FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: The medicinal product which is the subject of the application shall be identified by name and name of the active substance(s), together with the pharmaceutical form, the method of administration, the strength and the final presentation, including packaging.
Slovenian: Zdravilo, ki je predmet vloge, se opredeli z imenom ter z imenom zdravilne učinkovine (zdravilnih učinkovin), skupaj s farmacevtsko obliko, načinom dajanja zdravila, jakostjo ter končno obliko pakiranja zdravila, vključno z ovojnino.
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: Navede se ime in naslov vlagatelja, skupaj z imeni in naslovi proizvajalcev in mest, vključenimi v različne faze proizvodnje (vključno s proizvajalcem končnega izdelka ter proizvajalcem/proizvajalci zdravilne učinkovine (zdravilnih učinkovin)), in kadar je to primerno, imenom in naslovom uvoznika.
English: The applicant shall identify the number of volumes of documentation submitted in support of the application and indicate what samples, if any, are also provided.
Slovenian: Vlagatelj navede število zvezkov predložene dokumentacije, ki je priložena vlogi, ter navede kateri vzorci so tudi priloženi, če so.
English: Annexed to the administrative data shall be copies of the manufacturing authorization as defined in Article 40, together with a list of countries in which authorization has been granted, copies of all the summaries of product characteristics in accordance with Article 11 as approved by Member States and a list of countries in which an application has been submitted.
Slovenian: K administrativnim podatkom se priložijo kopije dovoljenja za proizvodnjo, kot je določeno v členu 40, skupaj s seznamom držav, v katerih je bilo izdano dovoljenje za promet, kopije vseh povzetkov glavnih značilnosti zdravila v skladu s členom 11, kot so jih odobrile države članice, ter seznam držav, v katerih je bila vloga predložena.
English: The applicant shall propose a summary of the product characteristics, in accordance with Article 11.
Slovenian: Vlagatelj predlaga povzetek glavnih značilnosti zdravila v skladu s členom 11.
English: In addition the applicant shall provide samples or mock-ups of the packaging, labels and package leaflets for the medicinal product concerned.
Slovenian: Vlagatelj predloži tudi vzorce ali osnutke ovojnine, nalepke in navodila za uporabo za zadevno zdravilo.
English: Expert reports
Slovenian: Strokovna poročila
English: In accordance with Article 12(2), expert reports must be provided on the chemical, pharmaceutical and biological documentation, the pharmacotoxicological documentation and the clinical documentation respectively.
Slovenian: V skladu s členom 12(2) je treba predložiti strokovna poročila o kemijski, farmacevtski in biološki dokumentaciji ter ustrezno farmakološko-toksikološko in klinično dokumentacijo.
English: The expert report shall consist of a critical evaluation of the quality of the medicinal product and the investigations carried out on animals and human beings and bring out all the data relevant for evaluation.
Slovenian: Strokovno poročilo je sestavljeno iz kritičnega ovrednotenja kakovosti zdravila ter raziskav, izvedenih na živalih in ljudeh, ter osvetljuje vse pomembne podatke za vrednotenje.
English: It shall be worded so as to enable the reader to obtain a good understanding of the properties, quality, the proposed specifications and control methods, the safety, the efficacy, the advantages and disadvantages of the medicinal product.
Slovenian: Napisano je tako, da bralcu omogoča dobro razumevanje lastnosti, kakovosti predlaganih specifikacij in kontrolnih metod, varnosti, učinkovitosti, prednosti in slabosti zdravila.
English: All important data shall be summarized in an appendix to the expert report, whenever possible including report formats in tabular or in graphic form.
Slovenian: Vsi pomembni podatki se povzamejo v dodatku k ekspertnemu poročilu, ki vključuje, kadarkoli je to mogoče, poročila v tabelarični ali grafični obliki.
English: The expert report and the summaries shall contain precise cross references to the information contained in the main documentation.
