natgillin/translations-raw huggingface dataset:
Kadar pristojni nacionalni organi menijo, da je to ustrezno, lahko širši javnosti dajo na voljo informacije o zdravilih in druge ustrezne informacije o zdravju, in sicer prek dogovorov s ponudniki internetnih storitev, ki lahko dajo na voljo informacije v javnem interesu v skladu s členom 21(4) Direktive 2009/136/ES Evropskega parlamenta in Sveta z dne 25. novembra 2009 o univerzalnih storitvah in pravicah uporabnikov v zvezi z elektronskimi komunikacijskimi omrežji in storitvami 1 .
Where deemed appropriate by the national competent authorities, they may also make available information on medicinal products and other relevant health information to the general public by way of agreements with internet service providers, who may make available public interest information in accordance with Article 21(4) of Directive 2009/136/EC of the European Parliament and of the Council of 25 November 2009 on universal service and users’ rights relating to electronic communications networks and services 1 .
V tem primeru bi bilo treba dati na voljo informacije z istimi sredstvi, kot se uporabljajo v redni komunikaciji med podjetji in njihovimi naročniki.
In such a case, information shall be made available by the same means used for regular communications between the undertakings and their subscribers.
Ker informacije o zdravilih ne sodijo v področje uporabe člena 21(4) Direktive 2009/136(ES), lahko ponudniki internetnih storitev nacionalnim organom zaračunajo dajanje teh informacij na voljo.
Since information on medicinal products falls outside the scope of Article 21(4) of Directive 2009/136/EC, internet service providers may charge national authorities for making available such information.
1 UL L 337, 18.12.2009, str.
1 OJ L 337, 18.12.2009, p.
Bolniki vedno pogosteje uporabljajo internet kot vir informacij.
Patients increasingly use the Internet as a source of information.
Toda pogosto so usmerjeni na ameriška spletna mesta, ki vsebujejo promocijske navedbe, ali druga dvomljiva spletna mesta.
Yet, they are often directed towards US websites, which contain promotional claims, or other dubious websites.
Da bi bolnikom zagotovili boljše informacije, bi bilo treba razviti nacionalne portale o zdravju.
In order to provide patients with better information, national health portals should be developed.
Nanje bi bilo treba gledati kot na sredstvo, ki dopolnjuje odnos med bolniki in zdravstvenimi delavci, namesto da bi ga nadomestilo.
They should be seen as a means to complement the relationship between patients and health care professionals rather than replacing it.
Upravljati bi jih moral pristojni organ države članice v sodelovanju z zainteresiranimi stranmi, kot so organizacije bolnikov ali zdravstveni delavci.
They should be managed by the competent authority of a Member State in cooperation with stakeholders such as patient organisations or health care professionals.
Javna sporočila iz Direktive 2009/136/ES se nanašajo na elektronske komunikacijske storitve.
The public messages concerned in Directive 2009/136/EC relate to electronic communications services.
Toda informacije o zdravilih in širše informacije o zdravju so lahko tudi v interesu javnosti.
However, information on medicines and broader health information might also be of public interest.
Ker ta vrsta informacij ne sodi v področje uporabe določb direktive o univerzalnih storitvah, se predlaga, da bi ta okvir uporabili na podlagi prostovoljnih dogovorov med ponudniki internetnih storitev in nacionalnimi organi.
Since this type of information falls outside the scope of the provisions in the USD, it is proposed that this framework should be used on the basis of voluntary agreements between ISPs and national authorities.
Ta kanal bi uporabili samo, kadar bi nacionalni organi menili, da je to nujno in ko bi to v smislu učinkovitosti v primerjavi z drugimi rednimi kanali imelo dodano vrednost.
This channel should be used only when national authorities consider it necessary and when it has an added value in terms of effectiveness compared to the other regular channels.
