natgillin/translations-raw huggingface dataset:
Kadar pride do vprašanja javnega interesa, kar velja za podatke farmakovigilance, mora biti vedno zagotovljena popolno javno razkritje.
When an overriding public interest is at stake, as it is the case concerning pharmacovigilance data, full disclosure has always to be guaranteed.
· Financiranje sistemov farmakovigilance bi moralo ostati javno v znak odgovornosti javnih organov za varovanje zdravja prebivalstva, pa tudi da bi zagotovili njihovo neodvisnost.
· The funding of the pharmacovigilance systems should remain public as recognition of the public authorities’ responsibility to protect their populations, and in order to guarantee their independency.
(7) Da se zagotovi razpoložljivost potrebnega strokovnega znanja in izkušenj ter sredstev za ocene farmakovigilance na ravni Skupnosti, je primerno ustanoviti nov znanstveni odbor v okviru Agencije, in sicer Svetovalni odbor za oceno razmerja med tveganji in koristmi na področju farmakovigilance.
(7) In order to ensure the availability of the necessary expertise and resources for pharmacovigilance assessments at Community level, it is appropriate to create a new scientific committee within the Agency, the Pharmacovigilance Risk-Benefit Assessment Advisory Committee.
Poimenovanje „Svetovalni odbor za oceno tveganja na področju farmakovigilance“ je preveč omejujoče in ne vključuje potrebe po analizi razmerja med tveganji in koristmi zdravila, temveč poudarja le analizo tveganja.
The name ‘Pharmacovigilance Risk Assessment Advisory Committee’ is too restrictive and overlooks the need for risk-benefit assessment of medicinal products, instead concentrating on risk analysis alone.
Odbor pa je pristojen za vsa vprašanja v zvezi s farmakovigilanco (predlog uredbe, člen 1(12)).
After all, the committee’s remit includes ‘any question relating to (...) pharmacovigilance’ (proposal for a regulation, Article 1(12)).
Ta predlog spremembe je namenjen, da se uporablja v celotnem besedilu predloga uredbe.
This amendment should be applied throughout the text of the proposal for a regulation.
„Pri izpolnjevanju nalog v zvezi s farmakovigilanco mu pomaga Svetovalni odbor za oceno tveganja na področju farmakovigilance iz člena 56(1)(aa).“
“For the fulfilment of its pharmacovigilance tasks, it shall be assisted by the Pharmacovigilance Risk Assessment Advisory Committee referred to in Article 56(1)(aa).”
„Pri izpolnjevanju nalog v zvezi s farmakovigilanco mu pomaga Svetovalni odbor za oceno razmerja med tveganji in koristmi na področju farmakovigilance iz člena 56(1)(aa).“
‘For the fulfilment of its pharmacovigilance tasks, it shall be assisted by the Pharmacovigilance Risk-Benefit Assessment Advisory Committee referred to in Article 56(1)(aa).’
Podatkovna baza Eudravigilance je v celoti dostopna pristojnim organom držav članic, Agenciji in Komisiji.
The Eudravigilance database shall be fully accessible to the competent authorities of the Member States and to the Agency and the Commission.
Imetnikom dovoljenj za promet je dostopna v ustreznem obsegu, da lahko izpolnijo svoje obveznosti v zvezi s farmakovigilanco .
It shall also be accessible to marketing authorisation holders to the extent necessary for them to comply with their pharmacovigilance obligations .
Dostopna je imetnikom dovoljenj za promet, zdravstvenemu osebju in javnosti, pri čemer je zagotovljeno varstvo osebnih podatkov .
It shall also be accessible to marketing authorisation holders , healthcare professionals and the public, with personal data protection being guaranteed.
Podatki, ki se hranijo v podatkovni bazi Eudravigilance, so javno dostopni v združeni obliki skupaj s pojasnilom o razlagi podatkov.
The data held on the Eudravigilance database shall be made publicly accessible in an aggregated format together with an explanation of how to interpret the data.
