FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: In this case, the manufacturer shall however provide the applicant with all the data which may be necessary for the latter to take responsibility for the medicinal product.
Slovenian: Proizvajalec vlagatelju predloži tudi vse podatke, ki jih ta potrebuje, da lahko prevzame odgovornost za zdravilo.
English: The manufacturer shall confirm in writing to the applicant that he shall ensure batch to batch consistency and not modify the manufacturing process or specifications without informing the applicant.
Slovenian: Proizvajalec vlagatelju pisno potrdi, da zagotavlja konsistentnost med serijami ter, da ne bo spreminjal postopka proizvodnje ali specifikacij, ne da bi o tem obvestil vlagatelja.
English: Documents and particulars supporting the application for such a change shall be supplied to the competent authorities.
Slovenian: Dokumenti in podrobni podatki, priloženi predlogu za tovrstno spremembo, se predložijo pristojnim organom.
English: The particulars and documents accompanying the application for marketing authorization pursuant to Article 8(3)(h) and (i) and 10(1), shall include the results of the tests, including batch analyses particularly for active substances, relating to quality control of all the constituents used.
Slovenian: Podrobni podatki in dokumenti, ki spremljajo vlogo za pridobitev dovoljenja za promet z zdravilom na podlagi člena 8(3)(h) in (i) ter 10(1), vključujejo tudi rezultate preskusov, vključno z analizami serij, zlasti za zdravilne učinkovine, ki se nanašajo na nadzor kakovosti vseh uporabljenih sestavin.
English: These shall be submitted in accordance with the following provisions.
Slovenian: Predložijo se v skladu z naslednjimi določbami.
English: The monographs of the European Pharmacopoeia shall be applicable to all substances appearing in it.
Slovenian: Monografije Evropske farmakopeje se uporabljajo za vse v njej navedene snovi.
English: In respect of other substances, each Member State may require observance of its own national pharmacopoeia with regard to products manufactured in its territory.
Slovenian: Pri ostalih snoveh vsaka država članica lahko zahteva upoštevanje njene nacionalne farmakopeje v zvezi z zdravili, proizvedenimi na njenem ozemlju.
English: Constituents fulfilling the requirements of the European Pharmacopoeia or the pharmacopoeia of one of the Member States shall be deemed to comply sufficiently with Article 8(3)(h).
Slovenian: Za sestavine, ki izpolnjujejo zahteve Evropske farmakopeje ali farmakopeje ene od držav članic, se šteje, da je njihova skladnost s členom 8(3)(h) zadostna.
English: In this case the description of the analytical methods may be replaced by a detailed reference to the pharmacopoeia in question.
Slovenian: V tem primeru se opis analiznih metod lahko nadomesti s podrobnim napotilom na zadevno farmakopejo.
English: However, where a starting material in the European Pharmacopoeia or in the pharmacopoeia of a Member State has been prepared by a method liable to leave impurities not controlled in the pharmacopoeia monograph, these impurities and their maximum tolerance limits must be declared and a suitable test procedure must be described.
Slovenian: Kadar je vhodna snov v Evropski farmakopeji ali v farmakopeji države članice pripravljena po postopku, pri katerem bi lahko nastale nečistote, ki niso nadzorovane z monografijo farmakopeje, je treba navesti nečistote in njihove najvišje dopustne meje vsebnosti ter opisati ustrezen postopek preskušanja.
English: Colouring matter shall, in all cases, satisfy the requirements of Directive 78/25/EEC.
Slovenian: Barvila morajo v vseh primerih ustrezati zahtevam Direktive 78/25/EGS.
English: The routine tests carried out on each batch of starting materials must be as stated in the application for marketing authorization.
Slovenian: Redni preskusi, opravljeni na vsaki seriji vhodnih snovi, morajo biti takšni kot preskusi, navedeni v vlogi za pridobitev dovoljenja za promet z zdravilom.
English: If tests other than those mentioned in the pharmacopoeia are used, proof must be supplied that the starting materials meet the quality requirements of that pharmacopoeia.
Slovenian: Če se uporabljajo preskusi, ki niso navedeni v farmakopeji, je treba predložiti dokaz, da vhodne snovi ustrezajo zahtevam glede kakovosti iz farmakopeje.
English: In cases where a specification contained in a monograph of the European Pharmacopoeia or in the national pharmacopoeia of a Member State might be insufficient to ensure the quality of the substance, the competent authorities may request more appropriate specifications from the marketing authorization holder.
