natgillin/translations-raw huggingface dataset:
For the purposes of this Regulation, in general the data included in a clinical study report should not be considered commercially confidential once a marketing authorisation has been granted, the procedure for granting themarketing authorisation has been completed, the application for marketing authorisation has been withdrawn.
Za namene te uredbe podatki iz poročil o kliničnih preskušanjih na splošno ne bi smeli veljati za poslovno zaupne po tem, ko je bilo dovoljenje za promet odobreno, postopek za odobritev dovoljenja za promet končan ali ko je bila vloga za dovoljenje za promet umaknjena.
In addition, the main characteristics of a clinical trial, the conclusion on Part I of the assessment report for the authorisation of a clinical trial, the decision on the authorisation of a clinical trial, the substantial modification of a clinical trial, and the clinical trial results including reasons for temporary halt and early termination, in general, should not be considered confidential.
Poleg tega ne bi smele veljati za zaupne glavne značilnosti kliničnega preskušanja, ugotovitve glede dela I poročila o oceni odobritve kliničnega preskušanja, odločitev o odobritvi kliničnega preskušanja, bistvena sprememba kliničnega preskušanja ter rezultati kliničnega preskušanja, vključno z razlogi za začasno ali predčasno ustavitev.
Within a Member State, there may be several bodies involved in the authorisation of clinical trials.
V državi članici je lahko v odobritev kliničnih preskušanj vključenih več organov.
In order to allow for effective and efficient cooperation between Member States, each Member State should designate one contact point.
Za uspešno in učinkovito sodelovanje med državami članicami bi morala vsaka država članica imenovati eno kontaktno točko.
The authorisation procedure set out in this Regulation is largely controlled by Member States.
Postopek odobritve, določen v tej uredbi, večinoma nadzirajo države članice.
Nevertheless, the Commission and the Agency should support the good functioning of that procedure, in accordance with this Regulation.
Kljub temu bi morali Komisija in Agencija v skladu s to uredbo podpirati neoviran potek tega postopka.
In order to carry out the activities provided for in this Regulation, Member States should be allowed to levy fees.
Za izvajanje dejavnosti iz te uredbe bi bilo treba državam članicam dovoliti zaračunavanje taks.
However, Member States should not require multiple payments to different bodies involved in the assessment, in a given Member State, of an application for authorisation of a clinical trial.
Vendar pa države članice ne bi smele zahtevati plačila taks več različnim organom, ki so v dani državi članici vključeni v ocenjevanje vloge za odobritev kliničnega preskušanja.
In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission in respect of the establishment and modification of rules on cooperation between the Member States when assessing the information provided by the sponsor on the Eudravigilance database and the specification of detailed arrangements for inspection procedures.
Za zagotovitev enotnih pogojev izvajanja te uredbe bi bilo treba na Komisijo prenesti izvedbena pooblastila v zvezi z vzpostavitvijo in spremembo pravil o sodelovanju med državami članicami, ko ocenjujejo informacije, ki jih zagotovijo sponzorji o: podatkovni zbirki EudraVigilance in podrobnostmi glede ureditev postopkov kontrol.
Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council [7].
Ta pooblastila bi bilo treba izvajati v skladu z Uredbo (EU) št. 182/2011 Evropskega parlamenta in Sveta [7].
In order to supplement or amend certain non-essential elements of this Regulation, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union (TFEU) should be delegated to the Commission in respect of: the amendment of Annexes I, II, IV and V to this Regulation in order to adapt them to technical progress or to take account of international regulatory developments in which the Union or the Member States are involved, in the field of clinical trials; the amendment of Annex III in order to improve the information on the safety of medicinal products, to adapt technical requirements to technical progress or to take account of international regulatory developments in the field of safety requirements in clinical trials endorsed by bodies in which the Union or the Member States participate; the specification of the principles and guidelines of good manufacturing practice and the detailed arrangements for inspection for ensuring the quality of investigational medicinal products; the amendment of Annex VI in order to ensure subject safety and the reliability and robustness of data generated in a clinical trial or to take account of technical progress.