Sistem farmakovigilance bi moral biti povsem pregleden, da bi vsem zainteresiranim stranem zagotavljal popolne informacije, zlasti pa da bi povrnil zaupanje bolnikov in državljanov v odgovornost zdravstvenih organov.
The Pharmacovigilance system should be entirely transparent in order to guarantee full information of all stakeholders, notably in order to restore patients’ and citizens’ trust in Health authorities’ accountability.
Javnost lahko zahteva posamezna poročila o neželenih učinkih, ki se hranijo v podatkovni bazi Eudravigilance.
Individual adverse reaction reports held on the Eudravigilance database may be requested by the public.
Agencija ali pristojni nacionalni organ, ki je prejel zahtevo, zagotovi poročila v 90 dneh od prejema zahteve, razen če bi razkritje ogrozilo anonimnost oseb iz poročila .
Those reports shall be provided by the Agency or the national competent authority from which they are requested within 90 days, unless disclosure would compromise the anonymity of the subjects of the reports .
Agencija ali pristojni nacionalni organ, ki je prejel zahtevo, zagotovi poročila v 90 dneh od prejema zahteve, pri čemer je zagotovljeno varstvo osebnih podatkov .
Those reports shall be provided by the Agency or the national competent authority from which they are requested within 90 days, with personal data protection being guaranteed .
Spoštovati je treba predpise o varstvu podatkov.
Data protection regulations should be respected.
Ta možnost poročanja prek spleta je vsem državljanom Unije na voljo v njihovem maternem jeziku.
All citizens of the Union shall have the option of submitting online declarations in their mother tongue.
Agencija daje na voljo javnosti tudi druga sredstva, s katerimi lahko bolniki poročajo o neželenih učinkih, med drugim tudi namensko telefonsko številko ali posebno elektronsko pošto.
The Agency shall also make available to the public other means for patients to report undesirable effects, such as a dedicated telephone number or special email address.
Člen 26 – odstavek 1 – točka 2
Article 26 – paragraph 1 – point 2
(2) podroben zapisnik vsakega sestanka odborov iz točk (a) in (aa) člena 56(1) te uredbe ter koordinacijske skupine v zvezi z dejavnostmi farmakovigilance;
(2) detailed minutes of each meeting of the committees referred to in points (a) and (aa) of Article 56(1) of this Regulation and the coordination group as regards pharmacovigilance activities;
Člen 26 – točka 3
Article 26 — point 3
(3) povzetek sistemov obvladovanja tveganja za zdravila, odobrena v skladu s to uredbo;
(3) a summary of risk management systems for medicinal products authorised in accordance with this Regulation;
Informacije na nacionalnih spletnih portalih o varnosti zdravil morajo biti predstavljene na preprost in razumljiv način.
Information on national safety web portals should be presented in an easy and understandable way.
Tehnični dokumenti morajo biti predstavljeni v obliki povzetka in v različici za nestrokovnjake.
Technical documents should be presented in a summary format and in lay version.
Na nacionalnih spletnih portalih za varnost zdravil je treba objaviti tudi navodila za uporabo in povzetek glavnih značilnosti zdravila, saj vsebujejo osnovne informacije o uporabi zdravil, ki so bistvene za njihovo varno uporabo.
The Package Leaflet (PL) and the Summary of Product Characteristics Additional should also be published in national safety web-portals as they contain basic information on the use of medicines which is key for their safe use.
Člen 26 – točka 4 a (novo)
Article 26 – point 4 a (new)
(4a) najsodobnejšo elektronsko različico navodil za uporabo in povzetek glavnih značilnosti zdravila za vsa obstoječa in nova zdravila;
(4a) the most up-to-date electronic version of the package leaflet and summary of product characteristics for all existing and new medicinal products;
Člen 26 – točka 4 b (novo)
Article 26 – point 4 b (new)
(4b) kratka zgodovina dokumenta s spremembami informacij o proizvodu
(4b) a brief document history of changes made to the product information.