Slovenian: Če je specifikacija, ki jo vsebuje monografija Evropske farmakopeje ali nacionalna farmakopeja države članice, nezadostna za zagotavljanje kakovosti snovi, pristojni organi od imetnika dovoljenja za promet z zdravilom lahko zahtevajo ustreznejše specifikacije.
English: The competent authorities shall inform the authorities responsible for the pharmacopoeia in question.
Slovenian: Pristojni organi obvestijo organe, odgovorne za zadevno farmakopejo.
English: The marketing authorization holder shall provide the authorities of that pharmacopoeia with the details of the alleged insufficiency and the additional specifications applied.
Slovenian: Imetnik dovoljenja za promet z zdravilom organom zadevne farmakopeje predloži podrobnosti o domnevnih pomanjkljivostih ter o dodatno uporabljenih specifikacijah.
English: In cases where a starting material is described neither in the European Pharmacopoeia nor in the pharmacopoeia of a Member State, compliance with the monograph of a third country pharmacopoeia can be accepted;
Slovenian: Če vhodna snov ni opisana v Evropski farmakopeji ali v farmakopeji države članice, je sprejemljiva skladnost z monografijo farmakopeje tretje države;
English: in such cases, the applicant shall submit a copy of the monograph accompanied where necessary by the validation of the test procedures contained in the monograph and by a translation where appropriate.
Slovenian: v tem primeru vlagatelj predloži kopijo monografije, po potrebi skupaj z validacijo postopkov preskušanja, ki jih monografija vsebuje, ter če je potrebno, še prevod.
English: Constituents which are not given in any pharmacopoeia shall be described in the form of a monograph under the following headings:
Slovenian: Sestavine, ki niso navedene v farmakopeji, se opišejo v obliki monografije pod naslednjimi naslovi:
English: the name of the substance, meeting the requirements of Section A, point 2, shall be supplemented by any trade or scientific synonyms;
Slovenian: ime snovi, ki izpolnjuje zahteve točke 2 oddelka A, se dopolni s sinonimi blagovne znamke ali sinonimi znanstvenega imena;
English: the definition of the substance, set down in a form similar to that used in the European Pharmacopoeia, shall be accompanied by any necessary explanatory evidence, especially concerning the molecular structure where appropriate;
Slovenian: opredelitev snovi, podana v podobni obliki, kot jo uporablja Evropska farmakopeja, ki so ji priloženi vsi potrebni dokazi z obrazložitvijo, zlasti o molekulski strukturi, kadar je to primerno;
English: it must be accompanied by an appropriate description of the method of synthesis.
Slovenian: priložen mora biti ustrezen opis postopka sinteze.
English: Where substances can only be described by their manufacturing method, the description should be sufficiently detailed to characterize a substance which is constant both in its composition and in its effects;
Slovenian: Kadar je snovi mogoče opisati samo s postopkom proizvodnje, mora biti opis dovolj podroben, da je razvidna njena stalna sestava in učinkovitost;
English: methods of identification may be described in the form of complete techniques as used for production of the substance, and in the form of tests which ought to be carried out as a routine matter;
Slovenian: metode identifikacije se lahko opišejo v obliki celotnih postopkov, ki se uporabljajo za proizvodnjo snovi, ter v obliki preskusov, ki jih je treba redno izvajati;
English: purity tests shall be described in relation to the sum total of predictable impurities, especially those which may have a harmful effect, and, if necessary, those which, having regard to the combination of substances to which the application refers, might adversely affect the stability of the medicinal product or distort analytical results;
Slovenian: preskusi čistote se opišejo glede na celotno količino predvidenih nečistot, zlasti tistih, ki imajo lahko škodljiv učinek in, če je to potrebno, tudi tistih, ki bi v kombinaciji snovi, na katere se vloga nanaša, lahko imele neželen vpliv na stabilnost zdravila ali bi lahko izkrivile analizne rezultate;
English: with regard to complex substances of plant or animal/human origin, a distinction must be made between the case where multiple pharmacological effects render chemical, physical or biological control of the principal constituents necessary, and the case of substances containing one or more groups of principles having similar activity, in respect of which an overall method of assay may be accepted;
Slovenian: glede na kompleksnost snovi rastlinskega ali živalskega/človeškega izvora je treba razlikovati med primeri, kjer je zaradi raznovrstnih farmakoloških učinkov obvezno treba izvajati kemijsko, fizikalni ali biološki nadzor glavnih sestavin, in primeri, ko snovi vsebujejo eno ali več skupin sestavin s podobnim delovanjem, ki jih je mogoče ovrednotiti s skupno metodo določanja vsebnosti;
English: when materials of animal/human origin are used, measures to ensure freedom from potentially pathogenic agents shall be described;
Slovenian: ko se uporabljajo snovi živalskega/človeškega izvora, je treba opisati ukrepe, ki zagotavljajo odsotnost potencialno patogenih snovi;
English: for radionuclides, the nature of the radionuclide, the identity of the isotope, likely impurities, the carrier, the use and the specific activity shall be given;
Slovenian: pri radionuklidih se navede narava radionuklida, istovetnost izotopa, možne nečistote, nosilec, uporaba in specifična aktivnost;
English: any special precautions that may be necessary during storage of the starting material and, if necessary, the maximum period of storage before retesting shall be given.
