natgillin/translations-raw huggingface dataset:
For veterinary medicinal products containing an active substance which is the subject of an application for marketing authorisation 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.
Pri zdravilih za uporabo v veterinarski medicini, ki vsebujejo zdravilno učinkovino, ki je prvič predmet vloge za pridobitev dovoljenja za promet z zdravilom v kateri koli državi članici, se količina zdravilne učinkovine, ki je sol ali hidrat, sistematično izrazi z maso aktivnega dela ali delov molekule.
All subsequently authorised veterinary medicinal products in the Member States shall have their quantitative composition stated in the same way for the same active substance.
Pri vseh zdravilih za uporabo v veterinarski medicini, ki pozneje pridobijo dovoljenje za promet v državah članicah, se količinska sestava za isto zdravilno učinkovino izrazi na enak način.
An explanation shall be provided with regard to the choice of composition, constituents, immediate packaging, possible further packaging, outer packaging if relevant, the intended function of the excipients in the finished product and the method of manufacture of the finished product.
Predloži se obrazložitev izbire sestave, sestavin, stične ovojnine, mogočih nadaljnjih ovojnin, zunanje ovojnine, če je ustrezno, predvidene funkcije pomožnih snovi v končnem zdravilu in postopka izdelave končnega zdravila.
This explanation shall be supported by scientific data on development pharmaceutics.
Obrazložitev se podpre z znanstvenimi podatki o farmacevtskem razvoju.
The overage, with justification thereof, shall be stated.
Navede in obrazloži se presežek.
The microbiological characteristics (microbiological purity and antimicrobial activity) and usage instructions shall be proven to be appropriate for the intended use of the veterinary medicinal product as specified in the marketing authorisation application dossier.
Dokaže se, da mikrobiološke lastnosti (mikrobiološka čistost in protimikrobna aktivnost) in navodila za uporabo ustrezajo predvideni uporabi zdravila za uporabo v veterinarski medicini, kakor je opredeljeno v vlogi za pridobitev dovoljenja za promet z zdravilom.
The name, address and responsibility of each manufacturer and each proposed production site or facility involved in manufacturing and testing shall be indicated.
Navedejo se ime, naslov in odgovornost vsakega izdelovalca ter vsak predlagan obrat izdelave ali objekt, vključen v izdelavo in preskušanje.
The description of the manufacturing method accompanying the application for marketing authorisation 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.
Opis postopka izdelave, ki spremlja vlogo za pridobitev dovoljenja za promet z zdravilom v skladu z členom 12(3)(d), se pripravi tako, da podaja ustrezen strnjen pregled značilnosti uporabljenih postopkov.
For this purpose it shall include at least:
V ta namen opis vsebuje najmanj:
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,
navedbo različnih stopenj izdelave tako, da se lahko pripravi ocena, ali bi uporabljeni postopek pri izdelavi farmacevtske oblike lahko povzročil neželeno spremembo sestavin,
in the case of continuous manufacture, full details concerning precautions taken to ensure the homogeneity of the finished product,
v primeru neprekinjene izdelave podrobne podatke o izvajanih varnostnih ukrepih, ki zagotavljajo homogenost končnega zdravila,
the actual manufacturing formula, with the quantitative particulars of all the substances used, the quantities of excipients, however, being given in approximate terms insofar as the pharmaceutical form makes this necessary; mention shall be made of any substances that may disappear in the course of manufacture; any overage shall be indicated and justified,
dejansko proizvodno formulo, s podrobnimi podatki o količini vseh uporabljenih snovi, količini pomožnih snovi ali s približnimi navedki, če tako zahteva farmacevtska oblika, navedbo vsake snovi, ki se lahko med postopkom izdelave izgubi, ter navedbo in obrazložitev kakršnega koli presežka,
a statement of the stages of manufacture at which sampling is carried out for in-process control tests and the limits applied, where other data in the documents supporting the application show such tests to be necessary for the quality control of the finished product,
navedbo stopenj izdelave, pri katerih se opravi vzorčenje za kontrolne preskuse med izdelavo, in uporabljenih omejitev, kadar drugi podatki v dokumentih, ki spremljajo vlogo, kažejo, da so takšni preskusi potrebni za nadzor kakovosti končnega zdravila,
experimental studies validating the manufacturing process and where appropriate a process validation scheme for production scale batches,
eksperimentalne študije, ki potrjujejo postopek izdelave, in po potrebi shemo postopka potrditve za serije obsega proizvodnje,
for sterile products, where non-pharmacopoeial standard sterilisation conditions are used, details of the sterilisation processes and/or aseptic procedures used.