Vsi podatki na spletnem portalu o varnosti zdravil, skupaj z vsemi podatki iz točk od 1 do 4b tega člena, so predstavljeni v obliki, razumljivi splošni javnosti.
All information on medicines safety web-portals, including all information set out in points 1 to 4b of this Article, shall be presented in a manner that is comprehensible to the general public.
Informacije na nacionalnih spletnih portalih EU o varnosti zdravil morajo biti predstavljene na preprost in razumljiv način.
Information on the EU safety web portal should be presented in an easy and understandable way.
Zakonodaja sicer predvideva, da se na evropskih spletnih portalih objavijo zelo podrobne informacije, ne vključuje pa sklicevanja na bistvene informacije za zagotovitev varne uporabe zdravil : prav zato morajo biti javnosti lahko dostopna navodila za uporabo in povzetek glavnih značilnosti zdravila ali evropska javna poročila o oceni zdravila.
While this legislation provides for very detailed information to be published on the European web-portal, it does not include reference to key information to ensure safe use of medicines : This is why the package leaflet, the Summary of Product Characteristics or the European Public Assessment Reports should be made easily accessible to the public.
Poleg tega bi kratka zgodovina sprememb informacij o zdravilu omogočila bolnikom in zdravstvenim delavcem, da čez čas vidijo posodobitve o zdravilih.
Additionally, a brief document history of changes would allow patients and healthcare professionals to see updates made to product information over time.
Pred oblikovanjem in vzpostavitvijo tega portala se Agencija posvetuje z zadevnimi zainteresiranimi skupinami (vključno s skupinami bolnikov, zdravstvenimi delavci in predstavniki industrije), da bi pridobila njihovo mnenje.
Before the design and launch of this portal, the Agency consults relevant stakeholders (including patient groups, healthcare professionals and industry representatives) to get their opinion.
Pomembno je, da se pred vzpostavitvijo tega spletnega mesta izvedejo posvetovanja z zainteresiranimi stranmi, ki jih zadevajo informacije na portalu Agencije.
Before the launch of this website, it seems important to consult stakeholders who are involved in the information provided on the portal of the Agency.
Člen 28 – odstavek 4 – pododstavek 1
Article 28 – paragraph 4 – subparagraph 1
Odbor za zdravila za uporabo v humani medicini v 30 dneh po prejemu priporočila Svetovalnega odbora za oceno tveganja na področju farmakovigilance sprejme mnenje o ohranitvi, spremembi, začasni ukinitvi ali razveljavitvi zadevnega dovoljenja za promet.
Within 30 days of receipt ofthe recommendation , by the Pharmacovigilance Risk Assessment Advisory Committee, the Committee for Medicinal Products for Human Use (CHMP) shall adopt an opinion on the maintenance, variation, suspension or revocation of the marketing authorisation concerned.
Ta priloga je prav tako dostopna javnosti.
That annex shall also be made available to the public.
Uskladitev z novo strukturo agencije, po kateri so farmakovigilanca in dovoljenja za promet strogo ločeni.
Bringing it into line with the Agency’s new structure, which strictly separates pharmacovigilance from marketing authorisations.
Poročila o oceni , mnenja in odločbe iz odstavkov od 3 do 5 tega člena se objavijo prek evropskega spletnega portala za varnost zdravil iz člena 26.
The assessment reports, opinions and decisions referred to in paragraphs 3 to 5 of this Article shall be made public by means of the European medicines safety web-portal referred to in Article 26.
