natgillin/translations-raw huggingface dataset:
Člen 100h – odstavek 1 – pododstavek 1
Article 100h – paragraph 1 – subparagraph 1
Države članice zagotovijo, da imetniki dovoljenja za promet registrirajo spletne strani, ki vsebujejo informacije o zdravilih, pri pristojnih nacionalnih organih države članice, katere domena najvišje ravni z državno kodo se bo uporabila za zadevno spletno stran.
Member States shall ensure that marketing authorisation holders register Internet websites containing information on medicinal products with the national competent authorities of the Member State of the country code Top Level Domain used by the website concerned, prior to making it available to the general public.
Člen 100h – odstavek 2 – pododstavek 2
Article 100h – paragraph 2 – subparagraph 2
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 .
Navedene spletne strani ne širijo video gradiva ali drugih digitalnih informacij, razen če to dovoli pristojni organ.
Those websites shall not disseminate video material or any other digital information format unless it is authorised by the respective authority.
Člen 100h – odstavek 3
Article 100h – paragraph 3
Država članica, v kateri je bila registrirana spletna stran, je odgovorna za spremljanje vsebine, širjene na navedeni spletni strani.
The Member State where the Internet website has been registered shall be responsible for the monitoring of the contents disseminated on that website.
Država članica, v kateri je bila registrirana spletna stran, je odgovorna za spremljanje vsebine, širjene na navedeni spletni strani v zvezi z informacijami o zdravilih na recept.
The Member State where the Internet website has been registered shall be responsible for the monitoring of the contents disseminated on that website in relation to medicinal products subject to medical prescription .
Potrebna je natančnejša ubeseditev, saj se veliko informacij na internetu ne navezuje na zdravila.
This additional precision is important, since much of the information contained on the Internet web pages may not relate to medicinal products.
Člen 100h – odstavek 5
Article 100h – paragraph 5
Države članice imetnikom dovoljenja za promet, ki so registrirali spletne strani v skladu z odstavki 1 do 4, dovolijo, da na te spletne strani vključijo izjavo o tem, da je stran registrirana in se spremlja v skladu s to direktivo.
Member States shall allow 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 site has been registered and is subject to monitoring in accordance with this Directive .
Izjava navaja nacionalni pristojni organ, ki spremlja zadevno spletno stran.
The statement shall identify the national competent authority monitoring the website concerned .
Prav tako navaja, da spremljanje spletne strani ne pomeni nujno, da so bile vse informacije na spletni strani 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.
Države članice zahtevajo, da :
Member States shall require that:
(b) je na prijavljenih spletnih mestih na vsaki strani na jasno vidnem mestu navedena nadpovezava na spletno stran podatkovne zbirke Eudravigilance, skupaj z obrazložitvijo, ki uporabnike obvešča, da je to uradna podatkovna zbirka Evropske agencije za zdravila.
(b) registered Internet websites include on each of their pages, in a prominent position, a hyperlink to the web page of the Eudravigilance database, together with an explanatory note informing users that this is the official database developed by the European Medicines Agency .
Člen 100i – odstavek 1 – pododstavek 1 a (novo)
Article 100i – paragraph 1 – subparagraph 1 a (new)
Člen 100i – odstavek 2 a (novo)
Article 100i – paragraph 2 a (new)
Države članice zagotovijo, da so pri obravnavi vsakega primera, v katerem so imetniki dovoljenja za promet obtoženi nespoštovanja določb iz tega naslova, lahko prisotni njihovi predstavniki ali da lahko izrazijo svoja stališča.
Member States shall ensure that marketing authorisations holders are represented and heard in any consideration of a case in which they are accused of non-compliance with the provisions set out in this Title.
Imetniki dovoljenja za promet se lahko glede odločitve v zvezi s takšnimi primeri pritožijo sodnemu ali pristojnemu organu.
Marketing authorisation holders may appeal any decision in such a case to a judicial or other competent body.
Namen predloga 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 final) je zagotoviti jasen pravni okvir za obveščanje potrošnikov o zdravilih na recept, da bi spodbujali boljšo izbiro bolnikov, ko se odločajo za mogoča zdravljenja.