Slovenian: Strokovno poročilo ter povzetki vsebujejo natančne sklice na podatke v glavni dokumentaciji.
English: Each expert report shall be prepared by a suitably qualified and experienced person.
Slovenian: Vsako strokovno poročilo pripravi ustrezna 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 professional experience of the expert.
Slovenian: Podpiše in z datumom opremi ga strokovnjak, poročilu pa se priloži kratka informacija o izobrazbi, usposobljenosti in strokovnih izkušnjah strokovnjaka.
English: The professional relationship of the expert to the applicant shall be declared.
Slovenian: Z izjavo se navede tudi poslovna povezava med strokovnjakom in vlagateljem.
English: CHEMICAL, PHARMACEUTICAL AND BIOLOGICAL TESTING OF MEDICINAL PRODUCTS
Slovenian: KEMIJSKO, FARMACEVTSKO IN BIOLOŠKO PRESKUŠANJE ZDRAVIL
English: All the test procedures shall correspond to the state of scientific progress at the time and shall be validated procedures;
Slovenian: Vsi postopki preskušanja ustrezajo stanju znanstvenega napredka v času preskušanja in so validirani;
English: results of the validation studies shall be provided.
Slovenian: predložijo se rezultati študij validacije.
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 se opiše tako natančno in podrobno, da jih je mogoče ponoviti v kontrolnih preskusih, ki se izvajajo na zahtevo pristojnega organa;
English: any special apparatus and equipment which may be used shall be described in adequate detail, possibly accompanied by a diagram.
Slovenian: vse posebne naprave in oprema, ki se lahko uporabljajo, se na primeren način podrobno opišejo, po možnosti se priloži shema.
English: The formulae of the laboratory reagents shall be supplemented, if necessary, by the manufacturing method.
Slovenian: Sestava laboratorijskih reagentov se, če je potrebno, dopolni s postopkom proizvodnje.
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: Pri postopkih preskušanja, vključenih v Evropsko farmakopejo ali farmakopejo države članice, se ta opis lahko nadomesti s podrobnim napotilom na zadevno farmakopejo.
English: Qualitative and quantitative particulars of the constituents
Slovenian: Podatki o kakovostni in količinski sestavi zdravila
English: The particulars and documents which must accompany applications for marketing authorization, pursuant to point 3 of Article 8(3)(c) shall be submitted in accordance with the following requirements.
Slovenian: Podrobni podatki in dokumenti, ki morajo spremljati vlogo za pridobitev dovoljenja za promet z zdravilom na podlagi točke 3 člena 8(3)(c), se predložijo v skladu z naslednjimi zahtevami.
English: "Qualitative particulars" of all the constituents of the medicinal product shall mean the designation or description of:
Slovenian: "Podrobni podatki o kakovostni sestavi" vseh sestavin zdravila vsebujejo navedbo ali opis:
English: the active substance(s),
Slovenian: zdravilne učinkovine (zdravilnih učinkovin),
English: the constituent(s) of the excipients, whatever their nature or the quantity used, including colouring matter, preservatives, adjuvants, stabilizers, thickeners, emulsifiers, flavouring and aromatic substances, etc.,
Slovenian: sestavin(e) pomožnih snovi, ne glede na njihovo vrsto 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 the patient, of the outer covering of the medicinal products - capsules, gelatine capsules, rectal capsules, etc.
Slovenian: sestavin, ki jih bolnik zaužije ali prejme na kak drug način, zunanjih delov zdravil — kapsul, želatinskih kapsul, rektalnih 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: Ti podrobni podatki se dopolnijo z vsemi ustreznimi podatki o vsebniku in, kadar je primerno, o načinu zapiranja vsebnika, skupaj s podatki o pripomočkih, s pomočjo katerih se zdravilo uporablja ali daje, in se izdajajo skupaj z zdravilom.
English: In the context of a radiopharmaceutical kit, which is to be radiolabelled after supply by the manufacturer, the active substance is considered to be that part of the formulation which is intended to carry or bind the radionuclide.