Da bi dopolnili ali spremenili nekatere nebistvene določbe te uredbe, bi bilo treba na Komisijo prenesti pooblastilo, da v skladu s členom 290 Pogodbe o delovanju Evropske unije (TEU) sprejeme akte v zvezi: s spremembami Prilog I, II, IV in V k tej uredbi zaradi njihove prilagoditve tehničnemu napredku ali zaradi upoštevanja sprememb v mednarodnem ureditvenem okviru na področju kliničnega preskušanja, v katerem sodelujejo Unija in države članice; s spremembami Priloge III zaradi izboljšanja informacij o varnosti zdravil, prilagajanja tehničnih zahtev tehničnemu napredku ali zaradi upoštevanja spremembe v mednarodnem ureditvenem okviru na področju varnostnih zahtev pri kliničnem preskušanju, ki jih sprejmejo organi, v katerih sodeluje Unija ali države članice; z določitvijo načel in smernic za dobro proizvodno prakso in ureditev postopkov kontrol zaradi zagotavljanja kakovosti zdravil v preskušanju; s spremembami Priloge VI zaradi zagotavljanja varnosti udeleženca ter zanesljivosti in ponovljivosti podatkov iz kliničnega preskušanja ali zaradi upoštevanja tehničnega napredka.
Directive 2001/83/EC provides that that Directive does not affect the application of national legislation prohibiting or restricting the sale, supply or use of medicinal products as abortifacients.
Direktiva 2001/83/ES določa, da navedena direktiva ne vpliva na izvajanje nacionalne zakonodaje, ki prepoveduje ali omejuje prodajo, dobavo ali uporabo zdravil kot sredstev za prekinitev nosečnosti.
Directive 2001/83/EC provides that national legislation prohibiting or restricting the use of any specific type of human or animal cells is not, in principle, affected by either that Directive or any of the Regulations referred to therein.
Direktiva 2001/83/ES določa, da navedena direktiva in vse uredbe, ki so navedene v njej, načeloma ne vpliva na nacionalno zakonodajo, ki prepoveduje ali omejuje uporabo katere koli posebne vrste človeških ali živalskih celic.
Likewise, this Regulation should not affect national law prohibiting or restricting the use of any specific type of human or animal cells, or the sale, supply or use of medicinal products used as abortifacients.
Prav tako ta uredba ne bi smela vplivati na nacionalno pravo, ki prepoveduje ali omejuje uporabo katere koli posebne vrste človeških ali živalskih celic ali prodajo, dobavo ali uporabo zdravil za prekinitev nosečnosti.
Member States should communicate those national provisions to the Commission.
Primerno je, da se ta določba ohrani.
Directive 2001/20/EC provides that no gene therapy trials may be carried out which result in modifications to the subject's germ line genetic identity.
Direktiva Evropskega parlamenta in Sveta 95/46/ES [8] se uporablja, pod nadzorom pristojnih organov držav članic, zlasti javnih neodvisnih organov, ki jih imenujejo države članice, za obdelavo osebnih podatkov v okviru te uredbe v državah članicah, Uredba (ES) št. 45/2001 Evropskega parlamenta in Sveta [9] pa se pod nadzorom Evropskega nadzornika za varstvo podatkov uporablja za obdelavo osebnih podatkov v okviru te uredbe na Komisiji in v Agenciji.
It is appropriate to maintain that provision.
Ti instrumenti krepijo pravice do varstva osebnih podatkov, vključno s pravico do dostopa, popravka in umika, obenem pa opredeljujejo situacije, ko je mogoče te pravice omejiti.
Directive 95/46/EC of the European Parliament and of the Council [8] applies to the processing of personal data carried out in the Member States within the framework of this Regulation, under the supervision of the Member States competent authorities, in particular the public independent authorities designated by the Member States and Regulation (EC) No 45/2001 of the European Parliament and of the Council [9] applies to the processing of personal data carried out by the Commission and the Agency within the framework of this Regulation, under the supervision of the European Data Protection Supervisor.
Da bi upoštevali te pravice, hkrati pa zaščito zanesljivosti in ponovljivosti podatkov iz kliničnih preskušanj, uporabljenih za znanstvene namene, ter varnost udeležencev kliničnih preskušanj, je primerno zagotoviti, da brez poseganja v Direktivo 95/46/ES preklic prostovoljne privolitve po poučitvi ne bi smel vplivati na rezultate že izvedenih dejavnosti, na primer na shranjevanje in uporabo podatkov, pridobljenih na podlagi prostovoljne privolitve po poučitvi pred njenim preklicem.
Those instruments strengthen personal data protection rights, encompassing the right to access, rectification and withdrawal, as well as specify the situations when restriction on those rights may be imposed.
Udeleženci ne bi smeli plačevati zdravil v preskušanju, pomožnih zdravil, medicinskih pripomočkov za dajanje zdravil in postopkov, ki jih protokol izrecno zahteva, razen če je v pravu zadevne države članice določeno drugače.
