natgillin/translations-raw huggingface dataset:
Having regard to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency [2], and in particular Article 10b thereof,
ob upoštevanju Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta z dne 31. marca 2004 o postopkih Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za humano in veterinarsko uporabo ter o ustanovitvi Evropske agencije za zdravila [2] in zlasti člena 10b Uredbe,
Authorisation decisions for medicinal products should be made on the basis of the objective criteria of quality, safety and efficacy of the medicinal product concerned, to ensure that only high quality medicinal products are placed on the market and administered to patients.
Sklepi o izdaji dovoljenj za promet z zdravili bi morali temeljiti na objektivnih merilih kakovosti, varnosti in učinkovitosti zadevnega zdravila, s čimer se zagotovi, da so v prometu in v uporabi le visokokakovostna zdravila.
As a consequence, new medicinal products have to undergo extensive studies, including clinical efficacy trials, before they are authorised.
Posledično je treba pred pridobitvijo dovoljenj za nova zdravila opraviti obsežne študije, vključno s kliničnimi preskušanji učinkovitosti.
According to Article 21a(f) of Directive 2001/83/EC and to Article 9(4)(cc) of Regulation (EC) No 726/2004 it may be necessary in specific situations to complement the data available at the time of authorisation with additional information concerning the efficacy of a medicinal product, to address concerns that could not be resolved prior to the granting of the marketing authorisation.
V skladu s členom 21a(f) Direktive 2001/83/ES in členom 9(4)(cc) Uredbe (ES) št. 726/2004 je v določenih razmerah podatke, ki so na voljo ob izdaji dovoljenja, morda potrebno dopolniti z dodatnimi informacijami v zvezi z učinkovitostjo zdravil, da se obravnavajo vprašanja, ki jih ob izdaji dovoljenja ni bilo mogoče rešiti.
Moreover, according to Article 22a(1)(b) of Directive 2001/83/EC and to Article 10a(1)(b) of Regulation (EC) No 726/2004 post-authorisation information may require significant revision of previous efficacy evaluations and call for additional, confirmatory efficacy data, while the marketing authorisation is maintained.
Poleg tega v skladu s členom 22a(1)(b) Direktive 2001/83/ES in členom 10a(1)(b) Uredbe (ES) št. 726/2004 informacije, pridobljene po pridobitvi dovoljenja, lahko zahtevajo občutno spremembo prejšnjih ocen učinkovitosti in dodatne, potrdilne podatke o učinkovitosti, pri čemer dovoljenje za promet z zdravilom ostaja veljavno.
In both situations, the national competent authorities, the European Medicines Agency and the Commission (hereinafter ‘the competent authorities’) may oblige the marketing authorisation holder to conduct a post-authorisation efficacy study.
V obeh primerih lahko nacionalni pristojni organi, Evropska agencija za zdravila in Komisija (v nadaljnjem besedilu: pristojni organi) zahtevajo, da imetnik dovoljenja za promet opravi študijo učinkovitosti po pridobitvi dovoljenja.
The obligation to conduct a post-authorisation efficacy study should address certain well-reasoned scientific concerns, which could have a direct impact on the maintenance of the marketing authorisation.
Z obveznostjo izvedbe študije učinkovitosti po pridobitvi dovoljenja bi se odpravili določeni utemeljeni znanstveni pomisleki, ki bi lahko neposredno vplivali na ohranitev dovoljenja za promet.
It should not be used as a justification for the premature granting of a marketing authorisation.
Ta obveznost se ne bi smela uporabljati za utemeljevanje prezgodaj pridobljenih dovoljenj za promet.
According to Article 22a(1) of Directive 2001/83/EC and to Article 10a(1) of Regulation (EC) No 726/2004 the obligation to conduct such a study should be justified on a case-by-case basis, taking into account the properties of a medicinal product and the available data.
