natgillin/translations-raw huggingface dataset:
8. izpostavlja, da je večja stopnja zaposlenosti bistvenega pomena za EU pri obvladovanju staranja prebivalstva, in poudarja, da je visoka udeležba na trgu dela pogoj za gospodarsko rast, družbeno vključenost ter trajnostno in konkurenčno tržno gospodarstvo;
Stresses that increased levels of employment are essential for the EU to cope with an ageing population and emphasises that high labour market participation is a precondition for economic growth, social integration and a sustainable and competitive social market economy;
11. opozarja, da dolgoročna uravnoteženost sistemov pokojninskega zavarovanja ni odvisna samo od demografskih sprememb, temveč tudi od produktivnosti zaposlenih, ki vplivajo na potencialno stopnjo rasti, kot tudi na delež BDP, namenjen financiranju teh sistemov;
Recalls that the long-term equilibrium of compulsory pension schemes depends not only on population developments but also on the productivity of those in work, who influence the potential growth rate, as well as on the proportion of GDP reserved for financing those schemes;
13. poudarja, da so implicitne pokojninske obveznosti na dolgi rok največji del vsega javnega dolga in da morajo države članice redno objavljati podatke o svojih implicitnih pokojninskih obveznostih na podlagi skupno dogovorjene metodologije;
Underlines that, in the long term, implicit pension liabilities are one of the largest parts of the total public debt, and that the Member States should regularly publish information on their implicit pension liabilities, following the commonly agreed methodology;
o dolgoročni vzdržnosti javnih financ za okrevajoče gospodarstvo
on long-term sustainability of public finances for a recovering economy
Pripravljavec mnenja: Ivailo Kalfin
Rapporteur: Ivailo Kalfin
A. ker pakt stabilnosti in rasti, kljub reviziji v letu 2005, ni zadostoval za preprečitev sedanje krize,
A. whereas the Stability and Growth Pact (SGP), despite its revision in 2005, did not suffice to prevent the current crisis,
B. ker vzdržnost javnih financ ni odločilna le za Evropo kot celoto, temveč še zlasti za proračun Evropske unije;
B. whereas sustainability of public finances is not only crucial for Europe as a whole but, also, for the budget of the European Union specifically,
C. ker bi morala splošna načela in predpostavke "vzdržnosti" veljati tudi za proračun Evropske unije, čeprav je trenutno omejen na 1 % skupnega evropskega BND;
C. whereas, although the budget of the European Union is currently limited to approximately 1% of total European GNI, the general principles and underlying assumptions of 'sustainability' should also apply to it,
8. meni, da ne bi smele biti le bonitetne agencije odgovorne za ocenjevanje javnega dolga, saj je to naloga, ki bi bila učinkoviteje opravljena z vzpostavitvijo mehanizma za dodatno ocenjevanje poštene vrednosti takšnih dolgov ter s povečanjem vloge Eurostata pri zagotavljanju zanesljivih podatkov;
Takes the view that credit-rating agencies alone should not be responsible for rating sovereign debt, a task which would be more effectively achieved through creating a mechanism for an additional assessment of the fair value of such debts and through increasing the role of Eurostat in providing reliable data;
o predlogu direktive Evropskega parlamenta in Sveta o spremembi Direktive 2001/83/ES glede preprečevanja vstopa zdravil, ki so ponarejena, kar zadeva njihovo istovetnost, zgodovino ali vir, v zakonito dobavno verigo
on the proposal for a directive of the European Parliament and of the Council amending Directive 2001/83/EC as regards the prevention of the entry into the legal supply chain of medicinal products which are falsified in relation to their identity, history or source
Poročevalka: Marisa Matias
Rapporteur: Marisa Matias
Pri spremembah, ki jih predlaga Parlament, je spremenjeno besedilo označeno s krepkim poševnim tiskom .
In amendments by Parliament, amendedments to the draft act are highlighted in bold italics .
