natgillin/translations-raw huggingface dataset:
poziva komisarja za pravosodje, naj zagotovi, da bo Parlament v prihodnosti tesneje sodeloval pri dejavnostih Komisije in Sveta na Haaški konferenci prek parlamentarnega opazovalca in z rednimi izjavami za pristojni parlamentarni odbor; v zvezi s tem opozarja Komisijo na institucionalne zaveze, ki jih je pred Parlamentom izrazil komisar Frattini septembra 2006, in sicer, da bo Komisija v celoti sodelovala s Parlamentom pri svojem delu s Haaško konferenco;
Calls upon the Commissioner for Justice to ensure that in future Parliament is more closely involved with the activities of the Commission and the Council at the Hague Conference through Parliament's observer and by means of regular statements to the competent parliamentary committee; in this context reminds the Commission of the institutional commitments expressed by Commissioner Frattini before Parliament in September 2006 that the Commission would cooperate fully with the Parliament in its work with the Hague Conference;
spodbuja Komisijo, naj v celoti odigra svojo vlogo pri delu Haaške konference; poziva Komisijo, naj sprejme ukrepe za zagotovitev, da EU ratificira Haaško konvencijo o zaščiti otrok z dne 19. oktobra 1996;
Encourages the Commission to play its full role in the work of the Hague Conference; urges the Commission to take steps to ensure that the EU ratifies the Hague Convention of 19 October 1996 on the Protection of Children;
sprejema odločitev, da ustanovi medparlamentarni forum o delu Haaške konference; meni, da ima spodbujanje avtonomije strank v pogodbenih odnosih po vsem svetu – že samo kot vzor – na Haaški konferenci tako resne posledice s stališča izogibanja obveznim določbam, da sta potrebna razprava in razmislek o tem na demokratičnih forumih po vsem svetu;
Resolves to set up an interparliamentary forum on the work of the Hague Conference; considers, by way of example only, that the promotion by the Hague Conference of party autonomy in contractual relations worldwide has such serious implications from the point of view of the evasion of mandatory rules as to warrant its being debated and reflected upon in democratic fora worldwide;
ugotavlja, da je Komisija ustanovila delovno skupino za arbitražo; opozarja Komisijo, naj ne sprejme nobene zakonodajne pobude na tem področju brez odprtega posvetovanja in ob celoviti vključitvi Evropskega parlamenta; poziva Komisijo, naj zagotovi, da je predstavnik pristojnega parlamentarnega odbora povabljen k sodelovanju pri vseh tovrstnih delovnih skupinah, ter brez odrekanja pravice Komisije do pobude meni, da bi moral imeti Evropski parlament pravico imenovati člana ali člane tovrstnih delovnih skupin, da se zagotovi, da so resnično reprezentativne;
Observes that the Commission has set up a working group on arbitration; cautions the Commission against adopting any legislative initiative in this area without holding open consultations while involving the European Parliament to the full; calls on the Commission to ensure that a representative of the competent parliamentary committee is invited to take part in all such working groups and considers that, without detracting from the Commission's right of initiative, the European Parliament should have the right to nominate a member or members of such working groups in order to ensure that they are truly representative;
poudarja, da je treba zagotoviti vzajemno priznavanje uradnih dokumentov nacionalnih uprav; pozdravlja prizadevanja komisije, da se državljanom omogoči uresničevanje njihove pravice do prostega gibanja, in odločno podpira načrte, da se omogoči medsebojno priznanje učinkov dokumentov o civilnem statusu; poziva k dodatnim prizadevanjem za zmanjšanje ovir za državljane, ki uresničujejo svojo pravico do prostega gibanja, zlasti kar zadeva dostop do socialnih ugodnosti, do katerih so upravičeni, in njihove pravice, da volijo na občinskih volitvah;
Stresses the need to ensure mutual recognition of official documents issued by national administrations; welcomes the Commission's efforts to empower citizens to exercise their free movement rights and strongly supports plans to enable the mutual recognition of the effects of civil status documents; calls for further efforts to reduce barriers for citizens who exercise their rights of free movement, particularly with regard to access to the social benefits to which they are entitled and their right to vote in municipal elections;
Resolucija Evropskega parlamenta z dne 24. novembra 2010 o predlogu spremembe proračuna Evropske unije št. 8/2010 za proračunsko leto 2010, oddelek III – Komisija (16722/2010 – C7-0388/2010 – 2010/2217(BUD) )
