natgillin/translations-raw huggingface dataset:
The EU database shall be established to enable cooperation between the competent authorities of the Member States concerned to the extent that it is necessary for the application of this Regulation and to search for specific clinical trials.
Kadar se v kliničnem preskušanjem uporablja zdravilo v preskušanju, ki že ima dovoljenje za promet v Uniji in/ali aktivna snov, ki je del zdravila z dovoljenjem za promet v Uniji, se v vlogi za klinično preskušanje sklicuje na ustrezno številko zdravila in aktivne snovi.
It shall also facilitate the communication between sponsors and Member States concerned and enable sponsors to refer to previous submissions of an application for authorisation of a clinical trial or a substantial modification.
Podatkovna zbirka EU je javno dostopna, razen če je vse ali del podatkov in informacij iz podatkovne zbirke upravičeno treba obravnavati zaupno iz naslednjih razlogov:
It shall also enable citizens of the Union to have access to clinical information about medicinal products.
varovanja osebnih podatkov v skladu z Uredbo (ES) št. 45/2001;
To this end all data held in the EU database shall be in an easily searchable format, all related data shall be grouped together by way of the EU trial number, and hyperlinks shall be provided to link together related data and documents held on the EU database and other databases managed by the Agency.
varovanja poslovno zaupnih informacij, predvsem z upoštevanjem statusa dovoljenja za promet z zdravilom, razen če ne prevlada javni interes za razkritje;
The EU database shall support the recording and submission to the Medicinal Product Dictionary, contained in the Eudravigilance database, of all the data on medicinal products without a marketing authorisation in the Union and substances not authorised as part of a medicinal product in the Union, that are necessary for the maintenance of that dictionary.
varovanja zaupne komunikacije med državami članicami v zvezi s pripravo poročila o oceni;
To this effect and also with the purpose of enabling the sponsor to cross-refer to prior applications, an EU medicinal product number shall be issued for every medicinal product without a marketing authorisation and an EU active substances code shall be issued for each new active substance not previously authorised as part of a medicinal product in the Union.
zagotavljanja učinkovitega nadzora s strani držav članic nad izvajanjem kliničnega preskušanja.
This shall be done before or during the application for authorisation of the first clinical trial with that product or active substance submitted in accordance with this Regulation.
Brez poseganja v odstavek 4 podatki v dosjeju vloge pred odločitvijo o kliničnem preskušanju niso javno dostopni, razen če prevlada javni interes za razkritje.
Those numbers shall be mentioned in all subsequent applications for clinical trials and for substantial modifications.
Podatkovna zbirka EU vsebuje osebne podatke le, v kolikor je to potrebno za namene iz odstavka 2.
The data submitted, in accordance with the first subparagraph, describing medicinal products and substances shall comply with Union and international standards for the identification of medicinal products and active substances.
Nobeni osebni podatki udeležencev niso javno dostopni.
When an investigational medicinal product which already has a marketing authorisation in the Union and/or an active substance which is part of a medicinal product with a marketing authorisation in the Union, is to be used in a clinical trial, the relevant product and active substance numbers shall be referred to in the application for that clinical trial.
Uporabniški vmesnik podatkovne zbirke EU je na voljo v vseh uradnih jezikih Unije.
The EU database shall be publicly accessible unless, for all or part of the data and information contained therein, confidentiality is justified on any of the following grounds:
Sponzor v podatkovni zbirki EU nenehno posodablja informacije o vseh spremembah kliničnih preskušanj, ki niso bistvene spremembe, vendar so relevantne za nadzor kliničnega preskušanja s strani zadevnih držav članic.
protecting personal data in accordance with Regulation (EC) No 45/2001;
Komisija, Agencija in države članice zagotovijo, da lahko udeleženec, na katerega se podatki nanašajo, učinkovito uveljavlja svoje pravice do informacij, dostopa, popravka in ugovora v skladu z Uredbo (ES) št. 45/2001 oziroma nacionalno zakonodajo na področju varstva podatkov za izvajanje Direktive 95/46/ES.
protecting commercially confidential information, in particular through taking into account the status of the marketing authorisation for the medicinal product, unless there is an overriding public interest in disclosure;
Zagotovijo, da lahko udeleženec, na katerega se podatki nanašajo, učinkovito uveljavlja pravico dostopa do podatkov, ki se nanašajo nanj, in ima pravico zahtevati, da se nepravilni ali nepopolni podatki popravijo ali izbrišejo.
protecting confidential communication between Member States in relation to the preparation of the assessment report;
Komisija, Agencija in države članice v okviru svojih pristojnosti zagotovijo, da se nepravilno in nezakonito obdelani podatki izbrišejo v skladu z veljavnim pravom.
ensuring effective supervision of the conduct of a clinical trial by Member States.
