natgillin/translations-raw huggingface dataset:
Insofar as possible, the conditions under which the challenge is carried out shall mimic the natural conditions for infection.
Za vse študije se predloži naslednje:
Details of the challenge strain and its relevance shall be provided.
ime organa, ki je študije izvajal;
For live vaccines, batches containing the minimum titre or potency shall be used unless justified.
podroben protokol poskusa z opisom uporabljenih metod, opreme in materialov, podatke, kot so živalska vrsta ali pasma, kategorija živali, izvor živali, identifikacija in številka živali, pogoji, pod katerimi so živali bile vzrejene in krmljene (med drugim se navede, ali so bile proste določenih patogenih organizmov in/ali protiteles, vrsta in količina krmnih dodatkov, ki jih je vsebovala krma), odmerek, način dajanja zdravila, shema dajanja zdravila ter datumi dajanja zdravila ter opis in obrazložitev uporabljenih statističnih metod;
For other products, batches containing the minimum active content shall be used unless otherwise justified.
za kontrolne živali podatek, ali so dobile placebo ali niso prejele ničesar;
If possible, the immune mechanism (cell-mediated/humoral, local/general classes of immunoglobulin) which is initiated after the administration of the immunological veterinary medicinal product to target animals by the recommended route of administration shall be specified and documented.
za zdravljene živali in kadar je ustrezno, ali so prejele preskusno zdravilo ali drugo zdravilo, odobreno v Skupnosti;
C. FIELD TRIALS
vse splošne in posamezne ugotovitve ter ugodni in neugodni ugotovljeni rezultati (s povprečji in standardnimi odstopanji).
Unless justified, results from laboratory trials shall be supplemented with data from field trials, using batches representative of the manufacturing process described in the marketing authorisation application.
Podatki se natančno opišejo, da se lahko rezultati kritično ocenijo neodvisno od razlage avtorja.
Both safety and efficacy may be investigated in the same field study.
Neobdelani podatki se predložijo v obliki tabele.
Where laboratory trials cannot be supportive of efficacy, the performance of field trials alone may be acceptable.
Rezultate lahko spremljajo razlage in ilustracije v obliki kopij zapisov, fotomikrografov itd.;
PART 5
lastnosti, pogostost in trajanje ugotovljenih neželenih učinkov;
A. INTRODUCTION
število živali, predčasno izločenih iz študij, ter razloge za takšno izločitev;
The dossier of the safety and efficacy studies shall include an introduction defining the subject and indicating the tests which have been carried out in compliance with Parts 3 and 4 as well as a summary, with detailed references to the published literature.
statistična analiza rezultatov, kadar to zahteva program preskušanja, in razlike v podatkih;
This summary shall contain an objective discussion of all the results obtained and lead to a conclusion on the safety and efficacy of the immunological veterinary medicinal product.
pojav in potek morebitne bolezni, ki se je medtem pojavila;
Omission of any tests or trials listed shall be indicated and discussed.
vsi podatki o zdravilih za uporabo v veterinarski medicini (razen tistih, ki se jih preskuša), ki jih je bilo treba dajati med potekom študije;
B. LABORATORY STUDIES
objektivno razpravo o ugotovljenih rezultatih, na podlagi katere je mogoč sklep o varnosti in učinkovitosti zdravila.
The following shall be provided for all studies:
Podrobni podatki o terenskih študijah so dovolj podrobni, da je možna objektivna ocena.
the name of the body having carried out the studies;
Podatki vključujejo naslednje:
a detailed experimental protocol giving a description of the methods, apparatus and materials used, details such as species or breed of animals, categories of animals, where they were obtained, their identification and number, the conditions under which they were housed and fed (stating, inter alia, whether they were free from any specified pathogens and/or specified antibodies, the nature and quantity of any additives contained in the feed), dose, route, schedule and dates of administration, a description and a justification of the statistical methods used;
ime, naslov, funkcijo in izobrazbo pooblaščenega preiskovalca;
in the case of control animals, whether they received a placebo or no treatment;
kraj in datum dajanja zdravila, identifikacijsko številko, s katero se lahko ugotovi ime in naslov lastnika živali;
in the case of treated animals and where appropriate, whether they received the test product or another product authorised in the Community;
podatke o protokolu preskušanja z opisom uporabljenih metod, opreme in materialov, podatke o poti uporabe, shemi dajanja zdravila, odmerku, kategorijah živali, trajanju opazovanja, serološki odziv ter druge preiskave, izvedene na živalih po dajanju zdravila;
all general and individual observations and results obtained (with averages and standard deviations), whether favourable or unfavourable.
