natgillin/translations-raw huggingface dataset:
Postopki za izbiro uslužbencev ESZD potekajo pregledno in na podlagi odličnosti strokovnih znanj in usposobljenosti, pomembnih za naloge ESZD, za zagotovitev storitev uslužbencev, ki bodo na najvišji ravni sposobnosti, učinkovitost in neoporečnosti, ter za vzpostavitev regionalnega in geografskega ravnovesja ter uravnotežene zastopanosti spolov v ESZD.
The selection procedures for EEAS staff shall be undertaken through a transparent procedure based on merit in terms of the skills and expertise relevant for the tasks of the EEAS, with the objective of securing the services of staff of the highest standard of ability, efficiency and integrity and with the aim of establishing regional, geographical and gender balance in the EEAS.
Osebje ESZD bi moralo biti sestavljeno po načelu smiselne zastopanosti predstavnikov vseh držav članic.
The staff of the EEAS should comprise a meaningful presence of nationals from all Member States.
Naslov VIIIa – člen 98 a (novo)
Title VIIIa - Article 98 a (new)
Ne glede na določbe finančne uredbe, ne sme uradnik ali začasni uslužbenec ESZD pod nobenimi pogoji prejeti kakršno koli plačilo, dodaten finančen ali drugačen prispevek v kakršni koli obliki in iz katerih koli virov izven ESZD.
Notwithstanding the provisions of the Financial Regulation, under no circumstances may any official or temporary agent of the EEAS receive any payments, supplementary financial or other contributions of any kind from any source outside the EEAS.
Naslov VIIIa – člen 98 b (novo)
Title VIIIa - Article 98 b (new)
Vsi uslužbenci ESZD uporabljajo in spoštujejo strokovni kodeks ravnanja, ki ga pripravi visoki predstavnik Evropske unije za zunanje zadeve in varnostno politiko ter podpredsednik Komisije.
The Code of Professional Conduct to be drawn up by the High-Representative of the Union for Foreign Affairs and Security Policy and Vice-President of the Commission shall be followed and respected by all EEAS staff.
Naslov VIIIa – člen 99 - odstavek 1 - pododstavek 1
Title VIIIa - Article 99 - paragraph 1- subparagraph 1
Naslov VIIIa – člen 99 a (novo)
Title VIIIa - Article 99 a (new)
Posamezni uradniki in uslužbenci ESZD najtesneje sodelujejo z Evropskim uradom za boj proti goljufijam, ki je izključno pristojen na področju boja proti goljufijam v zvezi z ESZD.
The individual officials and a gents of the EEAS shall work in the closest cooperation with the European Anti-Fraud Office, which has exclusive competence in the area of fight against fraud in respect of the EEAS.
Pogoji za zaposlitev drugih uslužbencev Evropskih skupnosti
Conditions of Employment of Other Servants of the European Union
Člen 50b – odstavek 2 a (novo)
Article 50b - paragraph 2 a (new)
V skladu s členom 66 finančne uredbe, so za svoja dejanja kot začasni uslužbenci ESZD odgovorni tudi po vrnitvi v nacionalno diplomatsko službo.
They shall be held liable, under Article 66 of the Financial Regulation, for their actions as temporary agents of the EEAS even after their return to their national diplomatic services .
