natgillin/translations-raw huggingface dataset:
The name and address of the applicant shall be given, together with the name and address of the manufacturer and the sites involved in the different stages of manufacture and control (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.
Predloži se ime in naslov predlagatelja, ime in naslov izdelovalca in obratov, vključenih v različne stopnje izdelave in kontrole (vključno z izdelovalcem končnega zdravila in izdelovalci zdravilnih učinkovin), in kadar je ustrezno, ime in naslov uvoznika.
Annexed to the administrative information shall be copies of a document showing that the manufacturer is authorised to produce immunological veterinary medicinal products, as defined in Article 44.
K upravnim informacijam se priložijo kopije dokumentov, ki dokazujejo, da ima izdelovalec dovoljenje za izdelavo imunoloških zdravil za uporabo v veterinarski medicini, kakor to določa člen 44.
Moreover, the list of organisms handled at the production site shall be given.
Poleg tega se predloži seznam organizmov, ki so bili uporabljeni v obratu izdelave.
The applicant shall submit a list of countries in which authorisation has been granted, and a list of countries in which an application has been submitted or refused.
Predlagatelj predloži seznam držav, ki so mu izdale dovoljenje, in seznam držav, v katerih je bila vloga vložena ali zavrnjena.
The applicant shall propose a summary of the product characteristics, in accordance with Article 14.
Predlagatelj predlaga povzetek glavnih značilnosti zdravila v skladu s členom 14.
Each detailed and critical summary referred to in the second subparagraph of Article 12(3) shall be prepared in the light of the state of scientific knowledge at the time of submission of the application.
Vsak podroben in kritičen povzetek, kakor je opredeljen v drugem pododstavku člena 12(3), se pripravi ob upoštevanju znanstvenih spoznanj ob predložitvi vloge.
It shall contain an evaluation of the various tests and trials, which constitute the marketing authorisation dossier and shall address all points relevant to the assessment of the quality, safety and efficacy of the immunological veterinary medicinal product.
Povzetek vsebuje oceno raznih preskusov in preskušanj iz vloge za pridobitev dovoljenja za promet z zdravilom ter obravnava vse točke v zvezi z oceno kakovosti, varnosti in učinkovitosti imunološkega zdravila za uporabo v veterinarski medicini.
It shall give the detailed results of the tests and trials submitted and precise bibliographic references.
V njem se navedejo podrobni rezultati predloženih preskusov in preskušanj ter natančna bibliografska sklicevanja.
All important data shall be summarised in an appendix to the detailed and critical summaries, whenever possible in tabular or graphic form.
Vsi pomembni podatki se povzamejo v dodatku k podrobnim in kritičnim povzetkom, če je to le mogoče v obliki tabel ali grafov.
The detailed and critical summaries shall contain precise cross references to the information contained in the main documentation.
Podrobni in kritični povzetki vsebujejo natančna sklicevanja na informacije, ki jih vsebuje glavna dokumentacija.
All test procedures shall fulfil the necessary criteria for analysis and control of the quality of the starting materials and the finished product and shall be validated procedures.
Vsi postopki preskušanja izpolnjujejo potrebna merila za analizo in nadzor kakovosti vhodnih snovi in končnih zdravil ter so potrjeni.
Any special apparatus and equipment which may be used shall be described in adequate detail, possibly accompanied by a diagram.
Ustrezno podrobno se opišejo kakršne koli posebne naprave in oprema, po možnosti s shemo.
The formulae of the laboratory reagents shall be supplemented, if necessary, by the manufacturing method.
Dodajo se formule laboratorijskih reagentov in, kadar je ustrezno, postopek izdelave.
Where available, chemical and biological reference material of the European Pharmacopoeia shall be used.
Kadar je na voljo, se uporablja kemijska in biološka referenčna snov iz Evropske farmakopeje.
“Qualitative particulars” of all the constituents of the immunological veterinary medicinal product shall mean the designation or description of:
‚Podrobni podatki o kakovostni sestavi‘ vseh sestavin imunološkega zdravila za uporabo v veterinarski medicini pomenijo navedbo ali opis:
the constituents of the adjuvants,
sestavin dodatkov,
the constituent(s) of the excipients, whatever their nature or the quantity used, including preservatives, stabilisers, emulsifiers, colouring matter, flavouring, aromatic substances, markers, etc.,
sestavin pomožnih snovi ne glede na njihovo vrsto ali uporabljeno količino, vključno s konzervansi, stabilizatorji, emulgatorji, barvili, snovmi za izboljšanje okusa, aromami, označevalci itd.,
the constituents of the pharmaceutical form administered to animals.
sestavin farmacevtske oblike, ki se daje živalim.
