FrancophonIA/DGT-Translation_Memory huggingface dataset:
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: Za zdravila, ki vsebujejo zdravilno učinkovino, ki je prvič predmet vloge za pridobitev dovoljenja za promet z zdravilom v kateri koli državi članici, se mora količinska navedba za zdravilno učinkovino, ki je sol ali hidrat, sistematično navesti z maso učinkovitega dela ali delov v molekuli.
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: Vsa zdravila, ki so pozneje pridobila dovoljenje za promet v državah članicah, morajo imeti za isto zdravilno učinkovino količinsko sestavo opisano na enak način.
English: Development pharmaceutics
Slovenian: Farmacevtski razvoj
English: An explanation shall be provided with regard to the choice of composition, constituents and container and the intended function of the excipients in the finished product.
Slovenian: Treba je podati obrazložitev glede izbire sestave, sestavin ter vsebnika ter predvidene funkcije pomožne snovi v končnem zdravilu.
English: This explanation shall be supported by scientific data on development pharmaceutics.
Slovenian: Obrazložitev mora biti podprta z znanstvenimi podatki o farmacevtskem razvoju.
English: The overage, with justification thereof, shall be stated.
Slovenian: Potrebna je navedba o presežku z obrazložitvijo.
English: DESCRIPTION OF THE MANUFACTURING METHOD
Slovenian: OPIS POSTOPKA IZDELAVE
English: The description of the manufacturing method accompanying the application for marketing authorization pursuant to Article 12(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 izdelave, ki spremlja vlogo za pridobitev dovoljenja za promet z zdravilom v skladu z členom 12(3)(d) mora biti napisan tako, da podaja ustrezen strnjen pregled o značilnostih uporabljenih postopkov.
English: For this purpose it shall include at least:
Slovenian: V ta namen mora opis vsebovati 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 izdelave tako, da se lahko poda ocena ali bi uporabljeni proces pri izdelavi zdravila lahko povzročil neželeno spremembe 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 izdelave, podrobne podatke o izvajanih varnostnih ukrepih, ki zagotavljajo 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 sestavino, s podrobnimi podatki o količini vseh uporabljenih snovi, količini pomožnih snovi, ali s približnimi navedki, če tako zahteva farmacevtska oblika;
English: mention shall be made of any substances that may disappear in the course of manufacture;
Slovenian: treba je omeniti vsako snov, ki lahko med postopkom izdelave izgubijo;
English: any overage shall be indicated and justified,
Slovenian: omeniti in obrazložiti je treba vsakršen presežek,
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: navedbo o fazah izdelave, pri katerih se opravi vzorčenje za kontrolne preskuse med izdelavo, če ostali podatki v dokumentaciji, ki spremlja vlogo kažejo, da so tovrstni preskusi potrebni za kontrolo kvalitete 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: eksperimentalne študije, validacije postopka izdelave, če se uporablja nestandardni postopek izdelave, ali če je to kritično za izdelek,
English: for sterile products, details of the sterilization processes and/or aseptic procedures used.
Slovenian: pri sterilnih zdravilih, podatki o sterilizacijskih postopkih in/ali uporabljenih aseptičnih postopkih.
English: CONTROL OF STARTING MATERIALS
Slovenian: KONTROLA VHODNIH SNOVI
English: For the purposes of this paragraph, "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: V tem odstavku so "vhodne snovi" vse sestavine zdravila in, če je potrebno, sestavine njegovega vsebnika, kakor to navedeno v točki 1 oddelka A zgoraj.
English: In the case of:
Slovenian: V primeru:
English: an active substance not described in the European Pharmacopoeia or in the pharmacopoeia of a Member State,
Slovenian: zdravilne učinkovine, ki ni opisana v Evropski farmakopeji ali farmakopeji države članice,
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 je bila pripravljena po postopku, pri katerem bi lahko nastale nečistoče, ki jih monografija farmakopeje ne navaja ter za katero je monografija neprimerna, da bi omogočala kontrolo 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 izdeluje oseba, ki je različna od predlagatelja, se lahko predlagatelj dogovori, do bo izdelovalec zdravilne učinkovine opis podrobnega postopka izdelave, kontrole kakovosti med izdelavo ter validacijo procesa direktno dostavil pristojnim organom.
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: V tem primeru mora izdelovalec dostaviti predlagatelju vse potrebne podatke, ki bi lahko bili potrebni pri prevzemanju odgovornosti 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: Izdelovalec mora predlagatelju pisno potrditi, da zagotavlja konsistentnost med serijami ter da ne bo spreminjal postopka izdelave ali specifikacij brez obveščanja predlagatelja.
English: Documents and particulars supporting the application for such a change shall be supplied to the competent authorities.
Slovenian: Dokumente in podrobne podatke, ki spremljajo vlogo za tako spremembo, je treba dostaviti pristojnim organom.
