natgillin/translations-raw huggingface dataset:
there are changes in the active substance or substances, indications for use, strength, pharmaceutical form or route of administration of the generic veterinary medicinal product compared to the reference veterinary medicinal product;
obstajajo razlike v zvezi s surovinami ali proizvodnimi postopki za biološko zdravilo za uporabo v veterinarski medicini in referenčno biološko zdravilo za uporabo v veterinarski medicini.
bioavailability studies cannot be used to demonstrate bioequivalence with the reference veterinary medicinal product; or
Predklinične študije ali klinična preskušanja hibridnih zdravil za uporabo v veterinarski medicini se lahko izvajajo s serijami referenčnih zdravil za uporabo v veterinarski medicini z dovoljenjem za promet v Uniji ali tretji državi.
there are differences relating to raw materials or in manufacturing processes of the biological veterinary medicinal product and the reference biological veterinary medicinal product.
Predlagatelj dokaže, da je referenčno zdravilo za uporabo v veterinarski medicini z dovoljenjem za promet v tretji državi dobilo dovoljenje v skladu z zahtevami, enakovrednimi tistim, ki so določene v Uniji za referenčna zdravila za uporabo v veterinarski medicini, in sta zdravili tako zelo podobni, da se lahko medsebojno nadomestita.
The pre-clinical studies or clinical trials for a hybrid veterinary medicinal product may be conducted with batches of the reference veterinary medicinal product authorised in the Union or in a third country.
Člen 20
The applicant shall demonstrate that the reference veterinary medicinal product authorised in a third country has been authorised in accordance with requirements equivalent to those established in the Union for the reference veterinary medicinal product and are so highly similar that they can substitute each other in the clinical trials.
Kombinirana zdravila za uporabo v veterinarski medicini
Article 20
Z odstopanjem od točke (b) člena 8(1) se v primeru zdravil za uporabo v veterinarski medicini, ki vsebujejo učinkovine, uporabljene v sestavi zdravila z dovoljenjem za promet za uporabo v veterinarski medicini, ne zahteva zagotavljanje podatkov o varnosti in učinkovitosti za vsako posamezno učinkovino.
Combination veterinary medicinal products
Člen 21
By way of derogation from point (b) of Article 8(1), in the case of veterinary medicinal products containing active substances used in the composition of authorised veterinary medicinal products it shall not be required to provide safety and efficacy data relating to each individual active substance.
Vloga na podlagi soglasja
Article 21
Z odstopanjem od točke (b) člena 8(1) predlagatelju za pridobitev dovoljenja za promet z zdravilom za uporabo v veterinarski medicini ni treba predložiti tehnične dokumentacije o kakovosti, varnosti in učinkovitosti, če v obliki izjave o dostopnosti podatkov dokaže, da mu je dovoljeno uporabljati to dokumentacijo, predloženo v zvezi z že odobrenim zdravilom za uporabo v veterinarski medicini.
Application based on informed consent
Člen 22
By way of derogation from point (b) of Article 8(1), an applicant for a marketing authorisation for a veterinary medicinal product shall not be required to provide the technical documentation on quality, safety and efficacy if that applicant demonstrates permission, in the form of a letter of access, to use such documentation submitted in respect of the already authorised veterinary medicinal product.
Vloga na podlagi bibliografskih podatkov
Article 22
Z odstopanjem od točke (b) člena 8(1) predlagatelju ni treba predložiti dokumentacije o varnosti in učinkovitosti, če dokaže, da so učinkovine v zdravilu za uporabo v veterinarski medicini dobro uveljavljene v veterinarski uporabi v Uniji vsaj deset let, da je njihova učinkovitost dokumentirana ter da zagotavljajo sprejemljivo raven varnosti.
Application based on bibliographic data
Vloga izpolnjuje zahteve iz Priloge II.