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 immunological veterinary medicinal product will be used or administered and which will be delivered with the medicinal product.
Ti podrobni podatki se dopolnijo s kakršnimi koli ustreznimi podatki o vsebniku, in kadar je ustrezno, načinu zapiranja vsebnika, s podatki o pripomočkih, s katerimi se bo zdravilo za uporabo v veterinarski medicini uporabljalo ali dajalo in ki se bodo dostavili skupaj z zdravilom.
If the device is not delivered together with the immunological veterinary medicinal product, relevant information about the device shall be provided, where necessary for the assessment of the product.
Če pripomoček ni priložen imunološkemu zdravilu za uporabo v veterinarski medicini, se priložijo ustrezne informacije o pripomočku, kadar je to primerno za oceno zdravila.
The “usual terminology”, to be used in describing the constituents of immunological veterinary medicinal products, shall mean, notwithstanding the application of the other provisions of Article 12(3)(c):
‚Običajna terminologija‘, ki se uporablja pri opisovanju sestavin imunoloških zdravil za uporabo v veterinarski medicini, pomeni ne glede na uporabo drugih določb člena 12(3)(c):
in respect of substances which appear in the European Pharmacopoeia or, failing this, in the pharmacopoeia of one of the Member States, the main title of the monograph in question, which will be obligatory for all such substances, with reference to the pharmacopoeia concerned,
pri snoveh, ki so navedene v Evropski farmakopeji ali, kadar ta ne obstaja, farmakopeji ene od držav članic, glavni naslov v zadevni monografiji, ki bo obvezen za vse takšne snovi, s sklicem na zadevno farmakopejo,
in respect of other substances, the international non-proprietary name recommended by the World Health Organisation, which may be accompanied by another non-proprietary name or, failing these, the exact scientific designation; 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,
pri drugih snoveh mednarodno nelastniško ime, ki ga priporoča Svetovna zdravstvena organizacija, ki ga lahko spremlja neko drugo nelastniško ime, ali, kadar ti imeni ne obstajata, natančna znanstvena oznaka; pri snoveh, ki nimajo mednarodnega nelastniškega imena ali natančne znanstvene oznake, se opiše, kako in iz česa so pripravljene, in kadar je ustrezno, se dodajo še drugi ustrezni podatki,
in respect of colouring matter, designation by the “E” code assigned to them in Directive 78/25/EEC.
barvila s kodami iz Direktive 78/25/EGS se označijo s kodo ‚E‘.
In order to give the “quantitative particulars” of the active substances of an immunological veterinary medicinal product, it is necessary to specify whenever possible the number of organisms, the specific protein content, the mass, the number of International Units (IU) or units of biological activity, either per dosage-unit or volume, and with regard to the adjuvant and to the constituents of the excipients, the mass or the volume of each of them, with due allowance for the details provided in Section B.
Za ‚podrobne podatke o količinski sestavi‘ zdravilnih učinkovin imunoloških zdravilih za uporabo v veterinarski medicini je treba, če je to le mogoče, opredeliti število organizmov, vsebnost specifičnih beljakovin, maso, število mednarodnih enot (IE) ali enot biološke aktivnosti na enoto odmerka ali volumna, pri dodatkih in pomožnih snoveh pa maso ali volumen, ob upoštevanju podatkov iz oddelka B.
Where an international unit of biological activity has been defined, this shall be used.
Kadar je določena mednarodna enota biološke aktivnosti, se uporabi.
The units of biological activity for which no published data exist shall be expressed in such a way as to provide unambiguous information on the activity of the ingredients, e.g. by stating the immunological effect on which the method of determining the dose is based.
Enote biološke aktivnosti, za katere ne obstajajo objavljeni podatki, se izrazijo na način, da zagotavljajo nedvoumno informacijo o aktivnosti sestavin, npr. z navedbo imunološkega učinka, na podlagi katerega se določa odmerek.