English: The particulars and documents accompanying the application for marketing authorization pursuant to Article 12(3)(i) and (j) and Article 13(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 ter dokumentacija, ki spremlja vlogo za pridobitev dovoljenja za promet z zdravilom v skladu s členoma 12(3)(i) in(j) ter 13(1), mora vsebovati rezultate testov kontrole kakovosti vseh uporabljenih sestavin, vključno z analizo serij, še posebno za zdravilne učinkovine.
English: These shall be submitted in accordance with the following provisions.
Slovenian: Te je treba predložiti v skladu z naslednjimi določili.
English: Starting materials listed in pharmacopoeias
Slovenian: Vhodne snovi, navedene v farmakopejah
English: The monographs of the European Pharmacopoeia shall be applicable to all substances appearing in it.
Slovenian: Monografije Evropske farmakopeje se morajo uporabljati za vse snovi, ki so v njej objavljene.
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 snovi lahko vsaka država članica zahteva upoštevanje lastne nacionalne farmakopeje, če gre za zdravila, izdelana 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 12(3)(i).
Slovenian: Za sestavine, ki ustrezajo zahtevam Evropske farmakopeje ali farmakopeje ene od držav članic, se šteje, da v zadostni meri izpolnjujejo pogoje iz člena 12(3)(i).
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 lahko opis analitskih metod nadomesti s podrobnim sklicem 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: Vendar pa, če je bila vhodna snov pripravljena po Evropski farmakopeji ali po farmakopeji države članice po postopku, pri katerem bo lahko nastale nečistoče, ki jih farmakopeja ne kontrolira, je treba te nečistoče ter njihove najvišje dopustne meje vsebnosti navesti ter opisati ustrezni postopek preskušanja.
English: Colouring matter shall, in all cases, satisfy the requirements of Council Directive 78/25/EEC.
Slovenian: Barvila morajo v vseh primerih ustrezati zahtevam Direktive Sveta 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: Rutinski preskusi, ki se izvajajo za vsako serijo vhodnih snovi, morajo biti taki, kot so bili 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 različni preskusi od tistih, ki jih navaja farmakopeja, mora biti predložen 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: V primeru, če bi lahko bile specifikacije, ki jih vsebuje monografija Evropske farmakopeje, ali nacionalna farmakopeja države članice nezadostne za zagotovitev kakovosti snovi, lahko pristojni organi od imetnika dovoljenja za promet z zdravilom zahtevajo ustreznejše specifikacije.
English: The competent authorities shall inform the authorities responsible for the pharmacopoeia in question.
Slovenian: Pristojni organi morajo obvestiti 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 mora organom farmakopeje dostaviti podatke o navedeni pomanjkljivosti ter o uporabljenih dodatnih 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: V primerih, ko vhodna snov ni navedena niti v Evropski farmakopeji niti v farmakopeji države članice, se lahko sprejme 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 takih primerih mora predlagatelj predložiti kopijo monografije, po potrebi pa še validacijo postopkov preskušanja, ki jih vsebuje monografija ter, če je to potrebno, še prevod.
English: Starting materials not in a pharmacopoeia
Slovenian: Vhodne snovi, ki niso navedene v farmakopeji
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 morajo opisati v obliki monografije po naslednjih poglavjih:
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 lahko nadomesti z blagovnim ali znanstvenim sinonimom;
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, opisano v podobni obliki kot jo uporablja Evropska farmakopeja, morajo spremljati vse potrebne obrazložitve, še posebno glede molekulske strukture, če je to potrebno;
English: it must be accompanied by an appropriate description of the method of synthesis.
Slovenian: to mora spremljati ustrezen opis postopka sinteze.
English: Where substances can only be described by their manufacturing method, the description shall be sufficiently detailed to characterise a substance which is constant both on its composition and in its effects;
Slovenian: V primeru, da se snovi lahko opišejo le s postopkom izdelave, mora biti opis dovolj podroben, da bi opredelil snov, 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 izdelavo snovi ter v obliki preskusov, ki jih je potrebno izvajati rutinsko;
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 morajo opisati glede na celotno količino predvidenih nečistot, posebno tistih, ki bi lahko imele škodljiv učinek in, če je to potrebno, tistih, ki bi v kombinaciji snovi, na katero se vloga nanaša, lahko imele neželen učinke na stabilnost zdravila, ali bi lahko popačile analitske rezultate;
English: with regard to complex substances of plant or animal origin, a distinction must be made between the case where multiple pharmacological effects render chemical, physical or biological control of the principal components 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: pri kompleksnih snoveh rastlinskega ali živalskega izvora je potrebno razlikovati med primeri, kjer različni farmakološki učinki pomenijo, da je potrebna kemijska, fizikalna ali biološka kontrola glavnih sestavin in primeri, kjer snovi vsebujejo eno ali več skupin učinkovin s podobnim delovanjem, za katere se lahko sprejme enotna metoda določanja vsebnosti;
English: when materials of animal origin are used, measures to ensure freedom from potentially pathogenic agents shall be described;
Slovenian: v primeru, da se uporabljajo materiali živalskega izvora, je potrebno opisati ukrepe, ki bodo zagotavljali odsotnost potencialnih patogenih dejavnikov;
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: vse posebne previdnostne ukrepe, potrebne za shranjevanje vhodnih snovi ter, če je to potrebno, najdaljši čas shranjevanja pred ponovnim preskušanjem.
