natgillin/translations-raw huggingface dataset:
appointing experts to accompany inspectors, if additional expertise is required for an inspection;
imenovanje strokovnjakov za spremljanje inšpektorjev, če je za inšpekcijski pregled potrebno dodatno strokovno znanje;
arranging inspections outside the Union;
pripravo inšpekcijskih pregledov zunaj Unije;
verification of good clinical practice compliance, including the modalities for examining the study management procedures and the conditions under which the clinical trial is planned, performed, monitored and recorded, as well as follow-up measures, such as a review of an analysis of the root cause of a significant non-compliance and verification of corrective and preventive actions implemented by the sponsor.
preverjanje skladnosti z dobro klinično prakso, vključno z načini za pregledovanje postopkov za upravljanje študije in pogoji, pod katerimi se klinično preskušanje načrtuje, izvaja, spremlja in evidentira, ter nadaljnjih ukrepov, kot sta pregled analize temeljnega vzroka za znatno neskladnost ter preverjanje korektivnih in preventivnih ukrepov, ki jih je izvedel sponzor.
Member States shall make those procedures and rules publicly available.
Države članice zagotovijo javno dostopnost teh postopkov in pravil.
Member States shall also define the powers of experts appointed to accompany inspectors.
Države članice tudi določijo pristojnosti strokovnjakov, imenovanih za spremljanje inšpektorjev.
The inspections may, where necessary, be carried out unannounced.
Inšpekcijski pregledi se lahko po potrebi izvedejo nenapovedano.
Collaboration between Member States
Sodelovanje med državami članicami
Member States shall collaborate with each other, with the Commission and with the European Medicines Agency to develop and improve commonly recognised standards of good clinical practice inspections.
Države članice sodelujejo med seboj, s Komisijo in z Evropsko agencijo za zdravila z namenom razviti in izboljšati splošno priznane standarde za inšpekcijske preglede dobre klinične prakse.
This collaboration may take the form of joint inspections, agreed processes and procedures and sharing of experience and training.
To sodelovanje se lahko izvaja s skupnimi inšpekcijskimi pregledi, z dogovorjenimi procesi in postopki, izmenjavo izkušenj ter s skupnim usposabljanjem.
The Commission shall make publicly available any guidance documents on the commonly recognised standards for the conduct of inspections, developed in collaboration with Member States and the European Medicines Agency.
Komisija javno objavi vse smernice o splošno priznanih standardih za izvajanje inšpekcijskih pregledov, ki so bile pripravljene v sodelovanju z državami članicami in Evropsko agencijo za zdravila.
The European Medicines Agency shall process and make available to Member States information on inspections that are envisaged, scheduled, or conducted, in order to assist Member States to ensure the most efficient use of inspection resources when planning their inspections.
3.
Member States may request assistance from the national competent authority of another Member State in the matter of inspection.
Evropska agencija za zdravila obdeluje informacije o predvidenih, načrtovanih ali opravljenih inšpekcijskih pregledih in jih da na voljo državam članicam, da jim pomaga zagotoviti najučinkovitejšo uporabo inšpekcijskih virov pri načrtovanju inšpekcijskih pregledov.
Article 10
Države članice lahko zahtevajo pomoč pristojnega nacionalnega organa druge države članice na področju inšpekcijskih pregledov.
Powers of inspectors
Člen 10
Inspections shall be carried out by inspectors appointed by Member States.
Pooblastila inšpektorjev
In order to ensure the availability of necessary skills for each inspection, Member States may appoint teams of inspectors and appoint experts with appropriate qualifications to accompany inspectors.
Inšpekcijske preglede izvajajo inšpektorji, ki jih imenujejo države članice.
Inspectors shall be entitled to inspect the clinical trial sites, documents, facilities, records, including individual patients' records, quality arrangements, data and any other resources and entities that are deemed by the competent authority to be related to the clinical trial.
Za zagotovitev razpoložljivosti potrebnega strokovnega znanja za vsak inšpekcijski pregled lahko država članica imenuje skupine inšpektorjev in strokovnjake z ustreznimi kvalifikacijami, ki spremljajo inšpektorje.
When performing an inspection, the inspectors shall be empowered to enter into sites, other related premises, and to access to data, including individual patients' records.
Inšpektorji imajo pravico pregledati mesta kliničnega preskušanja, dokumente, prostore, evidence, vključno z evidencami posameznih pacientov, ureditve glede kakovosti, podatke in vse druge vire in subjekte, za katere pristojni organ meni, da so povezani s kliničnim preskušanjem.
Inspectors shall be entitled to make copies of records and hard copies, print-outs of electronic records and take photos of premises and equipment.