By way of derogation from point (b) of Article 8(1), the applicant shall not be required to provide the documentation on safety and efficacy if that applicant demonstrates that the active substances of the veterinary medicinal product have been in well-established veterinary use within the Union for at least 10 years, that their efficacy is documented and that they provide an acceptable level of safety.
Oddelek 6
The application shall satisfy the requirements set out in Annex II.
Dovoljenja za promet za omejeni trg in v izjemnih okoliščinah
Section 6
Člen 23
Marketing authorisations for limited market and in exceptional circumstances
Vloge za omejene trge
Article 23
Z odstopanjem od točke (b) člena 8(1) predlagatelju ni treba zagotoviti celovite dokumentacije o varnosti ali učinkovitosti v skladu s Prilogo II, če sta izpolnjena oba naslednja pogoja:
Applications for limited markets
korist dostopnosti zdravila za uporabo v veterinarski medicini na trgu za zdravje živali ali javno zdravje odtehta tveganje, ki izhaja iz dejstva, da določena dokumentacija ni bila predložena;
By way of derogation from point (b) of Article 8(1), the applicant shall not be required to provide the comprehensive safety or efficacy documentation required in accordance with Annex II, if all of the following conditions are met:
predlagatelj predloži dokaze, da je zdravilo za uporabo v veterinarski medicini namenjeno za omejeni trg.
the benefit of the availability on the market of the veterinary medicinal product to the animal or public health outweighs the risk inherent in the fact that certain documentation has not been provided;
Kadar se za zdravilo za uporabo v veterinarski medicini izda dovoljenje za promet v skladu s tem členom, se v povzetku glavnih značilnosti zdravila jasno navede, da je bila opravljena le omejena ocena varnosti ali učinkovitosti zaradi pomanjkanja celovitih podatkov o varnosti ali učinkovitosti.
the applicant provides the evidence that the veterinary medicinal product is intended for a limited market.
Člen 24
Where a veterinary medicinal product has been granted a marketing authorisation in accordance with this Article, the summary of product characteristics shall clearly state that only a limited assessment of safety or efficacy has been conducted due to the lack of comprehensive safety or efficacy data.
Veljavnost dovoljenja za promet za omejeni trg in postopek za njegov ponovni pregled
Article 24
Z odstopanjem od člena 5(2) velja dovoljenje za promet za omejeni trg pet let.
Validity of a marketing authorisation for a limited market and procedure for its re-examination
Pred iztekom petletnega obdobja veljavnosti iz odstavka 1 tega člena se dovoljenja za promet za omejeni trg, izdana v skladu s členom 23, ponovno pregledajo na podlagi vloge imetnika dovoljenja za promet.
By way of derogation from Article 5(2), a marketing authorisation for a limited market shall be valid for a period of five years.
Ta vloga vključuje posodobljeno oceno razmerja med tveganji in koristmi.
Before the expiry of the five-year period of validity referred to in paragraph 1 of this Article, marketing authorisations for a limited market granted in accordance with Article 23 shall be re-examined on the basis of an application from the holder of that marketing authorisation.
Imetnik dovoljenja za promet za omejeni trg predloži vlogo za ponovni pregled pristojnemu organu, ki je izdal dovoljenje, ali Agenciji, kakor je ustrezno, vsaj šest mesecev pred iztekom petletnega obdobja veljavnosti iz odstavka 1 tega člena.
That application shall include an updated benefit-risk assessment.
Vloga za ponovni pregled je omejena na dokazovanje, da so še vedno izpolnjeni pogoji iz člena 23(1).
A holder of a marketing authorisation for a limited market shall submit an application for a re-examination to the competent authority that granted the authorisation or to the Agency, as applicable, at least six months before the expiry of the five-year period of validity referred to in paragraph 1 of this Article.
Ko se predloži vloga za ponovni pregled, ostane dovoljenje za promet za omejeni trg veljavno, dokler pristojni organ ali Komisija, kakor je ustrezno, ne sprejme odločitve o vlogi.
