natgillin/translations-raw huggingface dataset:
Acknowledges from the Agency that the transparency criteria for partner, patient, healthcare and consumer organisations has been revised during 2014 in order to increase the transparency of funding; notes the adoption of the document with detailed criteria regarding the evaluation of financial information from patients, consumers and healthcare professionals organisations; notes furthermore that this document is used to assess the organisations' eligibility to participate in the dialogue with the Agency; recalls that the document also states that the organisations have to declare any conflicts of interests at the start of the meetings through which the dialogue is commenced; notes with regret the reduction of the cooling-off period from five years to three years; notes with regret that the arbitrary distinction between direct and indirect conflicts of interests has been kept; calls on the Agency to furthermore introduce a list of the patients' organisations it is working with and to place it on its website, linking it to the funding sources of these organizations in order to enhance transparency;
je seznanjen s trditvami agencije, da je v letu 2014 pregledala merila preglednosti za partnerske organizacije, organizacije pacientov, organizacije zdravstvenega varstva ter potrošniške organizacije, da bi povečala preglednost financiranja; je seznanjen tudi s sprejetjem dokumenta, ki vsebuje podrobna merila za ocenjevanje finančnih podatkov organizacij pacientov, potrošnikov ter zdravstvenih delavcev; ugotavlja tudi, da se ta dokument uporablja za ocenjevanje, ali so organizacije upravičene sodelovati v dialogu z agencijo; opozarja, da dokument navaja tudi, da morajo organizacije ob začetku sej, s katerimi se začne dialog, navesti morebitna navzkrižja interesov; z obžalovanjem ugotavlja, da se je obdobje mirovanja skrajšalo s petih na tri leta; poleg tega z obžalovanjem ugotavlja, da je bilo ohranjeno samovoljno razlikovanje med neposrednimi in posrednimi navzkrižji interesov; poziva agencijo, naj v svoje delo prav tako uvede seznam organizacij bolnikov in ga objavi na svojem spletnem mestu ter ga poveže z navedbami virov financiranja teh organizacij, da bi povečala preglednost;
Acknowledges that the Agency complied with the recommendation made by the discharge authority that a specific part of its annual activity report be devoted to the prevention and management of conflicts of interests;
ugotavlja, da je agencija upoštevala priporočilo organa za podelitev razrešnice, da poseben del svojega letnega poročila o dejavnostih nameni preprečevanju in obvladovanju navzkrižij interesov;
Notes that the Agency's Management Board has endorsed a revised policy on the handling of declarations of interests of members of scientific committees and experts; notes with satisfaction that this policy entered into force on 30 January 2015; regrets that the main loopholes, such as the distinction between direct and indirect conflicts of interests prevail, while the Agency mainly takes into account direct conflicts of interests; encourages the Agency to actively address this issue; notes that the electronic declaration of interests form and the procedural guidelines were to be finalised during 2014; calls on the Agency to inform the discharge authority on the outcomes of this issue as soon as they are available;
ugotavlja, da je upravni odbor agencije podprl spremenjeno politiko obravnave navzkrižja interesov med člani znanstvenih odborov in strokovnjaki; z zadovoljstvom ugotavlja, da je ta politika začela veljati 30. januarja 2015; obžaluje, da glavne vrzeli, kot je razlikovanje med neposrednimi in posrednimi navzkrižji interesov, ostajajo, pri čemer agencija predvsem upošteva neposredna navzkrižja interesov; spodbuja agencijo, naj učinkovito obravnava to vprašanje; ugotavlja, da bo agencija elektronski obrazec za izjavo o interesih in postopkovne smernice dokončno oblikovala v letu 2014; poziva agencijo, naj organ za podelitev razrešnice obvesti o rezultatih, takoj ko bodo na voljo;