With a view to respecting those rights, while safeguarding the robustness and reliability of data from clinical trials used for scientific purposes and the safety of subjects participating in clinical trials, it is appropriate to provide that, without prejudice to Directive 95/46/EC, the withdrawal of informed consent should not affect the results of activities already carried out, such as the storage and use of data obtained on the basis of informed consent before withdrawal.
Postopek odobritve iz te uredbe bi se moral začeti uporabljati čim prej, da bodo sponzorji lahko izkoristili prednosti poenostavljenega postopka odobritve.
Subjects should not have to pay for investigational medicinal products, auxiliary medicinal products, medical devices used for their administration and procedures specifically required by the protocol, unless the law of the Member State concerned provides otherwise.
Zaradi pomena obsežnih funkcionalnosti informacijske tehnologije, potrebnih za postopek odobritve, pa je vseeno primerno predvideti, da bi morala ta Uredba začeti veljati šele, ko bo potrjeno, da portal EU in podatkovna zbirka EU v celoti delujeta.
The authorisation procedure set out in this Regulation should apply as soon as possible, in order for sponsors to reap the benefits of a streamlined authorisation procedure.
Direktivo 2001/20/ES bi bilo treba razveljaviti, da se zagotovi uporaba samo enega sklopa pravil za izvajanje kliničnih preskušanj v Uniji.
However, in view of the importance of the extensive IT functionalities required for the authorisation procedure, it is appropriate to provide that this Regulation should only become applicable once it has been verified that the EU portal and the EU database are fully functional.
Zaradi lažjega prehoda na pravila iz te uredbe bi bilo treba sponzorjem v prehodnem obdobju omogočiti, da začnejo in izvajajo klinično preskušanje v skladu z Direktivo 2001/20/ES.
Directive 2001/20/EC should be repealed to ensure that only one set of rules applies to the conduct of clinical trials in the Union.
Ta uredba je v skladu z glavnimi mednarodnimi smernicami o kliničnih preskušanjih, kot je različica Helsinške deklaracije Svetovne zdravniške organizacije iz leta 2008, in smernicami za dobro klinično prakso, ki prav tako temeljijo na Helsinški deklaraciji.
In order to facilitate the transition to the rules set out in this Regulation, sponsors should be allowed to start and conduct a clinical trial in accordance with Directive 2001/20/EC during a transitional period.
Izkušnje v zvezi z Direktivo 2001/20/ES kažejo tudi, da velik del kliničnih preskušanj izvajajo nekomercialni sponzorji.
This Regulation is in line with the major international guidance documents on clinical trials, such as the 2008 version of the World Medical Association's Declaration of Helsinki and good clinical practice, which has its origins in the Declaration of Helsinki.
Nekomercialni sponzorji so pogosto odvisni od financiranja, ki delno ali v celoti izhaja iz javnih sredstev ali dobrodelnih organizacij.
As regards Directive 2001/20/EC, experience also shows that a large proportion of clinical trials are conducted by non-commercial sponsors.
Da bi bil dragoceni prispevek takih nekomercialnih sponzorjev čim bolj izkoriščen in da bi se njihovo raziskovanje še naprej spodbujalo, vendar brez ogrožanja kakovosti kliničnih preskušanj, bi morale države članice sprejeti ukrepe za spodbujanje kliničnih preskušanj, ki jih izvajajo ti sponzorji.
Non-commercial sponsors frequently rely on funding which comes partly or entirely from public funds or charities.
Ta uredba temelji na dvojni pravni podlagi členov 114 in 168(4)(c) PDEU.
In order to maximise the valuable contribution of such non-commercial sponsors and to further stimulate their research but without compromising the quality of clinical trials, measures should be taken by Member States to encourage clinical trials conducted by those sponsors.
Njen cilj je vzpostavitev notranjega trga za klinična preskušanja in zdravila za uporabo v humani medicini na visoki stopnji varovanja zdravja.
This Regulation is based on the double legal basis of Articles 114 and 168(4)(c) TFEU.
Gre za doseganje obeh ciljev hkrati.
Both objectives are being pursued simultaneously.
Poleg tega ta uredba določa visoke standarde kakovosti in varnosti zdravil, ki se uporabljajo pri kliničnem preskušanju, s čimer se zagotovi varnost udeležencev v kliničnem preskušanju.
These two objectives are inseparably linked and one is not secondary to another.
Ta uredba spoštuje temeljne pravice in upošteva načela, ki jih priznava zlasti Listina, med njimi zlasti človekovo dostojanstvo, pravico do osebne celovitosti, otrokove pravice, spoštovanje zasebnega in družinskega življenja, varstvo osebnih podatkov in svobodo umetnosti in znanosti.