European Parliament resolution of 24 November 2010 on Council's position on Draft amending budget No 8/2010 of the European Union for the financial year 2010, Section III – Commission (16722/2010 – C7-0388/2010 – 2010/2217(BUD) )
ob upoštevanju Pogodbe o delovanju Evropske unije, zlasti člena 314 te pogodbe, v povezavi s Pogodbo o ustanovitvi Evropske skupnosti za atomsko energijo in zlasti člena 106a te pogodbe,
having regard to the Treaty on the Functioning of the European Union and in particular Article 314 thereof, and to the Treaty establishing the European Atomic Energy Community and in particular Article 106a thereof,
ob upoštevanju predloga spremembe proračuna Evropske unije št. 8/2010 za proračunsko leto 2010, ki ga je Komisija predložila 24. septembra 2010 ( KOM(2010)0533 ),
having regard to Draft amending budget No 8/2010 of the European Union for the financial year 2010, which the Commission presented on 24 September 2010 ( COM(2010)0533 ),
ob upoštevanju stališča Sveta o predlogu spremembe proračuna št. 8/2010, ki ga je Svet oblikoval 22. novembra 2010 (16722/2010 – C7-0388/2010 ),
having regard to Council's position on Draft amending budget No 8/2010, which the Council established on 22 November 2010 (16722/2010 – C7-0388/2010 ),
ob upoštevanju poročila Odbora za proračun ( A7-0327/2010 ),
having regard to the report of the Committee on Budgets ( A7-0327/2010 ),
ker predlog spremembe proračuna št. 8/2010 za splošni proračun za leto 2010 zajema naslednje elemente:
whereas Draft amending budget No 8/2010 to the general budget 2010 covers the following items:
uporabo Solidarnostnega sklada EU v znesku 13 022 500 EUR v obveznostih in plačilih za škodo, ki so jo povzročile poplave na Irskem,
mobilisation of the EU Solidarity Fund for an amount of EUR 13 022 500 in commitment and payment appropriations relating to the effects of flooding in Ireland,
ustrezno zmanjšanje plačil za 13 022 500 EUR v vrstici 04 02 01 – Zaključek Evropskega socialnega sklada (ESS) – Cilj 1 (2000–2006),
a corresponding reduction in payment appropriations of EUR 13 022 500 from line 04 02 01 - Completion of European Social Fund (ESF) - Objective 1 (2000–2006),
ker je namen predloga spremembe proračuna št. 8/2010, da se prilagoditev proračuna uradno vključi v proračun za leto 2010,
whereas the purpose of Draft amending budget No 8/2010 is to formally enter this budgetary adjustment into the 2010 budget,
se seznanja s predlogom spremembe proračuna št. 8/2010;
Takes note of Draft amending budget No 8/2010;
odobri nespremenjeno stališče Sveta o predlogu spremembe proračuna št. 8/2010 in naroči svojemu predsedniku, naj razglasi, da je bila sprememba proračuna št. 7/2010 dokončno sprejeta, ter poskrbi za njeno objavo v
Approves the Council's position on Draft amending budget No 8/2010 unamended and instructs its President to declare that Amending budget No 7/2010 has been definitively adopted and to arrange for its publication in the
ob upoštevanju osnutka sklepa Sveta (10496/2010),
having regard to the draft Council decision (10496/2010),
ob upoštevanju Sporazuma o partnerstvu in sodelovanju o partnerstvu med Evropskimi skupnostmi in njihovimi državami članicami na eni strani ter Republiko Moldavijo na drugi strani UL L 181, 24.6.1998, str.
having regard to the Partnership and Cooperation Agreement establishing a partnership between the European Communities and their Member States, of the one part, and the Republic of Moldova, of the other part OJ L 181, 24.6.1998, p.
, ki je bil sklenjen 28. novembra 1994,
, concluded on 28 November 1994,
ob upoštevanju zahteve za odobritev, ki jo je Svet vložil v skladu s členi 114, 168, 169, 172, 173(3), 188, 192 ter točko (a) drugega pododstavka člena 218(6), členom 218(7) in drugim pododstavkom člena 218(8) Pogodbe o delovanju Evropske unije ( C7-0330/2010 ),
having regard to the request for consent submitted by the Council pursuant to Articles 114, 168, 169, 172, 173(3), 188 and 192 and Article 218(6), second subparagraph, point (a), Article 218(7) and the second subparagraph of Article 218(8) of the Treaty on the Functioning of the European Union ( C7-0330/2010 ),
ob upoštevanju priporočila Odbora za zunanje zadeve ( A7-0300/2010 ),
having regard to the recommendation of the Committee on Foreign Affairs ( A7-0300/2010 ),
odobri sklenitev protokola;
Consents to conclusion of the Protocol;
naroči svojemu predsedniku, naj stališče Parlamenta posreduje Svetu, Komisiji ter vladam in parlamentom držav članic in Republike Moldavije.