Welcomes the fact that the revised policy includes an improved distinction of the declared interest: a person with an executive or leading role in the development of a medicine during a previous employment has a lifetime bar of non-involvement with the concerned company or product and for the majority of declared interests, a three-year cooling-off period is foreseen;
pozdravlja, da spremenjena politika vsebuje boljše razlikovanje prijavljenih interesov: oseba z izvršno ali vodstveno vlogo pri razvoju zdravila med prejšnjo zaposlitvijo ima doživljenjsko prepoved sodelovanja z zadevnim podjetjem ali v zvezi z zadevnim zdravilom, za večino prijavljenih interesov pa je predvideno triletno obdobje mirovanja;
Regrets that the policies on proactive publication of clinical trial data recently adopted by the Agency go against the transparency provisions of Regulation (EU) No 536/2014 of the European Parliament and of the Council [1] (the Clinical Trials Regulation) by allowing companies to redact data based on potential jeopardy of commercial interests; calls on the Agency to report to the discharge authority on this issue;
obžaluje, da so politike o proaktivnem objavljanju podatkov iz kliničnega preskušanja, ki jih je nedavno sprejela agencija, v nasprotju z določbami Uredbe (EU) št. 536/2014 Evropskega parlamenta in Sveta [1] (uredba o kliničnem preskušanju) o kliničnem preskušanju glede preglednosti, saj podjetjem omogočajo, da podatke pripravljajo na podlagi morebitnega ogrožanja poslovnih interesov; poziva agencijo, naj organu za podelitev razrešnice poroča o tem;
Notes with regret the Agency's understanding of what constitutes commercial confidential information (CCI) is far too broad and includes companies to redact key data about the trial design, methods, and calls on the Agency to properly implement the provisions of the Clinical Trials Regulation especially with regard to clinical trial data not to be considered CCI;
z obžalovanjem ugotavlja, da je razumevanje agencije, kaj predstavlja poslovne zaupne informacije, veliko preširoko in vključuje podjetja, ki pripravljajo ključne podatke glede zasnove in metod preskusa, in poziva agencijo, naj ustrezno izvede določbe uredbe o kliničnem preskušanju, zlasti v zvezi s podatki kliničnih preskusov, ki ne bi smeli veljati za poslovne zaupne informacije;
Calls on the Agency to publish on its website detailed reports of the scientific advice provided by the Agency to pharmaceutical companies during the drug development and pre-registration process at the time of trial authorisation and in any case not later than 12 months after the end of the trial; notes that advice provided by regulators to companies on drug development and pre-registration plans cannot be considered CCI since there is an overriding public interest in disclosure;
poziva agencijo, naj ob odobritvi preskušanja, v vsakem primeru pa ne kasneje kot 12 mesecev po koncu preskušanja, na svojem spletnem mestu objavi podrobna poročila o znanstvenih nasvetih, ki jih agencija posreduje farmacevtskim podjetjem med razvojem zdravila in postopkom predregistracije; je seznanjen s tem, da nasvetov, ki so jih regulatorji dali podjetjem v zvezi z razvojem zdravil in predregistracijo, ni mogoče šteti za poslovne zaupne informacije, saj je prisoten prednosten javni interes za razkritje;
Acknowledges that in 2013, the Commission's Internal Audit Service (IAS) carried out a consultancy engagement and a follow-up engagement according to its Strategic Audit Plan for the Agency for 2012-14 on Stakeholders Management & Communication;
potrjuje, da je služba Komisije za notranjo revizijo v skladu s svojim strateškim revizijskim načrtom za agencijo v obdobju 2012–2014 leta 2013 opravila posvetovanje o upravljanju deležnikov in komunikaciji z njimi ter se zavezala k nadaljnjemu spremljanju;
Takes note that in the course of the risk analysis, the IAS identified certain processes of a high inherent risk which could not be considered as auditable within the audit plan as the controls were assessed as absent or insufficient; notes furthermore that in response to these weaknesses, the Agency's management submitted an action plan; acknowledges that the actions will be followed-up by the IAS during its next in-depth risk analysis;