Regarding Article 114 TFEU, this Regulation harmonises the rules for the conduct of clinical trials in the Union, therefore ensuring the functioning of the internal market in view of the conduct of a clinical trial in several Member States, the acceptability throughout the Union of data generated in a clinical trial and submitted in the application for the authorisation of another clinical trial or of the placing on the market of a medicinal product, and the free movement of medicinal products used in the context of a clinical trial.
Države članice bi morale to uredbo uporabljati v skladu s temi pravicami in načeli.
Regarding Article 168(4)(c) TFEU, this Regulation sets high standards of quality and safety for medicinal products by ensuring that data generated in clinical trials are reliable and robust, thus ensuring that treatments and medicines which are intended to be an improvement of a treatment of patients build on reliable and robust data.
Evropski nadzornik za varstvo podatkov je podal mnenje [10] v skladu s členom 28(2) Uredbe (ES) št. 45/2001.
Moreover, this Regulation sets high standards of quality and safety of medicinal products used in the context of a clinical trial, thus ensuring the safety of subjects in a clinical trial.
Ker cilja te uredbe, in sicer zagotoviti zanesljivost in ponovljivost podatkov iz kliničnega preskušanja ter hkrati zagotoviti spoštovanje pravic, varnosti, dostojanstva in dobrobiti udeležencev po vsej Uniji, države članice ne morejo zadovoljivo doseči, temveč se ga zaradi njegovega obsega lažje doseže na ravni Unije, lahko Unija sprejme ukrepe v skladu z načelom subsidiarnosti iz člena 5 Pogodbe o Evropski uniji.
This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter and notably human dignity, the integrity of the person, the rights of the child, respect for private and family life, the protection of personal data and the freedom of art and science.
V skladu z načelom sorazmernosti iz navedenega člena ta uredba ne presega tistega, kar je potrebno za doseganje navedenega cilja –
This Regulation should be applied by the Member States in accordance with those rights and principles.
SPREJELA NASLEDNJO UREDBO:
The European Data Protection Supervisor has given an opinion [10] pursuant to Article 28(2) of Regulation (EC) No 45/2001.
POGLAVJE I
Since the objective of this Regulation, namely to ensure that, throughout the Union, clinical trial data are reliable and robust while ensuring respect for the rights, safety, dignity and well-being of subjects, cannot be sufficiently achieved by the Member States but can rather, by reason of its scale, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union.
SPLOŠNE DOLOČBE
In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective,
Člen 1
HAVE ADOPTED THIS REGULATION:
Področje uporabe
CHAPTER I
Ta uredba se uporablja za vsa klinična preskušanja, ki se izvajajo v Uniji.
GENERAL PROVISIONS
Ne uporablja se za neintervencijske študije.
Scope
Opredelitev pojmov
This Regulation applies to all clinical trials conducted in the Union.
V tej uredbi se uporabljajo opredelitve pojmov „zdravilo“, „radiofarmacevtski izdelek (radiofarmak)“, „neželeni učinek“, „resen neželeni učinek“, „stična ovojnina“ in „zunanja ovojnina“ iz točk (2), (6), (11), (12), (23) oziroma (24) člena 1 Direktive 2001/83/ES.
It does not apply to non-interventional studies.
V tej uredbi se uporabljajo tudi naslednje opredelitve pojmov:
Article 2
„klinična študija“ pomeni katero koli raziskavo na ljudeh, namenjeno:
Definitions
ugotavljanju ali preverjanju kliničnih, farmakoloških ali drugih farmakodinamičnih učinkov enega ali več zdravil;
For the purposes of this Regulation, the definitions of ‘medicinal product’, ‘radiopharmaceutical’, ‘adverse reaction’, ‘serious adverse reaction’, ‘immediate packaging’ and ‘outer packaging’ set out in points (2), (6), (11), (12), (23) and (24), respectively, of Article 1 of Directive 2001/83/EC apply.