Instructs its President to forward its position to the Council, the Commission and the governments and parliaments of the Member States and of the Republic of Moldova.
Zakonodajna resolucija Evropskega parlamenta z dne 24. novembra 2010 o predlogu direktive Evropskega parlamenta in Sveta o spremembi Direktive 2001/83/ES o zakoniku Skupnosti o zdravilih za uporabo v humani medicini v zvezi z informacijami za širšo javnost o zdravilih na recept ( KOM(2008)0663 – C6-0516/2008 – 2008/0256(COD) )
European Parliament legislative resolution of 24 November 2010 on the proposal for a directive of the European Parliament and of the Council amending, as regards information to the general public on medicinal products subject to medical prescription, Directive 2001/83/EC on the Community code relating to medicinal products for human use ( COM(2008)0663 – C6-0516/2008 – 2008/0256(COD) )
ob upoštevanju predloga Komisije Evropskemu parlamentu in Svetu ( KOM(2008)0663 ),
having regard to the Commission proposal to the European Parliament and the Council ( COM(2008)0663 ),
ob upoštevanju člena 251(2) in člena 95 Pogodbe ES, na podlagi katerih je Komisija Parlamentu podala predlog ( C6-0516/2008 ),
having regard to Article 251(2) and Article 95 of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament ( C6-0516/2008 ),
ob upoštevanju sporočila Komisije Evropskemu parlamentu in Svetu z naslovom „Posledice uveljavitve 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 interistitutional 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 European Union,
ob upoštevanju mnenja Odbora regij z dne 7. oktobra 2009 UL C 79, 27.3.2010, str.
having regard to the opinion of 7 October 2009 of the Committee of the Regions OJ C 79, 27.3.2010, p.
ob upoštevanju poročila Odbora za okolje, javno zdravje in varnost hrane ter mnenj Odbora za industrijo, raziskave in energetiko ter Odbora za notranji trg in varstvo potrošnikov ( A7-0290/2010 ),
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 ( A7-0290/2010 ),
ob upoštevanju Pogodbe o delovanju Evropske unije ter zlasti člena 114 in člena 168(4)(c) Pogodbe,
Having regard to the Treaty on the functioning of the European Union, and in particular Article 114 and Article 168(4)(c) thereof,
ob upoštevanju mnenja Evropskega ekonomsko-socialnega odbora UL C 306, 16.12.2009, str.
Having regard to the opinion of the European Economic and Social Committee OJ C 306, 16.12.2009, p.
ob upoštevanju mnenja Odbora regij UL C 79, 27.3.2010, str.
Having regard to the opinion of the Committee of the Regions OJ C 79, 27.3.2010, p.
v skladu z rednim zakonodajnim postopkom Stališče Evropskega parlamenta z dne 24. novembra 2010.
Acting in accordance with the ordinary legislative procedure Position of the European Parliament of 24 November 2010.
Direktiva Sveta 2001/83/ES Evropskega parlamenta in Sveta UL L 311, 28.11.2001, str.
Directive 2001/83/EC of the European Parliament and of the Council OJ L 311, 28.11.2001, p.
določa usklajene predpise o oglaševanju zdravil za uporabo v humani medicini.
establishes harmonised rules on the advertising of medicinal products for human use.
Direktiva zlasti prepoveduje oglaševanje zdravil na recept, namenjeno širši javnosti.
In particular, it prohibits the advertising to the general public of medicinal products subject to medical prescription.
Na področju informacij Direktiva 2001/83/ES določa podrobne predpise o dokumentih, ki jih je treba priložiti dovoljenju za promet in so namenjeni obveščanju: povzetek značilnosti zdravila (ki se posreduje zdravstvenim delavcem) in
In the area of information, Directive 2001/83/EC lays down detailed rules on the documents to be annexed to the marketing authorisation and intended for information purposes: the summary of product characteristics (distributed to healthcare professionals) and the
navodila bolnikom za uporabo
patient package leaflet
(vstavljena v embalažo zdravila, ko se to posreduje bolniku).
(inserted in the product's packaging when it is dispensed to the patient).