Inšpektorji so pooblaščeni, da pri inšpekcijskem pregledu dostopajo do mest in vstopijo v druge povezane prostore ter dostopajo do podatkov, vključno z evidencami posameznih pacientov.
Inspectors shall be entitled to ask any representative or member of staff of the inspected entity and any party involved in the clinical trial for explanations relating to the subject matter and purpose of the inspection and to record the answer.
Inšpektorji lahko kopirajo evidence in dokumente v papirni obliki, natisnejo elektronske evidence ter fotografirajo prostore in opremo.
Inspectors shall be empowered to contact the trial subjects directly, in particular in case of reasonable suspicion that they were not informed adequately of their participation in the clinical trial.
Inšpektorji lahko katerega koli predstavnika ali člana osebja pregledanega subjekta in katero koli stranko, udeleženo v kliničnem preskušanju, zaprosijo za razlago v zvezi s predmetom in namenom inšpekcijskega pregleda ter zabeležijo odgovor.
Member States shall provide inspectors with suitable means of their identification.
Inšpektorji so pooblaščeni za neposredno navezavo stika z udeleženci preskušanja, zlasti kadar utemeljeno sumijo, da niso bili ustrezno obveščeni o njihovi udeležbi v kliničnem preskušanju.
Member States shall establish a legal and administrative framework to ensure that inspectors from other Member States, on request and where appropriate, have access to sites, any premise of any entity related to the clinical trial as well as to related data.
Države članice inšpektorjem zagotovijo ustrezna sredstva za njihovo identifikacijo.
Article 11
Države članice vzpostavijo pravni in upravni okvir za zagotovitev, da imajo inšpektorji iz drugih držav članic, na zahtevo in če je to potrebno, dostop do mest in prostorov katerega koli subjekta, povezanega s kliničnim preskušanjem, ter do povezanih podatkov.
Recognition of inspection conclusions
Člen 11
Inspectors shall carry out inspections on behalf of the Union.
Priznavanje ugotovitev inšpekcijskega pregleda
The results of those inspections shall be recognised by all Member States.
Inšpektorji izvajajo inšpekcijske preglede v imenu Unije.
In case of divergences between Member States in relation to the verification of compliance with the applicable legislation, the Member States, or the European Medicines Agency within the framework of its powers as provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council [5], shall inform the Commission.
Rezultati teh pregledov se priznajo v vseh državah članicah.
The Commission, after consulting those Member States and the European Medicines Agency, may request a new inspection.Article 12
V primeru razlik med državami članicami pri preverjanju skladnosti z veljavno zakonodajo države članice ali Evropska agencija za zdravila v okviru njenih pristojnosti na podlagi Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta [5] obvesti Komisijo.
Resources
Komisija lahko po posvetovanju z navedenimi državami članicami in Evropsko agencijo za zdravila zahteva nov inšpekcijski pregled.Člen 12
Member Sates shall appoint an adequate number of inspectors to ensure effective verification of compliance of clinical trials with applicable requirements, as well as the timely reporting of inspection findings.
Viri
Article 13
Države članice imenujejo ustrezno število inšpektorjev, da se zagotovi učinkovito preverjanje skladnosti kliničnih preskušanj z veljavnimi zahtevami ter pravočasno poročanje o ugotovitvah inšpekcijskih pregledov.
Inspection reports and records
Člen 13
Without prejudice to the obligation to submit the inspection reports via the EU Portal in accordance with Article 78(6) of Regulation (EU) No 536/2014, Member States shall keep for at least 25 years relevant records of national inspections as well as of the inspections performed outside their territory, including information on the outcome of the inspection as regards good clinical practice compliance status as well as any action taken by the sponsor or Member State in the follow-up of the inspection.
Poročila in evidence o inšpekcijskih pregledih
The inspection reports submitted through the EU portal shall not contain personal data of clinical trials' subjects.
Ne glede na obveznost predložitve poročil o inšpekcijskem pregledu prek portala EU v skladu s členom 78(6) Uredbe (EU) št. 536/2014 države članice vsaj 25 let hranijo ustrezne evidence o nacionalnih inšpekcijskih pregledih in inšpekcijskih pregledih, ki so se izvajali zunaj njihovega ozemlja, vključno z informacijami o rezultatu inšpekcijskega pregleda glede stanja skladnosti z dobro klinično prakso in o kakršnih koli ukrepih, ki jih je sponzor ali država članica sprejela na podlagi inšpekcijskega pregleda.
Article 14
Poročila o inšpekcijskih pregledih, predložena prek portala EU, ne vsebujejo osebnih podatkov udeležencev kliničnih preskušanj.