Slovenian: V radiofarmacevtskem kompletu, ki ga je treba radioaktivno označiti po dobavi proizvajalca, se šteje za zdravilno učinkovino tisti del formulacije, ki nosi ali veže nase radionuklid.
English: Details of the source of the radionuclide shall be stated.
Slovenian: Navedejo se podrobnosti o izvoru radionuklida.
English: In addition, any compounds essential for the radiolabelling shall be stated.
Slovenian: Navedejo se tudi vse sestavine, ki so bistvene za radioaktivno označevanje.
English: In a generator, both mother and daughter radionuclides are to be considered as active substances.
Slovenian: V generatorju se kot zdravilne učinkovine štejejo starševski in hčerinski radionuklidi.
English: The "usual terminology", to be used in describing the constituents of medicinal products, shall mean, notwithstanding the application of the other provisions in Article 8(3)(c):
Slovenian: "Običajni strokovni izrazi", ki se uporabljajo pri opisovanju sestavin zdravil, so, ne glede na uporabo drugih določb člena 8(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, če ne v tej, v farmakopeji ene od držav članic, glavni naslov v glavi zadevne monografije, z napotilom na zadevno farmakopejo,
English: in respect of other substances, the international non-proprietary name recommended by the World Health Organization, 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 natančnega znanstvenega imena, se opišejo z navedbo, kako in iz česa se pripravljajo in kadar je to primerno, dopolnijo z vsemi drugimi potrebnimi podrobnostmi,
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", ki jim je bilo dodeljeno v Direktivi Sveta 78/25/EGS z dne 12. decembra 1977 o približevanju pravil držav članic o barvilih, ki jih je dovoljeno uporabljati v zdravilih [2].
English: In order to give "quantitative particulars" of 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: V "podrobnih podatkih o količinski sestavi" zdravilnih učinkovin v zdravilih je treba, odvisno od zadevne farmacevtske oblike, navesti maso ali število enot biološke aktivnosti na enoto odmerka ali enoto mase ali prostornine za vsako zdravilno učinkovino.
English: Units of biological activity shall be used for substances which cannot be defined chemically.
Slovenian: Enote biološke aktivnosti se uporabljajo za učinkovine, ki jih kemijsko ni mogoče opredeliti.
English: Where an International Unit of biological activity has been defined by the World Health Organization, this shall be used.
Slovenian: Če je Svetovna zdravstvena organizacija opredelila mednarodno enoto biološke aktivnosti, se ta uporablja.
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 opredeljena, se enote biološke aktivnosti izrazijo tako, da dajejo nedvoumno informacijo o aktivnosti učinkovin.
English: Whenever possible, biological activity per units of mass shall be indicated.
Slovenian: Kadarkoli je mogoče, se označi biološka aktivnost na enote mase.
English: This information shall be supplemented:
Slovenian: Ta informacija se dopolni:
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: pri zdravilih za injiciranje, z maso ali enotami biološke aktivnosti za vsako zdravilno učinkovino v enoti vsebnika, ob upoštevanju uporabne prostornine zdravila po dopolnitvi, kadar 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: pri zdravilih, ki se odmerjajo po kapljicah, z maso ali enotami biološke aktivnosti za vsako zdravilno učinkovino, ki jo vsebuje število kapljic, ki ustrezajo 1 ml ali 1 g pripravka,
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: pri sirupih, emulzijah, pripravkih v obliki granul ter drugih farmacevtskih oblikah, 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 designated 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, morajo biti navedene količinsko s celotno maso in, če je potrebno ali primerno, z maso učinkovitega dela ali delov molekule.
English: For medicinal products containing an active substance which is the subject of an application for marketing authorization in any Member State for the first time, the quantitative statement of an active substance which is a salt or hydrate shall be systematically expressed in terms of the mass of the active entity or entities in the molecule.
