natgillin/translations-raw huggingface dataset:
all details concerning other veterinary medicinal products which have been administered during the period of examination, either prior to or concurrently with the test product and, in the latter case, details of any interactions observed;
so prejele drugo zdravilo za uporabo v veterinarski medicini, odobreno v Skupnosti za uporabo za isto indikacijo pri isti ciljni živalski vrsti, ali
all results of the clinical trials, fully describing the results based on the efficacy criteria and end points specified in the clinical trial protocol and including the results of the statistical analyses, if appropriate;
so prejele isto učinkovino, ki se preskuša, v drugačni formulaciji ali na drugačen način;
all particulars of any unintended event, whether harmful or not, and of any measures taken in consequence; the cause-and-effect relationship shall be investigated if possible;
pogostost ugotovljenih neželenih učinkov;
effect on animals’ performance if appropriate;
ugotovitve o vplivu na proizvodnost živali, kadar je ustrezno;
effects on the quality of foodstuffs obtained from treated animals, particularly in the case of veterinary medicinal products intended for use as performance enhancers;
podatki o poskusnih živalih, pri katerih je tveganje povečano zaradi njihove starosti, načina gojenja ali hranjenja ali namena njihove uporabe, ali živalih, pri katerih fiziološko ali patološko stanje zahteva posebno obravnavo;
a conclusion on the safety and efficacy in each individual case or, summarised in terms of frequencies or other appropriate variables where specific mass treatment is concerned.
statistična analiza rezultatov.
Omission of one or more items (a) to (p) shall be justified.
Na koncu preiskovalec pripravi splošne sklepne ugotovitve o učinkovitosti in varnosti zdravila za uporabo v veterinarski medicini pod predlaganimi pogoji uporabe in predloži vse informacije o indikacijah in kontraindikacijah, odmerkih, povprečnem trajanju zdravljenja, kadar je ustrezno, vseh ugotovljenih medsebojnih vplivih z drugimi zdravili za uporabo v veterinarski medicini ali krmnimi dodatki, ter o posebnih previdnostnih ukrepih, ki jih je treba upoštevati med zdravljenjem, ter kliničnih simptomih prevelikega odmerjanja, kadar so ugotovljeni.
The marketing authorisation holder shall make all necessary arrangements to ensure that the original documents, which formed the basis of the data supplied, are kept for at least five years after the veterinary medicinal product is no longer authorised.
Pri zdravilih s fiksno kombinacijo preiskovalec pripravi tudi sklepne ugotovitve o varnosti in učinkovitosti zdravila v primerjavi z ločenim dajanjem zadevnih učinkovin.
In respect of each clinical trial, the clinical observations shall be summarised in a synopsis of the trials and the results thereof, indicating in particular:
NASLOV II
the number of control and test animals treated either individually or collectively, with a breakdown according to species, breed or strain, age and sex;
Zahteve za imunološka zdravila za uporabo v veterinarski medicini
the number of animals withdrawn prematurely from the trials and the reasons for such withdrawal;
Brez poseganja v posebne zahteve iz zakonodaje Skupnosti za nadzor in izkoreninjenje posebnih nalezljivih živalskih bolezni se za imunološka zdravila za uporabo v veterinarski medicini naslednje zahteve, razen ko so zdravila namenjena uporabi pri nekaterih vrstah ali za posebne indikacije, opredeljene v naslovu III in ustreznih smernicah.
in the case of control animals, whether they have:
Povzetek vloge
received no treatment,
Imunološko zdravilo za uporabo v veterinarski medicini, ki je predmet vloge, se opredeli z lastnim imenom in imeni učinkovin, biološko aktivnostjo, potenco ali titrom, farmacevtsko obliko, načinom uporabe zdravila, kadar je ustrezno, ter opisom končnega pakiranja zdravila, ki vključuje ovojnino, oznake in navodila za uporabo.
received a placebo, or
Razredčila se lahko pakirajo skupaj s stekleničko cepiva ali ločeno.
received another veterinary medicinal product authorised in the Community for the same indication for use in the same target animal species, or
Informacije o topilih, potrebne za pripravo končnega pripravka cepiva, se vključijo v vlogo.
received the same active substance under investigation in a different formulation or by a different route;
Imunološko zdravilo za uporabo v veterinarski medicini se šteje kot eno zdravilo, tudi če je potrebnih več razredčil za pripravo različnih pripravkov končnega proizvoda, ki so lahko primerni za uporabo po različnih poteh ali na različne načine.
the frequency of observed adverse reactions;
Predloži se ime in naslov predlagatelja, ime in naslov proizvajalca in obratov, vključenih v različne stopnje proizvodnje in kontrole (vključno s proizvajalcem končnega zdravila in proizvajalci učinkovin), in kadar je ustrezno, ime in naslov uvoznika.
observations as to the effect on animal performance, if appropriate;
K upravnim informacijam se priložijo kopije dokumentov, ki dokazujejo, da ima proizvajalec dovoljenje za izdelavo imunoloških zdravil za uporabo v veterinarski medicini, kakor to določa člen 44.
details concerning test animals which may be at increased risk owing to their age, their mode of rearing or feeding, or the purpose for which they are intended, or animals the physiological or pathological condition of which requires special consideration;
Poleg tega se predloži seznam organizmov, ki so bili uporabljeni v obratu izdelave.
a statistical evaluation of the results.