Marta Andreasen, Jean-Pierre Audy, Inés Ayala Sender, Zigmantas Balčytis, Andrea Češková, Jorgo Chatzimarkakis, Andrea Cozzolino, Ryszard Czarnecki, Luigi de Magistris, Tamás Deutsch, Martin Ehrenhauser, Jens Geier, Gerben-Jan Gerbrandy, Ingeborg Gräßle, Ville Itälä, Cătălin Sorin Ivan, Iliana Ivanova, Jan Olbrycht, Crescenzio Rivellini, Christel Schaldemose, Teodoros Skilakakis (Theodoros Skylakakis), Bart Staes, Georgios Stavrakakis, Søren Bo Søndergaard
Marta Andreasen, Jean-Pierre Audy, Inés Ayala Sender, Zigmantas Balčytis, Andrea Češková, Jorgo Chatzimarkakis, Andrea Cozzolino, Ryszard Czarnecki, Luigi de Magistris, Tamás Deutsch, Martin Ehrenhauser, Jens Geier, Gerben-Jan Gerbrandy, Ingeborg Gräßle, Ville Itälä, Cătălin Sorin Ivan, Iliana Ivanova, Jan Olbrycht, Crescenzio Rivellini, Christel Schaldemose, Theodoros Skylakakis, Bart Staes, Georgios Stavrakakis, Søren Bo Søndergaard
Alfredo Antoniozzi, Raffaele Baldassarre, Sebastian Valentin Bodu, Françoise Castex, Marielle Gallo, Lidia Joanna Geringer de Oedenberg, Klaus-Heiner Lehne, Antonio López-Istúriz White, Antonio Masip Hidalgo, Jiří Maštálka, Bernhard Rapkay, Evelyn Regner, Francesco Enrico Speroni, Dimiter Stojanov (Dimitar Stoyanov), Alexandra Thein, Diana Wallis, Cecilia Wikström, Zbigniew Ziobro, Tadeusz Zwiefka
Alfredo Antoniozzi, Raffaele Baldassarre, Sebastian Valentin Bodu, Françoise Castex, Marielle Gallo, Lidia Joanna Geringer de Oedenberg, Klaus-Heiner Lehne, Antonio López-Istúriz White, Antonio Masip Hidalgo, Jiří Maštálka, Bernhard Rapkay, Evelyn Regner, Francesco Enrico Speroni, Dimitar Stoyanov, Alexandra Thein, Diana Wallis, Cecilia Wikström, Zbigniew Ziobro, Tadeusz Zwiefka
o predlogu uredbe Evropskega parlamenta in Sveta o spremembi Uredbe (ES) št. 726/2004 o postopkih Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za humano in veterinarsko uporabo ter o ustanovitvi Evropske agencije za zdravila v zvezi z informacijami za širšo javnost o zdravilih na recept za uporabo v humani medicini
on the proposal for a regulation of the European Parliament and of the Council on amending, as regards information to the general public on medicinal products for human use subject to medical prescription, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
MNENJE Odbora za industrijo, raziskave in energetiko .............................17
OPINION of the Committee on Industry, Research and Energy ...............17
MNENJE Odbora za notranji trg in varstvo potrošnikov .........................26
OPINION of the Committee on the Internal Market and Consumer Protection 27
– ob upoštevanju predloga Komisije Evropskemu parlamentu in Svetu ( KOM(2008)0662 ),
– having regard to the Commission proposal to the European Parliament and the Council ( COM(2008)0662 ),
– ob upoštevanju členov 251(2) in 95 Pogodbe ES, na podlagi katerih je Komisija Parlamentu podala predlog ( C6-517/2008 ),
– having regard to Article 251(2) and Article 95 of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament ( C6-517/2008 ),
– ob upoštevanju sporočila Komisije Evropskemu parlamentu in Svetu z naslovom Posledice začetka veljavnosti Lizbonske pogodbe za še nedokončane medinstitucionalne postopke odločanja ( KOM(2009)0665 ),
– having regard to the communication from the Commission to the European Parliament and the Council entitled: 'Consequences of the entry into force of the Treaty of Lisbon for ongoing interinstitutional decision-making procedures' (COM (2009)0665),
– ob upoštevanju členov 294(3), 114 in 168(4)(c) Pogodbe o delovanju Evropske unije,
– having regard to Article 294(3), Article 114 and Article 168(4)(c) of the Treaty on the Functioning of the EU,
– ob upoštevanju poročila Odbora za okolje, javno zdravje in varnost hrane in mnenj Odbora za industrijo, raziskave in energetiko ter Odbora za notranji trg in varstvo potrošnikov ( A7‑0289/2010 ),
– having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinions of the Committee on Industry, Research and Energy and the Committee on the Internal Market and Consumer Protection ( A7‑0289/2010 ),
(1) Komisija je 20. decembra 2007 Evropskemu parlamentu in Svetu predložila Sporočilo o „poročilu o obstoječi praksi glede zagotavljanja informacij o zdravilih bolnikom“.