Nepravilne podatke se popravi in izbriše čim prej, vendar najpozneje v 60 dneh od take zahteve udeleženca, na katerega se podatki nanašajo.
Without prejudice to paragraph 4, unless there is an overriding public interest in disclosure, data contained in the application dossier shall not be publicly accessible before the decision on the clinical trial has been made.
Člen 82
The EU database shall contain personal data only insofar as this is necessary for the purposes of paragraph 2.
Funkcije portala EU in podatkovne zbirke EU
No personal data of subjects shall be publicly accessible.
Agencija v sodelovanju z državami članicami in Komisijo pripravi funkcijske specifikacije za portal EU in podatkovno zbirko EU in roke za njihovo izvedbo.
The user interface of the EU database shall be available in all official languages of the Union.
Ko upravni odbor Agencije preveri, da portal in podatkovna zbirka EU polno delujeta in da sistemi izpolnjujejo funkcijske specifikacije iz odstavka 1, na podlagi neodvisnega revizijskega poročila o tem obvesti Komisijo.
The sponsor shall permanently update in the EU database information on any changes to the clinical trials which are not substantial modifications but are relevant for the supervision of the clinical trial by the Member States concerned.
Ko Komisija ugotovi, da so pogoji iz odstavka 2 izpolnjeni, v Uradnem listu Evropske unije objavi obvestilo o tem.
The Agency, the Commission and Member States shall ensure that the data subject may effectively exercise his or her rights to information, to access, to rectify and to object in accordance with Regulation (EC) No 45/2001 and national data protection legislation implementing Directive 95/46/EC, respectively.
POGLAVJE XV
They shall ensure that the data subject may effectively exercise the right of access to data relating to him or her, and the right to have inaccurate or incomplete data corrected or erased.
SODELOVANJE MED DRžAVAMI ČLANICAMI
Within their respective responsibilities, the Agency, the Commission and Member States shall ensure that inaccurate and unlawfully processed data are deleted, in accordance with the applicable law.
Člen 83
Corrections and deletions shall be carried out as soon as possible, but no later than 60 days of a request being made by a data subject.
Nacionalne kontaktne točke
Article 82
Vsaka država članica določi eno nacionalno kontaktno točko, da se olajšajo postopki iz poglavij II in III.
Functionality of the EU portal and the EU database
Država članica sporoči to kontaktno točko iz odstavka 1 Komisiji.
The Agency shall, in collaboration with the Member States and the Commission, draw up the functional specifications for the EU portal and the EU database, together with the time frame for their implementation.
Komisija objavi seznam nacionalnih kontaktnih točk.
The Management Board of the Agency shall, on the basis of an independent audit report, inform the Commission when it has verified that the EU portal and the EU database have achieved full functionality and the systems meet the functional specifications drawn up pursuant to paragraph 1.
Člen 84
The Commission shall, when it is satisfied that the conditions referred to in paragraph 2 have been fulfilled, publish a notice to that effect in the Official Journal of the European Union.
Podpora Agencije in Komisije
CHAPTER XV
Agencija podpira sodelovanje med državami članicami pri postopkih odobritve iz poglavij II in III te uredbe, tako da vzdržuje in posodablja portal EU in podatkovno zbirko EU v skladu z izkušnjami, pridobljenimi med izvajanjem te uredbe.
COOPERATION BETWEEN MEMBER STATES
Komisija podpira sodelovanje med državami članicami iz člena 44(2).
National contact points
Koordinacijska in svetovalna skupina za klinično preskušanje
Each Member State shall designate one national contact point in order to facilitate the functioning of the procedures set out in Chapters II and III.
Ustanovi se koordinacijska in svetovalna skupina za klinično preskušanje (v nadaljnjem besedilu: skupina), ki jo sestavljajo nacionalne kontaktne točke iz člena 83.
Each Member State shall communicate the contact point referred to in paragraph 1 to the Commission.