Pri aktih o spremembi je besedilo, ki povzema obstoječo določbo, ki jo Parlament želi spremeniti, medtem ko v osnutku akta ni spremenjena, označeno s krepkim tiskom .
Highlighting in normal italics is an indication for the relevant departments showing parts of the draft act which may regquire correction when the final text is prepared - for instance, obvious errors or omissions in a language version).
O teh popravkih odločajo pristojne tehnične službe.
Any deletions that Parliament wishes to make in such passages are indicated thus: [...].
MNENJE Odbora za industrijo, raziskave in energetiko .............................81
OPINION of the Committee on Industry, Research and Energy ...............86
MNENJE Odbora za notranji trg in varstvo potrošnikov .......................128
OPINION of the Committee on the Internal Market and Consumer Protection 136
o predlogu direktive Evropskega parlamenta in Sveta o spremembi Direktive 2001/83/ES glede preprečevanja vstopa zdravil, ki so ponarejena, kar zadeva njihovo istovetnost, zgodovino ali vir, v zakonito dobavno verigo
on the proposal for a directive of the European Parliament and of the Council on amending Directive 2001/83/EC as regards the prevention of the entry into the legal supply chain of medicinal products which are falsified in relation to their identity, history or source
– ob upoštevanju predloga Komisije Evropskemu parlamentu in Svetu ( KOM(2008)0668 ),
– having regard to the Commission proposal to the European Parliament and the Council ( COM(2008)0668 ),
– ob upoštevanju členov 251(2) in 95 Pogodbe ES, na podlagi katerih je Komisija Parlamentu podala predlog ( C6–0513/2008 ),
– having regard to Article 251(2) and Article 95 of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament ( C6‑0513/2008 ),
– ob upoštevanju sporočila Komisije z naslovom Posledice začetka veljavnosti Lizbonske pogodbe za še nedokončane medinstitucionalne postopke odločanja ( KOM(2009)0665 ),
- having regard to the Commission Communication entitled 'Consequences of the entry into force of the Treaty of Lisbon for ongoing interinstitutional decision-making procedures' ( COM(2009)0665 ),
– ob upoštevanju členov 114 in 168(4)(c) Pogodbe o delovanju Evropske unije,
- having regard to Article 114 and Article 168(4)(c) on the Treaty of the Functioning of the European Union,
– 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 ( A7–0148/2010 ),
– 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 ( A7‑0148/2010 ),
(3a) V zvezi s to direktivo mora Komisija vsako leto Evropskemu parlamentu in Svetu predložiti statistično poročilo z zanesljivimi in natančnimi podatki o stanju, trendih in dogodkih na področju ponarejenih zdravil, vključno s podatki o tem, kdo je kje in kako odkril ponarejena zdravila, iz katere države izvirajo ter kaj natančno je ponarejeno (istovetnost, vir in/ali učinkovina/sestavine) v državah članicah.
(3a) In the light of this Directive the Commission should submit every year to the European Parliament and to the Council a statistical report with reliable and accurate data on the current situation, trends and developments in falsified medicin al products , including details of where, how and by whom the falsified products were detected, the country in which they originated , and the ‘ falsified ’ element itself (identity, source and/or ingredient/components) in the Member States and update the measures on the application of the safety features accordingly.
Tako študija o oceni učinka kot poročila Evropske komisije se ne osredotočajo zadosti na izvor in poglavitne vire ponarejenih zdravil ter jih ne razlagajo.
Neither the impact assessment study, nor other European Commission reports, sufficiently focus on and explain the origin and main sources of ‘counterfeit’ products.
Razlikovati je treba med kršitvami patentov ali spori zaradi teh kršitev in ponarejanjem zdravil.
It is important not to confuse patent violations or disputes with the problem of counterfeiting of medical products.