Člen 1 – točka 18 – točka (a)
Article 1 – point 18 - point a
Člen 67 – odstavek 3
Article 67 – paragraph 3
„Prihodki Agencije so sestavljeni iz prispevka Skupnosti in pristojbin, ki jih plačajo podjetja za pridobitev in ohranitev dovoljenj za promet Skupnosti ter za druge storitve, ki jih zagotavlja Agencija ali koordinacijska skupina v zvezi z izpolnjevanjem nalog v skladu s členom 107c, 107e, 107g, 107l in 107r Direktive 2001/83/ES.“
“The Agency's revenue shall consist of a contribution from the Community and fees paid by undertakings for obtaining and maintaining Community marketing authorisations and for other services provided by the Agency or the coordination group as regards the fulfilment of its tasks in accordance with in accordance with Articles 107c, 107e, 107g, 107l and 107r of Directive 2001/83/EC.”
„Prihodki Agencije so sestavljeni iz prispevka Skupnosti in pristojbin, ki jih plačajo podjetja za pridobitev in ohranitev dovoljenj za promet Skupnosti ter za druge storitve, ki jih zagotavlja Agencija ali koordinacijska skupina v zvezi z izpolnjevanjem nalog v skladu s členom 107c, 107e, 107g, 107l in 107r Direktive 2001/83/ES ter člena 28b te uredbe .
"The Agency's revenue shall consist of a contribution from the Community and fees paid by undertakings for obtaining and maintaining Community marketing authorisations and for other services provided by the Agency or the coordination group as regards the fulfilment of its tasks in accordance with in accordance with Articles 107c, 107e, 107g, 107l and 107r of Directive 2001/83/EC and 28b of this Regulation.
Proračunski organ, ki ga sestavljata Evropski parlament in Svet, po potrebi ponovno preučita raven prispevka Skupnosti na osnovi vrednotenja potreb in upoštevanja višine pristojbin.
The budgetary authority, composed of the European Parliament and the Council, shall re-examine, as necessary, the level of the Community contribution on the basis of an evaluation of needs and taking account of the level of fees ."
Agencija mora dobiti dovolj finančnih prispevkov, da bo lahko opravila svoje pomembne naloge.
The agency has to have enough financial contributions in order to be able to fulfil its important tasks.
Člen 1 – točka 18 – točka (b)
Article 1 – point 18 - point b
Člen 67 – odstavek 4
Article 67 – paragraph 4
To ne izključuje zbiranja pristojbin, ki jih morajo plačati imetniki dovoljenj za promet za dejavnosti, ki jih izvaja Agencija.“
This shall not preclude the collection of fees to be paid by marketing authorisation holders for the carrying out of these activities by the Agency."
Dejavnosti v zvezi s farmakovigilanco, delovanjem komunikacijskih mrež in nadzorom trga so pod stalnim nadzorom uprave in prejmejo javna sredstva , da se zagotovi neodvisnost Agencije.
Activities relating to pharmacovigilance, to the operation of communications networks and to market surveillance shall be under the permanent control of the Management Board and shall receive public funding, in order to guarantee the independence of the Agency.
Za financiranje farmakovigilance so odgovorni javni organi, saj morajo varovati javno zdravje in so pristojni tudi za odobritve.
Public authorities are responsible for funding pharmacovigilance, because they are accountable to protect public health and because they have assumed responsibility for granting authorization.