ugotavlja, da je služba za notranjo revizijo med analizo tveganja opredelila nekatere postopke z velikim pripadajočim tveganjem, ki jih ni mogoče revidirati v okviru revizijskega načrta, saj so bile kontrole ocenjene kot neobstoječe ali nezadostne; ugotavlja tudi, da je uprava agencije v odziv na odkrite pomanjkljivosti predložila akcijski načrt; potrjuje, da se bo služba za notranjo revizijo med naslednjo poglobljeno analizo tveganja ponovno posvetila tem ukrepom;
Notes from the IAS report that its follow-up was done through an audit on its earlier recommendations marked as ‘Very Important’ or ‘Important’ and through a desk review on the status of earlier recommendations marked as ‘Important’ or ‘Desirable’; notes furthermore that the follow-up engagement revealed that neither ‘Critical’ nor ‘Very Important’ recommendations were open as of 31 December 2013;
na podlagi poročila službe za notranjo revizijo ugotavlja, da je nadaljnja obravnava potekala z revizijo prejšnjih priporočil, ki so bila označena kot „zelo pomembna“ in „pomembna“, in s pregledom dokumentacije o stanju prejšnjih priporočil, označenih kot „pomembna“ ali „zaželena“; ugotavlja tudi, da se je pri nadaljnji obravnavi izkazalo, da 31. decembra 2013 ni bilo odprtih „kritičnih“ ali „zelo pomembnih“ priporočil;
Takes note that the Agency has adopted a set of internal-control standards (ICS) which are intended to guarantee a consistent level of internal control of all business activities throughout the Agency, and define the management rules that all services must follow in their management of resources;
je seznanjen, da je agencija sprejela niz standardov notranje kontrole, ki so namenjeni zagotavljanju dosledne ravni notranje kontrole nad vsemi poslovnimi dejavnostmi v vsej agenciji in ki opredeljujejo pravila upravljanja, ki jih morajo vse službe upoštevati pri svojem upravljanju virov;
Acknowledges that since 2012, the Agency's ‘Verifying Office’ performs ex ante checks focused on valuable commitments, sensitive contracts and complex procurement procedures where higher risks have been identified; notes that during 2013, no delays have been reported by the ‘Verifying Office’ and that all transactions were checked using checklists in line with the financial regulations and the charter of the verifying officer;
potrjuje, da od leta 2012 oddelek agencije za preverjanje opravlja predhodne kontrole, pri katerih se osredotoča na pomembne obveznosti, občutljive pogodbe in kompleksne postopke javnih naročil, pri katerih je bilo opredeljeno večje tveganje; ugotavlja, da oddelek v letu 2013 ni poročal o zamudah in da so bile vse transakcije preverjene na podlagi seznamov, v skladu s finančnimi predpisi in listino uradnika, zadolženega za preverjanje;
Takes note that the Agency, after completing a series of ex post controls during 2013, found no significant weaknesses in its internal controls;
je seznanjen s tem, da agencija, potem ko je v letu 2013 izvedla vrsto predhodnih kontrol, ni našla bistvenih pomanjkljivosti v notranji kontroli;
Acknowledges that in 2013, the Agency's internal audit function carried out audits in several areas; notes that the recommendations produced by the internal audit function have been already partially addressed while others are being implemented;
potrjuje, da je oddelek agencije za notranjo revizijo v letu 2013 opravil revizije na več področjih; ugotavlja, da so priporočila, ki jih je podal oddelek za notranjo revizijo, že bila delno obravnavana, medtem ko se druga izvajajo;
Refers, for other observations of a cross-cutting nature accompanying its decision on discharge, to its resolution of 29 April 2015 [2] on the performance, financial management and control of the agencies.
sporoča, da so druge pripombe k sklepu o razrešnici, ki so horizontalne narave, zbrane v resoluciji z dne 29. aprila 2015 [2] o uspešnosti, finančnem upravljanju in nadzoru agencij.
Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p. 1).
Uredba (EU) št. 536/2014 Evropskega parlamenta in Sveta z dne 16. aprila 2014 o kliničnem preskušanju zdravil za uporabo v humani medicini in o razveljavitvi Uredbe 2001/20/ES (UL L 158, 27.5.2014, str. 1).
Texts adopted of that date, P8_TA(2015)0130 (see page 431 of this Official Journal).
Sprejeta besedila z navedenega dne, P8_TA(2015)0130 (glej stran 431 tega Uradnega lista).