(1) On 20 December 2007, the Commission submitted a Communication to the European Parliament and the Council concerning the "Report on current practices with regard to the provision of information to patients on medicinal products".
Sklep poročila je, da države članice sprejemajo različna pravila in prakse glede zagotavljanja informacij, kar vodi do situacije, v kateri imajo bolniki in širša javnost neenak dostop do informacij o zdravilih.
The report concludes that Member States have adopted divergent rules and practices with regard to the provision of information, resulting in a situation where patients and the public at large have unequal access to information on medicinal products.
Izkušnje, pridobljene pri uporabi sedanjega pravnega okvira, so prav tako pokazale razlike v razlagi pravil Skupnosti v zvezi z oglaševanjem ter med nacionalnimi določbami o informacijah.
Experience gained from the application of the current legal framework has also shown disparities in the interpretation of the Community rules on advertising, and between national provisions on information.
Izkušnje, pridobljene pri uporabi sedanjega pravnega okvira, so prav tako pokazale razlike v razlagi pravil Unije v zvezi z oglaševanjem ter med nacionalnimi določbami o informacijah in nujno potrebo po pojasnitvi razlike med oglaševanjem in obveščanjem .
Experience gained from the application of the current legal framework has also shown disparities in the interpretation of the Union rules on advertising, and between national provisions on information , highlighting the urgent need for a more precise distinction between advertising and information .
Zaradi premalo jasnega razlikovanja med obveščanjem in oglaševanjem prihaja v EU do motenj pri dostopu do informacij, pri čemer je javnost podvržena različnim bolj ali manj omejujočim razlagam, ki jih države članice uporabljajo pri opredeljevanju, kaj je lahko in kaj ne more biti oglaševanje.
The lack of a clear distinction between information and advertising creates distortions in access to information within the EU, and the public is subject to differing, more or less restrictive interpretations by the Member States as regards the definition of what may or may not be considered advertising.
(2) Uvedba novega naslova VIIIa v Direktivo 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini navedena vprašanja obravnava z različnimi določbami za zagotavljanje razpoložljivosti visoko kakovostnih, objektivnih, zanesljivih in nepromocijskih informacij o zdravilih na recept za uporabo v humani medicini.
(2) The introduction of a new Title VIII a in Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on a Community code relating to medicinal products for human use addresses those concerns through various provisions intended to ensure the availability of good-quality, objective, reliable and non promotional information on medicinal products for human use subject to prescription.
(2) Uvedba novega naslova VIIIa v Direktivo 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini navedena vprašanja obravnava z različnimi določbami , katerih namen je zagotoviti razpoložljivost visoko kakovostnih, objektivnih, zanesljivih in nepromocijskih informacij o zdravilih na recept za uporabo v humani medicini ter poudariti pravice in interese bolnikov .
(2) The introduction of a new Title VIII a in Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on a Community code relating to medicinal products for human use addresses those concerns through various provisions intended to ensure the availability of good-quality, objective, reliable and non promotional information on medicinal products for human use subject to prescription and to place emphasis on the rights and interests of patients .
Direktiva o spremembi se mora osrediniti na bolnike in njihove interese ter mora biti vključena tudi v uredbo o spremembi.
The Amending Directive has to focus on the patients and their interests and it has to be reflected in the Amending Regulation as well.
V novih določbah direktive o spremembi mora biti namesto pravice farmacevtskih podjetij do razširjanja informacij poudarjena pravica bolnikov do obveščenosti.
The new provisions of the Amending Directive have to emphasise the right of patients for information instead of the right of the pharmaceutical companies to disseminate information .