identifikacijo zdravljenih in kontrolnih živalih (skupinsko ali individualno, kakor je ustrezno), kot so vrsta, pasma ali rod, starost, teža, spol, fiziološko stanje;
The data shall be described in sufficient detail to allow the results to be critically evaluated independently of their interpretation by the author.
kratek opis metode reje in krmljenja z navedbo lastnosti in količin dodatkov v krmi;
The raw data shall be presented in tabular form.
vse podrobne podatke o ugotovitvah, delovanju ter rezultatih (z navedbo povprečij in standardnih odstopanj); navedejo se posamezni podatki, kadar so bili preskusi in meritve opravljeni na posameznih živalih;
By way of explanation and illustration, the results may be accompanied by reproductions of recordings, photomicrographs, etc.;
vse ugotovitve in ugodni ali neugodni rezultati študij z izčrpnim poročilom o ugotovitvah in rezultatih objektivnih preskusov aktivnosti, potrebnih za oceno zdravila; uporabljene tehnike se morajo specificirati ter pojasniti pomen razhajanj pri rezultatih;
the nature, frequency and duration of observed adverse reactions;
učinke na proizvodnost živali;
the number of animals withdrawn prematurely from the studies and reasons for such withdrawal;
vse podatke o zdravilih za uporabo v veterinarski medicini (razen tistih, ki se jih preskuša), ki so bila dana živali pred ali hkrati s preskušanim zdravilom ali med dobo opazovanja; podatke o kakršnih koli ugotovljenih medsebojnih vplivih;
a statistical analysis of the results, where such is called for by the test programme, and variance within the data;
DEL 6
occurrence and course of any intercurrent disease;
Bibliografska sklicevanja
all details concerning veterinary medicinal products (other than the product under study), the administration of which was necessary during the course of the study;
Bibliografska sklicevanja, navedena v povzetku, opredeljenem v delu 1, se podrobno navedejo, in predložijo se kopije.
an objective discussion of the results obtained, leading to conclusions on the safety and efficacy of the product.
NASLOV III
Particulars concerning field studies shall be sufficiently detailed to enable an objective judgement to be made.
Zahteve za posebne vloge za pridobitev dovoljenja za promet z zdravilom
They shall include the following:
Vloge, predložene na podlagi člena 13 (generična zdravila za uporabo v veterinarski medicini), vsebujejo podatke iz delov 1 in 2 naslova I te priloge, oceno tveganja za okolje, podatke, ki dokazujejo, da ima zdravilo isto kakovostno in količinsko sestavo učinkovin in isto farmacevtsko obliko kot referenčno zdravilo, ter podatke, ki dokazujejo, da je zdravilo bioekvivalentno referenčnemu zdravilu.
name, address, function and qualifications of the investigator in charge;
Če je referenčno zdravilo za uporabo v veterinarski medicini biološko zdravilo, se upoštevajo zahteve iz oddelka 2 za podobna biološka zdravila za uporabo v veterinarski medicini.
place and date of administration, identity code that can be linked to the name and address of the owner of the animal(s);
Za generična zdravila za uporabo v veterinarski medicini se pri podrobnih in kritičnih povzetkih o varnosti in učinkovitosti opišejo zlasti naslednji elementi:
details of the trial protocol, giving a description of the methods, apparatus and materials used, details such as the route of administration, the schedule of administration, the dose, the categories of animals, the duration of observation, the serological response and other investigations carried out on the animals after administration;
razlogi za trditev o bistveni podobnosti;
identification of the treated and control animals (collective or individual, as appropriate), such as species, breeds or strains, age, weight, sex, physiological status;
povzetek nečistoč, prisotnih v serijah učinkovin, in nečistoč v končnem zdravilu (ter, kadar je ustrezno, razgradnih produktov, ki nastajajo med shranjevanjem), kakor je predlagano za uporabo v proizvodu skupaj z oceno teh nečistoč;
a brief description of the method of rearing and feeding, stating the nature and quantity of any additives contained in the feed;
ocena bioekvivalenčnih študij ali utemeljitev, zakaj niso bile opravljene študije ob upoštevanju uveljavljenih smernic,
all the particulars on observations, performances and results (with averages and standard deviation); individual data shall be indicated when tests and measurements on individuals have been carried out;
po potrebi predlagatelj predloži dodatne podatke za dokaz enakovrednosti glede varnosti in učinkovitosti različnih soli, estrov ali derivatov odobrene učinkovine; navedeni podatki vključujejo dokaz, da farmakokinetične ali farmakodinamične lastnosti terapevtskega dela zdravilne učinkovine in/ali toksičnost ni spremenjena, kar lahko vpliva na profil varnosti/učinkovitosti.