Potrebni so zanesljivi podatki in statistični podatki o tem, kje natančno so bila „ponarejena“ zdravila odkrita, iz katere države izvirajo in kaj natančno je „ponarejeno“ (istovetnost, vir in/ali učinkovina/sestavine).
Reliable data and statistics with details where ‘counterfeit’ products were detected, which country they came from, and the ‘counterfeit’ element itself (identity, source and/or ingredient/components) are needed.
(3b ) Po sprejetju te direktive mora Komisija v sodelovanju z Evropsko agencijo za zdravila (Agencijo) in organi držav članic začeti kampanjo obveščanja in ozaveščanja potrošnikov o tveganjih, ki jih prinaša nakup ponarejenih zdravil, pri čemer se osredotoči zlasti na ukrepe za preverjanje in zaščitne elemente (kot so hologrami in zaščitni pečati) na ovojnini zdravil ali drugje.
(3b ) After the adoption of this Directive, t he Commission should, in cooperation with the European Medicines Agency ("the Agency") and Member State authorities, launch campaigns informing and raising awareness among consumers of the risk involved in purchasing falsified medicinal products, focusing in particular on the authentication measures and safety features (such as holograms and safety seals) shown on the packaging of medicinal products or elsewhere.
Naraščajoče število ponarejenih zdravil kaže, da se potrošniki ne zavedajo, kakšno tveganje je povezano z nakupom teh zdravil, zlasti na nezakonitih spletnih mestih.
The increasing number of falsified medicinal products indicates that consumers are not aware of the risks involved in purchasing falsified medicinal products, in particular from illicit websites.
Ena izmed težav, o katerih poročajo, je pomanjkanje poznavanja veljavne zakonodaje med potrošniki.
One of the problems that has been reported is the lack of knowledge among consumers of the legislation in force.
Dobro obveščeni potrošniki bi lahko pripomogli k odkrivanju ponarejenih zdravil na trgu.
Well-informed consumers could contribute to the detection of falsified medicinal products on the market.
(4a) Ta direktiva ne posega v določbe o pravicah intelektualne in industrijske lastnine, njen izrecni cilj pa je preprečevati vstop ponarejenih zdravil v zakonito dobavno verigo.
(4a) This Directive is without prejudice to provisions concerning intellectual and industrial property rights and aims specifically to prevent falsified medici nal products from entering the legal distribution chain .
Direktiva bi se morala osredotočiti na posledice za javno zdravje, ne pa na možne težave, povezane s pravicami intelektualne lastnine ali patentnimi pravicami.
This directive should focus on the consequences for public health and should not deal with possible problems related to intellectual Property Rights or Patent Rights
(4c) Ponarejanje zdravil je svetovni problem, ki zahteva učinkovito in okrepljeno mednarodno usklajevanje za zagotovitev večje učinkovitosti proti-ponarejevalnih strategij.
(4 c ) The falsification of medicin al products is a global problem, requiring effective and enhanced international coordination and cooperation in order to ensure that anti-falsification strategies are more effective.
Tesnejše mednarodno sodelovanje in sodelovanje med vladnimi organi, kot so enote za zdravstvo, policija, carina, lokala uprava in pravosodje, so ključnega pomena za zmago nad ponarejanjem zdravil.
Increased international cooperation and collaboration among governmental entities such as health, police, customs, local administrative units, judiciary, is essential to defeat the falsification of medicines.
(4d) Evropska unija mora podpirati oblikovanje mednarodne konvencije, ki bo povečala kazni za ponarejanje zdravil, in dodatnega protokola h Konvenciji Združenih narodov o mednarodnem organiziranem kriminalu (Palermski konvenciji).
(4 d ) The European Union should support the drafting of an international agreement increasing the penalties for falsifying medicinal product s , and of an additional protocol to the United Nations Convention against Transnational Organised Crime (Palermo convention) .
Ponarejanje zdravil je postalo dejavnost mednarodnih kriminalnih mrež, zato tega vprašanja javnega zdravja ne moremo reševati samo znotraj evropskih mej.