with observations forming an integral part of the decision on discharge in respect of the implementation of the budget of the European Monitoring Centre for Drugs and Drug Addiction for the financial year 2013
s pripombami, ki so del sklepa o razrešnici glede izvrševanja proračuna Evropskega centra za spremljanje drog in zasvojenosti z drogami za proračunsko leto 2013
having regard to its decision on discharge in respect of the implementation of the budget of the European Monitoring Centre for Drugs and Drug Addiction for the financial year 2013,
ob upoštevanju sklepa o razrešnici glede izvrševanja proračuna Evropskega centra za spremljanje drog in zasvojenosti z drogami za proračunsko leto 2013,
A. whereas, according to its financial statements, the final budget of the European Monitoring Centre for Drugs and Drug Addiction (‘the Centre’) for the financial year 2013 was EUR 16308171,83 representing a decrease of 0,05 % compared to 2012,
A. ker računovodski izkazi Evropskega centra za spremljanje drog in zasvojenosti z drogami (v nadaljevanju: center) kažejo, da je končni proračun centra v proračunskem letu 2013 znašal 16308171,83 EUR, kar je 0,05 % manj kot leta 2012;
B. whereas the overall contribution of the Union to the Centre's budget for 2013 amounted to EUR 15550000, representing a decrease of 0,01 % compared to 2012,
B. ker je v letu 2013 skupni prispevek Unije v proračun centra znašal 15550000 EUR, kar je za 0,01 % manj kot v letu 2012;
C. whereas the Court of Auditors (‘the Court’), in its report on the annual accounts of the European Monitoring Centre for Drugs and Drug Addiction for the financial year 2013 (‘the Court's report’), has stated that it has obtained reasonable assurances that the Centre's annual accounts are reliable and that the underlying transactions are legal and regular,
C. ker je Računsko sodišče v svojem poročilu o zaključnem računu Evropskega centra za spremljanje drog in zasvojenosti z drogami za proračunsko leto 2013 (v nadaljevanju: poročilo Računskega sodišča) navedlo, da je prejelo razumno zagotovilo o zanesljivosti računovodskih izkazov centra ter o zakonitosti in pravilnosti z njimi povezanih transakcij;
Notes from the Court's report that regarding two comments made in the Court's 2011 report and marked as ‘Ongoing’ or ‘Outstanding’ in the Court's 2012 report, corrective actions were taken and one comment is marked in the Court's report as ‘Completed’ and the other as ‘Ongoing’; notes furthermore that, for the four comments made in the Court's 2012 report, one corrective action has been taken in response to the previous year's comments resulting in the comment being marked in the Court's report as ‘Completed’, while other three comments are marked as ‘Ongoing’;
na podlagi poročila Računskega sodišča ugotavlja, da so bili v zvezi z dvema pripombama iz poročila Računskega sodišča iz leta 2011, ki so bile v poročilu iz leta 2012 označene s „se izvaja“ oziroma z „neizveden“, sprejeti popravljalni ukrepi, od katerih je sedaj v poročilu Računskega sodišča ena označena z „zaključen“, ena pa s „se izvaja“; ugotavlja tudi, da je bil za štiri pripombe iz poročila Računskega sodišča iz leta 2012 sprejet en popravljalni ukrep kot odgovor na priporočila iz prejšnjega leta in da je sedaj ena označena z „zaključen“, tri pa s „se izvaja“;
it has implemented multiple processes and measures to ensure adequate ex ante and ex post verifications and control of costs related to grants for supporting cooperation under the Reitox network; notes that the measures include detailed ex ante controls, written instructions to Reitox National Focal Points (NFP), specific information sessions on the issues at stake, yearly analysis of the financial reporting of each NFP, on-site ex post verifications;
je izvedel številne postopke in ukrepe za zagotavljanje primernih predhodnih in naknadnih preverjanj stroškov, povezanih z nepovratnimi sredstvi za podporo sodelovanju v okviru omrežja Reitox; ugotavlja, da ukrepi vključujejo podrobne predhodne kontrole, pisna navodila za nacionalne informacijske točke v omrežju Reitox, posebna informativna srečanja za reševanje perečih vprašanj, letne analize finančnega poročanja vsake nacionalne informacijske točke, naknadna preverjanja na kraju samem;
it has revised its rules defining the requirements for ex post exercises in order to explicitly link the ex post verification to the results of the risk assessment; notes that the latest risk assessment exercise in 2014 confirmed the existence of certain medium to high risks likely to justify ex post verification, which are mostly of a technical nature related to IT security and software configuration;
je pregledal svoja pravila, ki opredeljujejo zahteve za naknadno preverjanje, da bi izrecno povezal ta preverjanja z rezultati ocene tveganja; ugotavlja, da je zadnja ocena tveganja iz leta 2014 potrdila obstoj nekaterih srednje velikih oziroma velikih tveganj, ki naj bi upravičila naknadna preverjanja, ki so v večini tehnične narave ter povezana z varnostjo IT in nastavitvijo programske opreme;