o internetu stvari
on the Internet of Things
MNENJE Odbora za notranji trg in varstvo potrošnikov .........................18
OPINION of the Committee on the Internal Market and Consumer Protection 20
MNENJE Odbora za pravne zadeve ...........................................................................21
OPINION OF THE COMMITTEE ON LEGAL AFFAIRS......................................................24
IZID KONČNEGA GLASOVANJA V ODBORU...................................................................25
RESULT OF FINAL VOTE IN COMMITTEE.........................................................................28
– ob upoštevanju sporočila Komisije Evropskemu parlamentu, Svetu, Evropskemu ekonomsko-socialnemu odboru in Odboru regij o internetu stvari – akcijski načrt za Evropo z dne 18. junija 2009 ( KOM(2009)0278 ),
– having regard to the communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions of 18 June 2009 on the ‘Internet of Things – An action plan for Europe’ ( COM(2009)0278 ),
– ob upoštevanju delovnega programa, ki ga je predstavilo špansko predsedstvo EU 27. novembra 2009, zlasti cilja o razvoju interneta prihodnosti,
– having regard to the work programme presented by the Spanish Presidency of the EU on 27 November 2009, and in particular the objective of developing the Internet of the Future,
– ob upoštevanju sporočila Komisije Naložbe danes za Evropo jutri ( KOM(2009)0036 ),
– having regard to the Commission communication of 28 January 2009 on ‘Investing today for tomorrow’s Europe’ ( COM(2009)0036 ),
– ob upoštevanju priporočila Komisije o izvajanju načel varstva zasebnosti in varstva podatkov v aplikacijah, podprtih z radiofrekvenčno identifikacijo (C(2009)3200),
– having regard to the Commission recommendation on the implementation of privacy and data protection principles in applications supported by radio-frequency identification (C(2009)3200),
– ob upoštevanju 95/46/ES Direktive Evropskega parlamenta in Sveta z dne 24. oktobra 1995 o varstvu posameznikov pri obdelavi osebnih podatkov in o prostem pretoku takih podatkov,
– having regard to 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,
– ob upoštevanju Direktive 2002/58/ES Evropskega parlamenta in Sveta z dne 12. julija 2002 o obdelavi osebnih podatkov in varstvu zasebnosti na področju elektronskih komunikacij,
– having regard to Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector,
– ob upoštevanju Evropskega načrta za oživitev gospodarstva za spodbuditev ponovne gospodarske rasti ( KOM(2008)0800 ),
– having regard to the European economic recovery plan for a swifter return to economic growth ( COM(2008)0800 ),
– ob upoštevanju poročila Odbora za industrijo, raziskave in energetiko o določitvi nove digitalne agende za Evropo: 2015.eu
– having regard to the report of the Committee on Industry, Research and Energy on a new Digital Agenda for Europe: 2015.eu
2009/2225(INI) , Del Castillovo poročilo, A7-0066/2010 . ,
2009/2225(INI) , Del Castillo report, A7-0066/2010 . ,
– ob upoštevanju poročila Odbora za industrijo, raziskave in energetiko ter mnenj Odbora za mednarodno trgovino, Odbora za notranji trg in varstvo potrošnikov ter Odbora za pravne zadeve ( A7-0154/2010 ),
– having regard to the report of the Committee on Industry, Research and Energy, and the opinions of the Committee on International Trade, the Committee on the Internal Market and Consumer Protection and the Committee on Legal Affairs ( A7-0154/2010 ),
A. ker se je internet v zadnjih petindvajsetih letih hitro razvijal, po napovedih pa se bo razvoj še nadaljeval tako na ravni razširjenosti zaradi razvoja širokopasovnih povezav kot na ravni novih aplikacij,
A. whereas the internet has developed rapidly in the last 25 years and this development is forecast to continue in terms of both distribution – with the expansion of broadband – and new applications,
B. ker lahko internet stvari izpolni pričakovanja družbe in državljanov, potrebne pa so raziskave, da bi razumeli, kakšna so ta pričakovanja ter na katerih področjih bi lahko občutljivost ter skrb za zasebnost in informacije preprečili aplikacije,
B whereas the Internet of Things (IoT) is able to meet the expectations of society and of citizens, and whereas research is needed in order to understand what those expectations are and the areas in which sensitivities about, and concern for, personal privacy and information may block applications,
C. ker so informacijske in komunikacijske tehnologije pomembne, saj podpirajo družbeni razvoj in gospodarsko rast ter spodbujajo raziskave, inovacije in ustvarjalnost v evropskih javnih in zasebnih subjektih,