Slovenian: navede se vse posebne previdnostne ukrepe za shranjevanje vhodne snovi ter, če je to potrebno, najdaljši dovoljeni čas shranjevanja do ponovnega preskušanja.
English: Physico-chemical characteristics liable to effect bio-availability
Slovenian: Fizikalno-kemijske lastnosti, ki lahko vplivajo na biološko uporabnost
English: The following items of information concerning active substances, whether or not listed in the pharmacopoeias, shall be provided as part of the general description of the active substances if the bio-availability of the medicinal product depends on them:
Slovenian: Kot del splošnega opisa zdravilnih učinkovin se predložijo naslednje posamezne informacije o zdravilnih učinkovinah, ne glede na to, ali so opisane v farmakopejah, če je od njih odvisna biološka uporabnost zdravila:
English: crystalline form and solubility coefficients,
Slovenian: kristalinična oblika in koeficienti raztapljanja,
English: particle size, where appropriate after pulverization,
Slovenian: velikost delcev, kadar je to primerno po upraševanju,
English: oil/water coefficient of partition(3).
Slovenian: porazdelitveni koeficient olje/voda [3].
English: The first three indents are not applicable to substances used solely in solution.
Slovenian: Prve tri alinee se ne nanašajo na snovi, ki se uporabljajo samo v raztopinah.
English: For biological medicinal products, such as immunological medicinal products and medicinal products derived from human blood or plasma, the requirements of this paragraph shall apply.
Slovenian: Za biološka zdravila, kot so imunološka zdravila ter zdravila, pridobljena iz človeške krvi ali plazme, se uporabljajo določbe tega odstavka.
English: For the purposes of this paragraph, starting materials shall mean any substance used in the manufacture of the medicinal product;
Slovenian: V tem odstavku izraz vhodne snovi pomeni vsako snov, ki se uporablja pri proizvodnji zdravila:
English: this includes the constituents of the medicinal product, and, if necessary, of its container, as referred to in paragraph A, point 1 above, as well as source materials such as microorganisms, tissues of either plant or animal origin, cells or fluids (including blood) of human or animal origin, and biotechnological cell constructs.
Slovenian: to vključuje sestavine zdravila, in če je potrebno, njegovega vsebnika, kot je določeno v točki 1 odstavka A zgoraj, kot tudi izvorne materiale, kot so mikroorganizmi, tkiva rastlinskega ali živalskega izvora, celice ali tekočine (vključno s krvjo) človeškega ali živalskega izvora, ter biotehnološko spremenjene celice.
English: The origin and history of starting materials shall be described and documented.
Slovenian: Opisati in dokumentirati je potrebno izvor in zgodovino vhodnih snovi.
English: The description of the starting material shall include the manufacturing strategy, purification/inactivation procedures with their validation and all in-process control procedures designed to ensure the quality, safety and batch to batch consistency of the finished product.
Slovenian: Opis vhodne snovi vsebuje strategijo proizvodnje, postopke čiščenja/inaktivacije skupaj z validacijo ter vsemi kontrolnimi postopki med proizvodnjo, ki zagotavljajo kakovost, varnost in konsistentnost med serijami končnega izdelka.
English: When cell banks are used, the cell characteristics shall be shown to have remained unchanged at the passage level used for the production and beyond.
Slovenian: Pri uporabi celičnih bank, se prikaže, da so lastnosti celic ostale nespremenjene v času prenosa v proizvodnjo in pozneje.
English: Seed materials, cell banks, pools of serum or plasma and other materials of biological origin and, whenever possible, the source materials from which they are derived shall be tested for adventitious agents.
Slovenian: Matični materiali, banke celic, zbiri serumov ali plazme in drugi materiali biološkega izvora, in kadarkoli je to mogoče, izvorni materiali, iz katerih se te snovi pridobivajo, je treba preskusiti na prisotnost naključnih snovi.