The application for re-examination shall be limited to demonstrating that the conditions referred to in Article 23(1) continue to be fulfilled.
Pristojni organ ali Agencija, kakor je ustrezno, oceni vlogi za ponovni pregled in podaljšanje veljavnosti dovoljenja za promet.
When an application for re-examination has been submitted, the marketing authorisation for a limited market shall remain valid until a decision has been adopted by the competent authority or the Commission, as applicable.
Na podlagi te ocene, če je razmerje med koristmi in tveganji še vedno pozitivno, pristojni organ ali Komisija, kakor je ustrezno, podaljša veljavnost dovoljenja za promet za dodatna petletna obdobja.
The competent authority or the Agency, as applicable, shall assess applications for a re-examination and for an extension of the validity of the marketing authorisation.
Pristojni organ ali Komisija, kakor je ustrezno, lahko kadar koli izda dovoljenje za promet z zdravilom za uporabo v veterinarski medicini za omejeni trg z neomejeno časovno veljavnostjo, če imetnik dovoljenja za promet za omejeni trg predloži manjkajoče podatke o varnosti ali učinkovitosti iz člena 23(1).
On the basis of that assessment, if the benefit-risk balance remains positive, the competent authority or the Commission, as applicable, shall extend the validity of the marketing authorisation by additional periods of five years.
Člen 25
The competent authority or the Commission, as applicable, may at any time grant a marketing authorisation valid for an unlimited period of time in respect of a veterinary medicinal product authorised for a limited market, provided that the holder of the marketing authorisation for a limited market submits the missing data on safety or efficacy referred to in Article 23(1).
Vloge v izjemnih okoliščinah
Article 25
Z odstopanjem od točke (b) člena 8(1) v izjemnih okoliščinah v zvezi z zdravjem živali ali javnim zdravjem, lahko predlagatelj predloži vlogo, ki ne izpolnjuje vseh zahtev navedene točke, pri kateri korist takojšnje dostopnosti zadevnega zdravila za uporabo v veterinarski medicini na trgu za zdravje živali ali javno zdravje odtehta tveganje, izhajajoče iz tega, da določena dokumentacija o kakovosti, varnosti ali učinkovitosti ni bila predložena.
Applications in exceptional circumstances
V tem primeru mora predlagatelj dokazati, da zaradi objektivnih in preverljivih razlogov ni mogoče zagotoviti določene dokumentacije o kakovosti, varnosti ali učinkovitosti v skladu s Prilogo II.
By way of derogation from point (b) of Article 8(1), in exceptional circumstances related to animal or public health, an applicant may submit an application which does not meet all requirements of that point, for which the benefit of the immediate availability on the market of the veterinary medicinal product concerned to the animal or public health outweighs the risk inherent in the fact that certain quality, safety or efficacy documentation has not been provided.
Člen 26
In such a case, the applicant shall be required to demonstrate that for objective and verifiable reasons certain quality, safety or efficacy documentation required in accordance with Annex II cannot be provided.
Pogoji za dovoljenje za promet v izjemnih okoliščinah
Article 26
V izjemnih okoliščinah iz člena 25 se lahko izda dovoljenje za promet, pri tem pa za imetnika dovoljenja za promet velja ena ali več od naslednjih zahtev:
Terms of the marketing authorisation in exceptional circumstances
zahteva po uvedbi pogojev ali omejitev, zlasti v zvezi z varnostjo zdravila za uporabo v veterinarski medicini;
In the exceptional circumstances referred to in Article 25, a marketing authorisation may be granted subject to one or more of the following requirements for the marketing authorisation holder:
zahteva po uradnem obveščanju pristojnih organov ali Agencije, kakor je ustrezno, o vseh neželenih dogodkih v zvezi z uporabo zdravila za uporabo v veterinarski medicini.
a requirement to introduce conditions or restrictions, in particular concerning the safety of the veterinary medicinal product;
zahteva po izvajanju študij po izdaji dovoljenja za promet.
a requirement to notify to the competent authorities or the Agency, as applicable, of any adverse event relating to the use of the veterinary medicinal product;
Kadar se za zdravilo za uporabo v veterinarski medicini izda dovoljenje za promet v skladu s tem členom, se v povzetku glavnih značilnosti zdravila jasno navede, da je bila opravljena le omejena ocena kakovosti, varnosti ali učinkovitosti zaradi pomanjkanja celovitih podatkov o kakovosti, varnosti ali učinkovitosti.
a requirement to conduct post-authorisation studies.
