je bil predmet vloge za pridobitev dovoljenja za promet v zadevni državi članici, mora ta država članica nemudoma zaprositi pristojne organe države članice, ki je izdala dovoljenje, da ji pošlje poročilo o oceni zdravila iz člena 25(4).
English: Within 90 days of receipt of the assessment report, the Member State concerned shall either recognise the decision of the first Member State and the summary of the product characteristics as approved by it or, if it considers that there are grounds for supposing that the authorization of the veterinary medicinal product concerned may present a risk to human or animal health or the environment, it shall apply the procedures set out in Articles 33 to 38.
Slovenian: V roku 90 dni po prejemu poročila o oceni zdravila mora zadevna država članica ali priznati odločitev prve države članice ter sprejeti povzetek glavnih značilnosti zdravila, ki ga je ta država odobrila, ali pa mora, če meni, da obstaja razlog za domnevo, da bi dovoljenje za promet z zdravilom za uporabo v veterinarski medicini lahko predstavljalo tveganje za zdravje ljudi ali živali ali okolja, uvesti postopke, kot jih določata člena 33 in 38.
English: In order to examine the application submitted pursuant to Articles 12 and 13(1), the competent authorities of the Member States:
Slovenian: Za preverjanje vloge vložene v skladu s členi 12 in 13(1), pristojni organi držav članic:
English: shall check that the documentation submitted in support of the application complies with Articles 12 and 13(1) and, on the basis of the reports drawn up by the experts pursuant to Article 15(2) and (3), ascertain whether the conditions for the issue of the marketing authorization have been fulfilled;
Slovenian: morajo preveriti, ali je vložena dokumentacija, ki podpira vlogo v skladu s členi 12 in 13(1) ter na osnovi izvedenskih poročil iz člena 15(2) in (3), in ali so izpolnjeni pogoji za izdajo dovoljenja za promet z zdravilom;
English: may submit the medicinal product, its raw materials and if necessary intermediate products or other constituent materials for testing by a State laboratory or by a laboratory designated for that purpose, in order to ensure that the testing methods employed by the manufacturer and described in the application documents, in accordance with Article 12(3)(i), are satisfactory;
Slovenian: lahko predložijo zdravilo, njegove vhodne snovi in če je treba vmesne spojine ali druge sestavine v preskušanje državnemu laboratoriju ali laboratoriju, ki je bil pooblaščen za ta namen, da bi zagotovili, da so metode preskušanja, ki jih je uporabil izdelovalec in ki so opisane v vloženi dokumentaciji, v skladu s členom 12(3)(i), ustrezne;
English: may, where appropriate, require the applicant to provide further information as regards the items listed in Articles 12 and 13(1).
Slovenian: lahko, če ustreza, zahtevajo od predlagatelja, da pridobi dodatne podatke o postavkah, naštetih v členih 12 in 13(1).
English: Where the competent authorities take this course of action, the time-limits specified in Article 21 shall be suspended until the further data required have been provided.
Slovenian: Če se pristojni organi odločijo za ta postopek, se časovni okvir, določen v členu 21 začasno odloži, dokler niso dostavljeni zahtevani podatki.
English: Similarly, these time-limits shall be suspended for any period which the applicant may be given to provide oral or written explanations;
Slovenian: Podobno je treba časovne okvire začasno odložiti za čas, ki je dan vlagatelju, da posreduje ustno ali pisno obrazložitev;
English: may require the applicant to submit substances in the quantities necessary to verify the analytical detection method proposed by the applicant in accordance with Article 12(3)(h) and to put it into effect as part of routine checks to reveal the presence of residues of the veterinary medicinal products concerned.
Slovenian: lahko zahtevajo od predlagatelja, da predloži snovi v količinah, potrebnih, da bi se preverila analitska metoda določanja, ki jo predlaga predlagatelj v skladu s členom 12(3)(h) ter da se jo uporabi kot del rutinskih pregledov za ugotavljanje prisotnosti zaostankov zadevnih zdravil za uporabo v veterinarski medicini.
English: Member States shall take all appropriate measures to ensure that:
Slovenian: Države članice morajo uvesti vse potrebne ukrepe da:
English: the competent authorities ascertain that the manufacturers and importers of veterinary medicinal products from third countries are able to manufacture them in compliance with the details supplied pursuant to Article 12(3)(d), and/or to carry out control tests in accordance with the methods described in the application documents under Article 12(3)(i);
Slovenian: pristojni organi zagotovijo, da izdelovalci in uvozniki zdravil za uporabo v veterinarski medicini iz tretjih držav lahko izdelujejo zdravila v skladu s podrobnimi podatki, predloženimi v skladu s členom 12(3)(d), in/ali da lahko izvedejo kontrolne preskuse v skladu z metodami, opisanimi v vloženi dokumentaciji po členu 12(3)(i);
English: the competent authorities may authorize manufacturers and importers of veterinary medicinal products from third countries, where circumstances so justify, to have certain stages of manufacture and/or certain of the control tests referred to in (a) carried out by third parties;
Slovenian: pristojni organi lahko dovolijo izdelovalcem in uvoznikom zdravil za uporabo v veterinarski medicini iz tretjih držav, kjer okoliščine to opravičujejo, da določeno stopnjo izdelave in/ali določene kontrolne preskuse iz (a), izvajajo tretje osebe;
English: in such cases, checks by the competent authorities shall also be carried out in the establishments concerned.
Slovenian: v takih primerih morajo pristojni organi opraviti preverjanje v zadevnih ustanovah.
English: Article 25
Slovenian: Člen 25
English: When the marketing authorization is issued, the holder shall be informed by the competent authorities of the Member State concerned, of the summary of the product characteristics as approved by it.
Slovenian: Ko je izdano dovoljenje za promet z zdravilom, mora pristojni organ zadevne države članice obvestiti imetnika o povzetku glavnih značilnosti zdravila, kakršnega je odobril.
English: The competent authorities shall take all necessary measures to ensure that the information given in the summary is in conformity with that accepted when the marketing authorization is issued or subsequently.
Slovenian: Pristojni organi morajo zagotoviti vse potrebno, da so podatki, podani v povzetku v skladu s tistimi, ki so bile sprejeti, ko je bilo izdano dovoljenje za promet z zdravilom ali naknadno.
English: The competent authorities shall forward to the Agency a copy of the authorization together with the summary of the product characteristics.
Slovenian: Pristojni organi morajo posredovati agenciji kopijo dovoljenja skupaj s povzetkom glavnih značilnosti zdravila.
English: The competent authorities shall draw up an assessment report and comments on the dossier as regards the results of the analytical and pharmacotoxicological tests and the clinical trials of the veterinary medicinal product concerned.
Slovenian: Pristojni organi morajo izdelati poročilo o oceni zdravila ter komentarje o dokumentaciji glede rezultatov analitskih in farmakološko toksikoloških preskusov ter kliničnih preskušanj za zadevno zdravilo za uporabo v veterinarski medicini.
English: The assessment report shall be updated whenever new information becomes available which is of importance for the evaluation of the quality, safety or efficacy of the veterinary medicinal product concerned.
Slovenian: Poročilo o oceni zdravila je treba dopolnjevat, kadar so na voljo novi podatki, kar je pomembno za oceno kakovosti, varnosti ali učinkovitosti zadevnih zdravil za uporabo v veterinarski medicini.
English: Article 26
Slovenian: Člen 26