all observations and results of the studies, whether favourable or unfavourable, with a full statement of the observations and the results of the objective tests of activity required to evaluate the product; the techniques used must be specified and the significance of any variations in the results explained;
Vsako trditev v povzetku glavnih značilnosti zdravila, ki ni znana ali povzeta iz lastnosti zdravila in/ali terapevtske skupine, je treba obravnavati v pregledih/povzetkih neklinične/klinične dokumentacije in utemeljiti z objavljeno literaturo in/ali dodatnimi študijami.
effects on the animals’ performance;
Za generična zdravila za uporabo v veterinarski medicini, ki se aplicirajo intramuskularno, subkutano ali transdermalno, se predložijo naslednji dodatni podatki:
all details concerning veterinary medicinal products (other than the product under study) which have been administered either prior to or concurrently with the test product or during the observation period; details of any interactions observed;
dokaz enakega ali različnega izločanja ostankov iz mesta vnosa, ki je lahko utemeljen z ustreznimi študijami izločanja ostankov,
PART 6
dokaz o toleranci pri ciljni živali na mestu aplikacije, ki je lahko utemeljen z ustreznimi študijami tolerance pri ciljnih živalih.
Bibliographical references
Podobna biološka zdravila za uporabo v veterinarski medicini
The bibliographical references cited in the summary mentioned under Part 1 shall be listed in detail and copies shall be provided.
Kadar biološko zdravilo za uporabo v veterinarski medicini, ki je podobno referenčnemu biološkemu zdravilu za uporabo v veterinarski medicini, v skladu s členom 13(4) ne izpolnjuje pogojev za opredelitev generičnega zdravila, se predložijo dodatne informacije poleg informacij iz delov 1 in 2 (farmacevtski, kemijski in biološki podatki) in podatki o bioekvivalenci in biološki uporabnosti.
TITLE III
V teh primerih se posredujejo dodatni podatki zlasti glede varnosti in učinkovitosti zdravila.
Requirements for specific marketing authorisation applications
Vrsta in količina dodatnih podatkov (tj. toksikoloških in drugih varnostnih študij in ustreznih kliničnih študij) se določi za vsak primer posebej v skladu z ustreznimi znanstvenimi smernicami.
Applications based on Article 13 (generic veterinary medicinal products) shall contain the data referred to in Parts 1 and 2 of Title I of this Annex together with an environmental risk assessment and data demonstrating that the product has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product and data showing bio-equivalence with the reference medicinal product.
Zaradi različnih bioloških zdravil za uporabo v veterinarski medicini pristojni organ ob upoštevanju posebnih lastnosti vsakega posameznega biološkega zdravila za uporabo v veterinarski medicini določi študije, ki so potrebne v skladu z deloma 3 in 4.
If the reference veterinary medicinal product is a biological medicinal product, the documentation requirements in Section 2 for similar biological veterinary medicinal products shall be fulfilled.
Splošna načela, ki se uporabljajo, se obravnavajo v smernici, ki jo ob upoštevanju lastnosti zadevnega biološkega zdravila za uporabo v veterinarski medicini objavi Agencija.
For generic veterinary medicinal products the detailed and critical summaries on safety and efficacy shall particularly focus on the following elements:
Če ima referenčno biološko zdravilo za uporabo v veterinarski medicini več kot eno indikacijo, se učinkovitost in varnost zdravila, za katera se trdi, da sta podobni, utemeljita ali, če je potrebno, dokažeta ločeno za vsako od navedenih indikacij.
the grounds for claiming essential similarity,
Dobro uveljavljena uporaba v veterinarski medicini
a summary of impurities present in batches of the active substance(s) as well as those of the finished medicinal product (and where relevant decomposition products arising during storage) as proposed for use in the product to be marketed together with an evaluation of these impurities,
Za zdravila za uporabo v veterinarski medicini, katerih uporaba učinkovin je dobro uveljavljena v veterinarski medicini v skladu s členom 13a in ki so priznano učinkovita in sprejemljivo varna, se uporabljajo naslednja posebna pravila.
an evaluation of the bio-equivalence studies or a justification as to why studies were not performed with reference to established guidance,
Predlagatelj predloži dela 1 in 2, kakor je opisano v naslovu I te priloge.
if applicable, additional data in order to demonstrate the equivalence of safety and efficacy properties of different salts, esters or derivatives of an authorised active substance shall be provided by the applicant; those data shall include evidence that there is no change in the pharmacokinetic or pharmacodynamic properties of the therapeutic moiety and/or in toxicity, which could influence the safety/efficacy profile.