C. whereas information and communication technologies (ICT) are important in that they promote social development and economic growth and encourage research, innovation and creativity among European public and private bodies,
D. ker mora EU oblikovati skupen referenčni okvir za ureditev in okrepitev upravljanja sistema, zaupnosti, varnosti informacij, etičnosti upravljanja, spoštovanja zasebnosti, zbiranja in hrambe osebnih podatkov ter obveščanja potrošnikov,
D. whereas the EU should devise a common framework of reference in order to frame and strengthen rules on system governance, confidentiality, information security, ethical management, privacy, the collection and storage of personal data and consumer information,
E. ker se izraz „internet stvari“ nanaša na splošni pojem predmetov (tako elektronskih artefaktov kot predmetov vsakdanje uporabe), ki jih lahko beremo, prepoznavamo, naslavljamo, iščemo in/ali upravljamo na daljavo prek interneta,
E. whereas the term ‘Internet of Things’ refers to the general concept of objects (both electronic artefacts and objects in everyday use) that can be read, recognised, addressed, located and/or controlled remotely through the internet,
F. ker je v prihodnjih letih pričakovati hiter razvoj interneta stvari, ta pa terja varno, pregledno in večstransko upravljanje,
F. whereas the Internet of Things is expected to develop rapidly in the years ahead and thus requires safe, transparent and multilateral governance,
G. ker bo internet v prihodnosti prerasel sedanje tradicionalne meje virtualnega sveta zaradi povezave s svetom fizičnih predmetov,
G. whereas the internet of the future will go beyond the present traditional boundaries of the virtual world by being linked to the world of physical objects,
H. ker ponujajo tehnologije radiofrekvenčne identifikacije (RFID) ter druge tehnologije, povezane z internetom stvari, prednosti v primerjavi s črtnimi kodami in magnetnimi zapisi ter omogočajo številne aplikacije, ki jih je mogoče povezati z drugimi omrežji (na primer mobilnimi telefonskimi omrežji) in še nadalje razviti, ko bo ustvarjena povezava s senzorji, ki merijo vidike, kot so geografski položaj (na primer satelitski sistem Galileo), temperatura, svetloba, tlak in gravitacijske sile; ker bi se morala z obsežnim uvajanjem čipov radiofrekvenčne identifikacije znatno zmanjšati njihova cena na enoto ter stroški njihovih čitalnikov,
H. whereas radio frequency identification (RFID) and other IoT-related technologies have advantages over bar codes and magnetic strips, and have many more applications, which can be interfaced with other networks – such as mobile phone networks – and could be developed still further once interfaced with sensors measuring aspects such as geolocation (e.g. the Galileo satellite system), temperature, light, pressure and g-forces; whereas the widespread introduction of RFID chips should significantly reduce their unit price as well as the cost of the respective readers,
I. ker lahko tehnologija radiofrekvenčne identifikacije katalizira in pospeši gospodarski razvoj informacijske in komunikacijske industrije,
I. whereas RFID technology may be regarded as a catalyst and accelerator for the economic development of the information and communication industry,
J. ker se tehnologija radiofrekvenčne identifikacije in druge tehnologije, povezane z internetom stvari, že uporabljajo na področju proizvodnje, logistike in dobavne verige, ker ponujajo prednosti v zvezi z identifikacijo in sledljivostjo proizvodov in ker obetajo pomembne razvojne možnosti na številnih drugih področjih, kot so zdravstvo, prevoz in energijska učinkovitost, okolje, maloprodaja in boj proti ponarejanju,
J. whereas RFID technology and other IoT-related technologies are already being applied in the manufacturing, logistics and supply-chain sectors, offer benefits in terms of product identification and traceability and have promising potential for developments in many other areas, such as health care, transport and energy efficiency, environment, retail and the fight against counterfeiting,
K. ker zasnova, razvoj in izvedba sistemov z radiofrekvenčno identifikacijo kot pri vseh sistemih e-zdravstva zahteva neposredno vključenost strokovnjakov s področja zdravstvenega varstva, bolnikov in ustreznih odborov (na primer na področju varstva podatkov in etike),
K. whereas, as with all e-Health systems, the design, development and implementation of RFID-enabled systems require the direct involvement of healthcare professionals, patients and relevant committees (on data protection and ethics, for example),