Člen 27
Where a veterinary medicinal product has been granted a marketing authorisation in accordance with this Article, the summary of product characteristics shall clearly state that only a limited assessment of quality, safety or efficacy has been conducted due to the lack of comprehensive quality, safety or efficacy data.
Veljavnost dovoljenja za promet v izjemnih okoliščinah in postopek za njegov ponovni pregled
Article 27
Z odstopanjem od člena 5(2) dovoljenje za promet v izjemnih okoliščinah velja eno leto.
Validity of a marketing authorisation in exceptional circumstances and procedure for its re-examination
Pred iztekom enoletnega obdobja veljavnosti iz odstavka 1 tega člena se dovoljenja za promet, izdana v skladu s členoma 25 in 26, ponovno pregledajo na podlagi vloge imetnika dovoljenja za promet.
By way of derogation from Article 5(2), a marketing authorisation in exceptional circumstances shall be valid for a period of one year.
Imetnik dovoljenja za promet v izjemnih okoliščinah predloži vlogo za ponovni pregled pristojnemu organu, ki je izdal dovoljenje, ali Agenciji, kakor je ustrezno, vsaj tri mesece pred iztekom enoletnega obdobja veljavnosti iz odstavka 1.
Before the expiry of the one-year period of validity referred to in paragraph 1 of this Article, marketing authorisations granted in accordance with Articles 25 and 26 shall be re-examined on the basis of an application from the holder of that marketing authorisation.
Vloga za ponovni pregled vsebuje dokaze, da še vedno obstajajo izjemne okoliščine v zvezi z zdravjem živali ali javnim zdravjem.
A holder of a marketing authorisation in exceptional circumstances shall submit an application for re-examination to the competent authority that granted the authorisation or to the Agency, as applicable, at least three months before the expiry of the one-year period of validity referred to in paragraph 1.
Ko se predloži vloga za ponovni pregled, ostane dovoljenje za promet veljavno, dokler pristojni organ ali Komisija, kakor je ustrezno, ne sprejme odločitve o vlogi.
The application for re-examination shall demonstrate that the exceptional circumstances related to animal health or public health remain.
Pristojni organ ali Agencija, kakor je ustrezno, oceni vlogo.
When an application for re-examination has been submitted, the marketing authorisation shall remain valid until a decision has been adopted by the competent authority or the Commission, as applicable.
Na podlagi te ocene, če je razmerje med koristmi in tveganji še vedno pozitivno, pristojni organ ali Komisija, kakor je ustrezno, podaljša veljavnost dovoljenja za promet za eno leto.
The competent authority or the Agency, as applicable, shall assess the application.
Pristojni organ ali Komisija, kakor je ustrezno, lahko kadar koli izda dovoljenje za promet z zdravilom za uporabo v veterinarski medicini z neomejeno časovno veljavnostjo v skladu s členoma 25 in 26, če imetnik dovoljenja za promet predloži manjkajoče podatke o kakovosti, varnosti ali učinkovitosti iz člena 25.
On the basis of that assessment, if the benefit-risk balance remains positive, the competent authority or the Commission, as applicable, shall extend the validity of the marketing authorisation for one year.
Oddelek 7
The competent authority or the Commission, as applicable, may at any time grant a marketing authorisation valid for an unlimited period of time in respect of a veterinary medicinal product authorised in accordance with Articles 25 and 26, provided that the marketing authorisation holder submits the missing data on quality, safety or efficacy referred to in Article 25.