Confidentiality
Člen 14
The inspectors and experts appointed to the inspection team shall maintain the confidentiality of information to which they gain access as a result of good clinical practice inspections.
Zaupnost
CHAPTER IV
Inšpektorji in strokovnjaki, imenovani v inšpekcijsko skupino, ohranijo zaupnost informacij, do katerih so pridobili dostop v okviru inšpekcijskih pregledov dobre klinične prakse.
Article 15
KONČNE DOLOČBE
Directive 2005/28/EC is repealed from the date referred to in the second paragraph of Article 17.
Razveljavitev
Article 16
Direktiva 2005/28/ES se razveljavi od datuma iz drugega odstavka člena 17.
Directive 2005/28/EC, except for its Chapters 5 and 6, shall continue to apply to the clinical trials governed by Directive 2001/20/EC pursuant to Article 98 of Regulation (EU) No 536/2014.
Prehodne določbe
Article 17
Direktiva 2005/28/ES, razen poglavij 5 in 6, se še naprej uporablja za klinična preskušanja, ki jih v skladu s členom 98 Uredbe (EU) št. 536/2014 ureja Direktiva 2001/20/ES.
Entry into force
Člen 17
It shall apply from 6 months after the date of publication in the Official Journal of the European Union of the notice referred to in Article 82(3) of Regulation (EU) No 536/2014.
Ta uredba začne veljati dvajseti dan po objavi v Uradnem listu Evropske unije.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Uporablja se po izteku šestih mesecev po objavi obvestila iz člena 82(3) Uredbe (EU) št. 536/2014 v Uradnem listu Evropske unije.
Done at Brussels, 24 March 2017.
Ta uredba je v celoti zavezujoča in se neposredno uporablja v vseh državah članicah.
For the Commission
V Bruslju, 24. marca 2017
OJ L 158, 27.5.2014, p. 1.
Predsednik
Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31).
UL L 158, 27.5.2014, str. 1.
Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirement for authorisation of the manufacturing or importations of such products (OJ L 91, 9.4.2005, p. 13).
Direktiva Evropskega parlamenta in Sveta 95/46/ES z dne 24. oktobra 1995 o varstvu posameznikov pri obdelavi osebnih podatkov in o prostem pretoku takih podatkov (UL L 281, 23.11.1995, str. 31).
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ L 121, 1.5.2001, p. 34).
Direktiva Komisije 2005/28/ES z dne 8. aprila 2005 o načelih in podrobnih smernicah za dobro klinično prakso v zvezi z zdravili v preskušanju za humano uporabo ter o zahtevah za pridobitev dovoljenja za proizvodnjo ali uvoz takšnih izdelkov (UL L 91, 9.4.2005, str. 13).
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 (OJ L 136, 30.4.2004, p.
Direktiva 2001/20/ES Evropskega parlamenta in Sveta z dne 4. aprila 2001 o približevanju zakonov in drugih predpisov držav članic v zvezi z izvajanjem dobre klinične prakse pri kliničnem preskušanju zdravil za ljudi (UL L 121, 1.5.2001, str. 34).
Commission Implementing Regulation (EU) 2017/557
Izvedbena uredba Komisije (EU) 2017/557
amending for the 263rd time Council Regulation (EC) No 881/2002 imposing certain specific restrictive measures directed against certain persons and entities associated with the ISIL (Da'esh) and Al-Qaida organisations
o dvestotriinšestdeseti spremembi Uredbe Sveta (ES) št. 881/2002 o posebnih omejevalnih ukrepih za nekatere osebe in subjekte, povezane z organizacijama ISIL (Daiš) in Al-Kaida
On 21 March 2017, the Sanctions Committee of the United Nations Security Council decided to amend two entries in its list of persons, groups and entities to whom the freezing of funds and economic resources should apply.
Odbor za sankcije Varnostnega sveta Združenih narodov je 21. marca 2017 sklenil spremeniti dva vnosa na seznamu oseb, skupin in subjektov, za katere bi morala veljati zamrznitev sredstev in gospodarskih virov.
Done at Brussels, 24 March 2017.
V Bruslju, 24. marca 2017
The identifying data for the following entries under the heading ‘Natural persons’ in Annex I to Regulation (EC) No 881/2002 are amended as follows:
„Ri'ad Muhammad Hasan Muhammad Hijazi (tudi (a) Hijazi, Raed M. (b) Al-Hawen, Abu-Ahmad (c) Al-Shahid, Abu-Ahmad (d) Raed Muhammad Hasan Muhammad Hijazi, (e) Al-Maghribi, Rashid (the Moroccan) (f) Al-Amriki, Abu-Ahmad (the American)).