Kar zadeva informacije, ki jih imetnik dovoljenja za promet
of information from the marketing authorisation holder to
daje na voljo bolnikom in
patients and
širši javnosti, pa Direktiva zgolj določa, da nekatere dejavnosti informiranja niso zajete s predpisi o oglaševanju, in ne predvideva usklajenega okvira glede vsebine in kakovosti nepromocijskih informacij o zdravilih ali glede kanalov, prek katerih se lahko te informacije
the general public, the Directive only provides that certain information activities are not covered by the rules on advertising, without providing for a harmonised framework on the contents and the quality of non-promotional information on medicinal products or on the channels through which this information may be
dajejo na voljo
made available
Na podlagi člena 88a Direktive 2001/83/ES je Komisija 20. decembra 2007 predložila sporočilo z naslovom „Poročilo o obstoječi praksi glede zagotavljanja informacij o zdravilih bolnikom“.
On the basis of Article 88a of Directive 2001/83/EC, on 20 December 2007 the Commission submitted a Communication entitled ‘Report on current practices with regard to the provision of information to patients on medicinal products’.
Poročilo ugotavlja, da so države članice sprejele različna pravila in prakse glede zagotavljanja informacij, zaradi česar bolniki in širša javnost nimajo enakega dostopa do informacij
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
v navodilih bolnikom za uporabo in v povzetku značilnosti zdravila
in the patient package leaflet and in the summary of product characteristics
Take neupravičene razlike pri dostopanju do informacij, ki so v drugih državah članicah javno dostopne, bi bilo treba odpraviti.
Such unjustifiable inequalities in accessing information that is publicly available in other Member States should be redressed.
Rezultat tega je, da državljani nekaterih držav članic ne morejo dostopati do kakovostnih nepromocijskih informacij o zdravilih v svojem jeziku.
As a result, citizens in certain Member States may be denied the right to have access, in their own language, to high-quality, non-promotional information on medicines.
Da bi bolnikom zagotovili varnost, bi bilo treba pojma oglaševanja in obveščanja opredeliti in razlagati enotno v vseh državah članicah.
The notions of advertising and information should be defined and interpreted uniformly across all Member States so as to ensure patient safety.
Navedene razlike v razlagi predpisov Unije o
Those disparities in the interpretation of the Union rules on
dajanju na voljo informacij bolnikom in širši javnosti
making available information to patients and the general public
in razlike med nacionalnimi predpisi o obveščanju negativno vplivajo na enotno uporabo predpisov Unije o
, and between national provisions on information, have a negative impact on the uniform application of Union rules on
ter na učinkovitost določb glede informacij o zdravilu, vsebovanih v povzetku značilnosti zdravila in
, and on the effectiveness of provisions on product information contained in the summary of products characteristics and the
navodilih bolnikom za uporabo
patient package leaflet
na voljo
making available
Različni nacionalni ukrepi prav tako verjetno vplivajo na pravilno delovanje notranjega trga za zdravila, saj možnosti imetnikov dovoljenja za promet za
The different national measures are also likely to have an impact on the proper functioning of the internal market for medicinal products, as the possibility for marketing authorisation holders to
dajanje na voljo
make available
informacij o zdravilih v državah članicah niso enake, medtem ko lahko ima informacija, ki se
information on medicinal products is not the same across Member States, while information
daje na voljo
made available
v eni državi članici, učinek v drugi državi članici.
in one Member State is likely to have effects in other Member States.
Ta vpliv bo večji pri zdravilih, katerih informacije o zdravilu (povzetek značilnosti zdravila in
This impact will be greater in the case of medicinal products whose product information (summary of product characteristics and
) so usklajene na ravni Unije.
) is harmonised at Union level.
To vključuje zdravila, ki so jih odobrile države članice na podlagi okvira vzajemnega priznavanja iz poglavja 4 naslova III Direktive 2001/83/ES.
This includes medicinal products authorised by the Member States under the mutual recognition framework of Chapter 4 of Title III of Directive 2001/83/EC.
Glede na zgoraj navedeno in ob upoštevanju tehnološkega napredka v zvezi s sodobnimi komunikacijskimi orodji ter dejstva, da postajajo bolniki po vsej Uniji na področju zdravstvenega varstva vse dejavnejši, je treba spremeniti obstoječo zakonodajo, da se zmanjšajo razlike v dostopu do informacij ter omogoči razpoložljivost kakovostnih, objektivnih, zanesljivih in nepromocijskih informacij o zdravilih
In the light of the above and taking into account technological progress with regard to modern communication tools and the fact that patients throughout the Union have become increasingly active as regards healthcare, it is necessary to amend the existing legislation in order to reduce differences in access to information and to allow for the availability of good-quality, objective, reliable and non promotional information on medicinal products
, pri čemer mora biti poudarek na pravicah in interesih bolnikov
by placing emphasis on the rights and interests of patients
Pristojni nacionalni organi in zdravstveni delavci bi morali ostati
National competent authorities and healthcare professionals should remain
vir informacij o zdravilih za širšo javnost.
of information on medicinal products for the general public.
