FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: The applicant shall not be required to provide the results of toxicological and pharmacological tests or the results of clinical trials if he can demonstrate:
Slovenian: se od vlagatelja ne zahteva predložitev rezultatov toksikoloških in farmakoloških preskusov ali rezultatov kliničnih preskušanj, če lahko dokaže, da:
English: either that the medicinal product is essentially similar to a medicinal product authorized in the Member State concerned by the application and that the holder of the marketing authorization for the original medicinal product has consented to the toxicological, pharmacological and/or clinical references contained in the file on the original medicinal product being used for the purpose of examining the application in question;
Slovenian: je zdravilo bistveno podobno zdravilu, za katerega je že izdano dovoljenje za promet v zadevni državi članici ter, da je imetnik dovoljenja za promet z zdravilom za originalno zdravilo privolil v navedbo sklica na toksikološko, farmakološko in/ali klinično dokumentacijo, ki jo vsebuje dosje originalnega zdravila, ki je bil uporabljen pri preučitvi zadevne vloge;
English: or that the constituent or constituents of the medicinal product have a well established medicinal use, with recognized efficacy and an acceptable level of safety, by means of a detailed scientific bibliography;
Slovenian: ali da je sestavina ali sestavine zdravila že dobro uveljavljena v medicinski uporabi, z znano učinkovitostjo ter sprejemljivo ravnijo varnosti, kar je podprto s podrobno znanstveno bibliografijo;
English: or that the 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 bistveno podobno zdravilu, za katerega je v Skupnosti izdano dovoljenje za promet v skladu z veljavnimi predpisi Skupnosti najmanj 6 let in je že v prometu v državi članici, v kateri je predložena vloga.
English: This period shall be extended to 10 years in the case of high-technology medicinal products having been authorised according to the procedure laid down in Article 2(5) of Council Directive 87/22/EEC(21).
Slovenian: To obdobje se podaljša na 10 let, če gre za visoko tehnološko zdravilo, za katerega je izdano dovoljenje za promet v skladu s postopkom iz člena 2(5) Direktive Sveta 87/22/EGS [21].
English: Furthermore, a Member State may also extend this period to 10 years by a single Decision covering all the medicinal products marketed on its territory where it considers this necessary in the interest of public health.
Slovenian: Država članica lahko podaljša to obdobje na 10 let z enotnim sklepom, ki zajema vsa zdravila, ki so v prometu na njenem ozemlju, kadar ocenjuje, 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 smejo odločiti, da ne uporabijo 6-letnega obdobja po datumu izteka patenta, ki ščiti originalno zdravilo.
English: However, where the medicinal product is intended for a different therapeutic use from that of the other medicinal products marketed or is to be administered by different routes or in different doses, the results of appropriate toxicological and pharmacological tests and/or of appropriate clinical trials must be provided.
Slovenian: Kadar je zdravilo namenjeno za drugačno terapevtsko uporabo, ki se razlikuje od uporabe zdravil, ki so že v prometu, ali bo način jemanja drugačen ali v drugačnih odmerkih, je treba predložiti rezultate ustreznih toksikoloških in farmakoloških preskusov in/ali ustreznih kliničnih preskušanj.
English: In the case of new 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 references relating to each individual constituent.
Slovenian: Če gre za nova zdravila, ki vsebujejo znane sestavine, dotlej še neuporabljene v kombinaciji za terapevtske namene, je treba predložiti rezultate toksikoloških in farmakoloških preskusov in kliničnih preskušanj za zadevno kombinacijo, ni pa jih treba predložiti za vsako posamezno sestavino.
English: Annex I shall apply by analogy where, pursuant to point (ii) of paragraph 1, (a), bibliographic references to published data are submitted.
Slovenian: Priloga 1 se smiselno uporablja, kadar se v skladu s točko (ii) odstavka 1(a) predložijo bibliografske reference k objavljenim podatkom.
English: The summary of the product characteristics shall contain the following information:
Slovenian: Povzetek glavnih značilnosti zdravila vsebuje naslednje podatke:
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, kar je bistvenega pomena za ustrezno dajanje zdravila.