The falsification of medicinal products has become an operation organised by international crime networks and efforts to tackle this threat to public health cannot be limited to measures taken within our European borders alone.
(4e) Komisija in države članice morajo podpreti novi osnutek konvencije Sveta Evrope o ponarejanju zdravil in podobnih kaznivih dejanjih, ki ogrožajo javno zdravje.
(4 e ) The new draft Convention of the Council of Europe on the counterfeiting of medical products and similar crimes involving threats to public health, should be supported by the Commission and the Member States.
Poleg tega morajo države članice sodelovati, tudi prek Europola, da bi okrepile izvajanje predpisov za omejitev trgovine s ponarejenimi zdravili, vključno z dobavo prek spleta.
Furthermore, the Member States should collaborate, including through Europol, to strengthen the enforcement of the rules designed to restrict trading in falsified medicin al products , including the supply via internet.
Sporazumni predlog spremembe vključuje predloge sprememb 4 (Matias), 115 (Chatzimarkakis, Krahmer), 116 (Liese, Ulmer), 117 (Rapti), 118 (Antonescu, Niculescu) in 119 (Bartolozzi).
This compromise amendment covers AM4 (Matias), 115 (Chatzimarkakis/Krahmer), 116 (Liese/Ulmer), 117 (Rapti), 118 (Antonescu/Niculescu), 119 (Bartolozzi)
(4f) Dobro znano je, da je internet eden glavnih vstopnih kanalov za ponarejena zdravila na evropsko tržišče.
(4 f ) It is well known that the internet represents one of the main routes by which falsified medicin al products enter the European market.
Ocenjuje se, da so zdravila, kupljena prek spleta na straneh, ki ne razkrijejo svojega dejanskega fizičnega naslova, ponarejena v več kot polovici primerov.
Medicin al products purchased over the internet from sites that conceal their actual physical address are estimated to be falsified in more than 50 % of cases.
Zato je treba razlikovati med zakonitimi lekarnami, ki prodajajo po pošti, ali spletnimi lekarnami, in nezakonito dobavno verigo preko nenadzorovanih nakupov na spletu.
Therefore, a distinction should be made between legitimate mail order or internet pharmacies and the illegal supply chain through non-controlled internet purchasing.
V skladu s členom 168 Pogodbe o delovanju Evropske unije so države članice pristojne za ureditev distribucije zdravil na zadnji stopnji trgovanja, zlasti v lekarnah.
In accordance with Article 168 TFEU, Member States are responsible for regulating the marketing of medicinal products at the last level of trade, particularly in pharmacies.
Ta pristojnost vključuje tudi ureditev distribucije zdravil po pošti ali prek spleta.
That responsibility also includes regulating the marketing of medicinal products by mail order or internet.
Spletne lekarne morajo v državah, kjer smejo delovati, zahtevati posebno dovoljenje pristojnih organov.
Internet pharmacies should, in Member States in which they are allowed to operate, require a special authorisation by the competent authority.
Države članice morajo zagotoviti stalen nadzor spletnih strani za prodajo zdravil.
Member States should ensure that the internet sale of medicinal products is continuously monitored .
Zakonita lekarna, ki prodaja po pošti, mora biti povezana z zakonito registrirano lekarno, s čimer se zagotovi, da zakonita lekarna, ki prodaja po pošti, izpolnjuje pravne zahteve za ustanovitev lekarn v državi članici, v kateri je zakonito ustanovljena.
A legitimate mail order pharmacy should be connected to a legally registered pharmacy, thereby ensuring that a legitimate mail order pharmacy must comply with all legal requirements applicable to any pharmacy establishment in the Member State where it is legally based.
Imenovanje vodje lekarne mora biti zakonska obveznost za vse zakonite lekarne, ki prodajajo po pošti.
The identification of the chief pharmacist should be a legal requirement for all legitimate mail order pharmacies.