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 medicinal prescription, Directive 2001/83/EC on the Community code relating to medicinal products for human use (COM (2008)0663 final) aims to provide for a clear legal framework for consumer information on prescription-only medicines with a view of promoting better patient choices when deciding on possible treatments.
Še vedno obstajajo neskladnosti pri razlaganju predpisov Skupnosti o oglaševanju in zagotavljanju informacij bolnikom.
There are still disparities in the interpretation of the Community rules on advertising and information to patients.
Če se omejitve za oglaševanje ne bodo spremenile, potrošniki v Evropi ne bodo imeli enakega dostopa do neodvisnih in kakovostnih informacij o zdravilih.
Whereas limitations on advertisement will not be changed, consumers across Europe do not have the same degree of access to independent quality information on medicinal products.
Informacije za bolnike morajo imeti naslednje glavne značilnosti:
Information to patients should fulfil the following main characteristics:
Predlagani zakonodajni dokument vpeljuje pravni okvir za širjenje informacij o zdravilih na recept širši javnosti.
The proposed piece of legislation introduces a legal framework for the dissemination of information on prescription-only medicines to the general public.
Pojavlja se vprašanje, kakšno vlogo bi morala imeti farmacevtska industrija pri zagotavljanju neposrednih informacij bolnikom.
The question arises which role the pharmaceutical industry should play in providing direct information to patients.
Razlika med zagotavljanjem informacij in oglaševanjem ni jasna.
The distinction between information and advertisement is not clear.
Potrošniki potrebujejo celovite, kakovostne vire informacij o zdravju (zlasti na spletu), da bi lahko ocenili svoje možnosti in oblikovali ozaveščeno mnenje.
Consumers require comprehensive quality sources for health information (especially on the internet) to evaluate their options and form an informed opinion.
Zbirka podatkov EudraPharm bi bila lahko uporabno orodje za zagotavljanje informacij bolnikom.
The EudraPharm Database could provide for a useful tool to provide information to patients.
Mogoče bi bilo tudi nadalje preučiti vire Evropske agencije za zdravila.
The resources of the EMEA ( European Medicines Agency ) could be further explored.
(2) 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 navodila za uporabo (vstavljena v embalažo zdravila, ko se to posreduje bolniku).
(2) 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 health-care professionals) and the package leaflet (inserted in the product’s packaging when it is dispensed to the patient).
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 .
Poudarek direktive mora biti na bolnikih.
This directive must be patient-centred.
Imetniki dovoljenja za promet morajo bolnikom in splošni javnosti dati na voljo nepromocijske informacije o zdravilih na podlagi izraženega zanimanja, kar pomeni, da dobijo bolniki/širša javnost dostop do informacij, če jih potrebujejo (v nasprotju s primeri, ko imetniki dovoljenja za promet sami 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).
(4) Izkušnje, pridobljene z uporabo obstoječega pravnega okvira, so prav tako pokazale, da so nekatere omejitve možnosti farmacevtskih družb za dajanje informacij na voljo bolnikom in širši javnosti 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 make information available to patients and the general public result from the fact that the distinction between the notions of advertising and information is not interpreted consistently across the Community.
Imetniki dovoljenja za promet morajo bolnikom in splošni javnosti dati na voljo nepromocijske informacije o zdravilih na podlagi izraženega zanimanja, kar pomeni, da dobijo bolniki/širša javnost dostop do informacij, če jih potrebujejo (v nasprotju s primeri, ko imetniki dovoljenja za promet sami širijo informacije med bolniki in širšo javnostjo).
Therefore non-promotional information on medicinal products must be made available to patients and to the general public by marketing authorisation holders according to the ‘pull principle’ whereby patients/the public have access to information if they need it (contrary to the ‘push principle’ whereby the marketing authorisation holders disseminate information among the patients and the general public).
(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.
(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.
Treba je poudariti, da je glavni poudarek te direktive na boljšem obveščanju bolnikov in širše javnosti o zdravilih, ne pa na oglaševanju.
It is necessary to emphasise the fact that the main focus of this directive is about better informing patients and the general public on medicinal products, and not about advertising.
(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 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 interest 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 .
Odobrena in registrirana spletna mesta bodo glavni kanal za zagotavljanje kakovostnih informacij o zdravju.
Certified and registered websites will be a key channel for providing quality health information .
