natgillin/translations-raw huggingface dataset:
Kar zadeva informacije, ki jih imetnik dovoljenja za promet zagotavlja 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, preko katerih se lahko te informacije širijo .
On the other hand, as regards the dissemination of information from the marketing authorisation holder to 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 disseminated .
Kar zadeva informacije, ki jih imetnik dovoljenja za promet daje na voljo bolnikom in 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, preko katerih se lahko te informacije dajejo na voljo .
On the other hand, as regards the making available of information from the marketing authorisation holder to patients and 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 made available .
(Sprememba velja za celotno besedilo.
(This amendment applies throughout the text.
Imetniki dovoljenja za promet morajo bolnikom in širši javnosti dati na voljo nepromocijske informacije o zdravilih na podlagi izraženega zanimanja, kar pomeni, da dobijo bolniki oziroma 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 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).
(3) Na podlagi člena 88a Direktive 2001/83/ES je Komisija 20. decembra 2007 Evropskemu parlamentu in Svetu predložila Sporočilo „Poročilo o obstoječi praksi glede zagotavljanja informacij o zdravilih bolnikom“.
(3) On the basis of Article 88a of Directive 2001/83/EC, on 20 December 2007 the Commission submitted a Communication to the European Parliament and the Council on a "Report on current practices with regard to the provision of information to patients on medicinal products".
Poročilo ugotavlja, da so države članice sprejele različne predpise in prakse glede zagotavljanja informacij, zaradi česar bolniki in širša javnost nimajo enakega dostopa 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 .
Poročilo ugotavlja, da so države članice sprejele različne predpise in prakse glede zagotavljanja informacij, zaradi česar bolniki in širša javnost nimajo enakega dostopa do informacij v priloženih navodilih za uporabo in v povzetku značilnosti zdravila .
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 in the package leaflet and in the summary of product characteristics .
Take neupravičene razlike pri dostopanju do informacij, ki so v drugih državah članicah javno dostopne, je treba odpraviti.
Such unjustifiable inequalities in accessing information that is publicly available in other Member States should be redressed.
Na voljo morajo biti vse informacije ne glede na resnost bolezni.
All information needs to be available regardless of severity of diseases.
(4) Izkušnje, pridobljene z uporabo obstoječega pravnega okvira, so prav tako pokazale, da so nekatere omejitve možnosti farmacevtskih družb za zagotavljanje informacij posledica dejstva, da se razlika med pojmoma oglaševanja in obveščanja v Skupnosti ne razlaga usklajeno.
(4) Experience gained from the application of the current legal framework has also shown that certain restrictions on the possibilities of pharmaceutical companies to provide information result from the fact that the distinction between the notions of advertising and information is not interpreted consistently across the Community .
(4) Izkušnje, pridobljene z uporabo obstoječega pravnega okvira, so prav tako pokazale, da se razlika med pojmoma oglaševanja in obveščanja v Uniji ne razlaga usklajeno , kar pomeni, da je javnost lahko izpostavljena prikritemu oglaševanju .
(4) Experience gained from the application of the current legal framework has also shown that the distinction between the notions of advertising and information is not interpreted consistently across the Union , and that this has given rise to situations where the general public is exposed to disguised advertising .
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 oba pojma opredeliti in razlagati enotno v vseh državah članicah.
Each notion should be defined and should be interpreted uniformly across all Member States so to ensure patient safety.
(5) Navedene razlike v razlagi predpisov Skupnosti o oglaševanju in razlike med nacionalnimi predpisi o obveščanju negativno vplivajo na enotno uporabo predpisov Skupnosti o oglaševanju ter na učinkovitost določb glede informacij o zdravilu, vsebovanih v povzetku značilnosti zdravila in navodilih za uporabo.
(5) Those disparities in the interpretation of the Community rules on advertising , and between national provisions on information have a negative impact on the uniform application of Community rules on advertising , and on the effectiveness of the provisions on product information contained in the summary of products characteristics and the package leaflet.