Pri delih 3 in 4 se v podrobni znanstveni bibliografiji navedejo vse raziskave, povezane z varnostjo in učinkovitostjo.
Every claim in the summary of product characteristics not known from or inferred from the properties of the medicinal product and/or its therapeutic group should be discussed in the non-clinical/clinical overviews/summaries and substantiated by published literature and/or additional studies.
Za dokazovanje dobro uveljavljene uporabe v veterinarski medicini se uporabljajo naslednja posebna pravila:
For generic veterinary medicinal products intended to be administered by intramuscular, subcutaneous or transdermal routes, the following additional data shall be provided:
dejavniki, ki se upoštevajo pri ugotavljanju dobro uveljavljene uporabe v veterinarski medicini sestavin zdravila za uporabo v veterinarski medicini, so naslednji:
evidence to demonstrate equivalent or differing depletion of residues from the administration site, which may be substantiated by appropriate residue depletion studies,
časovno obdobje, v katerem se učinkovina že uporablja,
evidence to demonstrate target animal tolerance at the administration site, which may be substantiated by appropriate target animal tolerance studies.
količine učinkovine, ki se uporabljajo,
Similar biological veterinary medicinal products
stopnja znanstvenega zanimanja za uporabo učinkovine (ki se odraža v objavljeni znanstveni literaturi),
In accordance with Article 13(4), where a biological veterinary medicinal product which is similar to a reference biological veterinary medicinal product does not meet the conditions in the definition of generic medicinal product, information to be supplied shall not be limited to Parts 1 and 2 (pharmaceutical, chemical and biological data), supplemented with bio-equivalence and bioavailability data.
povezanost znanstvenih ocen.
In such cases, additional data shall be provided, in particular on the safety and efficacy of the product.
Za ugotavljanje dobro uveljavljene uporabe različnih snovi so morda potrebna različna časovna obdobja.
The type and amount of additional data (i.e. toxicological and other safety studies and appropriate clinical studies) shall be determined on a case-by-case basis in accordance with relevant scientific guidelines.
V vsakem primeru pa časovno obdobje, potrebno za ugotavljanje dobro uveljavljene uporabe sestavine zdravila v veterinarski medicini, ne sme biti krajše od desetih let od prve sistematične in dokumentirane uporabe navedene snovi kot zdravila za uporabo v veterinarski medicini v Skupnosti.
Due to the diversity of biological veterinary medicinal products, the competent authority shall determine the necessary studies foreseen in Parts 3 and 4, taking into account the specific characteristic of each individual biological veterinary medicinal product.
Dokumentacija, ki jo predloži predlagatelj, vključuje celotno oceno varnosti in učinkovitosti zdravila za predlagano indikacijo pri ciljni vrsti, pri čemer se nanaša na predlagano pot uporabe in režim odmerjanja.
The general principles to be applied shall be addressed in guideline which shall be adopted by the Agency, taking into account the characteristics of the concerned biological veterinary medicinal product.
Mora vključevati ali se nanašati na pregled ustrezne literature, pri čemer se upoštevajo študije pred in po dajanju na trg ter objavljena znanstvena literatura glede epidemioloških študij in zlasti primerjalnih epidemioloških študij.
If the reference biological veterinary medicinal product has more than one indication, the efficacy and safety of the biological veterinary medicinal product claimed to be similar shall be justified or, if necessary, demonstrated separately for each of the claimed indications.
Predloži se ugodna in neugodna dokumentacija.
Well-established veterinary use
Glede na določbe o ‚dobro uveljavljeni uporabi v veterinarski medicini‘ je zlasti treba pojasniti, da se lahko poleg podatkov o preskusih in preskušanjih kot veljaven dokaz o varnosti in učinkovitosti zdravila uporabi sklic na bibliografije (študije po dajanju na trg, epidemiološke študije itd.), če je v vlogi zadovoljivo pojasnjena in utemeljena uporaba teh virov informacij.
For veterinary medicinal products the active substance(s) of which has/have been in ‘well-established veterinary use’ as referred to in Article 13a, with recognised efficacy and an acceptable level of safety, the following specific rules shall apply.
Posebna pozornost je treba posvetiti kakršnim koli manjkajočim informacijam in predložiti je treba utemeljitev, zakaj prikaz sprejemljive stopnje varnosti in/ali učinkovitosti zadošča, čeprav nekatere študije manjkajo.