pri sterilnih zdravilih, kadar se uporabljajo standardne sterilizacijske razmere, ki niso navedene v farmakopeji, podrobne podatke o uporabljenih postopkih sterilizacije in/ali postopkih asepse.
For the purposes of this paragraph, “starting materials” shall mean all the constituents of the veterinary medicinal product and, if necessary, of its container including its closure, as referred to in Section A, point 1, above.
V tem odstavku so ‚vhodne snovi‘ vse sestavine zdravila za uporabo v veterinarski medicini in po potrebi sestavine njegovega vsebnika, vključno s sistemom zapiranja, kakor je navedeno v točki 1 oddelka A zgoraj.
The dossier shall include the specifications and information on the tests to be conducted for quality control of all batches of starting materials.
V vlogi se navedejo specifikacije in informacije o preskusih, ki se izvajajo za nadzor kakovosti vseh serij vhodnih snovi.
The routine tests carried out on each batch of starting materials must be as stated in the application for marketing authorisation.
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.
If tests other than those mentioned in a pharmacopoeia are used, this shall be justified by providing proof that the starting materials meet the quality requirements of that pharmacopoeia.
Če se uporabljajo še preskusi, ki niso navedeni v farmakopeji, se predložijo dokazi, da vhodne snovi izpolnjujejo zahteve glede kakovosti iz navedene farmakopeje.
Where a Certificate of Suitability has been issued by the European Directorate for the Quality of Medicines and HealthCare for a starting material, active substance or excipient, this Certificate constitutes the reference to the relevant monograph of the European Pharmacopoeia.
Kadar je Evropska direkcija za kakovost zdravil in zdravstva za vhodno snov, zdravilno učinkovino ali pomožno snov izdala certifikat o ustreznosti, je ta certifikat sklic na ustrezno monografijo Evropske farmakopeje.
Where a Certificate of Suitability is referred to, the manufacturer shall give an assurance in writing to the applicant that the manufacturing process has not been modified since the granting of the certificate of suitability by the European Directorate for the Quality of Medicines and HealthCare.
Kadar se uporabi sklic na certifikat o ustreznosti, izdelovalec pisno zagotovi predlagatelju, da se postopek izdelave ni spremenil od izdaje certifikata o ustreznosti s strani Evropske direkcije za kakovost zdravil in zdravstva.
Certificates of Analysis shall be presented for the starting materials in order to demonstrate compliance with the defined specification.
Za vhodne snovi se predloži certifikat o analizi, da se potrdi izpolnjevanje opredeljenih specifikacij.
Active substances
Zdravilne učinkovine
The name, address, and responsibility of each manufacturer and each proposed production site or facility involved in manufacturing and testing of an active substance shall be indicated.
Navedejo se ime, naslov in odgovornost vsakega izdelovalca in vsak predlagan obrat izdelave ali objekt, vključen v izdelavo in preskušanje.
For a well-defined active substance, the active substance manufacturer or the applicant may arrange for the following information to be supplied in a separate document directly to the competent authorities by the manufacturer of the active substance as an Active Substance Master File:
Za dobro opredeljeno zdravilno učinkovino lahko proizvajalec zdravilne učinkovine ali predlagatelj uredi, da izdelovalec zdravilne učinkovine v ločenem dokumentu neposredno pristojnemu organu predloži naslednje informacije kot glavno datoteko o zdravilni učinkovini:
a detailed description of the manufacturing process;
podroben opis postopka izdelave;
a description of the quality control during manufacture;
opis nadzora kakovosti med izdelavo;
a description of the process validation.
opis postopka potrditve.
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 veterinary medicinal product.