Skupina opravlja naslednje naloge:
The Commission shall publish a list of the national contact points.
podpira izmenjavo informacij med državami članicami in Komisijo o izkušnjah pri izvajanju te uredbe;
Article 84
pomaga Komisiji pri zagotavljanju podpore iz drugega pododstavka člena 84;
Support by the Agency and the Commission
pripravlja priporočila o merilih za izbor države članice poročevalke.
The Agency shall support the functioning of the cooperation of the Member States in the framework of the authorisation procedures set out in Chapters II and III of this Regulation by maintaining and updating the EU portal and the EU database in accordance with the experience acquired during the implementation of this Regulation.
Skupini predseduje predstavnik Komisije.
The Commission shall support the functioning of the cooperation of the Member States referred to in Article 44(2).
Skupina se sestaja redno in po potrebi na zahtevo Komisije ali države članice.
Article 85
Vse točke srečanja se uvrstijo na dnevni red na zahtevo Komisije ali države članice.
Clinical Trials Coordination and Advisory Group
Tajniško osebje zagotovi Komisija.
A Clinical Trials Coordination and Advisory Group (CTAG), composed of the national contact points referred to in Article 83 is hereby established.
Skupina sprejme svoj poslovnik.
The CTAG shall have the following tasks:
Poslovnik se objavi.
to support the exchange of information between the Member States and the Commission on the experience acquired with regard to the implementation of this Regulation;
POGLAVJE XVI
to assist the Commission in providing the support referred to in the second paragraph of Article 84;
TAKSE
to prepare recommendations on criteria regarding the selection of a reporting Member State.
Člen 86
The CTAG shall be chaired by a representative of the Commission.
Ta uredba ne posega v možnost držav članic, da zaračunajo takse za dejavnosti iz te uredbe, če se višina takse določi na pregleden način in na podlagi načela povračila stroškov.
The CTAG shall meet at regular intervals and whenever the situation requires, on a request from the Commission or a Member State.
Države članice lahko določijo znižane takse za nekomercialna klinična preskušanja.
Any item of the agenda of the meeting shall be placed at the request of the Commission or a Member State.
Člen 87
The secretariat shall be provided by the Commission.
Ena plačilo na dejavnost na državo članico
The CTAG shall draw up its rules of procedure.
Država članica za oceno iz poglavij II in III ne zahteva več plačil različnim organom, ki sodelujejo pri oceni.
The rules of procedure shall be made public.
POGLAVJE XVII
CHAPTER XVI
IZVEDBENI IN DELEGIRANI AKTI
FEES
Člen 88
Article 86
Postopek v odboru
This Regulation shall be without prejudice to the possibility for Member States to levy a fee for the activities set out in this Regulation, provided that the level of the fee is set in a transparent manner and on the basis of cost recovery principles.
Komisiji pomaga Stalni odbor za zdravila za uporabo v humani medicini, ustanovljen z Direktivo 2001/83/ES.
Member States may establish reduced fees for non-commercial clinical trials.
Ta odbor je odbor v smislu Uredbe (EU) št. 182/2011.
Article 87
Pri sklicevanju na ta odstavek se uporablja člen 5 Uredbe (EU) št. 182/2011.
One payment per activity per Member State
Kadar odbor ne poda mnenja, Komisija osnutka izvedbenega akta ne sprejme in se uporabi tretji pododstavek člena 5(4) Uredbe (EU) št. 182/2011.
A Member State shall not require, for an assessment as referred to in Chapters II and III, multiple payments to different bodies involved in this assessment.
Člen 89
CHAPTER XVII
Izvajanje pooblastila
IMPLEMENTING ACTS AND DELEGATED ACTS
Pooblastilo za sprejemanje delegiranih aktov je preneseno na Komisijo pod pogoji, določenimi v tem členu.
Article 88
Pooblastilo za sprejemanje delegiranih aktov iz členov 27, 39, 45, 63(1) in 70 se prenese na Komisijo za obdobje petih let od datuma iz drugega odstavka člena 99.
Committee procedure
Komisija pripravi poročilo o prenesenem pooblastilu najpozneje šest mesecev pred koncem petletnega obdobja.
The Commission shall be assisted by the Standing Committee on Medicinal Products for Human Use established by Directive 2001/83/EC.
Prenos pooblastila se samodejno podaljša za enako obdobje, razen če Evropski parlament ali Svet nasprotuje temu podaljšanju najpozneje tri mesece pred koncem vsakega obdobja.
That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.
Pooblastilo iz členov 27, 39, 45, 63(1) in 70 lahko kadar koli prekliče Evropski parlament ali Svet.
Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
Z odločitvijo o preklicu preneha veljati prenos pooblastila, naveden v tej odločitvi.
Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply.
Odločitev začne učinkovati dan po njeni objavi v Uradnem listu Evropske unije ali na poznejši dan, ki je v njej določen.
Article 89
Odločitev ne vpliva na veljavnost že veljavnih delegiranih aktov.
Exercise of the delegation
Takoj ko Komisija sprejme delegirani akt, o tem istočasno uradno obvesti Evropski parlament in Svet.
The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
Delegirani akt, sprejet v skladu s členi 27, 39, 45, 63(1) in 70, začne veljati le, če niti Evropski parlament niti Svet ne nasprotuje delegiranemu aktu v roku dveh mesecev od uradnega obvestila Evropskemu parlamentu ali Svetu o tem aktu ali če sta pred iztekom tega roka tako Evropski parlament kot Svet obvestila Komisijo, da mu ne bosta nasprotovala.
The power to adopt delegated acts referred to in Articles 27, 39, 45, 63(1) and 70 shall be conferred on the Commission for a period of five years from the date referred to in the second paragraph of Article 99.
Ta rok se na pobudo Evropskega parlamenta ali Sveta podaljša za dva meseca.
The Commission shall draw up a report in respect of the delegated powers not later than six months before the end of the five year period.
POGLAVJE XVIII
The delegation of powers shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
RAZNE DOLOČBE
The delegation of power referred to in Articles 27, 39, 45, 63(1) and 70 may be revoked at any time by the European Parliament or by the Council.
Člen 90
A decision of revocation shall put an end to the delegation of the power specified in that decision.
Posebne zahteve za posebne skupine zdravil
It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein.
Ne smejo se izvajati nobena klinična preskušanja z genskim zdravljenjem, ki bi povzročila spremembe genoma v zarodni liniji udeleženca.
It shall not affect the validity of any delegated acts already in force.
Člen 91
As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
Povezava z drugo zakonodajo Unije
A delegated act adopted pursuant to Articles 27, 39, 45, 63(1) and 70 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months from notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object.
Ta uredba ne posega v Direktivo Sveta 97/43/Euratom [13], Direktivo Sveta 96/29/Euratom [14], Direktivo 2001/18/ES Evropskega parlamenta in Sveta [15], Direktivo 2004/23/ES Evropskega parlamenta in Sveta [16], Direktivo 2002/98/ES Evropskega parlamenta in Sveta [17], Direktivo 2010/53/ES Evropskega parlamenta in Sveta [18] in Direktivo 2009/41/ES Evropskega parlamenta in Sveta [19].Člen 92
That period shall be extended by two months at the initiative of the European Parliament or the Council.
Brezplačnost zdravil v preskušanju, drugih zdravil in postopkov za udeleženca
MISCELLANEOUS PROVISIONS
Člen 93
Article 90
Varstvo podatkov
Specific requirements for special groups of medicinal products
Države članice za obdelavo osebnih podatkov v državah članicah v skladu s to uredbo uporabljajo Direktivo 95/46/ES.
This Regulation shall not affect the application of 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 containing, consisting of or derived from those cells, or of medicinal products used as abortifacients or of medicinal products containing narcotic substances within the meaning of the relevant international conventions in force such as the Single Convention on Narcotic Drugs of 1961 of the United Nations.
Komisija in Agencija za obdelavo osebnih podatkov v skladu s to uredbo uporabljata Uredbo (ES) št. 45/2001.
The Member States shall communicate that national law to the Commission.
Člen 94
No gene therapy clinical trials may be carried out which result in modifications to the subject's germ line genetic identity.
Kazni
Article 91
Države članice določijo pravila o kaznih za kršitve te uredbe in sprejmejo vse potrebne ukrepe za zagotovitev njihovega izvajanja.
Relation with other Union legislation
Kazni so učinkovite, sorazmerne in odvračilne.
This Regulation shall be without prejudice to Council Directive 97/43/Euratom [13], Council Directive 96/29/Euratom [14], Directive 2001/18/EC of the European Parliament and of the Council [15], Directive 2004/23/EC of the European Parliament and of the Council [16], Directive 2002/98/EC of the European Parliament and of the Council [17], Directive 2010/53/EC of the European Parliament and of the Council [18], and Directive 2009/41/EC of the European Parliament and of the Council.