(b) morata upoštevati splošne potrebe in pričakovanja bolnikov ;
(b) it must take into account the general needs and expectations of patient s;
(b) morata biti usmerjena k bolniku, da bolje izpolnjujeta njihove potrebe ;
(b) it must be patient oriented to better meet their needs ;
Člen 100 d – odstavek 2 – točka c
Article 100d – paragraph 2 – point c
(c) izjavo, da informacije da na voljo poimensko naveden imetnik dovoljenja za promet ali so dane na voljo v njegovem imenu ;
(c) a statement indicating that the information is made available by or on behalf of a named marketing authorisation holder;
Člen 100 d – odstavek 3 – točka a
Article 100d – paragraph 3 – point a
(a) primerjav med zdravili glede njihove kakovosti, varnosti in učinkovitosti, če jih širi imetnik dovoljenja za promet, razen :
(a) comparisons between medicinal products regarding their quality, safety and efficiency, if disseminated by marketing authorisation holders except:
– če so te primerjave del uradno odobrenih dokumentov, kot je povzetek značilnosti zdravil;
- where those comparisons are included in officially approved documents, such as the Summary of Product Characteristics;
– če te primerjave temeljijo na primerjalnih znanstvenih študijah, ki jih objavijo ustrezni nacionalni organi ali Evropska agencija za zdravila ;
- where those comparisons are based on comparative scientific studies published by the relevant national authorities or the European Medicines Agency ;
Člen 100 d – odstavek 3 – točka b a (novo)
Article 100d – paragraph 3 – point b a (new)
(ba) informacij o drugih zdravilih, za katera farmacevtska družba ni imetnik dovoljenja za promet.
(ba) information on other medicinal products for which the pharmaceutical company is not the marketing authorisation holder.
Napačne informacije tretjih družb o zdravilih, za katera so pristojni organi izdali dovoljenje za promet, je treba strogo prepovedati.
Misinformation campaigns by third part companies on medicinal products which have obtained a marketing authorisation from competent authorities must be prohibited by any means.
Predhodno poročilo je na tej povezavi: http://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/preliminary_report.pdf
The preliminary report can be found following the link : http://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/preliminary_report.pdf
Metode lahko vključujejo prostovoljni nadzor informacij o zdravilih prek koregulativnih organov in pritožbo na takšne organe, če so postopki pred takimi organi možni poleg sodnih ali upravnih postopkov, ki so na voljo v državah članicah.
The methods may include the voluntary control of information on medicinal products by co-regulatory bodies and recourse to such bodies, if proceedings before such bodies are possible in addition to the judicial or administrative proceedings available in the Member States.
Treba je imeti ustrezen nadzorni sistem, da bi preprečili zlorabo informacij.
It is necessary to have an appropriate monitoring system in order to avoid information misuse.
Samoregulacija se ne zdi dovolj prepričljivo orodje za doseganje tega cilja.
Self-regulation does not appear a sufficiently coercive tool to reach this objective.
Po posvetovanju z državami članicami in drugimi zainteresiranimi stranmi Komisija pripravi smernice, ki zadevajo informacije, dovoljene na podlagi tega naslova, in vključujejo obvezen kodeks ravnanja za imetnike dovoljenja za promet, ki splošni javnosti ali njenim članom zagotavljajo informacije o odobrenih zdravilih na recept.
After consulting the Member States and other stakeholders , the Commission shall draw up guidelines concerning information allowed under this Title and containing a mandatory code of conduct for marketing authorisation holders providing information to the general public or members thereof on authorised medicinal products subject to medical prescription.
Da bi zagotovili, da imetniki dovoljenja za promet upoštevajo predpise, ki jih Komisija vključi v kodeks ravnanja, je treba izrecno poudariti, da je ta kodeks obvezen, ne pa prostovoljen.
In order to make sure that marketing authorization holders abide by the rules established by the Commission in the code of conduct, it should be specified that the latter should be mandatory, not voluntary.