V skladu s členom 22a(1) Direktive 2001/83/ES in členom 10a(1) Uredbe (ES) št. 726/2004 bi morala biti obveznost izvedbe takšne študije upravičena na podlagi vsakega posameznega primera, prav tako pa bi morala upoštevati lastnosti zdravila in razpoložljive podatke.
The study should provide the competent authorities and the marketing authorisation holder with necessary information, in order to either complement initial evidence or to verify whether the marketing authorisation should be maintained as granted, varied, suspended or revoked on the basis of new data resulting from the study.
Pristojnim organom in imetniku dovoljenja za promet bi morala študija zagotoviti potrebne informacije, s katerimi lahko dopolnijo prvotne dokaze ali preverijo, ali bi bilo treba dovoljenje za promet na podlagi novih podatkov, pridobljenih v študiji, ohraniti, spremeniti, začasno preklicati ali ukiniti.
Article 22b of Directive 2001/83/EC and Article 10b of Regulation (EC) No 726/2004 empowers the Commission to specify the situations in which post-authorisation efficacy studies may be required.
Člen 22b Direktive 2001/83/ES in člen 10b Uredbe (ES) št. 726/2004 pooblaščata Komisijo za določanje razmer, v katerih bi lahko bile potrebne študije učinkovitosti po pridobitvi dovoljenja.
In the interests of transparency and legal certainty, and in the light of developments in scientific knowledge, it is appropriate to draw up a list of specific situations and the circumstances that might be considered.
Zaradi preglednosti in pravne varnosti in glede na napredek znanstvenih spoznanj je primerno sestaviti seznam razmer in okoliščin, ki jih je morda treba upoštevati.
In various therapeutic areas, surrogate endpoints, such as biomarkers or tumour shrinkage in oncology, have been used as a tool to define the efficacy of medicinal products in exploratory or confirmatory clinical studies.
Na različnih področjih zdravljenja se kot orodje za določanje učinkovitosti zdravil v raziskovalnih ali potrditvenih študijah uporabljajo nadomestni izidi, kot so na primer biološki označevalci ali zmanjševanje tumorja v onkologiji.
To substantiate the assessment based on those endpoints, it may be relevant to generate further efficacy data in the post-authorisation phase to verify the impact of the intervention on clinical outcome or disease progression.
Za podkrepitev ocen, ki temeljijo na navedenih izidih, je lahko pomembno, da se v obdobju po pridobitvi dovoljenja zberejo dodatni podatki o učinkovitosti, da se preveri vpliv uporabe na klinični izid ali razvoj bolezni.
It may also be necessary to verify whether the overall survival data in the post-authorisation phase is discordant with or confirmative of the outcome of the surrogate endpoint.
Prav tako bi morda bilo treba preveriti, ali so splošni podatki o preživetju v obdobju po pridobitvi dovoljenja neskladni z nadomestnimi izidi ali jih potrjujejo.
Some medicinal products may be used regularly in combination with other medicinal products.
Nekatera zdravila se lahko redno uporabljajo v kombinaciji z ostalimi zdravili.
While the applicant for marketing authorisation is expected to address the effects of such combinations in clinical studies, it is often neither required nor appropriate to study exhaustively all possible combinations covered by the marketing authorisation in general terms pre-authorisation.
Čeprav se od vlagatelja vloge za dovoljenje za promet pričakuje, da v okviru kliničnih študij obravnava učinke takšnih kombinacij, pogosto ni potrebno niti primerno, da se pred pridobitvijo dovoljenja raziščejo vse možne kombinacije, ki jih na splošno pokriva dovoljenje za promet.
Instead, the scientific assessment may be based partly on extrapolation of existing data.
Namesto tega lahko znanstvena ocena delno temelji na ekstrapolaciji obstoječih podatkov.
In certain cases it may be relevant to gain further clinical evidence post-authorisation for some specific combinations if such studies could clarify an uncertainty that has not already been addressed.