English: The usual common name or chemical description shall be used.
Slovenian: Uporablja se običajno splošno ime ali kemijsko ime.
English: Pharmaceutical form.
Slovenian: Farmacevtsko obliko.
English: Pharmacological properties and, in so far as this information is useful for therapeutic purposes, pharmacokinetic particulars.
Slovenian: Farmakološke lastnosti in, če je ta informacija koristna za terapevtske namene, farmakokinetične podatke.
English: Clinical particulars:
Slovenian: Klinične podatke:
English: contra-indications,
Slovenian: kontraindikacije;
English: adverse reactions (frequency and seriousness),
Slovenian: neželeni učinki (pogostost in resnost);
English: special precautions for use and, in the case of immunological medicinal products, any special precautions to be taken by persons handling such products and administering them to patients, together with any precautions to be taken by the patient,
Slovenian: posebna opozorila pri uporabi in če gre za imunološka zdravila, vse posebne previdnostne ukrepe, ki jih morajo osebe, ki imajo opraviti s takimi zdravili in jih dajejo bolnikom, upoštevati skupaj z vsemi morebitnimi previdnostnimi ukrepi, ki jih mora upoštevati bolnik;
English: use during pregnancy and lactation,
Slovenian: uporaba med nosečnostjo in dojenjem;
English: interaction with other medicaments and other forms of interaction,
Slovenian: medsebojno delovanje z drugimi zdravili in druge oblike interakcij;
English: posology and method of administration for adults and, where necessary, for children,
Slovenian: odmerjanje in način uporabe zdravila za odrasle, in kadar je to potrebno, za otroke;
English: overdose (symptoms, emergency procedures, antidotes),
Slovenian: preveliko odmerjanje (simptomi, nujni ukrepi, antidoti);
English: effects on ability to drive and to use machines.
Slovenian: vpliv na sposobnost vožnje in upravljanje s stroji.
English: major incompatibilities,
Slovenian: glavne inkompatibilnosti;
English: shelf life, when necessary after reconstitution of the medicinal product or when the immediate packaging is opened for the first time,
Slovenian: rok uporabnosti, če je potrebno po rekonstituciji zdravila ali po prvem odpiranju stične ovojnine;
English: special precautions for storage,
Slovenian: posebna navodila za shranjevanje;
English: nature and contents of the immediate packaging,
Slovenian: vrsta stične ovojnine in vsebina;
English: special precautions for disposal of unused medicinal products or waste materials derived from such medicinal products, if appropriate.
Slovenian: posebni previdnostni ukrepi pri odlaganju neuporabljenih zdravil ali odpadkov, ki iz njih nastanejo, če je to primerno.
English: Name or corporate name and permanent address of the marketing authorization holder.
Slovenian: Ime ali naziv podjetja ter stalni naslov imetnika dovoljenja za promet z zdravilom.
English: For radiopharmaceuticals, full details of internal radiation dosimetry.
Slovenian: Za radiofarmacevtske izdelke, podrobne podatke o interni radiacijski dozimetriji.
English: For radiopharmaceuticals, additional detailed instructions for extemporaneous preparation and quality control of such preparation and, where appropriate, maximum storage time during which any intermediate preparation such as an eluate or the ready-to-use pharmaceutical will conform with its specifications.
Slovenian: Za radiofarmacevtske izdelke veljajo dodatna podrobna navodila za sprotno pripravo in nadzor kakovosti takega pripravka, in kadar je to primerno, še najdaljši čas shranjevanja v katerem vmesni izdelek, kot je eluat ali na mestu pripravljeno zdravilo, ustreza specifikacijam.
English: Member States shall take all appropriate measures to ensure that the documents and particulars listed in Article 8(3)(h) and (i), and Article 10(1)(a)(ii) are drawn up by experts with the necessary technical or professional qualifications before they are submitted to the competent authorities.
Slovenian: Države članice sprejmejo vse ustrezne ukrepe, da dokumente in podrobne podatke, navedene v členu 8(3)(h) in (i) ter členu 10(1)(a)(ii), pripravijo strokovnjaki z ustrezno tehnično ali strokovno usposobljenostjo, preden se predložijo pristojnim organom.