An explanation shall be provided with regard to the composition, components and containers, supported by scientific data on product development.
Predloži se obrazložitev glede sestave, sestavin in vsebnika, ki jo podpirajo znanstveni podatki o razvoju zdravila.
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 description of the nature of the operations employed.
Opis postopka izdelave, ki je priložen vlogi za pridobitev dovoljenja za promet z zdravilom v skladu s členom 12(3)(d), se pripravi tako, da ustrezno opisuje naravo uporabljenih postopkov.
For this purpose the description shall include at least:
V ta namen opis vsebuje najmanj:
the various stages of manufacture (including production of the antigen and purification procedures) so that an assessment can be made of the reproducibility of the manufacturing procedure and of the risks of adverse effects on the finished products, such as microbiological contamination; the validation of key stages in the production process shall be demonstrated and the validation of the production process as a whole shall be demonstrated with provision of results of three consecutive batches produced using the method described,
različne stopnje izdelave (vključno s postopki izdelave antigena in postopki čiščenja), tako da je mogoče oceniti ponovljivost postopka izdelave in tveganje neželenih učinkov na končna zdravila, kot je na primer mikrobiološka onesnaženost; prikaže se postopek potrditve ključnih stopenj postopka izdelave in postopek potrditve celotnega postopka izdelave ob upoštevanju rezultatov 3 zaporednih serij, dobljenih pri opisani metodi,
in the case of continuous manufacture, full details concerning precautions taken to ensure the homogeneity and consistency of each batch of the finished product,
v primeru neprekinjene izdelave vse podrobne podatke o sprejetih previdnostnih ukrepih za zagotavljanje homogenosti in konsistentnosti med serijami končnega zdravila,
listing of all the substances at the appropriate steps where they are used, including those which cannot be recovered in the course of manufacturing,
seznam vseh snovi, uporabljenih v ustreznih stopnjah, vključno s tistimi, ki jih med izdelavo ni mogoče reciklirati,
the details of the blending, with the quantitative particulars of all the substances used,
podatke o mešanju in podrobne podatke o količini vseh uporabljenih snovi,
a statement of the stages of manufacture at which sampling is carried out for control tests during production.
navedbo stopenj izdelave, v katerih se opravi vzorčenje za kontrolne preskuse med izdelavo.
For the purposes of this paragraph “starting materials” means all components used in the production of the immunological veterinary medicinal product.
V tem odstavku so ‚vhodne snovi‘ vse sestavine, uporabljene pri izdelavi imunološkega zdravila za uporabo v veterinarski medicini.
Culture media consisting of several components used for production of the active substance shall be regarded as one starting material.
Gojišče za celične kulture, ki je sestavljeno iz številnih sestavin in se uporablja pri izdelavi zdravilne učinkovine, se šteje kot ena vhodna snov.
Nevertheless, the qualitative and quantitative composition of the any culture media shall be presented in so far as the authorities consider that this information is relevant to the quality of the finished product and any risks that might be posed.
Kakovostna in količinska sestava katerega koli gojišča za celične kulture se predloži, kadar organi menijo, da je ta informacija pomembna za kakovost končnega zdravila in za tveganja, ki jih lahko predstavlja.
If materials of animal origin are used for preparation of these culture media, the animal species and the tissue used have to be included.
Če se pri pripravi gojišča za celične kulture uporabijo snovi živalskega izvora, se navedejo uporabljene živalske vrste in tkiva.
The dossier shall include the specifications, information on the tests to be conducted for the quality control of all batches of starting materials and results for a batch for all components used and shall be submitted in accordance with the following provisions.
Vloga vključuje specifikacije, informacije o preskusih, ki se izvajajo za nadzor kakovosti vseh serij vhodnih snovi, in rezultate serije za vse sestavine ter se predloži v skladu z naslednjimi določbami.
Starting materials listed in pharmacopoeias
Vhodne snovi, navedene v farmakopejah
The monographs of the European Pharmacopoeia shall be applicable to all starting materials appearing in it.
Monografije Evropske farmakopeje se uporabljajo za vse vhodni snovi, ki so v njej navedene.
In respect of other substances, each Member State may require observance of its own national pharmacopoeia with regard to products manufactured in its territory.
Za druge snovi lahko vsaka država članica zahteva, da se upošteva njena nacionalna farmakopeja, kadar gre za zdravila, ki se izdelujejo na njenem ozemlju.