English: If the presence of potentially pathogenic adventitious agents is inevitable, the correspondant material shall be used only when further processing ensures their elimination and/or inactivation, and this shall be validated.
Slovenian: Če je prisotnost potencialno patogenih naključnih snovi neizogibna, se sme snov uporabljati samo, če nadaljnja obdelava zagotavlja njihovo odstranitev in/ali inaktivacijo, kar mora biti validirano.
English: Whenever possible, vaccine production shall be based on a seed lot system and on established cell banks;
Slovenian: Kadarkoli je mogoče, proizvodnja cepiva temelji na sistemu matične serije ter na vzpostavljenih bankah celic;
English: for serums, defined pools of starting materials shall be used.
Slovenian: pri serumih se uporabljajo definirani zbiri vhodnih snovi.
English: For bacterial and viral vaccines, the characteristics of the infectious agent shall be demonstrated on the seed.
Slovenian: Pri bakterijskih in virusnih cepivih se pokaže na matičnem materialu lastnosti patogenih mikrobov.
English: In addition, for live vaccines, the stability of the attenuation characteristics shall be demonstrated on the seed;
Slovenian: Poleg tega se pri živih cepivih prikaže stabilnost oslabitvenih lastnosti na matičnem materialu;
English: if this proof is not sufficient, the attenuation characteristics shall also be demonstrated at the production stage.
Slovenian: če ta dokaz ne zadošča, se oslabitvene lastnosti prikažejo tudi v fazi proizvodnje.
English: For allergen products, the specifications and control methods for the source materials shall be described in as much detail as possible.
Slovenian: Pri alergenih se čimbolj podrobno opišejo specifikacije in kontrolne metode za izvorne materiale.
English: The description shall include particulars concerning collection, pretreatment and storage.
Slovenian: Opis vsebuje podrobne podatke glede zbiranja, predhodne obdelave ter shranjevanja.
English: For medicinal products derived from human blood or plasma, the origin and the criteria and procedures for collection, transportation and storage of the source material shall be described and documented.
Slovenian: Pri zdravilih, pridobljenih iz človeške krvi ali plazme, se opišejo in dokumentirajo izvor ter merila in postopki za zbiranje, prevoz in shranjevanje izvornega materiala.
English: Defined pools of source material shall be used.
Slovenian: Uporabljajo se definirani zbiri izvornega materiala.
English: For radiopharmaceuticals, starting materials include irradiation target materials.
Slovenian: Pri radiofarmacevtskih izdelkih vhodne snovi vključujejo obsevalne tarče.
English: Specific measures concerning the prevention of the transmission of animal spongiform encephalopathies
Slovenian: Posebni ukrepi za preprečevanje prenosa živalske spongiformne encefalopatije
English: The applicant must demonstrate that the medicinal product is manufactured in accordance with the Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Medicinal Products and its updates, published by the Commission in Volume 3 of its publication The rules governing medicinal products in the European Community.
Slovenian: Vlagatelj mora dokazati, da je zdravilo proizvedeno v skladu z navodili o zmanjšanju tveganja prenosa povzročiteljev živalske spongiformne encefalopatije z zdravili na najmanjšo možno mero ter v skladu z njegovimi dopolnitvami, ki jih je Komisija objavila v 3. zvezku publikacije Pravila, ki urejajo zdravila v Evropski skupnosti.
English: Control tests carried out at intermediate stages of the manufacturing process
Slovenian: Kontrolni preskusi, ki se izvajajo na vmesnih fazah postopka proizvodnje
English: The particulars and documents accompanying an application for marketing authorization, pursuant to Article 8(3)(h) and (i) and Article 10, paragraph 1 of this Directive, shall include particulars relating to the product control tests that may be carried out at an intermediate stage of the manufacturing process, with a view to ensuring the consistency of the technical characteristics and the production process.
Slovenian: Podrobni podatki ter dokumenti, ki spremljajo vlogo za pridobitev dovoljenja za promet z zdravilom na podlagi člena 8(3)(h) ter (i) in odstavka 1 člena 10 te direktive, vključujejo podrobne podatke v zvezi s kontrolnimi preskusi izdelka, ki se lahko opravljajo v vmesni fazi postopka proizvodnje, da se zagotovi konsistentnost med tehničnimi značilnostmi ter postopkom proizvodnje.
English: These tests are essential for checking the conformity of the medicinal product with the formula when, exceptionally, an applicant proposes an analytical method for testing the finished product which does not include the assay of all the active substances (or of all the excipient constituents subject to the same requirements as the active substances).