English: These documents and particulars shall be signed by the experts.
Slovenian: Navedene dokumente in podrobne podatke strokovnjaki podpišejo.
English: The duties of the experts according to their respective qualifications shall be:
Slovenian: Dolžnosti strokovnjakov, glede na njihovo ustrezno usposobljenost, so:
English: to perform tasks falling within their respective disciplines (analysis, pharmacology and similar experimental sciences, clinical trials) and to describe objectively the results obtained (qualitatively and quantitatively);
Slovenian: izvajanje nalog, ki sodijo v področje njihove stroke (analize, farmakologija in podobne eksperimentalne znanosti, klinična preskušanja) in objektiven opis dobljenih rezultatov (kakovostno in količinsko);
English: to describe their observations in accordance with Annex I, and to state, in particular:
Slovenian: opis njihovih opažanj v skladu s Prilogo I, in navedba zlasti:
English: in the case of the analyst, whether the medicinal product is consistent with the declared composition, giving any substantiation of the control methods employed by the manufacturer;
Slovenian: če gre za analitika, ali zdravilo ustreza navedeni sestavi, kar se utemelji s kontrolnimi metodami, ki jih je proizvajalec uporabil,
English: in the case of the pharmacologist or the specialist with similar experimental competence, the toxicity of the medicinal product and the pharmacological properties observed;
Slovenian: če gre za farmakologa ali specialista s podobno usposobljenostjo za izvajanje poskusov, opažena toksičnost zdravila in farmakološke lastnosti,
English: in the case of the clinician, whether he has been able to ascertain effects on persons treated with the medicinal product which correspond to the particulars given by the applicant in accordance with Articles 8 and 10, whether the patient tolerates the medicinal product well, the posology the clinician advises and any contra-indications and adverse reactions;
Slovenian: če gre za kliničnega zdravnika, ali je lahko potrdil vpliv na osebe, zdravljene z zdravilom, ki ustreza podrobnim podatkom, ki jih je vlagatelj predložil v skladu s členoma 8 in 10, ali bolnik dobro prenaša zdravilo, odmerjanje, ki ga svetuje klinični zdravnik, ter kontraindikacije in neželene učinke;
English: where applicable, to state the grounds for using the bibliography mentioned in point (a)(ii) of Article 10(1).
Slovenian: kadar je potrebno, navedba utemeljitev za uporabo bibliografije, omenjene v točki (a)(ii) člena 10(1).
English: Detailed reports by the experts shall form part of the particulars accompanying the application which the applicant submits to the competent authorities.
Slovenian: Podrobna poročila strokovnjakov so del podatkov, priloženih vlogi, ki jo vlagatelj predloži pristojnim organom.
English: Specific provisions applicable to homeopathic medicinal products
Slovenian: Posebne določbe, ki se uporabljajo za homeopatska zdravila
English: Member States shall ensure that homeopathic medicinal products manufactured and placed on the market within the Community are registered or authorized in accordance with Articles 14, 15 and 16, except where the products are covered by a registration or authorization which was granted under national law on or before 31 December 1993 (and whether or not that registration or authorization has been renewed after that date).
Slovenian: Države članice zagotovijo, da se homeopatska zdravila, ki se proizvajajo in dajejo v promet v Skupnosti, registrirajo ali pridobijo dovoljenje za promet v skladu s členi 14, 15 in 16, razen kadar so ti izdelki zajeti z registracijo ali pridobitvijo dovoljenja za promet po nacionalni zakonodaji na dan ali pred 31. decembrom 1993 (in če je bilo dovoljenje za promet ali registracija podaljšana po tem datumu, ali ni bila podaljšana).
English: Each Member State shall take due account of registrations and authorizations previously granted by another Member State.
Slovenian: Vsaka država članica upošteva registracijo in izdana dovoljenja za promet, ki jih je predhodno odobrila druga država članica.
English: A Member State may refrain from establishing a special, simplified registration procedure for the homeopathic medicinal products referred to in Article 14.