Države članice zagotovijo, da imetniki dovoljenja za promet registrirajo spletna mesta pod njihovim nadzorom, ki so usmerjene neposredno na državljane ene ali več držav članic in ki vsebujejo informacije o zdravilih na recept, ki spadajo pod ta naslov, preden jih dajo na voljo širši javnosti .
Member States shall ensure that marketing authorisation holders register Internet websites under their control that are directed specifically at citizens of one or more Member States and that contain information on prescription-only medicines covered by this Title, prior to making it available to the general public.
Po registraciji spletnega mesta se predlogi sprememb vsebine v zvezi z zdravilom na recept spremljajo v skladu z odstavkom 3.
After registration of the website, any amendments to the content relating to medicinal products subject to medical prescription shall be subject to monitoring in accordance with paragraph 3.
Člen 100 h – odstavek 2
Article 100h – paragraph 2
Spletne strani, registrirane v skladu z odstavkom 1, ne vsebujejo povezav na druge spletne strani imetnika dovoljenja za promet, razen če so bile tudi te registrirane v skladu z navedenim odstavkom.
Internet websites registered in accordance with paragraph 1 shall not contain links to other marketing authorisation holder websites unless they have also been registered in accordance with that paragraph.
Navedene spletne strani navajajo pristojni organ, ki je podelil dovoljenje za promet, in njegov spletni naslov.
Those websites shall identify the competent authority which granted the marketing authorisation and its website address.
Spletna mesta, registrirana v skladu z odstavkom 1, ne vsebujejo povezav na druga spletna mesta imetnika dovoljenja za promet, ki vsebujejo informacije iz tega naslova, razen če so bila tudi ta registrirana v skladu z navedenim odstavkom.
Internet websites registered in accordance with paragraph 1 shall not contain links to other marketing authorisation holder websites containing information covered by this Title unless they have also been registered in accordance with that paragraph.
Navedena spletna mesta navajajo pristojni organ, ki je podelil dovoljenje za promet, in njegov spletni naslov.
Those websites shall identify the competent authority which granted the marketing authorisation and its website address.
Spletne strani, registrirane v skladu z odstavkom 1, ne omogočajo identifikacije članov javnosti, ki imajo dostop do navedenih spletnih strani , ali pojava nezaželenega gradiva na teh spletnih straneh , ki se aktivno razpošilja širši javnosti ali njenim članom .
Internet websites registered in accordance with paragraph 1 shall not allow the identification of members of the general public which have access to those websites or the appearance therein of unsolicited material actively distributed to the general public or members thereof.
Navedene spletne strani ne vsebujejo spletne TV.
Those websites shall not contain web-TV .
Spletna mesta, registrirana v skladu z odstavkom 1, ne omogočajo avtomatične identifikacije članov javnosti, ki imajo dostop do navedenih spletnih mest , ali pojava nezaželenega gradiva na teh spletnih mestih , ki se aktivno razpošilja širši javnosti ali njenim članom.
Internet websites registered in accordance with paragraph 1 shall not allow the automatic identification of members of the general public which have access to those websites or the appearance therein of unsolicited material actively distributed to the general public or members thereof.
Navedena spletna mesta ne vsebujejo tehnologij videoradiodifuzije .
Those websites shall not contain video broadcast material .
Ne glede na to prepoved lahko spletna mesta, registrirana v skladu z odstavkom 1, zagotavljajo video vsebino, kadar je njen namen podpreti varno in učinkovito uporabo zdravil na splošno in pod pogojem, da ne vsebuje promocijskih navedb za zdravila.
Without prejudice to this prohibition, websites registered in accordance with paragraph 1 can provide video content where they are aimed at supporting the safe and effective use of medicinal products in general and provided that it does not contain any promotional claims relating to medicinal products.
Izpolnjevanje teh dveh pogojev se nadzoruje v skladu s členom 100g.
Compliance with these two conditions shall be subject to monitoring in accordance with Article 100g.
Video vsebina, pri čemer je izključeno promocijsko video gradivo, lahko ima dodano vrednost, kadar prikazuje pravilno uporabo različnih zdravil ali medicinskih naprav, kot so inhalatorji.