‘Ri'ad Muhammad Hasan Muhammad Hijazi (alias (a) Hijazi, Raed M. (b) Al-Hawen, Abu-Ahmad (c) Al-Shahid, Abu-Ahmad (d) Raed Muhammad Hasan Muhammad Hijazi, (e) Al-Maghribi, Rashid (the Moroccan) (f) Al-Amriki, Abu-Ahmad (the American)).
Datum rojstva: 30. 12. 1968.
Date of birth: 30.12.1968.
Kraj rojstva: Kalifornija, Združene države Amerike.
Place of birth: California, United States of America.
Državljanstvo: jordansko.
Commission Implementing Regulation (EU) 2017/558
Izvedbena uredba Komisije (EU) 2017/558
supplementing Directive 2014/65/EU of the European Parliament and of the Council as regards organisational requirements and operating conditions for investment firms and defined terms for the purposes of that Directive
o dopolnitvi Direktive 2014/65/EU Evropskega parlamenta in Sveta v zvezi z organizacijskimi zahtevami in pogoji poslovanja investicijskih podjetij ter opredeljenimi izrazi za namene navedene direktive
Having regard to Directive 2014/65/EU of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Directive 2002/92/EC and Directive 2011/61/EU [1], and in particular Article 2(3), the second subparagraph of Article 4(1)(2), and Articles 4(2), 16(12), 23(4), 24(13), 25(8), 27(9), 28(3), 30(5), 31(4), 32(4), 33(8), 52(4), 54(4), 58(6), 64(7), 65(7) and 79(8) thereof,
ob upoštevanju Direktive 2014/65/EU Evropskega parlamenta in Sveta z dne 15. maja 2014 o trgih finančnih instrumentov ter spremembi Direktive 2002/92/ES in Direktive 2011/61/EU [1], in zlasti člena 2(3), drugega pododstavka člena 4(1)(2), člena 4(2), člena 16(12), člena 23(4), člena 24(13), člena 25(8), člena 27(9), člena 28(3), člena 30(5), člena 31(4), člena 32(4), člena 33(8), člena 52(4), člena 54(4), člena 58(6), člena 64(7), člena 65(7) in člena 79(8) navedene direktive,
Directive 2014/65/EU establishes the framework for a regulatory regime for financial markets in the Union, governing operating conditions relating to the performance by investment firms of investment services and, where appropriate, ancillary services and investment activities; organisational requirements for investment firms performing such services and activities, for regulated markets and data reporting services providers; reporting requirements in respect of transactions in financial instruments; position limits and position management controls in commodity derivatives; transparency requirements in respect of transactions in financial instruments.
Direktiva 2014/65/EU določa okvir za regulativno ureditev finančnih trgov v Uniji, ki ureja pogoje poslovanja za investicijska podjetja pri opravljanju investicijskih storitev in, če je primerno, pomožnih storitev in investicijskih dejavnosti; organizacijske zahteve za investicijska podjetja, ki opravljajo take storitve, in izvajalce storitev sporočanja podatkov; zahteve v zvezi s poročanjem o poslih s finančnimi instrumenti; omejitve pozicij in nadzor upravljanja pozicij pri izvedenih finančnih instrumentih na blago; zahteve glede preglednosti za posle s finančnimi instrumenti.
Directive 2014/65/EU empowers the Commission to adopt a number of delegated acts.
Direktiva 2014/65/EU pooblašča Komisijo, da sprejme več delegiranih aktov.
It is important that all the detailed supplementing rules regarding the authorisation, ongoing operation, market transparency and integrity, which are inextricably-linked aspects inherent to the taking up and pursuit of the services and activities covered by Directive 2014/65/EU, begin to apply at the same time as Directive 2014/65/EU so that the new requirements can operate effectively.
Pomembno je, da vsi natančni dopolnilni predpisi v zvezi z dovoljenjem, tekočim poslovanjem, preglednostjo in celovitostjo trgov, kar so neločljivo povezani vidiki, ključni za začetek izvajanja in izvajanje storitev in dejavnosti iz Direktive 2014/65/EU, začnejo veljati istočasno kot Direktiva 2014/65/EU, tako da se lahko nove zahteve začnejo učinkovito izvajati.
To ensure coherence and to facilitate a comprehensive view and compact access to the provisions by persons subject to those obligations as well as by investors, it is desirable to include the delegated acts related to the above-mentioned rules in this Regulation.
Za zagotovitev skladnosti in za omogočanje celovitega pregleda nad določbami in enotnega dostopa do njih za osebe, za katere veljajo navedene obveznosti, vključno z vlagatelji, je zaželeno, da se vsi delegirani akti, povezani z zgoraj navedenimi predpisi, vključijo v to uredbo.