Slovenian: Pri zdravilih, ki vsebujejo zdravilno učinkovino, ki je prvič predmet vloge za pridobitev dovoljenja za promet z zdravilom v katerikoli državi članici, se navedba količine zdravilne učinkovine, ki je sol ali hidrat, sistematično izrazi v smislu mase učinkovitega dela ali delov molekule.
English: All subsequently authorized medicinal products in the Member States shall have their quantitative composition stated in the same way for the same active substance.
Slovenian: Pri vseh zdravilih, za katera se pozneje izda dovoljenje za promet v državah članicah, se količinska sestava za isto zdravilno učinkovino navede na enak način.
English: For allergen products, the quantitative particulars shall be expressed by units of biological activity, except for well defined allergen products for which the concentration may be expressed by mass/unit of volume.
Slovenian: Pri alergenih se podrobni podatki o količinski sestavi izrazijo z enotami biološke aktivnosti, razen pri točno definiranih alergenih, pri katerih se koncentracija lahko izrazi z maso/enoto prostornine.
English: The requirement to express the content of active substances in terms of the mass of active entities, as in point 3.3. above, may not apply to radiopharmaceuticals.
Slovenian: Zahteva, da se vsebnost zdravilnih učinkovin izrazi z maso učinkovitih delov, kot v točki 3.3 zgoraj, se ne sme uporabljati za radiofarmacevtske izdelke.
English: For radionuclides, radioactivity shall be expressed in becquerels at a given date and, if necessary, time with reference to time zone.
Slovenian: Pri radionuklidih se radioaktivnost izrazi v becquerelih, izmerjenih na določen datum, in če je to potrebno, na čas, z navedbo časovnega območja.
English: The type of radiation shall be indicated.
Slovenian: Navede se tip sevanja.
English: An explanation should be provided with regard to the choice of composition, constituents and container and the intended function of the excipients in the finished product.
Slovenian: Predložiti je treba obrazložitev glede izbire sestave, sestavin in vsebnika ter predvidene funkcije pomožnih snovi v končnem izdelku.
English: This explanation shall be supported by scientific data on development pharmaceutics.
Slovenian: Obrazložitev se podpre z znanstvenimi podatki o farmacevtskem razvoju.
English: The overage during manufacture, with justification thereof, should be stated.
Slovenian: Navesti je treba presežek med proizvodnjo in ga utemeljiti.
English: For radiopharmaceuticals, this should include a consideration of chemical/radiochemical purity and its relationship to biodistribution.
Slovenian: Pri radiofarmacevtskih izdelkih mora to vključevati upoštevanje kemične/radiokemične čistote ter njeno povezavo z biološko porazdelitvijo.
English: Description of manufacturing method
Slovenian: Opis postopka proizvodnje
English: The description of the manufacturing method accompanying the application for marketing authorization pursuant to Article 8(3)(d), shall be drafted in such a way as to give an adequate synopsis of the nature of the operations employed.
Slovenian: Opis postopka proizvodnje, ki spremlja vlogo za pridobitev dovoljenja za promet z zdravilom na podlagi člena 8(3)(d), je zasnovan tako, da daje ustrezen strnjen pregled vrste uporabljenih postopkov.