Predlagatelj predloži seznam držav, ki so mu izdale dovoljenje, in seznam držav, v katerih je bila vloga vložena ali zavrnjena.
Finally, the investigator shall draw general conclusions on the efficacy and safety of the veterinary medicinal product under the proposed conditions of use, and in particular any information relating to indications and contraindications, dosage and average duration of treatment and where, appropriate, any interactions observed with other veterinary medicinal products or feed additives as well as any special precautions to be taken during treatment and the clinical symptoms of overdosage, when observed.
Predlagatelj predlaga povzetek glavnih značilnosti zdravila v skladu s členom 14.
In the case of fixed combination products, the investigator shall also draw conclusions concerning the safety and the efficacy of the product when compared with the separate administration of the active substances involved.
Vsak podroben in kritičen povzetek, kakor je opredeljen v drugem pododstavku člena 12(3), se pripravi ob upoštevanju znanstvenih spoznanj ob predložitvi vloge.
TITLE II
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.
Requirements for immunological veterinary medicinal products
V njem se navedejo podrobni rezultati predloženih preskusov in preskušanj ter natančna bibliografska sklicevanja.
Without prejudice to specific requirements laid down by Community legislation for the control and eradication of specific infectious animal diseases, the following requirements shall apply to immunological veterinary medicinal products, except when the products are intended for use in some species or with specific indications as defined in Title III and in relevant guidelines.
Vsi pomembni podatki se povzamejo v dodatku k podrobnim in kritičnim povzetkom, če je to le mogoče v obliki tabel ali grafov.
Summary of the dossier
Podrobni in kritični povzetki vsebujejo natančna sklicevanja na informacije, ki jih vsebuje glavna dokumentacija.
The immunological veterinary medicinal product, which is the subject of the application, shall be identified by name and by name of the active substance(s), together with the biological activity, potency or titre, the pharmaceutical form, the route and method if appropriate of administration and a description of the final presentation of the product, including packaging, labelling and leaflet.
Kemijske, farmacevtske in biološke/mikrobiološke informacije (kakovost)
Diluents may be packed together with the vaccine vials or separately.
Vsi postopki preskušanja izpolnjujejo potrebna merila za analizo in nadzor kakovosti vhodnih snovi in končnih zdravil ter so potrjeni.
Information on diluents needed for making the final vaccine preparation shall be included in the dossier.
Ustrezno podrobno se opišejo kakršne koli posebne naprave in oprema, po možnosti s shemo.
An immunological veterinary medicinal product is regarded as one product even when more than one diluent is required so that different preparations of the final product can be prepared, which may be for administration by different routes or methods of administration.
Dodajo se formule laboratorijskih reagentov in, kadar je ustrezno, način proizvodnje.
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.
Kadar je na voljo, se uporablja kemijska in biološka referenčna snov iz Evropske farmakopeje.
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.
„Podrobni podatki o kakovostni sestavi“ vseh sestavin imunološkega zdravila za uporabo v veterinarski medicini pomenijo navedbo ali opis:
Moreover, the list of organisms handled at the production site shall be given.
učinkovin,
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.
sestavin dodatkov,
The applicant shall propose a summary of the product characteristics, in accordance with Article 14.
sestavin pomožnih snovi ne glede na njihovo vrsto ali uporabljeno količino, vključno s konzervansi, stabilizatorji, emulgatorji, barvili, snovmi za izboljšanje okusa, aromami, označevalci itd.,
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.
sestavin farmacevtske oblike, ki se daje živalim.
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.
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.
It shall give the detailed results of the tests and trials submitted and precise bibliographic references.
Če pripomoček ni priložen imunološkemu zdravilu za uporabo v veterinarski medicini, se priložijo ustrezne informacije o pripomočku, kadar je to primerno za oceno zdravila.
All important data shall be summarised in an appendix to the detailed and critical summaries, whenever possible in tabular or graphic form.
„Običajna terminologija“
The detailed and critical summaries shall contain precise cross references to the information contained in the main documentation.
„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):
Chemical, pharmaceutical and biological/microbiological information (quality)
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,
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.
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,
Any special apparatus and equipment which may be used shall be described in adequate detail, possibly accompanied by a diagram.
barvila s kodami iz Direktive 78/25/EGS se označijo s kodo ‚E‘.
The formulae of the laboratory reagents shall be supplemented, if necessary, by the manufacturing method.
Za „podrobne podatke o količinski sestavi“ 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 available, chemical and biological reference material of the European Pharmacopoeia shall be used.