Video content, to the exclusion of promotional video materials, can bring an added value when showing the correct use of different medicines or medical devices such as inhalers.
To video gradivo bi morali nadzirati v skladu s členom 100g, da se zagotovi, da je popolnoma nevtralno in ne vsebuje promocijskih navedb za izdelke.
These video materials should be subject to monitoring in accordance with Article 100g so that we can ensure that they are completely neutral and do not contain any product promotional claims.
Člen 100 h – odstavek 2 – pododstavek 2 b (novo)
Article 100 h – paragraph 2 – subparagraph 2 b (new)
Člen 100 h – odstavek 3
Article 100h – paragraph 3
Država članica, v kateri je bilo registrirano spletno mesto , je odgovorna za spremljanje vsebine v zvezi z zdravili na recept, ki je na voljo na navedenem spletnem mestu .
The Member State where the Internet website has been registered shall be responsible for the monitoring of the contents , relating to medicinal products subject to medical prescription , made available on that website.
Člen 100 h – odstavek 5
Article 100h – paragraph 5
Države članice od imetnikov dovoljenja za promet, ki so registrirali spletna mesta v skladu z odstavki 1 do 4, zahtevajo , da na ta spletna mesta vključijo izjavo o tem, da je mesto registrirano in se spremlja v skladu s to direktivo.
Member States shall require marketing authorisation holders which have registered Internet websites in accordance with paragraphs 1 to 4 to include a statement therein to the effect that the website has been registered and is subject to monitoring in accordance with this Directive.
Izjava navaja nacionalni pristojni organ, ki spremlja zadevno spletno mesto .
The statement shall identify the national competent authority monitoring the website concerned.
Prav tako navaja, da spremljanje spletnega mesta ne pomeni nujno, da so bile vse informacije na spletnem mestu predhodno odobrene.
It shall also specify that the fact that the website is monitored does not necessarily mean that all the information on the website has been subject to prior approval.
Splošna javnost mora biti obveščena o kakovosti spletnega mesta, ki so ga obiskali.
The general public has to be informed about the quality of the website they visit.
Zato je bolje, da se izjava o postopkih registracije in spremljanja zahteva, ne zgolj dovoli.
It is, therefore, better that the availability of the statement about the registration and monitoring procedures is required not simply allowed.
To je potrebno, da se javnosti pokaže, da lahko zaupa temu spletnemu mestu.
This is necessary to show the general public that they can trust the website.
Člen 100 i – odstavek 2 a (novo)
Article 100i – paragraph 2 a (new)
Imetniki dovoljenja za promet imajo glede vsake odločitve pravico do pritožbe pri sodnem organu ali drugem organu.
The marketing authorisation holders shall have the right to appeal any decision to a judicial or other body.