The applicant shall submit Parts 1 and 2 as described in Title I of this Annex.
V podrobnih in kritičnih povzetkih o varnosti in učinkovitost je treba obrazložiti pomembnost vseh predloženih podatkov o zdravilu, ki se razlikuje od zdravila, namenjenega za dajanje na trg.
For Parts 3 and 4, a detailed scientific bibliography shall address all aspects of the safety and efficacy.
Presoditi je treba, ali se preiskovano zdravilo lahko šteje kot podobno zdravilu, za katerega je že bila predložena vloga za pridobitev dovoljenja za promet z zdravilom, kljub obstoječim razlikam.
The following specific rules shall apply in order to demonstrate the well-established veterinary use:
Izkušnje z drugimi zdravili po dajanju na trg, ki vsebujejo enake sestavine, so zlasti pomembne, zato vlagatelji to še posebej poudarijo.
The following factors shall be taken into account in order to establish a well-established veterinary medicinal use of constituents of veterinary medicinal products:
V vlogah za kombinacije zdravil za uporabo v veterinarski medicini, predloženih na podlagi člena 13b, se predloži dokumentacija z deli 1, 2, 3 in 4.
the time over which an active substance has been used;
Študij o varnosti in učinkovitosti vsake učinkovine ni nujno predložiti.
quantitative aspects of the use of the active substance;
Vendar pa mora biti mogoče vključiti informacije o posameznih snoveh v vlogo za fiksno kombinacijo.
the degree of scientific interest in the use of the active substance (reflected in the published scientific literature);
Predložitev podatkov o vsaki posamezni učinkovini, skupaj z zahtevanimi testi varnosti za uporabnike, študijami izločanja ostankov in kliničnimi študijami zdravili s fiksno kombinacijo, se lahko šteje za ustrezno utemeljitev za manjkajoče podatke o kombiniranem zdravilu, in sicer zaradi dobrobiti živali in nepotrebnega testiranja na živalih, razen če se zaradi domnevnega medsebojnega delovanja lahko poveča toksičnost.
the coherence of scientific assessments.
Po potrebi se predložijo informacije o mestih proizvodnje in oceni varnosti tujih snovi.
Different periods of time may be necessary for establishing well-established use of different substances.
Vloge na podlagi informirane privolitve
In any case, however, the period of time required for establishing a well-established veterinary use of a constituent of a medicinal product shall not be less than 10 years from the first systematic and documented use of that substance as a veterinary medicinal product in the Community.
Vloge, predložene na podlagi člena 13c, vključujejo podatke iz dela 1 naslova 1 te priloge, če je imetnik dovoljenja za promet z originalnim zdravilom za uporabo v veterinarski medicini dal predlagatelju soglasje, da se lahko sklicuje na vsebino delov 2, 3 in 4 dokumentacije navedenega zdravila.
The documentation submitted by the applicant shall cover all aspects of the safety and/or efficacy assessment of the product for the proposed indication in the target species using the proposed route of administration and dosage regimen.
V tem primeru ni treba predložiti podrobnih in kritičnih povzetkov o kakovosti, varnosti in učinkovitosti.
It must include or refer to a review of the relevant literature, taking into account pre- and post-marketing studies and published scientific literature concerning experience in the form of epidemiological studies and in particular of comparative epidemiological studies.
Dokumentacija za vloge v izjemnih okoliščinah
All documentation, both favourable and unfavourable, shall be communicated.
Dovoljenje za promet z zdravilom se lahko izda, če predlagatelj izpolni nekatere posebne zahteve in uvede posebne postopke glede varnosti in učinkovitosti zdravila za uporabo v veterinarski medicini, kadar dokaže, da ne more predložiti izčrpnih podatkov o učinkovitosti in varnosti pri normalnih pogojih uporabe, kakor je določeno v členu 26(3) te direktive.
With respect to the provisions on well-established veterinary use, it is in particular necessary to clarify that bibliographic reference to other sources of evidence (post-marketing studies, epidemiological studies etc.) and not just data related to tests and trials may serve as a valid proof of safety and efficacy of a product if an application explains and justifies the use of these sources of information satisfactorily.
Pri določitvi osnovnih zahtev za vse vloge, navedene v tem oddelku, je treba upoštevati smernice, ki jih sprejme Agencija.
Particular attention must be paid to any missing information and justification must be given as to why demonstration of an acceptable level of safety and/or efficacy can be supported although some studies are lacking.
Mešane vloge za pridobitev dovoljenja za promet z zdravilom