Kadar je določena mednarodna enota biološke aktivnosti, se uporabi.
‘Qualitative particulars’ of all the constituents of the immunological veterinary medicinal product shall mean the designation or description of:
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.
the active substance(s),
Razvoj proizvoda
the constituents of the adjuvants,
Predloži se obrazložitev glede sestave, sestavin in vsebnika, ki jo podpirajo znanstveni podatki o razvoju zdravila.
the constituent(s) of the excipients, whatever their nature or the quantity used, including preservatives, stabilisers, emulsifiers, colouring matter, flavouring, aromatic substances, markers, etc.,
B. OPIS NAČINA PROIZVODNJE
the constituents of the pharmaceutical form administered to animals.
Opis načina proizvodnje, 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.
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.
V ta namen opis vsebuje najmanj:
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.
različne stopnje proizvodnje (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,
‘Usual terminology’
v primeru neprekinjene proizvodnje vse podrobne podatke o sprejetih previdnostnih ukrepih za zagotavljanje homogenosti in konsistentnosti med serijami končnega 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):
seznam vseh snovi, uporabljenih v ustreznih stopnjah, vključno s tistimi, ki jih med proizvodnjo ni mogoče reciklirati,
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,
podatke o mešanju in podrobne podatke o količini vseh uporabljenih snovi,
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,
navedbo stopenj proizvodnje, v katerih se opravi vzorčenje za kontrolne preskuse med izdelavo.
in respect of colouring matter, designation by the ‘E’ code assigned to them in Directive 78/25/EEC.
C. IZDELAVA IN KONTROLA VHODNIH SNOVI
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.
V tem odstavku so „vhodne snovi“ vse sestavine, uporabljene pri izdelavi imunološkega zdravila za uporabo v veterinarski medicini.
Where an international unit of biological activity has been defined, this shall be used.
Gojišče za celične kulture, ki je sestavljeno iz številnih sestavin in se uporablja pri izdelavi učinkovine, se šteje kot ena vhodna snov.
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.
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.
Product development
Če se pri pripravi gojišča za celične kulture uporabijo snovi živalskega izvora, se navedejo uporabljene živalske vrste in tkiva.
An explanation shall be provided with regard to the composition, components and containers, supported by scientific data on product development.
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.
B. DESCRIPTION OF MANUFACTURING METHOD
Vhodne snovi, navedene v farmakopejah
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.
Monografije Evropske farmakopeje se uporabljajo za vse vhodni snovi, ki so v njej navedene.
For this purpose the description shall include at least:
Za druge snovi lahko vsaka država članica zahteva, da se upošteva njena nacionalna farmakopeja, kadar gre za zdravila, ki se proizvajajo na njenem ozemlju.
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,
V tem primeru se lahko opis analitskih metod nadomesti s podrobnim sklicem na zadevno farmakopejo.
in the case of continuous manufacture, full details concerning precautions taken to ensure the homogeneity and consistency of each batch of the finished product,
Barvilo v vseh primerih izpolnjuje zahteve iz Direktive 78/25/EGS.
listing of all the substances at the appropriate steps where they are used, including those which cannot be recovered in the course of manufacturing,
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.
the details of the blending, with the quantitative particulars of all the substances used,
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.
a statement of the stages of manufacture at which sampling is carried out for control tests during production.
Domnevna nezadostnost se sporoči organom, pristojnim za zadevno farmakopejo.
C. PRODUCTION AND CONTROL OF STARTING MATERIALS
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.
For the purposes of this paragraph ‘starting materials’ means all components used in the production of the immunological veterinary medicinal product.
Kadar se uporabljajo vhodne snovi živalske izvora, so v skladu z ustreznimi monografijami, vključno s splošnimi monografijami in splošnimi poglavji Evropske farmakopeje.
Culture media consisting of several components used for production of the active substance shall be regarded as one starting material.
Preskusi in kontrole, ki se izvajajo, morajo biti primerni za vhodno 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.
Predlagatelj predloži dokumentacijo, ki dokazuje, da vhodne snovi in proizvodnja 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.
If materials of animal origin are used for preparation of these culture media, the animal species and the tissue used have to be included.
Vhodne snovi, ki niso navedene v farmakopeji
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.
Vhodne snovi biološkega izvora
Starting materials listed in pharmacopoeias
Opišejo se v obliki monografije.
The monographs of the European Pharmacopoeia shall be applicable to all starting materials appearing in it.
Kadar koli je mogoče, temelji izdelava cepiva na sistemu matične serije ter na vzpostavljenih celičnih serijah.
In respect of other substances, each Member State may require observance of its own national pharmacopoeia with regard to products manufactured in its territory.
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.
In this case the description of the analytical methods may be replaced by a detailed reference to the pharmacopoeia in question.
Opiše in dokumentira se izvor vhodnih snovi, vključno z zemljepisno regijo, in njihova zgodovina.