Notes from the Court's report that the Centre launched a procurement procedure to rent office equipment over a 4-year period and that the technical requirements were subject to a significant modification during the course of the procedure; is concerned that the technical requirements were further adjusted for the conclusion of the contract, in accordance with the option announced in the published specifications, leading to a decrease in the contract value; regrets that the information published on the contract's price structure was not sufficiently clear, which led to a misinterpretation by one bidder who therefore had a smaller chance of being awarded the contract;
na podlagi poročila Računskega sodišča ugotavlja, da je center sprožil postopek za oddajo javnega naročila za štiriletni najem pisarniške opreme, in da so bile tehnične zahteve med postopkom precej spremenjene; je zaskrbljen, ker so bile tehnične zahteve ponovno spremenjene pred podpisom pogodbe v skladu z možnostjo, navedeno v objavljenih specifikacijah, zaradi česar se je vrednost pogodbe znižala; obžaluje, da objavljene informacije o cenovni strukturi pogodbe niso bile dovolj jasne, zaradi česar jih je en ponudnik narobe razumel in je imel manj možnosti, da bi bil izbran;
Notes with concern that the evaluation criteria for the abovementioned procedure were not sufficiently specific to ensure full transparency and the equal treatment of bidders; observes that the abovementioned weakness affected the efficiency and effectiveness of this procurement procedure, as well as creating the risk of hindering the competition;
z zaskrbljenostjo ugotavlja, da merila za vrednotenje zgoraj omenjenega postopka niso bila dovolj podrobna, da bi zagotovila popolno preglednost in enako obravnavanje ponudnikov; ugotavlja, da so navedene slabosti vplivale na učinkovitost in uspešnost tega postopka za oddajo javnega naročila ter povzročile tveganje oviranja konkurence;
Acknowledges from the Centre that the relevant contract notice was published via the information system for European public procurement, which imposes some restrictions on the information that can be published; acknowledges furthermore that all tenderers were treated equally and evaluated in accordance with the established and published award criteria and method; calls on the Centre to nonetheless improve its procurement processes and to report to the discharge authority on the measures taken;
na podlagi izjav centra ugotavlja, da je bilo zadevno obvestilo o oddaji javnega naročila objavljeno prek informacijskega sistema za evropska javna naročila, ki nalaga nekaj omejitev za informacije, ki so lahko objavljene; poleg tega ugotavlja, da so bili vsi ponudniki obravnavani enako in ocenjeni v skladu z določenimi in objavljenimi merili in metodo za dodelitev naročila; poziva center, naj kljub temu izboljša postopke javnega naročanja in organu za podelitev razrešnice poroča o sprejetih ukrepih;
Notes that budget monitoring efforts during the financial year 2013 resulted in a budget implementation rate of 99,73 % and that the payment appropriations execution rate was 97,71 %, representing a slight decrease of 0,1 % compared to 2012; acknowledges from the Court's report that the high overall level of committed appropriations indicated the commitments being made in a timely manner;
ugotavlja, da je zaradi proračunskega spremljanja v proračunskem letu 2013 stopnja izvrševanja proračuna dosegla 99,73 %, stopnja izvrševanja plačil pa 97,71 %, kar pomeni manjše zmanjšanje v višini 0,1 % v primerjavi z letom 2012; na podlagi poročila Računskega sodišča ugotavlja, da je visoka skupna raven prevzetih obveznosti pokazala, da so bile proračunske obveznosti izvršene pravočasno;
Takes note that the Centre improved the efficiency of its payments processes; notes in particular that payments were successfully processed on average 16 days before the relevant deadline;
je seznanjen s tem, da je center povečal učinkovitost svojih plačilnih procesov; zlasti ugotavlja, da so bila plačila uspešno obdelana v povprečju 16 dni pred ustreznim rokom;
Acknowledges that the Court's annual audit has found no notable issues as regards the level of carry-overs in 2013; takes note of the Centre's compliance with the principle of annuality and the timely execution of its budget;
ugotavlja, da Računsko sodišče pri letni reviziji ni našlo večjih težav v zvezi s stopnjo prenosov v letu 2013; ugotavlja, da je center upošteval načelo enoletnosti in pravočasnega izvrševanja proračuna;
Acknowledges from the Centre that it has reviewed its policy on the prevention and management of conflicts of interests in line with the Commission's guidelines; notes that the revised policy was approved by the Centre's Management Board at its meeting of 4 and 5 December 2014; awaits the publication of declarations of interests of the Management Board, senior management and the Director;
na podlagi izjav centra ugotavlja, da je pregledal svojo politiko o preprečevanju in obvladovanju navzkrižja interesov v skladu s smernicami Komisije; ugotavlja, da je spremenjeno politiko odobril upravni odbor centra na svojih sestankih 4. in 5. decembra 2014; pričakuje objavo izjav o interesih upravnega odbora, višjega vodstva in direktorja;