(4) Direktiva 2001/83/ES določa, da morajo nacionalni pristojni organi držav članic nekatere vrste informacij nadzorovati, preden se začnejo širiti .
(4) Directive 2001/83/EC provides that certain types of information are subject to control by the Member States' national competent authorities prior to their dissemination.
To vključuje informacije o ne-intervencijskih znanstvenih študijah ali spremljevalnih ukrepih za preprečevanje in zdravljenje ali informacije, ki zdravilo predstavljajo v okviru stanja, ki ga je treba preprečiti ali zdraviti.
This concerns information about non-interventional scientific studies, or accompanying measures to prevention and medical treatment, or information which presents the medicinal product in the context of the condition to be prevented or treated.
V primeru zdravil za uporabo v humani medicini, odobrenih v skladu z naslovom II Uredbe (ES) št. 726/2004, mora Evropska agencija za zdravila (v nadaljnjem besedilu: Agencija) zagotoviti vnaprejšnje preverjanje nekaterih vrst informacij.
In the case of medicinal products for human use authorised pursuant to Title II of Regulation (EC) No 726/2004, provision should also be made for certain types of information to be subject to prior vetting by the European Medicines Agency (hereinafter referred to as the 'Agency').
(4) Direktiva 2001/83/ES določa, da morajo nacionalni pristojni organi držav članic nekatere vrste informacij nadzorovati, preden se dajo na razpolago .
(4) Directive 2001/83/EC provides that certain types of information are subject to control by the Member States' national competent authorities prior to being made available.
V primeru zdravil za uporabo v humani medicini, odobrenih v skladu z naslovom II Uredbe (ES) št. 726/2004, mora Evropska agencija za zdravila (v nadaljnjem besedilu: Agencija) zagotoviti vnaprejšnje preverjanje nekaterih vrst informacij in nadzorovati ukrepe, ki jih bo proizvajalec sprejel po poročanju o neželenih učinkih, nato pa posodobiti literaturo .
In the case of medicinal products for human use authorised pursuant to Title II of Regulation (EC) No 726/2004, provision should also be made for certain types of information to be subject to prior vetting by the European Medicines Agency (hereinafter referred to as the 'Agency') , and for the Agency to monitor the measures to be taken by the manufacturer following a report of adverse reactions, and the consequent updating of the literature .
Predlog spremembe se nanaša na informacije, ki jih pristojni organi niso odobrili pri registraciji zdravila, in gre dejansko za prikrito aktivno posredovanje informacij.
The proposed amendment relates to information not approved by competent authorities during the registration of medicinal products and is in fact hidden “push” information.
Vse ustrezne informacije v zvezi s študijami so vključene v navodila za uporabo in povzetek značilnosti zdravil, ki so del dokumentov v vlogi za registracijo.
Any relevant information relating to studies is included in the patient leaflet and the Summary of Product Characteristics (SmPC), which is part of the registration file for approval.
(5a) Če se izkaže, da so za Agencijo zaradi predhodnega preverjanja posameznih vrst informacij v skladu s to uredbo nastali dodatni stroški, ki se ne morejo pokriti iz prispevkov imetnikov dovoljenj za promet z zdravili, je treba preveriti višino prispevka Evropske unije v proračun Agencije.
(5a) In the event that the additional costs incurred by the Agency as a result of its preliminary checking of certain types of information pursuant to this Regulation are not covered by the fees payable by the marketing authorisation holders for this purpose, the amount of the European Union’s contribution to the Agency’s budget should be reviewed.
Tudi na ravni držav članic si je treba prizadevati za ustrezno prilagoditev prispevka Evropske unije.
Accordingly, efforts should be initiated at Member State level with a view to the possible amendment of the European Union’s contribution to the Agency.
Člen 9 – odstavek 4 – točka e a (novo)
Article 9 – paragraph 4 – point e a (new)
(-1) V členu 9(4) se doda naslednja točka:
(-1) In Article 9(4), the following point is added:
„(ea) javni povzetek poročila o oceni iz člena 13(3)“.