It is necessary to further specify the criteria to determine under what circumstances contracts in relation to wholesale energy products must be physically settled for the purposes of the limitation of scope set out in Section C(6) of Annex I to Directive 2014/65/EU.
Nadalje je treba opredeliti merila za določitev, v katerih okoliščinah je treba fizično poravnati pogodbe v zvezi z veleprodajnimi energetskimi proizvodi za namene omejitve področja uporabe iz oddelka C(6) Priloge I k Direktivi 2014/65/EU.
In order to ensure that the scope of this exemption is limited to avoid loopholes it is necessary that such contracts require that both buyer and seller should have proportionate arrangements in place to make or receive delivery of the underlying commodity upon the expiry of the contract.
Za zagotovitev, da je področje uporabe te izjeme omejeno na preprečevanje zakonodajnih vrzeli, morajo takšne pogodbe zahtevati, da imata tako kupec kot prodajalec sorazmerne ureditve za dobavo ali prevzem zadevnega blaga ob izteku pogodbe.
In order to avoid loopholes in case of balancing agreements with the Transmission System Operator in the areas of electricity and gas, such balancing arrangements should only be considered as a proportionate arrangement if the parties to the arrangement have the obligation to physically deliver electricity or gas.
Da bi se preprečile zakonodajne vrzeli v primeru bilančnih pogodb z operaterjem prenosnega sistema na področju elektrike in plina, bi bilo treba takšne bilančne ureditve obravnavati kot sorazmerne ureditve le, če za stranki v ureditvi velja obveznost fizične dobave elektrike ali plina.
Contracts should also establish clear obligations for physical delivery which cannot be offset whilst recognising that forms of operational netting as defined in Regulation (EU) No 1227/2011 of the European Parliament and of the Council [2] or national law should not considered as offsetting.
V pogodbah morajo biti prav tako jasno določene obveznosti za fizično dobavo, ki jih ni mogoče medsebojno izravnati, pri čemer se priznava, da oblik operativnega pobota, kot so opredeljene v Uredbi (EU) št. 1227/2011 Evropskega parlamenta in Sveta [2] ali nacionalni zakonodaji, ne bi smeli šteti za izravnavo.
Contracts which must be physically settled should be permitted to deliver in a variety of methods however all methods should involve a form of transfer of right of an ownership nature of the relevant underlying commodity or a relevant quantity thereof.
Pogodbe, ki jih je treba fizično poravnati, bi moralo biti mogoče izvršiti z več različnimi metodami, vendar bi morale vse metode vključevati določeno obliko prenosa lastninskih pravic za zadevno osnovno blago ali ustrezno količino tega blaga.
In order to clarify when a contract in relation to wholesale energy product must be physically settled, it is necessary to further specify when certain circumstances such as force majeure or bona fide inability to settle provisions are present, and which should not alter the characterisation of those contracts as ‘must be physically settled’.
Za razjasnitev, kdaj mora biti pogodba v zvezi z veleprodajnimi energetskimi proizvodi fizično poravnana, je treba dodatno opredeliti, kdaj so prisotne nekatere okoliščine, kot je višja sila ali pristni razlogi za nezmožnost izpolnjevanja določb, ki pa ne bi smele spremeniti označitve teh pogodb kot pogodb, ki jih je treba fizično poravnati.
It is important to also clarify how oil and coal energy derivatives should be understood for the purposes of Section C(6) of Annex I to Directive 2014/65/EU.
Prav tako je pomembno razjasniti, kako bi bilo treba za namene oddelka C6 Priloge I k Direktivi 2014/65/EU obravnavati izvedene finančne instrumente na energente, ki se nanašajo na nafto in premog.
In this context, contracts related to oil shale should not be understood to be coal energy derivatives.
V tem kontekstu se pogodbe, ki se nanašajo na naftni skrilavec, ne bi smele razumeti kot izvedeni finančni instrumenti na energente, ki se nanašajo na premog.
A derivative contract should only be considered to be a financial instrument under Section C(7) of Annex I to Directive 2014/65/EU if it relates to a commodity and meets a set of criteria for determining whether a contract should be considered as having the characteristics of other derivative financial instruments and as not being for commercial purposes.
Pogodba o izvedenem finančnem instrumentu bi se morala šteti kot finančni instrument v skladu z oddelkom C(7) Priloge I k Direktivi 2014/65/EU samo, če se nanaša na blago in izpolnjuje merila za določitev, ali se lahko zanjo šteje, da ima značilnosti drugih izvedenih finančnih instrumentov in da ni za komercialne namene.