English: Physico-chemical characteristics liable to affect bioavailability
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, če je od njih odvisna biološka uporabnost zdravil, je treba predložiti naslednje podatke o zdravilnih učinkovinah, ne glede na to, ali so opisane v farmakopejah ali ne:
English: crystalline form and solubility coefficients,
Slovenian: kristalinična oblika ter koeficient raztapljanja,
English: particle size, where appropriate after pulverization,
Slovenian: velikost delcev, kjer je po upraševanju to potrebno,
English: state of solvation,
Slovenian: stopnja solvatacije,
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 točke se ne uporabljajo pri snoveh, ki se uporabljajo samo v raztopinah.
English: Where source materials such as micro-organisms, tissues of either plant or animal origin, cells or fluids (including blood) of human or animal origin or biotechnological cell constructs are used in the manufacture of veterinary medicinal products, the origin and history of starting materials shall be described and documented.
Slovenian: V primeru, da se v izdelavi zdravil za uporabo v veterinarski medicini uporabljajo vhodne snovi, kot so mikroorganizmi, tkiva bodisi rastlinskega ali živalskega izvora, celice ali tekočine (vključno s krvjo) človeškega ali živalskega izvora, ali biotehnološko spremenjene celice, je treba opisati in dokumentirati izvor ter 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 vhodnih snovi mora vsebovati strategijo izdelave, postopke čiščenja/inaktivacije skupaj z validacijo ter vsemi kontrolnimi postopki med izdelavo, ki so bili predvideni za zagotavljanje kakovosti, varnosti in konsistentnosti 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 celične banke mora biti prikazano, da so lastnosti celic ostale nespremenjene v času prenosa v proizvodnjo in tudi pozneje.
English: Seed materials, cell banks, pools of serum and other material of biological origin and, whenever possible, the source materials from which they are derived shall be tested for adventitious agents.
Slovenian: Matične materiale, banke celic, zbire serumov in druge materiale biološkega izvora, in kjer je to mogoče, izvorne materiale, 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 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 neizbežna, se mora material uporabljati le kadar nadaljnja obdelava zagotavljajo, da jih je možno odstraniti in/ali inaktivirati, kar pa je potrebno validirati.
English: SPECIFIC MEASURES CONCERNING THE PREVENTION OF THE TRANSMISSION OF ANIMAL SPONGIFORM ENCEPHALOPATHIES
Slovenian: POSEBNI UKREPI ZA PREPREČEVANJE PRENOSA ŽIVALSKIH SPONGIFORMNIH ENCEFALOPATIJ
English: The applicant must demonstrate that the veterinary medical product is manufactured in accordance with the Note for Guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via veterinary medicinal products and its updates, published by the European Commission in Volume 7 of its publication "The rules governing medicinal products in the European Community".
Slovenian: Predlagatelj mora dokazati, da se zdravilo za uporabo v veterinarski medicini izdeluje v skladu s Pojasnili k navodilom o zmanjševanju tveganj prenosa povzročiteljev živalske spongiformne encefalopatije z zdravile za uporabo v veterinarski medicini ter v skladu z novejšimi dopolnitvami, ki jih je objavila Evropska komisija v zvezku 7 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 IZDELAVE
English: The particulars and documents accompanying an application for marketing authorization, pursuant to Article 12(3)(i) and (j) and also Article 13(1), 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 dokumentacija, ki spremlja vlogo za pridobitev dovoljenja za promet z zdravilom, v skladu s členom 12(3)(i) ter (j) in tudi členom 13(l), mora vsebovati podrobne podatke, ki se nanašajo na kontrolne preskuse izdelka, ki se lahko izvedejo v vmesni fazi postopka izdelave, z namenom da bi zagotovili konsistentnost med tehničnimi lastnostmi ter postopkom izdelave.
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 components subject to the same requirements as the active substances).
Slovenian: Ti preskusi so ključnega pomena za preverjanje skladnosti zdravila s sestavo, če izjemoma predlagatelj predlaga analitsko metodo za preskušanje končnega proizvoda, ki ne vključuje določanja vsebnosti vseh zdravilnih učinkovin (ali vseh sestavin pomožnih snovi, za katere veljajo iste zahteve 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 substance is essentially defined by its manufacturing method.
Slovenian: Isto velja za končne izdelke, kjer je kontrola kakovosti odvisna od preskusov medfazne kontrole, posebno če je zdravilo v bistvu opredeljeno s postopkom ali pripravo.
English: CONTROL TESTS ON THE FINISHED PRODUCT
Slovenian: KONTROLNI PRESKUSI KONČNEGA IZDELKA