Slovenian: Ti preskusi so pomembni za preverjanje skladnosti zdravila s sestavo, če vlagatelj izjemoma predlaga analizno metodo za preskušanje končnega izdelka, ki ne vključuje določanja vsebnosti vseh zdravilnih učinkovin (ali vseh sestavin pomožnih snovi ob upoštevanju enakih zahtev kot za zdravilne učinkovine).
English: The same applies where the quality control of the finished product depends on in-process control tests, particularly if the medicinal product is essentially defined by its method or preparation.
Slovenian: Enako velja, kadar je nadzor kakovosti končnega izdelka odvisen od preskusov medfaznega nadzora, zlasti, če je zdravilo v bistvu opredeljeno s postopkom ali pripravo.
English: For biological medicinal products, such as immunological medicinal products and medicinal products derived from human blood or plasma, the procedures and the criteria of acceptability published as recommendations of the WHO (Requirements for Biological Substances) shall serve as guidelines for all controls of production stages which are not specified in the European Pharmacopoeia, or falling this, in the national pharmacopoeia of a Member State.
Slovenian: Pri bioloških zdravilih, kot so imunološka zdravila in zdravila, pridobljena iz človeške krvi ali plazme, se kot smernice za vse nadzore faz proizvodnje, ki niso navedene v Evropski farmakopeji ali farmakopeji države članice, upoštevajo postopki in merila sprejemljivosti, objavljeni kot priporočila WHO (Zahteve za biološke snovi).
English: For inactivated or detoxified vaccines, effective inactivation or detoxification shall be verified during each production run, unless this control is dependent upon a test for which the availability of susceptible animals is limited.
Slovenian: Pri inaktiviranih ali detoksificiranih cepivih se preveri učinkovitost inaktivacije ali detoksifikacije med proizvodnjo vsake serije, razen če nadzor ni odvisen od preskusa, za katerega je razpoložljivost dovzetnih živali omejena.
English: In this case, the test shall be carried out until consistency of production and correlation with appropriate in process controls have been established and thereafter compensated by appropriate in-process controls.
Slovenian: V tem primeru se preskus izvaja, vse dokler ni zagotovljena konsistentnost proizvodnje in korelacija z ustreznimi medfaznimi nadzori, ki lahko nato nadomestijo ustrezne medfazne nadzore.
English: For modified or adsorbed allergen products, the products shall be qualitatively and quantitatively characterized at an intermediate stage, as late as possible in the manufacturing process.
Slovenian: Pri spremenjenih ali adsorbiranih alergenih se kakovost in količina označita v vmesni fazi, čim pozneje v postopku proizvodnje.
English: Control tests on the finished product
Slovenian: Kontrolni preskusi končnega izdelka
English: For the control of the finished product, a batch of a medicinal product comprises all the units of a pharmaceutical form which are made from the same initial quantity of material and have undergone the same series of manufacturing and/or sterilization operations or, in the case of a continuous production process, all the units manufactured in a given period of time.
Slovenian: Pri nadzoru končnega izdelka obsega serija zdravila vse enote farmacevtske oblike, ki so proizvedene iz iste začetne količine snovi in so bile podvržene istim vrstam postopkov proizvodnje in/ali postopkov sterilizacije, ali v primeru neprekinjenega postopka proizvodnje, vse enote, proizvedene v določenem časovnem obdobju.
English: The application for marketing authorization shall list those tests which are carried out routinely on each batch of finished product.
Slovenian: V vlogi za pridobitev dovoljenja za promet z zdravilom se navedejo vsi preskusi, ki se redno izvajajo na vsaki seriji končnega izdelka.
English: The frequency of the tests which are not carried out routinely shall be stated.
Slovenian: Navede se pogostost preskusov, ki se ne opravljajo redno.
English: Release limits shall be indicated.
Slovenian: Navedejo se meje za sproščanje serij.
English: The particulars and documents accompanying the application for marketing authorization pursuant to Article 8(3)(h) and (i) and Article 10(1) of this Directive, shall include particulars relating to control tests on the finished product at release.
Slovenian: Podrobni podatki in dokumenti, ki spremljajo vlogo za pridobitev dovoljenja za promet z zdravilom na podlagi člena 8(3)(h) ter (i) in člen 10(1) te direktive, vključujejo podrobne podatke v zvezi s kontrolnimi preskusi končnega izdelka ob sproščanju.
English: They shall be submitted in accordance with the following requirements.
Slovenian: Predložijo se v skladu z naslednjimi zahtevami.