Čeprav so navedeni predpisi v celoti usklajeni, da se zagotovi enaka raven varovanja javnega zdravja po vsej Skupnosti, je ta cilj oslabljen, če so dovoljeni zelo različni nacionalni predpisi o širjenju takšnih ključnih informacij.
Although those rules are fully harmonised to ensure the same level of protection of public health across the Community, this objective is undermined if widely divergent national rules on the dissemination of such key information are allowed.
(5) Navedene razlike v razlagi predpisov Skupnosti o zagotavljanju informacij bolnikom in širši javnosti in razlike med nacionalnimi predpisi o obveščanju negativno vplivajo na enotno uporabo predpisov Skupnosti o zagotavljanju informacij bolnikom in širši javnosti ter na učinkovitost določb glede informacij o zdravilu, vsebovanih v povzetku značilnosti zdravila in navodilih za uporabo.
(5) Those disparities in the interpretation of the Community rules on providing information to patients and the general public, and between national provisions on information have a negative impact on the uniform application of Community rules on providing information to patients and the general public, and on the effectiveness of the provisions on product information contained in the summary of products characteristics and the package leaflet.
Čeprav so navedeni predpisi v celoti usklajeni, da se zagotovi enaka raven varovanja javnega zdravja po vsej Skupnosti, je ta cilj oslabljen, če so dovoljeni zelo različni nacionalni predpisi o dajanju takšnih ključnih informacij na voljo .
Although those rules are fully harmonised to ensure the same level of protection of public health across the Community, this objective is undermined if widely divergent national rules on the making available of such key information are allowed.
V žarišču direktive ne bi smelo biti oglaševanje, pač pa dajanje informacij na voljo javnosti.
The focus of the Directive should be not on advertising but on making information available to the public.
(7) Glede na zgoraj navedeno in ob upoštevanju tehnološkega napredka v zvezi s sodobnimi komunikacijskimi orodji ter dejstva, da postajajo bolniki po vsej Evropski 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.
(7) 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 European 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.
(7) Glede na zgoraj navedeno in ob upoštevanju tehnološkega napredka v zvezi s sodobnimi komunikacijskimi orodji ter dejstva, da postajajo bolniki po vsej Evropski 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 , pri čemer mora biti poudarek na pravicah in interesih bolnikov .
(7) 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 European 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 by placing emphasis on the rights and interests of patients .
Imeti morajo pravico do lahkega dostopa do nekaterih informacij, kot so povzetek značilnosti zdravila ter priložena navodila za uporabo v elektronski ali tiskani obliki.
They should have the right to easily access certain information such as a summary of product characteristics and the package leaflet in electronic and printed form .
Zato so potrebna odobrena in registrirana spletna mesta za neodvisne, objektivne in nepromocijske informacije.
Certified and registered websites for independent, objective and non-promotional information are therefore necessary.
Direktiva za spremembo direktive se mora osrediniti na bolnike in njihove interese.
The Amending Directive has to focus on the patients and their interests.
V novih določbah mora biti namesto pravice farmacevtskih podjetij do razširjanja informacij poudarjena pravica bolnikov do informiranosti.
The new provisions have to emphasise the right of patients for information instead of the right of the pharmaceutical companies to disseminate information.
(8) Pristojni nacionalni organi in zdravstveni delavci morajo ostati pomemben vir informacij o zdravilih za širšo javnost.
(8) National competent authorities and health care professionals should remain important sources of information on medicinal products for the general public.
Države članice morajo olajšati dostop državljanov do kakovostnih informacij prek ustreznih kanalov.
Member States should facilitate the access of citizens to high-quality information through appropriate channels .
Imetniki dovoljenja za promet so lahko dragocen vir nepromocijskih informacij o svojih zdravilih.
Marketing authorisation holders may be a valuable source of non promotional information on their medicinal products.
Ta direktiva mora zato vzpostaviti pravni okvir za imetnike dovoljenja za promet za širjenje specifičnih informacij o zdravilih širši javnosti.
This Directive should therefore establish a legal framework for the dissemination of specific information on medicinal products by marketing authorisation holders to the general public.
Prepoved oglaševanja zdravil na recept, namenjenega širši javnosti, je treba ohraniti.