ugotavljanju morebitnih neželenih učinkov enega ali več zdravil, ali
For the purposes of this Regulation, the following definitions also apply:
preučevanju absorpcije, porazdelitve, metabolizma in izločanja enega ali več zdravil
‘Clinical study’ means any investigation in relation to humans intended:
zaradi zagotovitve varnosti in/ali učinkovitosti teh zdravil;
to discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more medicinal products;
„klinično preskušanje“ pomeni klinično študijo, ki izpolnjuje katerega koli od naslednjih pogojev:
to identify any adverse reactions to one or more medicinal products; or
strategija zdravljenja je za udeleženca določena že vnaprej in ni zajeta z običajno klinično prakso zadevne države članice;
to study the absorption, distribution, metabolism and excretion of one or more medicinal products;
odločitev o predpisovanju zdravil v preskušanju in odločitev o vključitvi udeleženca v klinično študijo se sprejmeta istočasno, ali
with the objective of ascertaining the safety and/or efficacy of those medicinal products;
za udeležence so predvidene dodatne preiskave ali spremljanje, ki ne sodijo v običajno klinično prakso;
‘Clinical trial’ means a clinical study which fulfils any of the following conditions:
„klinično preskušanje z minimalno intervencijo“ pomeni klinično preskušanje, ki izpolnjuje vse naslednje pogoje:
the assignment of the subject to a particular therapeutic strategy is decided in advance and does not fall within normal clinical practice of the Member State concerned;
zdravila v preskušanju razen placeba, ki so odobrena;
the decision to prescribe the investigational medicinal products is taken together with the decision to include the subject in the clinical study; or
v skladu s protokolom kliničnega preskušanja:
diagnostic or monitoring procedures in addition to normal clinical practice are applied to the subjects.
se zdravila v preskušanju uporabljajo v skladu s pogoji dovoljenja za promet ali
‘Low-intervention clinical trial’ means a clinical trial which fulfils all of the following conditions:
uporaba zdravil v preskušanju temelji na dokazih in je podprta z objavljenimi dokazi o varnosti in učinkovitosti teh zdravil v preskušanju v kateri koli zadevni državi članici in
the investigational medicinal products, excluding placebos, are authorised;
dodatne preiskave ali postopki spremljanja predstavljajo le minimalno dodatno tveganje za varnost udeleženca ali minimalno dodatno ogrožanje varnosti udeleženca v primerjavi z običajno klinično prakso v kateri koli zadevni državi članici;
according to the protocol of the clinical trial,
„neintervencijska študija“ pomeni klinično študijo, ki ni klinično preskušanje;
the investigational medicinal products are used in accordance with the terms of the marketing authorisation; or
„zdravilo v preskušanju“ pomeni zdravilo, ki se v kliničnem preskušanju preskuša ali uporablja kot primerjalno zdravilo, vključno s placebom;
the use of the investigational medicinal products is evidence-based and supported by published scientific evidence on the safety and efficacy of those investigational medicinal products in any of the Member States concerned; and
„običajna klinična praksa“ pomeni režim zdravljenja, ki se običajno uporablja za zdravljenje, preprečevanje ali diagnosticiranje bolezni ali motnje;
the additional diagnostic or monitoring procedures do not pose more than minimal additional risk or burden to the safety of the subjects compared to normal clinical practice in any Member State concerned;
„zdravilo za napredno zdravljenje v preskušanju“ pomeni zdravilo v preskušanju, ki je zdravilo za napredno zdravljenje, kot je opredeljeno v točki (a) člena 2(1) Uredbe (ES) št. 1394/2007 Evropskega parlamenta in Sveta [11];
‘Non-interventional study’ means a clinical study other than a clinical trial;
„pomožno zdravilo“ pomeni zdravilo, ki se uporablja za potrebe kliničnega preskušanja, kot je opisano v protokolu, vendar ne kot zdravilo v preskušanju;
‘Investigational medicinal product’ means a medicinal product which is being tested or used as a reference, including as a placebo, in a clinical trial;
„odobreno zdravilo v preskušanju“ pomeni zdravilo, odobreno v skladu z Uredbo (ES) št. 726/2004 ali v kateri koli zadevni državi članici v skladu z Direktivo 2001/83/ES, ne glede na spremembe v označevanju zdravila, ki se uporablja kot zdravilo v preskušanju;
‘Normal clinical practice’ means the treatment regime typically followed to treat, prevent, or diagnose a disease or a disorder;
„odobreno pomožno zdravilo“ pomeni zdravilo, odobreno v skladu z Uredbo (ES) št. 726/2004 ali v kateri koli zadevni državi članici v skladu z Direktivo 2001/83/ES, ne glede na spremembe v označevanju zdravila, ki se uporablja kot pomožno zdravilo;
‘Advanced therapy investigational medicinal product’ means an investigational medicinal product which is an advanced therapy medicinal product as defined in point (a) of Article 2(1) of Regulation (EC) No 1394/2007 of the European Parliament and of the Council [11];
„odbor za etiko“ pomeni neodvisno telo, ustanovljeno v državi članici, v skladu s pravom te države članice in pooblaščeno za dajanje mnenj za namene te uredbe, ki pri svojem delu upošteva stališča nestrokovnjakov, zlasti pacientov ali organizacij pacientov;