Že sedaj obstaja veliko neodvisnih informacij o zdravilih, na primer informacije, ki jih posredujejo nacionalni organi ali zdravstveni delavci, vendar se stanje zelo razlikuje med državami članicami in med različnimi proizvodi, ki so na voljo.
While there is already a lot of independent information on pharmaceuticals, for example information provided by national authorities or healthcare professionals, the situation differs very much between Member States and between the different products available.
in Komisija bi si
and the Commission
bolj prizadevati, da bi olajšale
make much greater efforts to
dostop državljanov do kakovostnih informacij prek ustreznih kanalov. ▌
facilitate citizens' access to high-quality information through appropriate channels. ▌
Brez poseganja v pomembno vlogo, ki jo imajo pristojni nacionalni organi in zdravstveni delavci pri boljšem obveščanju bolnikov in širše javnosti, so lahko imetniki dovoljenja za promet dodaten vir nepromocijskih informacij o svojih zdravilih.
Without prejudice to the importance of the role played by national competent authorities and healthcare professionals in better informing patients and the general public, marketing authorisation holders may be an additional source of non-promotional information on their medicinal products.
Ta direktiva bi zato morala vzpostaviti pravni okvir za imetnike dovoljenja za promet za dajanje specifičnih informacij o zdravilih na voljo bolnikom in širši javnosti.
This Directive should therefore establish a legal framework for the making available of specific information on medicinal products by marketing authorisation holders to patients and the general public.
Prepoved oglaševanja zdravil na recept, namenjenega bolnikom in širši javnosti, bi bilo treba ohraniti.
The ban on advertising to patients and the general public for prescription-only medicinal products should be maintained.
V skladu z načelom sorazmernosti je ustrezno omejiti področje uporabe te direktive
In accordance with the principle of proportionality, it is appropriate to limit the scope of this Directive to
na dajanje informacij o zdravilih
the making available of information on
na recept, saj trenutni predpisi Unije omogočajo oglaševanje zdravil brez recepta za
prescription-only medicinal products, as current Union rules allow the advertising to
širšo javnost, ob upoštevanju nekaterih pogojev.
the general public of medicinal products not subject to prescription, under certain conditions.
Določbe te direktive ne posegajo v pravico oseb ali organizacij, zlasti tiska, bolnikov ali organizacij bolnikov, da izrazijo svoje stališče o zdravilih, ki se izdajajo samo na recept, pod pogojem, da delujejo neodvisno, ne pa neposredno ali posredno v imenu imetnika dovoljenja za promet, po njegovih navodilih ali v njegovem interesu.
The provisions of this Directive are without prejudice to the right of any other person or organisation, in particular the press or patients and patient organisations, to express their views on prescription-only medicinal products, provided that they are acting independently and not directly or indirectly on behalf of, on the instructions of, or in the interest of, the marketing authorisation holder.
Ta direktiva državam članicam nalaga, da imetnikom dovoljenja za promet ali tretjim stranem, ki delujejo v njihovem imenu, dovolijo, da daje na voljo bolnikom in javnosti prek določenih kanalov in ob ustreznem spremljanju nekatere informacije o odobrenih zdravilih na recept.
This Directive requires Member States to permit, via certain channels and subject to appropriate monitoring, the making available by a marketing authorisation holder or a third party acting on its behalf of certain information on authorised medicines subject to prescription to patients and the general public.
Če ne gre za oglaševanje, se dovolijo obvestila, ki ne spadajo pod naslov VIIIa Direktive 2001/83/ES.
Communications that do not fall within Title VIIIa of Directive 2001/83/EC are permitted, provided that they do not constitute advertising.
zdravil na recept.
medicinal products subject to medical prescription
Zato mora biti vsaka informacija za
Therefore, any information to
bolnike ali
patients or
širšo javnost o zdravilih na recept
the general public on prescription-only medicinal products should
vnaprej odobrena s strani pristojnih organov in dana na voljo izključno v odobreni obliki
be approved in advance by the competent authorities and should made available only in an approved form
Za nadaljnjo zagotovitev, da bodo imetniki dovoljenja za promet
In order to further ensure that marketing authorisation holders
dajali na voljo
make available