V tem primeru izdelovalec zagotovi predlagatelju vse potrebne podatke, ki bi lahko bili potrebni pri prevzemanju odgovornosti za zdravilo za uporabo v veterinarski medicini.
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.
Izdelovalec predlagatelju pisno potrdi, da zagotavlja konsistentnost med serijami ter da ne bo spreminjal postopka izdelave ali specifikacij brez obvestila predlagatelja.
Documents and particulars supporting the application for such a change shall be supplied to the competent authorities those documents and particulars shall also be supplied to the applicant where they concern the applicant’s part of the Active Substance Master File.
Dokumenti in podrobni podatki, ki podpirajo vlogo za takšno spremembo, se predložijo pristojnim organom; navedeni dokumenti in podrobni podatki se predložijo predlagatelju, kadar zadevajo njegovo vlogo pri glavni datoteki o zdravilni učinkovini.
Additionally, information on the method of manufacture, on quality control and on impurities as well as evidence of the molecular structure shall be provided where a Certificate of Suitability for the active substance is not available:
Kadar certifikat o ustreznosti zdravilne učinkovine ni na voljo, se predložijo informacije o načinu izdelave, nadzoru kakovosti, nečistočah ter dokazi o molekularni strukturi.
Information on the manufacturing process shall include a description of the active substance manufacturing process that represents the applicant’s commitment for the manufacture of the active substance.
Informacije o postopku izdelave vključujejo opis postopka izdelave zdravilne učinkovine, ki je zaveza predlagatelja za izdelavo zdravilne učinkovine.
All materials needed in order to manufacture the active substance(s) shall be listed, identifying where each material is used in the process.
Navede se seznam vseh snovi, potrebnih za izdelavo zdravilnih učinkovin, ter opredeli, na kateri stopnji postopka se posamezne snovi uporabljajo.
Information on the quality and control of those materials shall be provided.
Predložijo se informacije o kakovosti in kontroli teh snovi.
Information demonstrating that materials meet standards which are appropriate for their intended use shall be provided.
Navedejo se informacije, ki dokazujejo, da snovi izpolnjujejo standarde, ustrezne za predvideno uporabo.
Information on quality control shall contain tests (including acceptance criteria) carried out at every critical step, information on the quality and control of intermediates and process validation and/or evaluation studies as appropriate.
Informacije o nadzoru kakovosti vključujejo preskuse (vključno s preskusi sprejemljivosti), izvedene pri vsaki pomembni stopnji, informacije o kakovosti in kontroli vmesnih stopenj ter študije postopka potrditve in/ali ocenjevanja, kakor je primerno.
It shall also contain validation data for the analytical methods applied to the active substance, where appropriate.
Vključujejo tudi podatke o potrditvi analitskih metod, ki se uporabljajo za zdravilno učinkovino, kakor je primerno.
Information on impurities shall indicate predictable impurities together with the levels and nature of observed impurities.
V informacijah o nečistočah se navedejo predvidene nečistoče ter ravni in narava ugotovljenih nečistoč.
It shall also contain information on the safety of these impurities where relevant.
Kadar je primerno, se navedejo tudi informacije o varnosti teh nečistoč.
For biotechnological veterinary medicinal products, evidence of molecular structure shall include the schematic amino acid sequence and relative molecular mass.
Za biotehnološka zdravila za uporabo v veterinarski medicini se pri podatkih o molekularni strukturi navedejo shematična zaporedja aminokislin in relativna molekulska masa.
The general and specific monographs of the European Pharmacopoeia shall be applicable to all active substances appearing in it.
Splošne in specifične monografije Evropske farmakopeje se uporabljajo za vse zdravilne učinkovine, ki so v njej objavljene.
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).
Za sestavine, ki izpolnjujejo zahteve Evropske farmakopeje ali farmakopeje ene od držav članic, se šteje, da v zadostni meri izpolnjujejo pogoje iz člena 12(3)(i).
In this case the description of the analytical methods and procedures shall be replaced in each relevant section by an appropriate reference to the pharmacopoeia in question.
V tem primeru se lahko opis analitskih metod in postopkov nadomesti s podrobnim sklicem na zadevno farmakopejo v vsakem ustreznem oddelku.