English: For this purpose it shall include at least:
Slovenian: V ta namen opis vsebuje najmanj:
English: mention of the various stages of manufacture, so that an assessment can be made of whether the processes employed in producing the pharmaceutical form might have produced an adverse change in the constituents,
Slovenian: navedbo različnih faz proizvodnje tako, da se lahko naredi ocena, ali bi uporabljeni postopki za proizvodnjo farmacevtske oblike lahko povzročili neželeno spremembo sestavin,
English: in the case of continuous manufacture, full details concerning precautions taken to ensure the homogeneity of the finished product,
Slovenian: v primeru neprekinjene proizvodnje, vse podrobnosti o previdnostnih ukrepih, da se zagotovi homogenost končnega izdelka,
English: the actual manufacturing formula, with the quantitative particulars of all the substances used, the quantities of excipients, however, being given in approximate terms in so far as the pharmaceutical form makes this necessary;
Slovenian: dejansko proizvodno formulo s podatki o količini vseh uporabljenih snovi, količini pomožnih snovi, ki se navedejo v približnih vrednostih, če je to potrebno zaradi farmacevtske oblike;
English: mention shall be made of any substances that may disappear in the course of manufacture;
Slovenian: navede se vse snovi, ki se v postopku proizvodnje zdravila lahko izgubijo;
English: any overage shall be indicated and justified,
Slovenian: navedejo in utemeljijo se vsi presežki,
English: a statement of the stages of manufacture at which sampling is carried out for in-process control tests, where other data in the documents supporting the application show such tests to be necessary for the quality control of the finished product,
Slovenian: izjavo o fazah proizvodnje, v katerih se izvaja vzorčenje za kontrolne preskuse med proizvodnjo, kadar drugi podatki v dokumentih, priloženih vlogi, kažejo, da so tovrstni preskusi potrebni za nadzor kakovosti končnega izdelka,
English: experimental studies validating the manufacturing process, where a non-standard method of manufacture is used or where it is critical for the product,
Slovenian: poskusne študije validacije postopka proizvodnje, kadar se uporablja nestandarden postopek proizvodnje ali kadar je pomemben za izdelek,
English: for sterile medicinal products, details of the sterilization processes and/or aseptic procedures used.
Slovenian: pri sterilnih zdravilih, podrobnosti o uporabljenih postopkih sterilizacije in/ali aseptičnih postopkih.
English: For radiopharmaceutical kits, the description of the manufacturing method shall also include details of the manufacture of the kit and details of its recommended final processing to produce the radioactive medicinal product.
Slovenian: Pri radiofarmacevtskih kompletih opis postopka proizvodnje vključuje tudi podrobnosti o proizvodnji kompleta ter podrobnosti o njegovi priporočeni končni pripravi za proizvodnjo radioaktivnega zdravila.
English: For radionuclides, the nuclear reactions involved shall be discussed.
Slovenian: Pri radionuklidih je treba poročati o vpletenih jedrskih reakcijah.
English: Controls of starting materials
Slovenian: Nadzor vhodnih snovi
English: For the purposes of this section, "starting materials" shall mean all the constituents of the medicinal product and, if necessary, of its container, as referred to in Section A, point 1, above.
Slovenian: Za potrebe tega oddelka so "vhodne snovi" vse sestavine zdravila in, če je potrebno, sestavine vsebnika, kot je navedeno v točki 1 oddelka A zgoraj.
English: an active substance not described in the European Pharmacopoeia or in the pharmacopoeia of a Member State, or
Slovenian: zdravilne učinkovine, ki ni opisana v Evropski farmakopeji ali farmakopeji države članice, ali
English: an active substance described in the European Pharmacopoeia or in the pharmacopoeia of a Member State when prepared by a method liable to leave impurities not mentioned in the pharmacopoeial monograph and for which the monograph is inappropriate to adequately control its quality,
Slovenian: zdravilne učinkovine, ki je opisana v Evropski farmakopeji ali v farmakopeji države članice, če se pripravlja po postopku, pri katerem bi lahko nastale nečistote, ki jih monografija farmakopeje ne omenja, in za katere je monografija neprimerna za ustrezen nadzor kakovosti,
English: which is manufactured by a person different from the applicant, the latter may arrange for the detailed description of the manufacturing method, quality control during manufacture and process validation to be supplied directly to the competent authorities by the manufacturer of the active substance.
Slovenian: ki jo proizvaja oseba, ki ni vlagatelj, se slednji lahko dogovori, da proizvajalec zdravilne učinkovine pristojnim organom neposredno predloži podroben opis postopka proizvodnje, nadzora kakovosti med proizvodnjo in validacijo procesa.