Pregled vlog in podlaga za izdajo dovoljenj za promet
Section 7
Člen 28
Examination of applications and basis for granting marketing authorisations
Pregled vlog
Article 28
Pristojni organ ali Agencija, kakor je ustrezno, ki mu oziroma ji je bila predložena vloga v skladu s členom 6:
Examination of applications
preveri, ali predloženi podatki izpolnjujejo zahteve iz člena 8;
The competent authority or the Agency, as applicable, to which the application has been submitted in accordance with Article 6 shall:
oceni zdravilo za uporabo v veterinarski medicini glede na predloženo dokumentacijo o kakovosti, varnosti in učinkovitosti;
verify that the data submitted complies with the requirements laid down in Article 8;
pripravi sklep o razmerju med koristmi in tveganji za zdravilo za uporabo v veterinarski medicini.
assess the veterinary medicinal product regarding the quality, safety and efficacy documentation provided;
Med postopkom pregledovanja vlog za pridobitev dovoljenj za promet z zdravili za uporabo v veterinarski medicini, ki vsebujejo gensko spremenjene organizme ali so iz njih sestavljeni, kot je navedeno v členu 8(5) te uredbe, Agencija opravi potrebno posvetovanje z organi, ki jih Unija ali države članice vzpostavijo v skladu z Direktivo 2001/18/ES.
draw up a conclusion on the benefit-risk balance for the veterinary medicinal product.
Člen 29
During the process of examination of applications for marketing authorisations for veterinary medicinal products containing or consisting of genetically modified organisms as referred to in Article 8(5) of this Regulation, the Agency shall hold the necessary consultations with the bodies set up by the Union or Member States in accordance with Directive 2001/18/EC.
Zahteve za laboratorije med pregledovanjem vlog
Article 29
Pristojni organ ali Agencija, kakor je ustrezno, ki pregleduje vlogo, lahko od predlagatelja zahteva, da referenčnemu laboratoriju Evropske unije, uradnemu kontrolnemu laboratoriju za preskušanje zdravil ali laboratoriju, ki ga je za ta namen določila država članica, predloži vzorce, ki so potrebni, da:
Requests to laboratories in the course of the examination of applications
se testirajo zdravilo za uporabo v veterinarski medicini, njegove vhodne snovi in po potrebi vmesni proizvodi ali druge sestavine, da se zagotovi zadovoljivost metod nadzora, ki jih uporablja proizvajalec in ki so opisane v dokumentaciji vloge;
The competent authority or the Agency, as applicable, examining the application may require an applicant to provide to the European Union reference laboratory, an official medicines control laboratory or a laboratory that a Member State has designated for that purpose samples which are necessary to:
se v primeru zdravil za uporabo v veterinarski medicini, predvidenih za živali za proizvodnjo hrane, preveri, ali je analizna metoda za detekcijo, ki jo predlaga predlagatelj za namene testov izločanja ostankov, zadovoljiva in primerna za odkrivanje prisotnosti ostankov, zlasti tistih, ki presegajo mejne vrednosti ostankov farmakoloških učinkovin, ki jih je določila Komisija v skladu z Uredbo (ES) št. 470/2009, ter za namen uradnega nadzora nad živalmi in proizvodi živalskega izvora v skladu z Uredbo (EU) 2017/625.
test the veterinary medicinal product, its starting materials and, if necessary, intermediate products or other constituent materials in order to ensure that the control methods employed by the manufacturer and described in the application documents are satisfactory;
Roki iz členov 44, 47, 49, 52 in 53 se odložijo, dokler niso predloženi vzorci, zahtevani v skladu z odstavkom 1 tega člena.
verify that, in the case of veterinary medicinal products intended for food-producing animals, the analytical detection method proposed by the applicant for the purposes of residue depletion tests is satisfactory and suitable for use to reveal the presence of residue levels, particularly those exceeding the maximum residue level of the pharmacologically active substance established by the Commission in accordance with Regulation (EC) No 470/2009, and for the purpose of official controls of animals and products of animal origin in accordance with Regulation (EU) 2017/625.