Cristian Silviu Buşoi, Lara Comi, Anna Maria Corazza Bildt, António Fernando Correia De Campos, Jürgen Creutzmann, Christian Engström, Evelyne Gebhardt, Louis Grech, Małgorzata Handzlik, Malcolm Harbour, Philippe Juvin, Sandra Kalniete, Alan Kelly, Eija-Riitta Korhola, Edvard Kožušník, Kurt Lechner, Toine Manders, Mitro Repo, Robert Rochefort, Zuzana Roithová, Heide Rühle, Andreas Schwab, Róża grofica Von Thun Und Hohenstein, Kiriakos Triantafilidis (Kyriacos Triantaphyllides), Bernadette Vergnaud, Barbara Weiler
Cristian Silviu Buşoi, Lara Comi, Anna Maria Corazza Bildt, António Fernando Correia De Campos, Jürgen Creutzmann, Christian Engström, Evelyne Gebhardt, Louis Grech, Małgorzata Handzlik, Malcolm Harbour, Iliana Ivanova, Philippe Juvin, Sandra Kalniete, Alan Kelly, Eija-Riitta Korhola, Edvard Kožušník, Kurt Lechner, Toine Manders, Mitro Repo, Robert Rochefort, Heide Rühle, Andreas Schwab, Róża Gräfin Von Thun Und Hohenstein, Kyriacos Triantaphyllides, Bernadette Vergnaud, Barbara Weiler, Anja Weisgerber
o 26. letnem poročilu o spremljanju uporabe prava Evropske unije (2008)
on the 26th Annual Report on Monitoring the Application of European Union Law (2008)
MNENJE Odbora za notranji trg in varstvo potrošnikov ...........................9
OPINION of the Committee on the Internal Market and Consumer Protection 9
MNENJE Odbora za peticije ..........................................................................................12
OPINION of the Committee on Petitions ...............................................................12
o 26. letnem poročilu o spremljanju uporabe prava Evropske unije (2008)
on the 26th Annual Report on Monitoring the application of European Union law (2008)
– ob upoštevanju poročila Komisije o oceni pilotnega projekta EU ( KOM(2010)0070 ),
– having regard to the Report from the Commission entitled ‘EU Pilot Evaluation Report’ ( COM(2010)0070 ),
– ob upoštevanju 25. letnega poročila Komisije o spremljanju uporabe prava Skupnosti (2007) ( KOM(2008)0777 ),
– having regard to the 25th Annual Report from the Commission on Monitoring the application of Community law (2007) ( COM(2008)0777 ),
– ob upoštevanju delovnih dokumentov služb Komisije ( SEK(2009)1683 , SEK(2009)1684 , SEK(2009)1685 in SEK(2010)0182 ),
– having regard to the Commission staff working documents ( SEC(2009)1683 , SEC(2009)1684 , SEC(2009)1685 and SEC(2010)0182 ),
– ob upoštevanju sporočila Komisije z dne 5. septembra 2007 z naslovom „Evropa rezultatov - uporaba prava skupnosti“ ( KOM(2007)0502 ),
– having regard to the Commission Communication of 5 September 2007 entitled ‘A Europe of results – applying Community law’ ( COM(2007)0502 ),
– ob upoštevanju sporočila Komisije z dne 20. marca 2002 o odnosih s pritožnikom v zvezi s kršitvami prava Skupnosti ( KOM(2002)0141 ),
– having regard to the Commission Communication of 20 March 2002 on Relations with the complainant in respect of infringements of Community law ( COM(2002)0141 ),
– ob upoštevanju svoje resolucije z dne 21. februarja 2008 o 23. letnem poročilu Komisije o nadzoru uporabe prava Skupnosti (2005)
– having regard to its resolution of 21 February 2008 on the Commission’s 23rd Annual report on monitoring the application of Community law (2005)
UL C 256E, 9.10.2008, str.155. ,
OJ C 256E, 9.10.2008, p.155. ,
– ob upoštevanju poročila Odbora za pravne zadeve ter mnenj Odbora za notranji trg in varstvo potrošnikov in Odbora za peticije ( A7-0291/2010 ),
– having regard to the report of the Committee on Legal Affairs and the opinions of the Committee on the Internal Market and Consumer Protection and the Committee on Petitions ( A7‑0291/2010 ),
Poročilo o oceni pilotnega projekta EU, str.
EU Pilot Evaluation Report, p.
2. in v tesnem sodelovanju z nacionalnimi upravami preučuje, kako izvajati zakonodajo Evropske unije; meni, da ta pobuda ustreza novi potrebi, ki je nastala s sprejetjem Lizbonske pogodbe, in sicer po sodelovanju med vsemi institucijami Evropske unije v korist dobro delujoče Unije, ki v središče postavlja državljana; poudarja dolžnost Komisije iz člena 17 Pogodbe o Evropski uniji, da „skrbi za uporabo Pogodb in ukrepov, ki jih institucije sprejmejo na njuni podlagi”;
2. and is considering, in close cooperation with national administrations, how to deal with the application of European Union law; considers that this initiative responds to the new need for cooperation between all Institutions of the European Union in the interests of a well functioning, citizen-focused Union following the adoption of the Lisbon Treaty; underlines the obligation on the Commission laid down in Article 17 TEU to ‘ensure the application of the Treaties, and of measures adopted by the institutions pursuant to them’;
Sporočilo Komisije iz leta 2002, str.