In this case the description of the analytical methods may be replaced by a detailed reference to the pharmacopoeia in question.
V tem primeru se lahko opis analitskih metod nadomesti s podrobnim sklicem na zadevno farmakopejo.
Colouring matter shall, in all cases, satisfy the requirements of Directive 78/25/EEC.
Barvilo v vseh primerih izpolnjuje zahteve iz Direktive 78/25/EGS.
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.
Če se uporabljajo še drugi preskusi, ki niso navedeni v farmakopeji, se morajo predložiti dokazi, da vhodne snovi izpolnjujejo zahteve glede kakovosti iz navedene farmakopeje.
In cases where a specification or other provisions contained in a monograph of the European Pharmacopoeia or in the 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 applicant for marketing authorisation.
Kadar so specifikacija ali druge določbe iz monografije Evropske farmakopeje ali farmakopeje države članice nezadostne za zagotovitev kakovosti snovi, lahko pristojni organi od predlagatelja vloge za pridobitev dovoljenja za promet z zdravilom zahtevajo ustreznejše specifikacije.
The alleged insufficiency shall be reported to the authorities responsible for the pharmacopoeia in question.
Domnevna nezadostnost se sporoči organom, pristojnim za zadevno farmakopejo.
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; 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.
Kadar vhodna snov ni opisana niti v Evropski farmakopeji niti v farmakopeji države članice, se lahko sprejme skladnost z monografijo farmakopeje tretje države; v takih primerih predlagatelj predloži kopijo monografije, po potrebi potrditev postopkov preskušanj, ki jih monografija navaja, ter, kadar je to potrebno, prevod.
When starting materials of animal origin are used, they shall comply with the relevant monographs including general monographs and general chapters of the European Pharmacopoeia.
Kadar se uporabljajo vhodne snovi živalske izvora, so v skladu z ustreznimi monografijami, vključno s splošnimi monografijami in splošnimi poglavji Evropske farmakopeje.
The tests and controls conducted shall be appropriate to the starting material.
Preskusi in kontrole, ki se izvajajo, morajo biti primerni za vhodno snov.
The applicant shall supply documentation to demonstrate that the starting materials and the manufacturing of the veterinary medical product is in comply with the requirements of the Note for Guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products, as well as with the requirements of the corresponding monograph of the European Pharmacopoeia.
Predlagatelj predloži dokumentacijo, ki dokazuje, da vhodne snovi in izdelava zdravila za uporabo v veterinarski medicini izpolnjuje zahteve iz Navodil o zmanjšanju tveganja prenosa povzročiteljev živalske spongiformne encefalopatije z zdravili za uporabo v humani in veterinarski medicini ter zahteve iz ustreznih monografij Evropske farmakopeje.
The description shall be given in the form of a monograph.
Opišejo se v obliki monografije.
Whenever possible, vaccine production shall be based on a seed lot system and on established cell seeds.
Kadar koli je mogoče, temelji izdelava cepiva na sistemu matične serije ter na vzpostavljenih celičnih serijah.
For the production of immunological veterinary medicinal products consisting of serums, the origin, general health and immunological status of the producing animals shall be indicated and defined pools of source materials shall be used.
Pri izdelavi imunoloških zdravil za uporabo v veterinarski medicini, sestavljenih iz serumov, se navedejo izvor ter splošno zdravstveno in imunološko stanje proizvodne živali, uporabljajo pa se opredeljeni zbiri izvornih snovi.
The origin, including geographical region, and history of starting materials shall be described and documented.
Opiše in dokumentira se izvor vhodnih snovi, vključno z zemljepisno regijo, in njihova zgodovina.
For genetically engineered starting materials this information shall include details such as the description of the starting cells or strains, the construction of the expression vector (name, origin, function of the replicon, promoter enhancer and other regulator elements), control of the sequence of DNA or RNA effectively inserted, oligonucleotidic sequences of plasmid vector in cells, plasmid used for cotransfection, added or deleted genes, biological properties of the final construct and the genes expressed, copy number and genetic stability.