The ban on advertising to the general public for prescription-only medicinal products should be maintained .
(8) Pristojni nacionalni organi in zdravstveni delavci morajo ostati glavni vir informacij o zdravilih za širšo javnost.
(8) National competent authorities and health care professionals should remain the main source 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 among the different products available.
Države članice in Komisija si morajo bolj prizadevati, da bi olajšale dostop državljanov do kakovostnih informacij prek ustreznih kanalov.
Member States and Commission should make much greater efforts to facilitate the access of citizens to high-quality information through appropriate channels.
(8a) Ne glede na 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.
(8a) 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 mora zato vzpostaviti pravni okvir za imetnike dovoljenja za promet za dajanje specifičnih informacij o zdravilih na voljo 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 the general public.
Prepoved oglaševanja zdravil na recept, namenjenega širši javnosti, je treba ohraniti.
The ban on advertising to the general public for prescription-only medicinal products should be maintained.
(9) V skladu z načelom sorazmernosti je ustrezno omejiti področje uporabe te direktive na zdravila na recept, saj trenutni predpisi Skupnosti omogočajo oglaševanje zdravil brez recepta za širšo javnost, ob upoštevanju nekaterih pogojev.
(9) In accordance with the principle of proportionality, it is appropriate to limit the scope of this Directive to prescription-only medicinal products, as current Community rules allow the advertising to the general public of medicinal products not subject to prescription, under certain conditions.
(9) V skladu z načelom sorazmernosti je ustrezno omejiti področje uporabe te direktive na dajanje informacij o zdravilih na recept, saj trenutni predpisi Skupnosti omogočajo oglaševanje zdravil brez recepta za širšo javnost, ob upoštevanju nekaterih pogojev.
(9) In accordance with the principle of proportionality, it is appropriate to limit the scope of this Directive to the making available of information on prescription-only medicinal products as current Community rules allow the advertising to 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 morajo imetnikom dovoljenja za promet ali tretjim stranem, ki delujejo v njihovem imenu, dovoliti, da širši javnosti prek določenih kanalov in ob ustreznem spremljanju zagotavljajo nekatere informacije o odobrenih zdravilih na recept.
This Directive requires Member States to permit, via certain channels and subject to appropriate monitoring, the provision by a marketing authorisation holder or a third party acting on its behalf of certain information on authorised medicines subject to prescription to the general public.
Če ne gre za oglaševanje, se dovolijo obvestila, ki ne spadajo pod naslov VIIIa.
Communications that do not fall within Title VIIIa are permitted, provided that they do not constitute advertising.
Glede na nedavno dogajanje v sodni praksi je treba poudariti, da določbe te direktive v nobenem primeru ne vplivajo na pravico oseb, organizacij, zlasti medijev ali skupin bolnikov, da izrazijo svoje stališče o zdravilih, ki se izdajajo samo na recept, a pod pogojem, da ne delujejo v interesu ali v imenu farmacevtskih podjetij.
With reference to recent developments in the case law it has to be emphasised that the provisions of this Directive do not affect the right of any other person or organisation, in particular the press or patients' groups to express their views on prescription-only medicines as long as they are acting not in the interest of, or on behalf of the pharmaceutical companies.
(10) Uvesti je treba določbe, s katerimi se zagotovi, da se širijo samo kakovostne nepromocijske informacije o koristih in tveganjih zdravil na recept.
(10) Provisions should be established to ensure that only high-quality non-promotional information about the benefits and the risks of medicinal products subject to medical prescription may be disseminated.
Informacije morajo upoštevati potrebe in pričakovanja bolnikov, da se zagotovi večji vpliv bolnikov, omogoči sprejemanje premišljenih odločitev in izboljša razumna uporaba zdravil.
The information should take into account patients needs and expectations in order to empower patients, allow informed choices and enhance the rational use of medicinal products.
Zato mora biti vsaka informacija za širšo javnost o zdravilih na recept skladna s sklopom meril kakovosti .
Therefore, any information to the general public on prescription-only medicinal products should comply with a set of quality criteria .