V nekaterih primerih je lahko pomembno, da se po pridobitvi dovoljenja pridobijo dodatni klinični dokazi o določenih kombinacijah, če bi takšne študije lahko razjasnile negotovosti, ki še niso bile obravnavane.
This applies particularly if such combinations are used or are expected to be used in everyday medical practice.
To zlasti velja v primerih, ko se takšne kombinacije uporabljajo ali se pričakuje, da se bodo uporabljale v vsakodnevni medicinski praksi.
In the pivotal clinical studies conducted prior to granting marketing authorisation, it may be difficult to gather robust representation of all the different sub-populations to which the medicinal product is administered.
V ključnih kliničnih študijah, opravljenih pred izdajo dovoljenja za promet, je včasih težko pridobiti zanesljiv vzorec vseh podpopulacij, ki zdravilo uporabljajo.
This may not necessarily preclude an overall positive benefit-risk balance at the time of authorisation.
To nima nujno negativnega vpliva na splošno pozitivno razmerje med koristjo in tveganjem v času pridobitve dovoljenja.
However, for some specific sub-populations for which uncertainties with respect to benefits have been raised, further substantiation of evidence of efficacy may be necessary, with specifically targeted clinical studies in the post-authorisation phase.
Vendar je v določenih podpopulacijah, pri katerih so se pojavile negotovosti glede koristi, morda potrebno dodatno podkrepiti dokaze o učinkovitosti s ciljno usmerjenimi kliničnimi študijami v obdobju po pridobitvi dovoljenja.
Under normal circumstances, there is no mandatory requirement for long-term follow-up of efficacy of medicinal products as part of post-authorisation surveillance, even for medicinal products authorised for chronic conditions.
V običajnih okoliščinah ni nujno dolgoročno nadalje spremljati učinkovitosti zdravil v okviru nadzora po pridobitvi dovoljenja, kar velja tudi za zdravila, odobrena za zdravljenje kroničnih bolezni.
In many instances, the effects of a medicinal product wane over time, requiring a redefinition of therapy.
V številnih primerih učinki zdravila sčasoma oslabijo in je potrebna ponovna opredelitev zdravljenja.
However, this does not necessarily compromise the benefit-risk balance of the medicinal product and the appraisal of the beneficial effect exerted up to that point in time.
Vendar ni nujno, da bi to negativno vplivalo na razmerje med koristjo in tveganjem zdravila ter oceno koristnih učinkov, ki so se do takrat pokazali.
In exceptional cases, post-authorisation studies should be imposed where a potential lack of efficacy in the long term could raise concerns with respect to the maintenance of a positive benefit-risk balance of the intervention.
Študije po pridobitvi dovoljenja bi morale biti obvezne v izjemnih primerih, ko obstaja možnost, da bi se zaradi premajhne učinkovitosti v daljšem obdobju pojavili pomisleki glede vzdrževanja pozitivnega razmerja med koristjo in tveganjem uporabe.
This could be the case for innovative therapies in which interventions are supposed to modify the course of the disease.
To bi lahko veljalo za inovativne oblike zdravljenja, s katerimi naj bi spremenili potek bolezni.
In exceptional situations, studies in everyday medical practice could be requested where there is clear evidence that the benefits of a medicinal product demonstrated in randomised controlled clinical trials is significantly affected by the real-life conditions of use or where the specific scientific concern is best studied by having access to data collected in everyday medical practice.
Študije v vsakodnevni medicinski praksi bi se lahko zahtevale v izjemnih primerih, ko obstajajo jasni dokazi, da na korist zdravila, ki se je pokazala v naključnih nadzorovanih kliničnih preskusih, bistveno vplivajo stvarni pogoji uporabe, ali v primerih specifičnih znanstvenih pomislekov, ki jih je najbolje raziskati na podlagi podatkov, zbranih v vsakodnevni medicinski praksi.
Furthermore, protective efficacy studies of vaccines are not always feasible.
Poleg tega študije varovalne učinkovitosti cepiv niso vedno izvedljive.