C ommission 2002 Communication, p.
5: „Komisija je vedno priznavala ključno vlogo, ki jo pri odkrivanju kršitev prava Skupnosti igrajo pritožniki”. , po drugi strani pa so v pilotnem projektu EU še v večji meri izključeni iz nadaljnjih postopkov; meni, da to ni v skladu s slovesnimi izjavami iz pogodb, da se „odločitve sprejemajo čim bolj javno in v kar najtesnejši povezavi z državljani” (člen 1 PEU), da institucije Unije „pri svojem delu kar najbolj upoštevajo načelo javnosti delovanja” (člen 15 PDEU) in da „Unija pri vseh svojih dejavnostih upošteva načelo enakosti svojih državljanov, ki so deležni enake obravnave s strani njenih institucij” (člen 9 PEU);
5: ‘the Commission has regularly acknowledged the vital role played by the complainant in detecting infringements of Community law’. , whilst on the other – in EU Pilot – they are even further excluded from any subsequent procedure; considers that this is not in line with the Treaties’ solemn declarations that ‘decisions are taken as openly as possible and as closely as possible to the citizen’ (Article 1 TEU), that ‘the Union institutions ... shall conduct their work as openly as possible’ (Article 15 TFEU) and that ‘[I]n all its activities, the Union shall observe the principle of the equality of its citizens, who shall receive equal attention from its institutions’ (Article 9 TEU);
Poročilo Komisije o oceni pilotnega projekta EU ( KOM(2010)0070 ), str.
Report from the Commission ‘EU Pilot Evaluation Report’ COM (2010) 0070, p.
2. , ki služi za komuniciranje med službami Komisije in organi držav članic; poziva Komisijo, naj Parlamentu omogoči pravi dostop do te podatkovne baze, da bo lahko opravljal svojo funkcijo nadzora nad tem, kako Komisija opravlja svojo funkcijo varuhinje Pogodb;
2. for communication between Commission services and Member State authorities; calls on the Commission to give Parliament meaningful access to that database in order to enable it to perform its role of scrutiny of the Commission’s discharge of its role as guardian of the Treaties;
9. ugotavlja, da zamude pri pravilni uporabi, prenosu in izvrševanju zakonodaje Evropske unije neposredno vplivajo na vsakdanje življenje državljanov in uživanje njihovih pravic, kar vodi v pravno negotovost in državljanom preprečuje, da bi v polni meri uživali koristi notranjega trga; opozarja na visoke stroške zaradi neupoštevanja in neuporabe zakonodaje EU ter posledično pomanjkanje zaupanja v evropske institucije;
Notes that delays in correctly applying, transposing and enforcing European Union law directly affect the daily lives of citizens and businesses and the enjoyment of their rights, resulting in legal uncertainty and preventing them from enjoying the full benefits of the internal market; highlights the high costs deriving from non-compliance with, and non‑application of, EU law and the consequent lack of trust in the European Institutions;
12. opozarja, da je Odbor za pravne zadeve pred nedavnim ustanovil delovno skupino za upravno pravo EU, da bi preučila, ali je mogoča kodifikacija upravnega prava EU in kaj bi takšen projekt vključeval v praksi; meni, da bi bilo treba zaključke te delovne skupine upoštevati pri razpravah o evropskem upravnem zakoniku;
Recalls that its Legal Affairs Committee recently launched a Working Group on EU administrative law with the aim of examining whether a codification of EU administrative law is possible and what such a project would involve in practice; considers that the conclusions of this Working Group should be taken into account when discussing a European administrative code;