In cases where a specification contained in a monograph of the European Pharmacopoeia or in the national pharmacopoeia of a Member State is insufficient to ensure the quality of the substance, the competent authorities may request more appropriate specifications from the applicant, including limits for specific impurities with validated test procedures.
Kadar je specifikacija iz monografije Evropske farmakopeje ali nacionalne farmakopeje države članice nezadostna za zagotovitev kakovosti snovi, lahko pristojni organi od predlagatelja zahtevajo ustreznejše specifikacije, vključno z omejitvami specifičnih nečistoč, določenimi s potrjenimi postopki preskušanja.
The competent authorities shall inform the authorities responsible for the pharmacopoeia in question.
Pristojni organi obvestijo organe, pristojne za zadevno farmakopejo.
The marketing authorisation holder shall provide the authorities of that pharmacopoeia with the details of the alleged insufficiency and the additional specifications applied.
Imetnik dovoljenja za promet z zdravilom organom zadevne farmakopeje predloži podatke o domnevnih pomanjkljivostih ter o dodatnih uporabljenih specifikacijah.
In the absence of a European Pharmacopoeia monograph for an active substance, and where the active substance is described in the pharmacopoeia of a Member State, that monograph may be applied.
Kadar je zdravilna učinkovina opisana v farmakopeji države članice, ne pa v monografiji Evropske farmakopeje, se uporablja farmakopeja države članice.
In cases where an active substance is described neither in the European Pharmacopoeia nor in the pharmacopoeia of a Member State, compliance with the monograph of a third country pharmacopoeia may be accepted if its suitability is demonstrated; in such cases, the applicant shall submit a copy of the monograph accompanied by a translation where appropriate.
Kadar zdravilna učinkovina ni opisana niti v Evropski farmakopeji niti v farmakopeji države članice, se lahko sprejme skladnost z monografijo farmakopeje tretje države, če se dokaže njena ustreznost; v teh primerih predlagatelj predloži kopijo monografije, ter po potrebi njen prevod.
Data to demonstrate the ability of the monograph to adequately control the quality of the active substance shall be presented.
Predložijo se podatki, ki dokazujejo, da je monografija ustrezna za kontrolo zdravilne učinkovine.
Constituents which are not given in any pharmacopoeia shall be described in the form of a monograph under the following headings:
Sestavine, ki niso navedene v farmakopeji, se opišejo v obliki monografije po naslednjih poglavjih:
the name of the constituent, meeting the requirements of Section A point 2, shall be supplemented by any trade or scientific synonyms;
ime sestavine, ki izpolnjuje zahteve iz točke 2 oddelka A, se lahko nadomesti z blagovnimi ali znanstvenimi sopomenkami;
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.
opredelitev snovi, opisane v podobni obliki, kot jo uporablja Evropska farmakopeja, spremljajo vse potrebne obrazložitve, še posebno glede molekulske strukture.
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;
Kadar se snovi lahko opišejo le s postopkom izdelave, je opis dovolj podroben, da se lahko opredelijo konstantna sestava in konstantni učinki snovi;
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;
metode identifikacije se lahko opišejo v obliki celotnih tehnik, ki se uporabljajo za izdelavo snovi, ter v obliki preskusov, ki jih je treba izvajati rutinsko;
purity tests shall be described in relation to each individual predictable impurity, 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;
preskusi čistosti se opišejo za vsako posamezno predvideno nečistočo, zlasti tiste, ki imajo lahko škodljiv učinek, in po potrebi tiste, ki bi v kombinaciji snovi, na katere se vloga nanaša, lahko imele neželen učinek na stabilnost zdravila ali popačile analitske rezultate;
tests and limits to control parameters relevant to the finished product, such as particle size and sterility shall be described and methods shall be validated where relevant;
preskusi in omejitve kontrolnih parametrov, pomembnih za končno zdravilo, kot sta velikost delca in sterilnost, se opišejo in po potrebi se potrdijo metode;
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.
pri kompleksnih snoveh rastlinskega ali živalskega izvora je treba razlikovati med primeri, kjer je zaradi farmakoloških učinkov 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.