Alternatively, estimates of effectiveness from prospective studies conducted during vaccination campaigns after authorisation could be used in order to gain further knowledge on the ability of the vaccine to confer protection in the short or long term.
Namesto tega bi se lahko uporabile ocene učinkovitosti iz prospektivnih raziskav, opravljenih med akcijami cepljenja v obdobju po pridobitvi dovoljenja, da se pridobijo dodatne informacije o kratkoročnih in dolgoročnih varovalnih lastnostih cepiva.
During the life cycle of an authorised medicinal product, a significant change may occur in the standard of care for the diagnosis, treatment or prevention of a disease, leading to the need to re-open discussions on the established benefit-risk balance of the medicinal product.
Med življenjskim ciklom zdravila z dovoljenjem za promet lahko pride do bistvenih sprememb v standardnem načinu postavljanja diagnoz, zdravljenja ali preprečevanja bolezni, zaradi katerih je treba ponovno razpravljati o vzpostavljenem razmerju med koristjo in tveganjem zdravila.
The European Court of Justice has ruled that a modified consensus within the medical community regarding the appropriate assessment criteria of the therapeutic efficacy of a medicinal product may constitute concrete and objective factors capable of acting as a basis for the finding of a negative benefit-risk assessment of that product [3].
Sodišče Evropske unije je odločilo, da je spremenjeno soglasje znotraj medicinske skupnosti glede primernih meril za ocenjevanje terapevtske učinkovitosti zdravila lahko konkreten in objektiven dejavnik, ki je lahko podlaga za negativno oceno razmerja med koristjo in tveganjem zadevnega zdravila [3].
It may therefore be necessary to provide new evidence on the efficacy of the medicinal product to maintain a positive benefit-risk assessment.
Zato bi morda bilo treba zagotoviti nove dokaze o učinkovitosti zdravila, na podlagi katerih bi se ohranila pozitivna ocena razmerja med koristjo in tveganjem.
Likewise, if an improved understanding of the disease or the pharmacology of a medicinal product has brought into question the criteria used to establish the efficacy of the medicinal product at the time the marketing authorisation was granted, additional studies may be considered.
Prav tako bi bilo morda treba razmisliti o dodatnih študijah, če so zaradi boljšega razumevanja bolezni ali farmakologije zdravila merila za določanje učinkovitosti iz časa, ko je bilo dovoljenje za promet izdano, postala vprašljiva.
To obtain meaningful data, it is necessary to ensure that the design of a post-authorisation efficacy study is appropriate to answer the scientific question that it intends to address.
Za pridobitev pomembnih podatkov je treba zagotoviti, da je študija učinkovitosti po pridobitvi dovoljenja primerno zasnovana za razrešitev znanstvenih vprašanj, ki jih namerava obravnavati.
Competent authorities may impose obligations to ensure or confirm efficacy of a human medicinal product in the context of a conditional marketing authorisation and/or a marketing authorisation that has been granted subject to exceptional circumstances, or as a result of a referral procedure initiated under Articles 31 and 107i of Directive 2001/83/EC or Article 20 of Regulation (EC) No 726/2004.
Pristojni organi lahko naložijo obveznosti za zagotavljanje ali potrjevanje učinkovitosti zdravil za uporabo v humani medicini v okviru pogojnega dovoljenja za promet in/ali dovoljenja za promet, izdanega pod izjemnimi okoliščinami, ali po izvedenem postopku napotitve v skladu s členoma 31 in 107i Direktive 2001/83/ES ali členom 20 Uredbe (ES) št. 726/2004.
Additionally, holders of a marketing authorisation for an advanced therapy medicinal product or a medicinal product for paediatric use may have to comply with certain measures to ensure the follow-up of efficacy.
Poleg tega bodo imetniki dovoljenja za promet z zdravili za napredno zdravljenje ali z zdravili za pediatrično uporabo morda morali izvajati določene ukrepe za zagotovitev nadaljnjega spremljanja učinkovitosti.