Slovenian: Država članica se lahko vzdrži uvedbe posebnega, poenostavljenega postopka registracije homeopatskih zdravil iz člena 14.
English: A Member State shall inform the Commission accordingly.
Slovenian: Država članica o tem ustrezno obvesti Komisijo.
English: The Member State concerned shall allow the use in its territory of homeopathic medicinal products registered by other Member States in accordance with Articles 14 and 15.
Slovenian: Zadevna država članica lahko na svojem ozemlju dovoli uporabo homeopatskih zdravil, ki so jih registrirale druge države članice v skladu s členoma 14 in 15.
English: Only homeopathic medicinal products which satisfy all of the following conditions may be subject to a special, simplified registration procedure:
Slovenian: Po posebnem, poenostavljenem postopku je možno registrirati samo homeopatska zdravila, ki izpolnjujejo vse naslednje pogoje:
English: they are administered orally or externally,
Slovenian: da se dajejo peroralno ali zunanje,
English: no specific therapeutic indication appears on the labelling of the medicinal product or in any information relating thereto,
Slovenian: da na ovojnini izdelka niso navedene nobene posebne terapevtske indikacije ali druge informacije s tem v zvezi,
English: there is a sufficient degree of dilution to guarantee the safety of the medicinal product;
Slovenian: da je izdelek dovolj razredčen, in je zajamčena njegova varnost;
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 substances whose presence in an allopathic medicinal product results in the obligation to submit a doctor's prescription.
Slovenian: izdelek zlasti ne sme vsebovati več kot en del pratinkture na 10000 delov, ali več kot 1/100 najmanjšega odmerka zdravilne učinkovine, ki se uporablja v alopatiji in katerih prisotnost v alopatskem zdravilu zahteva obvezno izdajo na zdravniški recept.
English: At the time of registration, Member States shall determine the classification for the dispensing of the medicinal product.
Slovenian: Ob času registracije, države članice določijo razvrstitev glede izdajanja homeopatskega zdravila.
English: The criteria and rules of procedure provided for in Article 4(4), Article 17(1) and Articles 22 to 26, 112, 116 and 125 shall apply by analogy to the special, simplified registration procedure for homeopathic medicinal products, with the exception of the proof of therapeutic efficacy.
Slovenian: Merila in pravila postopka, predpisana v členu 4(4), členu 17(1) in členih 22 do 26, 112, 116 in 125, se smiselno uporabljajo pri posebnem, poenostavljenem postopku registracije homeopatskih zdravil, razen dokaza o terapevtski učinkovitosti.
English: The proof of therapeutic efficacy shall not be required for homeopathic medicinal products registered in accordance with paragraph 1 of this Article, or, where appropriate, admitted in accordance with Article 13(2).
Slovenian: Dokaz o terapevtski učinkovitosti se ne zahteva za homeopatska zdravila, registrirana v skladu z odstavkom 1 tega člena ali, kadar je to primerno, priznana v skladu s členom 13(2).
English: An application for special, simplified registration may cover a series of medicinal products derived from the same homeopathic stock or stocks.
Slovenian: Vloga za posebno poenostavljeno registracijo lahko zajema serijo zdravil, pridobljenih 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: V vlogo se vključijo naslednji dokumenti, da se dokaže zlasti farmacevtska kakovost in homogenost serij zadevnih izdelkov:
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 poti uporabe izdelka, farmacevtskih oblik ter stopnje razredčitve, ki se jo želi registrirati,
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: dosje z opisom, kako se pridobiva in nadzira homeopatska surovina ali surovine, in utemeljitvijo homeopatske narave surovine ali surovin, na podlagi ustrezne bibliografije,
English: manufacturing and control file for each pharmaceutical form and a description of the method of dilution and potentization,
Slovenian: dokumentacija o proizvodnji in nadzoru za vsako farmacevtsko obliko ter opis metode razredčevanja in potenciranja,
English: manufacturing authorization for the medicinal product concerned,
Slovenian: dovoljenje za proizvodnjo zadevnega zdravila,
English: copies of any registrations or authorizations obtained for the same medicinal product in other Member States,
Slovenian: kopije vseh registracij ali dovoljenj za promet, pridobljenih v drugih državah članicah za isto zdravilo,
English: one or more specimens or mock-ups of the outer packaging and the immediate packaging of the medicinal products to be registered,
Slovenian: en ali več vzorcev ovojnine ali osnutkov zunanje in stične ovojnine zdravila v postopku registracije,
English: data concerning the stability of the medicinal product.