Those data shall demonstrate that the proposed set of test procedures is sufficient to control the quality of the active substance from the defined source.
Navedeni podatki dokažejo, da so predlagani postopki preskušanja zadostni za nadzor kakovosti zdravilne učinkovine iz opredeljenega vira.
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 bioavailability of the veterinary medicinal product depends on them:
Kot del splošnega opisa zdravilnih učinkovin, če je od njih odvisna biološka uporabnost zdravila za uporabo v veterinarski medicini, se predložijo naslednji podatki o zdravilnih učinkovinah, ne glede na to, ali so opisane v farmakopejah ali ne:
crystalline form and solubility coefficients,
kristalinična oblika in koeficient raztapljanja,
particle size, where appropriate after pulverisation,
velikost delcev, kadar je po upraševanju to potrebno,
state of hydration,
stopnja vsebnosti vlage,
oil/water coefficient of partition,
porazdelitveni koeficient olje/voda,
pK/pH values.
vrednosti pK/pH.
The first three indents are not applicable to substances used solely in solution.
Prve tri alinee se ne uporabljajo pri snoveh, ki se uporabljajo samo v raztopinah.
The general and specific monographs of the European Pharmacopoeia shall be applicable to all substances appearing in it.
Splošne in specifične monografije Evropske farmakopeje se uporabljajo za vse snovi, ki so v njej objavljene.
Excipients shall comply with the requirements of the appropriate European Pharmacopoeia monograph.
Pomožne snovi izpolnjujejo zahteve ustrezne monografije Evropske farmakopeje.
Where such a monograph does not exist reference may be made to the pharmacopoeia of a Member State.
Kadar takšna monografija ne obstaja, se lahko uporabi sklic na farmakopejo države članice.
In the absence of such a monograph reference may be made to the pharmacopoeia of a third country.
Kadar takšen sklic na monografijo ne obstaja, se lahko uporabi sklic na farmakopejo tretje države.
In this case the suitability of this monograph shall be demonstrated.
V tem primeru se dokaže ustreznost te monografije.
Where appropriate, additional tests to control parameters such as particle size, sterility, residual solvents shall supplement the requirements of the monograph.
Po potrebi zahteve monografije dopolnjujejo dodatni preskusi za kontrolo parametrov, kot so velikost delcev, sterilnost in topnost ostankov.
In the absence of a pharmacopoeial monograph a specification shall be proposed and justified.
Kadar ne obstaja monografija farmakopeje, se predlaga in utemelji specifikacija.
The requirements for specifications as set out in section 1.1.2 (a to e) for the active substance shall be followed.
Za zdravilno učinkovino se upoštevajo zahteve za specifikacije iz oddelka 1.1.2 (a do e).
The proposed methods and their supporting validation data shall be presented.
Predložijo se predlagane metode in podatki, ki podpirajo njihove potrditve.
Colouring matters for inclusion in veterinary medicinal products shall satisfy the requirements of Directive 78/25/EEC, except for certain veterinary medicinal products for topical use, such as insecticidal collars and ear tags, where the use of other colouring matters is justified.
Barvila, za katera se predlaga vključitev med zdravila za uporabo v veterinarski medicini, izpolnjujejo zahteve iz Direktive Sveta 78/25/EGS, razen nekatera zdravila za uporabo v veterinarski medicini za lokalno uporabo, kot so insekticidni ovratniki in ušesne znamke, pri katerih je upravičena uporaba drugih barvil.
Colouring matters shall meet the purity criteria as laid down in Commission Directive 95/45/EC [11].For novel excipients, that is to say excipient(s) used for the first time in a veterinary medicinal product or by a new route of administration, details of manufacture, characterisation, and controls, with cross references to supporting safety data, both clinical and non-clinical, shall be provided.
Barvila izpolnjujejo merila čistosti iz Direktive Komisije 95/45/ES [11].Za nove pomožne snovi, tj. pomožne snovi, ki se v zdravilu za uporabo v veterinarski medicini uporabljajo prvič ali je način dajanja nov, se predložijo podatki o postopku izdelave, opis lastnosti in kontrol ter sklicevanja na spremljajoče podatke o klinični in neklinični varnosti.