"(ea) the public summary of the assessment report referred to in Article 13(3)".
Člen 20 b – odstavek 1
Article 20b – paragraph 1
Z odstopanjem od člena 100g(1) Direktive 2001/83/ES Agencija informacije v zvezi z zdravili iz člena 100b(d) navedene direktive preveri, preden se začnejo širiti .
By way of derogation from Article 100g(1) of Directive 2001/83/EC, medicinal product-related information referred to in Article 100b(d) of that Directive shall be subject to vetting by the Agency prior to its dissemination.
Z odstopanjem od člena 100g(1) Direktive 2001/83/ES Agencija informacije v zvezi z zdravili iz člena 100b(d) navedene direktive preveri, preden se dajo na razpolago, razen če so te informacije objavljene na spletnem mestu, katerega vsebino mora v skladu s členom 100h Direktive 2001/83/ES spremljati posamezna država članica .
By way of derogation from Article 100g(1) of Directive 2001/83/EC, medicinal product-related information referred to in Article 100b(d) of that Directive shall be subject to vetting by the Agency prior to its being made available, unless this information appears on a website, the responsibility for monitoring the content of which rests with a Member State in accordance with Article 100h of Directive 2001/83/EC .
Skladnost z določbami člena 100h Direktive 2001/83/ES.
Consistency with the provisions of Article 100h of Directive 2001/83/EC.
Člen 20 b – odstavek 2
Article 20b – paragraph 2
Za namene odstavka 1 imetnik dovoljenja za promet Agenciji predloži model informacij, ki jih namerava širiti .
For the purposes of paragraph 1, the marketing authorisation holder shall submit to the Agency a mock-up of the information to be disseminated .
Za namene odstavka 1 imetnik dovoljenja za promet Agenciji predloži model informacij, ki jih namerava dati na razpolago .
For the purposes of paragraph 1, the marketing authorisation holder shall submit to the Agency a mock-up of the information to be made available .
Poudarek direktive mora biti na bolnikih.
This Directive must be patient-centered.
Imetniki dovoljenja za promet morajo bolnikom in splošni javnosti dati na voljo nepromocijske informacije o zdravilih na podlagi izraženega zanimanja, kar pomeni, da dobijo bolniki/širša javnost dostop do informacij, če jih potrebujejo (v nasprotju s primeri, ko imetniki dovoljenja za promet širijo informacije med bolniki in širšo javnostjo).
Therefore non-promotional information on medicinal products must be made available to patients and to the general public by marketing authorisation holders according to the "pull principle" whereby patients/the public have access to information if they need it (contrary to the "push principle" whereby the marketing authorisation holders disseminate information among the patients and the general public).
Člen 20 b – odstavek 3
Article 20b – paragraph 3
Agencija lahko na podlagi razlogov, povezanih z neizpolnjevanjem določb naslova VIIIa Direktive 2001/83/ES, predloženim informacijam ali delom teh informacij ugovarja v 60 dneh po prejemu obvestila.
The Agency may object to the information submitted or parts thereof on grounds related to non-compliance with the provisions of Title VIIIa of Directive 2001/83/EC within 60 days after receipt of the notification.
Če Agencija ne ugovarja v 60 dneh , se informacije štejejo za sprejete in se lahko objavijo.
If the Agency does not object within 60 days , the information shall be deemed accepted and may be published.
Agencija lahko na podlagi razlogov, povezanih z neizpolnjevanjem določb naslova VIIIa Direktive 2001/83/ES, predloženim informacijam ali delom teh informacij ugovarja v 120 dneh po prejemu obvestila.
The Agency may object to the information submitted or parts thereof on grounds related to non-compliance with the provisions of Title VIIIa of Directive 2001/83/EC within 120 days after receipt of the notification.
Če Agencija ne ugovarja v 120 dneh , se informacije štejejo za sprejete in se lahko objavijo.