(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 sources of information on medicinal products for the general public.
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.
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.
Treba je poudariti, da so pristojni nacionalni organi in zdravstveni delavci najpomembnejši in glavni vir zanesljivih in objektivnih informacij o zdravilih za bolnike in širšo javnost.
It is important to underline that national competent authorities and healthcare professionals are the most important and the main sources of reliable and objective information on medicinal products for the patients and the general public.
Imetniki dovoljenja za promet lahko nudijo dodatne informacije, ne morejo pa nadomestiti pristojnih nacionalnih organov in zdravstvenih delavcev.
Marketing authorisation holders can provide complementary information but cannot substitute themselves for the national competent authorities and the health care professionals.
(10) Uvesti je treba določbe, s katerimi se zagotovi, da se dajo 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 may be made available .
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 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 smejo dati 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 may be made available should be defined.
Zato je treba imetnikom dovoljenja za promet omogočiti, da dajo na voljo 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 make available the contents of the approved summaries of product characteristics and package leaflets , information that is compatible with those documents without going beyond their key elements, and other well-defined medicinal product-related information.
Imetniki dovoljenja za promet morajo bolnikom in splošni javnosti dati na voljo nepromocijske informacije o zdravilih na podlagi izraženega zanimanja, kar pomeni, da dobijo bolniki/širša javnost dostop do informacij, če jih potrebujejo (v nasprotju s primeri, ko imetniki dovoljenja za promet sami širijo informacije med bolniki in širšo javnostjo).
Therefore non-promotional information on medicinal products must be made available by marketing authorisation holders to patients and to the general public according to the ‘pull principle’ whereby patients/the general 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).
(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 .
(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 the Internet and health-related publications, to ensure that the effectiveness of the prohibition on advertising is not undermined by unsolicited provision of information to the public.
Kadar se informacije dajejo na voljo prek televizije ali radia, bolniki pred takšnimi nezaželenimi informacijami niso zaščiteni, zato je treba takšno dajanje na voljo prepovedati.
Where information is made available via television or radio, patients are not protected against such unsolicited information and such making available should therefore be prohibited .
Treba je jasno navesti, da televizija in radio nista primerno sredstvo za obveščanje bolnikov o zdravilih.
It is necessary to make clear that the television and the radio are not appropriate means to inform patients about medicinal products.
(12a) Internet je pomemben vir informacij za vedno več bolnikov.
(12a) The internet is a major source of information for a growing number of patients.
Ta trend se bo v prihodnjih letih še okrepil.
This trend is likely to increase in the coming years.
Da bi se prilagodili temu razvoju in okrepili vedno večji pomen e-zdravja, bi bilo treba informacije o zdravilih dati na voljo tudi na nacionalnih spletnih mestih o zdravju.
In order to adapt to this development and to add to the growing importance of e-health, information on medicinal products should also be made available via national health websites.
Ta spletna mesta bi morali spremljati pristojni organi v državah članicah.
These websites should be monitored by competent authorities in the Member States.
Države članice bi morale biti v sodelovanju z zainteresiranimi stranmi, kot so zdravstveni delavci ali organizacije bolnikov, odgovorne za upravljanje teh spletnih mest.
Member States in cooperation with stakeholders such as healthcare professionals or patient organisations should be responsible for managing these websites.
Internet je postal pomemben in močan vir informacij.
The Internet has become an important and powerful source of information.
Ker so lahko napačne informacije, ki jih je mogoče najti na internetu, škodljive, se je nujno treba odzvati na potrebe bolnikov in vzpostaviti uradno potrjena spletna mesta o zdravju.
As misinformation obtained on the Internet can cause harm, there is an urgent need to respond to the needs of patients and set up officially validated health websites.
Da bi bile informacije na teh spletnih mestih neodvisne in objektivne, bi morale biti države članice odgovorne za nadzor nad njimi.
In order to ensure that the information on these websites is independent and objective, Member States shall be responsible for controlling the information.
Za bolniku prijazne informacije bi morali pri ustvarjanju in upravljanju teh spletnih mest sodelovati zdravstveni delavci in organizacije bolnikov.
Since the information should be patient-friendly, health care professionals and patient organisations should be involved in creating and managing the websites.