(10) Uvesti je treba določbe, s katerimi se zagotovi, da so na voljo samo kakovostne nepromocijske informacije o koristih in tveganjih odobrenih zdravil na recept.
(10) Provisions should be established to ensure that only high-quality non-promotional information about the benefits and the risks of authorised medicinal products subject to medical prescription is accessible .
Zato mora biti vsaka informacija za širšo javnost o zdravilih na recept vnaprej odobrena s strani pristojnih organov in posredovana izključno v odobreni obliki .
Therefore, any information to the general public on prescription-only medicinal products should be approved in advance by the competent authorities a nd should be supplied only in an approved form .
(11) Za nadaljnjo zagotovitev, da bodo imetniki dovoljenja za promet širili samo kakovostne informacije, in za razlikovanje med nepromocijskimi informacijami in oglaševanjem, je treba opredeliti vrste informacij, ki se smejo širiti .
(11) In order to further ensure that marketing authorisation holders disseminate only high-quality information and to distinguish non-promotional information from advertising, the types of information which may be disseminated should be defined.
Zato je treba imetnikom dovoljenja za promet omogočiti, da širijo vsebino odobrenih povzetkov značilnosti zdravila in navodil za uporabo, informacije, ki so skladne z navedenima dokumentoma, brez preseganja njunih ključnih prvin, in druge natančno opredeljene informacije, povezane z zdravili.
It is appropriate to allow marketing authorisation holders to disseminate the contents of the approved summaries of product characteristics and package leaflet, information that is compatible with those documents without going beyond their key elements, and other well-defined medicinal product-related information.
(11) Za nadaljnjo zagotovitev, da bodo imetniki dovoljenja za promet dajali na voljo samo kakovostne informacije, in za razlikovanje med nepromocijskimi informacijami in oglaševanjem, je treba opredeliti vrste informacij, ki se dajo na voljo .
(11) In order to further ensure that marketing authorisation holders make available only high-quality information and to distinguish non-promotional information from advertising, the types of information which are made available should be defined.
Imetnik dovoljenja za promet mora zagotoviti odobrene in najnovejše različice vsebine povzetkov značilnosti zdravil, ovojnino in navodilo za uporabo ter javno dostopno različico poročila o oceni.
Marketing authorisation holders should make available the approved and most recent contents of summaries of product characteristics, labelling and package leaflet and the publicly accessible version of the assessment report.
Zato je treba imetnikom dovoljenja za promet omogočiti, da dajo na voljo druge natančno opredeljene informacije, povezane z zdravili.
It is appropriate to allow marketing authorisation holders to make available other well-defined medicinal product-related information.
Corresponding recital.
Corresponding recital.
(11a) Povzetek značilnosti zdravil, ovojnino in navodila za uporabo ter javno dostopno različico poročila o oceni ali katero koli posodobljeno različico teh dokumentov morajo odobriti pristojni organi med postopkom izdaje dovoljenja za promet.
(11a) The summary of product characteristics, labelling and package leaflet, and the publicly accessible version of the assessment report or any updated versions of these documents shall require approval by the competent authorities during the course of marketing authorisation.
Zato ni potrebna dodatna odobritev pred objavo teh informacij v skladu s to direktivo.
Therefore this information should not be subject to further approval prior to its being made available pursuant to this Directive .
Pojasnilo uvodne izjave.
Clarifying recital.
(12) Informacije za širšo javnost o zdravilih na recept je treba zagotoviti samo preko posebnih kanalov komuniciranja, vključno s spletom in publikacijami v zvezi z zdravjem , da se učinkovitost prepovedi oglaševanja nezaželenih informacij za javnost ne bi zmanjšala.
(12) Information to the general public on prescription-only medicinal products should only be provided through specific channels of communication, including Internet and health-related publications , to avoid that the effectiveness of the prohibition on advertising is undermined by unsolicited provision of information to the public.
Kadar se informacije širijo prek televizije ali radia, bolniki pred takšnimi nezaželenimi informacijami niso zaščiteni, zato je treba takšno širjenje prepovedati.
Where information is disseminated via television or radio, patients are not protected against such unsolicited information and such dissemination should therefore not be allowed.