As a consequence, it is necessary to conduct a post-authorisation efficacy study.
Zato bo treba izvesti študijo učinkovitosti po pridobitvi dovoljenja.
The need for such a study should be assessed in the context of those procedures and independently of the specific situations and circumstances specified in this Regulation,
Potrebo po takšni študiji bi bilo treba oceniti v okviru navedenih postopkov in neodvisno od specifičnih razmer in okoliščin iz te uredbe –
The national competent authorities, the European Medicines Agency or the Commission may require a post-authorisation efficacy study to be carried out by the holder of a marketing authorisation in accordance with Articles 21a(f) and 22a(1)(b) of Directive 2001/83/EC and Articles 9(4)(cc) and 10a(1)(b) of Regulation (EC) No 726/2004:
Nacionalni pristojni organi, Evropska agencija za zdravila ali Komisija lahko od imetnika dovoljenja za promet zahtevajo izvedbo študije učinkovitosti po pridobitvi dovoljenja v skladu s členom 21a(f) in členom 22a(1)(b) Direktive 2001/83/ES ter členoma 9(4)(cc) in 10a(1)(b) Uredbe (ES) št. 726/2004:
where concerns relating to some aspects of efficacy of the medicinal product are identified and can be resolved only after the medicinal product has been marketed;
če se pojavijo pomisleki glede nekaterih vidikov učinkovitosti zdravila, ki se lahko razrešijo šele po tem, ko je bilo zdravilo dano v promet;
where the understanding of the disease, the clinical methodology or the use of the medicinal product under real-life conditions indicate that previous efficacy evaluations might have to be revised significantly.
če razumevanje bolezni, klinična metodologija ali uporaba zdravila v stvarnih pogojih pokažejo, da bo morda potrebna korenita sprememba predhodnih ocen učinkovitosti.
The national competent authorities, the European Medicines Agency or the Commission shall only apply paragraph 1 if one or more of the following cases arise:
Nacionalni pristojni organi, Evropska agencija za zdravila ali Komisija odstavek 1 uporabljajo samo v naslednjih primerih:
an initial efficacy assessment that is based on surrogate endpoints, which requires verification of the impact of the intervention on clinical outcome or disease progression or confirmation of previous efficacy assumptions;
prvotna ocena učinkovitosti temelji na nadomestnih izidih, zato je treba preveriti vpliv uporabe na klinični rezultat ali razvoj bolezni ali potrditi prvotne ocene učinkovitosti;
in case of medicinal products that are used in combination with other medicinal products, the need for further efficacy data to clarify uncertainties that had not been addressed when the medicinal product was authorised;
pri zdravilih, ki se uporabljajo v kombinaciji z ostalimi zdravili, so potrebni dodatni podatki o učinkovitosti, da se razjasnijo negotovosti, ki ob izdaji dovoljenja za promet niso bile obravnavane;
uncertainties with respect to the efficacy of a medicinal product in certain sub-populations that could not be resolved prior to marketing authorisation and require further clinical evidence;
negotovosti v zvezi z učinkovitostjo zdravila v določenih podpopulacijah, ki niso bile razjasnjene pred pridobitvijo dovoljenja za promet in zahtevajo dodatne klinične dokaze;
the potential lack of efficacy in the long term that raises concerns with respect to the maintenance of a positive benefit-risk balance of the medicinal product;
možnost dolgoročno premajhne učinkovitosti, zaradi katere se pojavijo pomisleki glede vzdrževanja pozitivnega razmerja med koristjo in tveganjem zdravila;
benefits of a medicinal product demonstrated in clinical trials are significantly affected by the use of the medicinal product under real-life conditions, or, in the case of vaccines, protective efficacy studies have not been feasible;
na koristi zdravila, ki so se pokazale pri kliničnem preskušanju, bistveno vpliva uporaba zdravila v stvarnih pogojih ali pa, v primeru cepiv, študije varovalne učinkovitosti niso bile izvedljive;
a change in the understanding of the standard of care for a disease or the pharmacology of a medicinal product that requires additional evidence on its efficacy;
sprememba standardnega načina razumevanja bolezni ali farmakologije zdravila, ki zahteva dodatne dokaze o učinkovitosti zdravila;
new concrete and objective scientific factors that may constitute a basis for finding that previous efficacy evaluations might have to be revised significantly.
novi konkretni in objektivni znanstveni dejavniki, na podlagi katerih bi se lahko sklepalo, da je morda potrebna korenita sprememba predhodnih ocen učinkovitosti.