Člen 30
The time limits laid down in Articles 44, 47, 49, 52 and 53 shall be suspended until the samples requested in accordance with paragraph 1 of this Article have been provided.
Informacije o proizvajalcih v tretjih državah
Article 30
Pristojni organ ali Agencija, kakor je ustrezno, ki mu oziroma ji je bila predložena vloga v skladu s členom 6, s postopkom, določenim v členih 88, 89 in 90, potrdi, da so proizvajalci zdravil za uporabo v veterinarski medicini iz tretjih držav zmožni proizvajati zadevno zdravilo za uporabo v veterinarski medicini ali izvesti kontrolne preskuse v skladu z metodami, opisanimi v dokumentaciji, predloženi v podporo vlogi v skladu s členom 8(1).
Information on manufacturers in third countries
Pristojni organ ali Agencija, kakor je ustrezno, lahko zahteva, da zadevni organ predloži informacije, ki potrjujejo, da so proizvajalci zdravil za uporabo v veterinarski medicini zmožni izvajati dejavnosti iz tega člena.
The competent authority or the Agency, as applicable, to which the application has been submitted in accordance with Article 6 shall ascertain, through the procedure laid down in Articles 88, 89 and 90, that the manufacturers of veterinary medicinal products from third countries are able to manufacture the veterinary medicinal product concerned or carry out control tests in accordance with the methods described in the documentation submitted in support of the application in accordance with Article 8(1).
Člen 31
A competent authority or the Agency, as applicable, may request the relevant competent authority to present information ascertaining that the manufacturers of veterinary medicinal products are able to carry out the activities referred to in this Article.
Dodatne informacije predlagatelja
Article 31
Pristojni organ ali Agencija, kakor je ustrezno, ki mu oziroma ji je bila predložena vloga v skladu s členom 6, predlagatelja obvesti, če je dokumentacija, predložena v podporo vlogi, nezadostna.
Additional information from the applicant
Pristojni organ ali Agencija, kakor je ustrezno, od predlagatelja zahteva, da predloži dodatne informacije v določenem roku.
The competent authority or the Agency, as applicable, to which the application has been submitted in accordance with Article 6, shall inform the applicant if the documentation submitted in support of the application is insufficient.
V takem primeru se roki iz členov 44, 47, 49, 52 in 53 odložijo, dokler se ne predložijo dodatne informacije.
The competent authority or the Agency, as applicable, shall request the applicant to provide additional information within a given time limit.
Člen 32
In such a case the time limits laid down in Articles 44, 47, 49, 52 and 53 shall be suspended until the additional information has been provided.
Umik vlog
Article 32
Predlagatelj lahko umakne vlogo za pridobitev dovoljenja za promet, predloženo pristojnemu organu ali Agenciji, kakor je ustrezno, kadar koli pred sprejetjem sklepa iz člena 44, 47, 49, 52 ali 53.
Withdrawal of applications
Če predlagatelj umakne vlogo za pridobitev dovoljenja za promet, predloženo pristojnemu organu ali Agenciji, kakor je ustrezno, preden je pregled vloge iz člena 28 zaključen, predlagatelj o razlogih za to obvesti pristojni organ ali Agencijo, kakor je ustrezno, ki mu oziroma ji je bila predložena vloga v skladu s členom 6.
An applicant may withdraw the application for marketing authorisation submitted to a competent authority or the Agency, as applicable, at any time before the decision referred to in Article 44, 47, 49, 52 or 53 has been taken.
Pristojni organ ali Agencija, kakor je ustrezno, po izbrisu vseh poslovno zaupnih informacij objavi informacijo o tem, da je vloga skupaj z že pripravljenim poročilom ali mnenjem, kakor je ustrezno, umaknjena.