If the Agency does not object within 120 days , the information shall be deemed accepted and may be published.
Imetnik dovoljenja za promet je še vedno v celoti odgovoren in pristojen za informacije, zagotovljene v vseh primerih.
The marketing authorisation holder shall remain fully liable and responsible for the information provided in all cases.
Bistveno je podaljšati rok za oceno informacij, da bi izpolnili organizacijske potrebe Agencije in zagotovili, da so podjetja še naprej v celoti odgovorna za informacije, ki jih zagotavljajo širši javnosti.
It is essential to extend the timeline for the evaluation of the information in order to meet the organisational needs of the Agency and to ensure that the companies remain fully liable for the information they provide to the general public.
Člen 20 b – odstavek 3 a (novo)
Article 20b – paragraph 3 a (new)
Če Agencija zahteva spremembe dokumenta, ki ga je predložil imetnik dovoljenja za promet, in če ta ponovno predloži izboljšani predlog v 30 delovnih dneh, Agencija nanj odgovori v 60 delovnih dneh.
If the Agency asks for changes to a document submitted by the marketing authorisation holder, and if the latter resubmits an improved proposal within 30 working days, the Agency shall communicate its response to the new proposal within 60 working days.
Za to oceno Agencija imetniku dovoljenja za promet zaračuna novo pristojbino.
The Agency shall charge the marketing authorisation holder a new fee for this assessment.
Namen predloga spremembe je zagotoviti večjo učinkovitost postopka s skrajšanjem časa za oceno s 120 na 60 dni, če imetnik dovoljenja za promet v 30 dneh popravi dokument, ki ga je predložil.
This amendment aims to ensure greater efficiency in the process with a reduction of the assessment time to 60 days instead of 120 days if the marketing authorisation holder corrects a document previously submitted within 30 days.
Člen 57 – odstavek 1 – točka 1
Article 57 – paragraph 1 – point l
(1a) V členu 57(1) se točka (l) nadomesti z naslednjim besedilom:
(1a) In Article 57(1), point (l) is replaced by the following:
„ (l) ustvarjanje baze podatkov o zdravilih, ki naj bo dostopna javnosti, v vseh uradnih jezikih EU, zagotavljanje njenega posodabljanja in upravljanja neodvisno od poslovnih interesov farmacevtskih podjetij; baza podatkov olajša iskanje podatkov že odobrenih zdravil za navodila za uporabo; vključuje skupino podatkov o zdravilih, odobrenih za zdravljenje otrok; podatki za javnost se oblikujejo v primernem in razumljivem jeziku in so namenjeni nestrokovnjakom ;“
" (l) creating a database on medicinal products, to be accessible to the general public, in all official languages of the EU, and ensuring that it is updated, and managed independently of the commercial interests of pharmaceutical companies; the database shall facilitate the search for information already authorised for package leaflets; it shall include a section on medicinal products authorised for the treatment of children; the information provided to the public shall be worded in an appropriate and comprehensible manner designed for non-expert s ; "
Okrepitev vloge, ki jo ima agencija EMEA na področju obveščanja javnosti o zdravilih, ki se izdajajo na zdravniški recept, je nujna za zagotovitev kakovostnih informacij, ki so vsem državljanom dostopne po enakih pogojih.
Strengthening the EMEA’s role with regard to information for the public on medicinal products for which a medical prescription is required is crucial in order to ensure that all citizens have equal access to high-quality information.
Pri upravljanju baze podatkov z informacijami za javnost morajo biti izpolnjena merila o nepristranskosti teh informacij.
The management of the database of information for the public should comply with exemption criteria for that information.
Člen 57 – odstavek 1 – točka u a (novo)
Article 57 – paragraph 1 – point ua (new)
(2a) V členu 57(1) se doda naslednja točka:
(2a) In Article 57(1), the following point is added:
„(ua) spodbujanje obstoječih virov neodvisnih zanesljivih zdravstvenih informacij.“
"(ua) promoting existing sources of independent reliable health information."