The situations set out in paragraph 1 and 2 are without prejudice to the imposition of the obligation on the holder of a marketing authorisation to conduct a post-authorisation efficacy study in the context of any of the following situations:
Primeri iz odstavkov 1 in 2 ne posegajo v obveznost imetnika dovoljenja za promet, da izvede študije učinkovitosti po pridobitvi dovoljenja v naslednjih primerih:
a conditional marketing authorisation granted in accordance with Article 14(7) of Regulation (EC) No 726/2004;
pogojno dovoljenje za promet v skladu s členom 14(7) Uredbe (ES) št. 726/2004;
a marketing authorisation granted in exceptional circumstances and subject to certain conditions in accordance with Article 14(8) of Regulation (EC) No 726/2004 or Article 22 of Directive 2001/83/EC;
dovoljenje za promet v izjemnih okoliščinah in ob upoštevanju določenih pogojev v skladu s členom 14(8) Uredbe (ES) št. 726/2004 ali členom 22 Direktive 2001/83/ES;
a marketing authorisation granted to an advanced therapy medicinal product in accordance with Article 14 of Regulation (EC) No 1394/2007 of the European Parliament and of the Council [4];
dovoljenje za promet z zdravili za napredno zdravljenje v skladu s členom 14 Uredbe (ES) št. 1394/2007 Evropskega parlamenta in Sveta [4];
the paediatric use of a medicinal product in accordance with Article 34(2) of Regulation (EC) No 1901/2006 of the European Parliament and of the Council [5];
pediatrična uporaba zdravila v skladu s členom 34(2) Uredbe (ES) št. 1901/2006 Evropskega parlamenta in Sveta [5];
a referral procedure initiated in accordance with Articles 31 or 107i of Directive 2001/83/EC or Article 20 of Regulation (EC) No 726/2004.
postopek napotitve v skladu s členom 31 ali 107i Direktive 2001/83/ES ali členom 20 Uredbe (ES) št. 726/2004.
OJ L 311, 28.11.2001, p. 67.
UL L 311, 28.11.2001, str. 67.
OJ L 136, 30.4.2004, p. 1.
UL L 136, 30.4.2004, str. 1.
Case C-221/10P Artegodan v Commission, not yet published, paragraphs 100-103.
Zadeva C-221/10P, Artegodan proti Komisiji, še ni objavljena, točke 100–103.
Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121).
Uredba (ES) št. 1394/2007 Evropskega parlamenta in Sveta z dne 13. novembra 2007 o zdravilih za napredno zdravljenje ter o spremembi Direktive 2001/83/ES in Uredbe (ES) št. 726/2004 (UL L 324, 10.12.2007, str. 121).
Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 378, 27.12.2006, p. 1).
Uredba (ES) št. 1901/2006 Evropskega parlamenta in Sveta z dne 12. decembra 2006 o zdravilih za pediatrično uporabo in spremembah Uredbe (EGS) št. 1768/92, Direktive 2001/20/ES, Direktive 2001/83/ES in Uredbe (ES) št. 726/2004 (UL L 378, 27.12.2006, str. 1).
Commission Regulation (EU) No 358/2014
Uredba Komisije (EU) št. 358/2014
amending Annexes II and V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products
o spremembi prilog II in V k Uredbi (ES) št. 1223/2009 Evropskega parlamenta in Sveta o kozmetičnih izdelkih