Lekarna, ki prodaja po pošti, lahko izda naročena zdravila na recept le, če originalni recept prejme vnaprej.
A mail order pharmacy may only dispense an ordered prescription medicinal product if the original prescription has been obtained by the respective mail order pharmacy in advance.
Sporazumni predlog spremembe vključuje predloge sprememb 5 (Matias), 58 (Rossi), 63 (Chatzimarkakis), 107 (Schnellhardt), 120 (Liese, Ulmer) in 121 (Ulmer).
This compromise amendment covers AM5 (Matias), 58 (Rossi), 63 (Chatzimarkakis), 107 (Schnellhardt), 120 (Liese/Ulmer), 121 (Ulmer).
(4g) Evropsko javnost je treba seznaniti s tveganji, ki jih za njihovo zdravje predstavljajo zdravila, naročena na nenadzorovanih spletnih straneh ali v nezakonitih dobavnih verigah.
(4 g ) The European public should be made aware of the health risks of ordering products from non-controlled internet sites or from the illegal supply chain.
Komisija mora v sodelovanju z državami članicami sprejeti ukrepe za boljše obveščanje javnosti o tveganjih, povezanih s spletnim nakupom zdravil.
The Commission, in cooperation with the Member States, should adopt measures to better inform the public of the risks of purchasing medicinal products online.
Kampanje ozaveščanja javnosti na nacionalni in evropski ravni morajo povečati ozaveščenost o tveganjih in državljane seznaniti, kako ugotovijo, ali so spletne lekarne uradno registrirane in pod nadzorom javnih organov.
Public awareness campaigns at national and European level should be conducted to increase awareness of the risks and to inform citizens about how to identify whether internet pharmacies are officially registered and controlled by public authorities.
Sporazumni predlog spremembe vključuje predloge sprememb 6 (Matias), 60 (Chatzimarkakis), 94 (Bartolozzi), 95 (Rivellini), 96 (Antonescu, Niculescu), 97 (Chatzimarkakis, Krahmer), 98 (Liese, Ulmer) in 99 (Grossetête, Ries).
This compromise amendment covers AM6 (Matias), 60 (Chatzimarkakis), 94 (Bartolozzi), 95 (Rivellini), 96 (Antonescu/Niculescu), 97 (Chatzimarkakis/Krahmer), 98 (Liese/Ulmer), 99 (Grossetête/Ries)
Uvodna izjava 4 h (novo)
Recital 4 h (new)
(4h) Koristno je uvesti opredelitev pojma „ponarejeno zdravilo“, da bi se ta zdravila razločevala od zakonitih zdravil v nepooblaščeni prodaji.
(4 h ) It is useful to introduce a definition of the concept of ‘falsified medicinal product’ in order to distinguish such products from legal but unauthorised medicinal products.
Poleg tega ne gre zamenjevati zdravil z dovoljenjem za promet ali drugače zakonitih zdravil, ki imajo kakovostne napake, ter zdravil, ki zaradi proizvodnih napak ali nadaljnjega ravnanja ne ustrezajo zahtevam dobre proizvodne ali distribucijske prakse, s ponarejenimi zdravili.
Furthermore, authorised or otherwise legitimate products with quality defects and medicinal products that due to errors in the manufacturing or subsequent handling do not comply with the requirement s of g ood m anufacturing p ractices or g ood d istribution p ractices should not be confused with falsified medicin al products .
(5) Današnja distribucijska mreža za zdravila je vedno bolj zapletena in vključuje številne udeležence, ki niso nujno distributerji na debelo, opredeljeni v Direktivi 2001/83/ES.
(5) Today’s distribution network for medicinal products is increasingly complex and involves many players which are not necessarily wholesale distributors as defined in Directive 2001/83/EC.