Pravila iz odstavka 1 med drugim obravnavajo naslednje:
[19]Article 92
neupoštevanje določb te uredbe o predložitvi informacij, ki so namenjene javni objavi v podatkovni zbirki EU;
Investigational medicinal products, other products and procedures, free of charge for the subject
neupoštevanje določb te uredbe o varnosti udeležencev.
Without prejudice to the Member States' competence for the definition of their health policy and for the organisation and delivery of health services and medical care, the costs for investigational medicinal products, auxiliary medicinal products, medical devices used for their administration and procedures specifically required by the protocol shall not be borne by the subject, unless the law of the Member State concerned provides otherwise.
Člen 95
Article 93
Civilna in kazenska odgovornost
Data protection
Ta uredba ne posega v nacionalno pravo in pravo Unije glede civilne in kazenske odgovornosti sponzorja ali raziskovalca.
Member States shall apply Directive 95/46/EC to the processing of personal data carried out in the Member States pursuant to this Regulation.
POGLAVJE XIX
Regulation (EC) No 45/2001 shall apply to the processing of personal data carried out by the Commission and the Agency pursuant to this Regulation.
KONČNE DOLOČBE
Article 94
Člen 96
Penalties
Razveljavitev
Member States shall lay down rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented.
Direktiva 2001/20/ES se razveljavi od datuma iz drugega odstavka člena 99.
The penalties provided for shall be effective, proportionate and dissuasive.
Sklicevanja na Direktivo 2001/20/ES se štejejo za sklicevanja na to uredbo in se berejo v skladu s korelacijsko tabelo iz Priloge VII.
The rules referred to in paragraph 1 shall address, inter alia, the following:
Člen 97
non-compliance with the provisions laid down in this Regulation on submission of information intended to be made publicly available to the EU database;
Pregled
non-compliance with the provisions laid down in this Regulation on subject safety.
Komisija Evropskemu parlamentu in Svetu v petih letih po datumu iz drugega odstavka člena 99 in nato vsakih pet let predloži poročilo o izvajanju te uredbe.
Article 95
To poročilo vsebuje oceno učinka uredbe na znanstveni in tehnološki napredek, celovite informacije o različnih vrstah kliničnih preskušanj, odobrenih v skladu s to uredbo, ter potrebne ukrepe za ohranitev konkurenčnosti evropskih kliničnih raziskav.
Civil and criminal liability
Če je ustrezno, Komisija na podlagi poročila pripravi zakonodajni predlog za posodobitev določb te uredbe.
This Regulation is without prejudice to national and Union law on the civil and criminal liability of a sponsor or an investigator.
Člen 98
CHAPTER XIX
Prehodna določba
FINAL PROVISIONS
Z odstopanjem od člena 96 (1) te uredbe klinično preskušanje, za katerega je bila vloga za odobritev predložena pred datumom iz drugega odstavka člena 99 te uredbe v skladu z Direktivo 2001/20/ES do tri leta od datuma iz tega odstavka še vedno ureja navedena direktiva.
Article 96
Z odstopanjem od člena 96(1) te uredbe se lahko klinično preskušanje, za katerega je bila vloga za odobritev predložena od šest mesecev po objavi obvestila iz člena 82(3) te uredbe in 18 mesecev po objavi tega obvestila, ali – če do objave obvestila pride pred 28. novembrom 2015 – med 28. majem 2016 in 28. majem 2017, začne v skladu s členi 6, 7 in 9 Direktive 2001/20/ES.
Repeal
To klinično preskušanje še naprej ureja navedena direktiva do 42 mesecev po objavi obvestila iz člena 82(3) te uredbe, ali – če do objave pride pred 28. novembrom 2015 – do 28. maja 2019.
Directive 2001/20/EC is repealed as from the date referred to in the second paragraph of Article 99.
Člen 99
References to Directive 2001/20/EC shall be construed as references to this Regulation and shall be read in accordance with the correlation table laid down in Annex VII.
Začetek veljavnosti
Article 97
Ta uredba začne veljati dvajseti dan po objavi v Uradnem listu Evropske unije.
Review
Uporablja se od šestih mesecev po objavi obvestila iz člena 82(3), nikakor pa ne pred 28. majem 2016.
Five years after the date referred to in the second paragraph of Article 99, and every five years thereafter, the Commission shall present a report to the European Parliament and to the Council on the application of this Regulation.
Ta uredba je v celoti zavezujoča in se neposredno uporablja v vseh državah članicah.