Pri gensko pridobljenih vhodnih snoveh ta informacija vsebuje podrobne podatke, kot so opis začetnih celic ali sevov, priprava ekspresijskega vektorja (ime, izvor, funkcija replikona, ojačevalec promotorja ter drugi regulacijski elementi), kontrola zaporedja učinkovito vrinjene DNK ali RNK, oligonukleotidno zaporedje plazmidnega vektorja v celicah, uporabljeni plazmid za kotransfekcijo, dodani ali izbrisani geni, biološke lastnosti končno spremenjenih celic ter izraženi geni, število kopij in genska stabilnost.
Seed materials, including cell seeds and raw serum for anti-serum production shall be tested for identity and extraneous agents.
Pri matičnem materialu, vključno s celičnimi linijami ter surovim serumom za proizvodnjo anti-seruma, se preskusi istovetnost in prisotnost naključnih snovi.
Information shall be provided on all substances of biological origin used at any stage in the manufacturing procedure.
Predložijo se informacije o vseh snoveh biološkega izvora, uporabljenih pri kateri koli stopnji postopka izdelave.
The information shall include:
Te informacije vključujejo:
details of the source of the materials,
podatke o izvoru snovi,
details of any processing, purification and inactivation applied, with data on the validation of these process and controls during production,
podatke o predelavi, čiščenju, inaktivaciji, potrditvi teh postopkov ter kontrol med izdelavo,
details of any tests for contamination carried out on each batch of the substance.
podatke o kakršnih koli preskusih onesnaženosti, opravljenih na vsaki seriji snovi.
If the presence of extraneous agents is detected or suspected, the corresponding material shall be discarded or used in very exceptional circumstances only when further processing of the product ensures their elimination and/or inactivation; elimination and/or inactivation of such extraneous agents shall be demonstrated.
Če se ugotovi ali sumi na prisotnost naključnih snovi, se ustrezni material zavrže ali uporabi v izjemnih okoliščinah le, kadar nadaljnja predelava zdravila zagotavlja, da se te snovi lahko odstranijo in/ali inaktivirajo; odstranitev in/ali inaktivacija takšnih naključnih snovi se dokaže.
When cell seeds are used, the cell characteristics shall be shown to have remained unchanged up to the highest passage level used for the production.
Pri uporabi celičnih linij se dokaže, da se lastnosti celic niso spremenile vse do najvišje ravni prenosa med postopkom izdelave.
For live attenuated vaccines, proof of the stability of the attenuation characteristics of the seed has to be given.
Pri živih oslabljenih cepivih je treba podati dokaz o stabilnih lastnosti oslabljenega matičnega materiala.
Documentation shall be supplied to demonstrate that the seed materials, cell seeds, batches of serum and other material originating from animal species relevant for the transmission of TSE comply with the Note for Guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products, as well as with the corresponding monograph of the European Pharmacopoeia.
Priloži se dokumentacija, ki dokazuje, da matični materiali, celične linije, serije serumov in drugi materiali, ki izvirajo iz živalskih vrst, pri katerih lahko pride do prenosa transmisivne spongiformne encefalopatije, izpolnjujejo Navodila o zmanjšanju tveganja prenosa povzročiteljev živalske spongiformne encefalopatije z zdravili za uporabo v humani in veterinarski medicini in ustrezne monografije Evropske farmakopeje.
Certificates of Suitability issued by the European Directorate for the Quality of Medicines and HealthCare, with reference to the relevant monograph of the European Pharmacopoeia, can be used to demonstrate compliance.
Kot dokaz izpolnjevanja zahtev se lahko uporabi certifikat o ustreznosti, ki ga je izdala Evropska direkcija za kakovost zdravil in zdravstva, s sklicem na ustrezno monografijo Evropske farmakopeje.
When required, samples of the biological starting material or reagents used in the testing procedures shall be provided to enable the competent authority to arrange for check tests to be carried out.
Na zahtevo se zagotovijo vzorci biološke vhodne snovi ali reagentov, uporabljenih v postopkih preskušanja, da se pristojnemu organu omogoči preverjanje preskusov.
The description shall be given in the form of a monograph under the following headings:
Opis v obliki monografije vključuje:
the name of the starting material meeting the requirements of point 2 of Section A shall be supplemented by any trade or scientific synonyms,
ime vhodne snovi, ki izpolnjuje zahteve iz točke 2 dela A, se dopolni s kakršno koli blagovno ali znanstveno sopomenko,