Da se zagotovi zanesljivost v distribucijski verigi, morajo biti v farmacevtski zakonodaji obravnavani vsi udeleženci distribucijske verige: v to so vključeni distributerji, ki nabavljajo, hranijo, skladiščijo in dobavljajo zdravila, ter osebe, ki so vpletene v posle, ne da bi bile v stiku z zdravili.
In order to ensure reliability in the distribution chain, pharmaceutical legislation should address all actors in the distribution chain: this includes not only distributors who procure, hold, store and supply products, but also persons who are involved in transactions without handling the products.
Zanje morajo veljati sorazmerna pravila, da se z vsemi izvedljivimi sredstvi izključi možnost, da bi zdravila, ki so ponarejena, kar zadeva njihovo istovetnost, zgodovino ali vir odobrenega zdravila, vstopila v zakonito dobavno verigo v Skupnosti .
They should be submitted to proportionate rules in order to exclude, by all practical means, the possibility that medicinal products which are falsified in relation to their identity, history or source to enter the legal supply chain in the Community .
(5) Današnja distribucijska mreža za zdravila je vedno bolj zapletena in vključuje številne udeležence, ki niso nujno distributerji na debelo, opredeljeni v Direktivi 2001/83/ES , na primer trgovce in posrednike .
(5) Today’s distribution network for medicinal products is increasingly complex and involves many players which are not necessarily wholesale distributors as defined in Directive 2001/83/EC , such as traders and brokers .
Da se zagotovi zanesljivost v distribucijski verigi, morajo biti v farmacevtski zakonodaji obravnavani vsi udeleženci distribucijske verige: v to so vključeni distributerji, ki nabavljajo, hranijo, skladiščijo in dobavljajo zdravila, ter osebe, ki so vpletene v posle, ne da bi bile v stiku z zdravili , na primer trgovci in posredniki .
In order to ensure reliability in the distribution chain, pharmaceutical legislation should address all actors in the distribution chain: this includes not only distributors who procure, hold, store and supply products, but also persons who are involved in transactions without handling the products , such as traders and brokers .
Vsi udeleženci in njihove pristojnosti morajo biti jasno in nedvoumno opredeljeni, poleg tega pa morajo zanje veljati sorazmerna pravila, da se z vsemi izvedljivimi sredstvi izključi možnost, da bi lahko zdravila, ki so ponarejena, kar zadeva njihovo istovetnost, zgodovino ali vir odobrenega zdravila, vstopila v zakonito dobavno verigo v Uniji .
All players should be clearly and unambiguously defined, as should their responsibilities, and should be subject to proportionate rules in order to exclude, by all practical means, the possibility that medicinal products which are falsified in relation to their identity, history or source might enter the legal supply chain in the Union .
Zlasti morajo imeti ti udeleženci veljavno licenco za svojo poslovno dejavnost, ki jo morajo izvajati v skladu s smernicami dobre prakse, ki jih je opredelila Komisija v sodelovanju z Agencijo in organi držav članic, enako kot velja za proizvajalce in distributerje zdravil.
In particular, such persons should have a valid licence for their business activities, which should be conducted in accordance with the good practice guidelines laid down by the Commission, in cooperation with the Agency and the Member State authorities, by analogy with those applying to manufacturers and distributors of medicinal products.
Da bi zagotovili varnost farmacevtskih proizvodov, je treba upoštevati vse udeležence, ki delajo v sektorju, ne samo distributerjev na debelo.
To ensure the safety of pharmaceutical products, due account needs to be taken of all those working in the sector and not just wholesale distributors.
(7) Zaradi upoštevanja novih profilov tveganj in hkratnega zagotavljanja delovanja notranjega trga za zdravila je treba na ravni Skupnosti opredeliti zaščitne elemente, namenjene za zagotavljanje istovetnosti, potrditev pristnosti in sledljivost zdravil na recept.
(7) In order to take account of new risk profiles, while at the same time ensuring the functioning of the internal market for medicinal products, safety features designed to ensure the identification, authentication and traceability of prescription medicinal products should be established at Community level.