Slovenian: podatke o stabilnosti homeopatskega zdravila.
English: Homeopathic medicinal products other than those referred to in Article 14(1) shall be authorized and labelled in accordance with Articles 8, 10 and 11.
Slovenian: Za homeopatska zdravila, ki niso navedena v členu 14(1), je treba pridobiti dovoljenje za promet in jih označiti v skladu s členi 8, 10 in 11.
English: A Member State may introduce or retain in its territory specific rules for the toxicological and pharmacological tests and clinical trials of homeopathic medicinal products other than those referred to in Article 14(1) in accordance with the principles and characteristics of homeopathy as practised in that Member State.
Slovenian: Država članica na svojem ozemlju lahko uvede ali ohrani posebna pravila za toksikološke in farmakološke preskuse ter klinična preskušanja homeopatskih zdravil, ki se razlikujejo od navedenih v členu 14(1) v skladu z načeli in značilnostmi homeopatske dejavnosti, kakor se opravlja v tej državi članici.
English: In this case, the Member State concerned shall notify the Commission of the specific rules in force.
Slovenian: Država članica o posebnih pravilih, ki veljajo na njenem ozemlju, obvesti Komisijo.
English: Title IX shall apply to homeopathic medicinal products, with the exception of those referred to in Article 14(1).
Slovenian: Naslov IX se uporablja za homeopatska zdravila razen navedenih v členu 14(1).
English: Procedures relevant to the marketing authorization
Slovenian: Postopki 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 medicinal product on the market is completed within 210 days of the submission of a valid application.
Slovenian: Države članice sprejmejo vse ustrezne ukrepe, da zagotovijo, da se postopek za pridobitev dovoljenja za dajanje zdravila v promet zaključi v roku 210 dni od predložitve popolne vloge.
English: Where a Member State notes that an application for authorization is already under active examination in another Member State in respect of that 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 21(4).
Slovenian: Kadar država članica ugotovi, da se vloga za pridobitev dovoljenja za promet za določeno zdravilo že aktivno preučuje v drugi državi članici, se lahko zadevna država članica odloči opustiti podrobno preučevanje vloge ter počaka poročilo o oceni zdravila, ki ga pripravi druga država članica v skladu s členom 21(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: Zadevna država članica obvesti drugo državo članico ter vlagatelja o svoji odločitvi o opustitvi podrobne preučitve vloge.
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: Takoj ko druga država članica zaključi postopek preučevanja vloge in sprejme odločitev, zadevni državi članici pošlje izvod poročila o oceni zdravila.
English: Where a Member State is informed in accordance with Article 8(3)(l) that another Member State has authorized a 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 21(4).
Slovenian: Kadar je država članica v skladu s členom 8(3)(l) obveščena, da je druga država članica odobrila zdravilo, ki je predmet vloge za pridobitev dovoljenja za promet v zadevni državi članici, ta država članica takoj zaprosi pristojne organe države članice, ki je izdala dovoljenje za promet, da ji pošlje poročilo o oceni zdravila, navedeno v členu 21(4).
English: Within 90 days of the receipt of the assessment report, the Member State concerned shall either recognize 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 medicinal product concerned may present a risk to public health, it shall apply the procedures set out in Articles 29 to 34.
Slovenian: V 90 dneh od prejema poročila o oceni zdravila, zadevna država članica prizna odločitev prve države članice in povzetek glavnih značilnosti zdravila, kot ga je odobrila prva država članica, ali pa, če meni, da obstajajo razlogi za domnevo, da dovoljenje za promet z zadevnim zdravilom lahko predstavlja tveganje za javno zdravje, uporabi postopke, določene v členih 29 do 34.