natgillin/translations-raw huggingface dataset:
Informacije morajo biti prilagojene na zahteve iz te direktive in usklajene z registracijsko dokumentacijo zdravila.
This information shall comply with the requirements laid down in this Directive and shall be in accordance with the registration dossier for the medicinal product.
Prav tako ne vključuje spletnih mest podjetij, na katerih so informacije o podjetju, vključno s podatki o prodaji zdravila in z drugimi poslovnimi informacijami o zdravilu.
Also it does not cover business sites that contain corporate information including product sales figures and other product related business information.
Člen 100 h – odstavek 1– pododstavek 2
Article 100h - paragraph 1 - subparagraph 2
Po registraciji spletne strani lahko imetnik dovoljenja za promet informacije o zdravilu z navedene spletne strani objavi na drugih spletnih straneh po vsej Skupnosti, če je vsebina enaka.
After registration of the Internet website, the information on a medicinal product contained therein may be provided by the marketing authorisation holder on other Internet websites throughout the Community if the contents are identical.
Po registraciji spletnega mesta lahko imetnik dovoljenja za promet informacije o zdravilu z navedenega spletnega mesta objavi na drugih spletnih mestih , ki jih imetnik dovoljenja za promet v skladu z določbami prvega pododstavka prijavi po vsej Skupnosti, če je vsebina enaka.
After registration of the Internet website, the information on a medicinal product contained therein may be provided by the marketing authorisation holder on other Internet websites registered by the marketing authorisation holder in accordance with the provisions of the first subparagraph throughout the Community if the contents are identical.
Takšne spletne strani jasno opredeljujejo imetnika dovoljenja za promet.
Such websites shall clearly identify the marketing authorisation holder.
Člen 100 h – odstavek 1 – pododstavek 2 a (novo)
Article 100h – paragraph 1 – subparagraph 2 a (new)
Po registraciji spletnega mesta se predlogi sprememb vsebine v zvezi z zdravilom na recept nadzirajo v skladu z odstavkom 3.
After registration of the Internet website, any amendments to the content relating to medicinal products subject to medical prescription shall be subject to monitoring in accordance with paragraph 3.
Za takšne spremembe ni potrebna ponovna registracija spletnega mesta.
Such changes shall not require re-registration of the website.
Če se spremeni vsebina spletnega mesta, mora te spremembe spremljati država članica, v kateri je bila spletno mesto registrirano.
If changes to the content of a website are made, these should be monitored by the Member State where the Internet website has been registered.
Da bi preprečili nepotrebno birokracijo, se ne sme zahtevati ponovne registracije.
A re-registration should not be required to avoid unnecessary bureaucracy.
Člen 100 h – odstavek 2 – pododstavek 2
Article 100 h - paragraph 2 - subparagraph 2
Spletne strani , registrirane v skladu z odstavkom 1, ne omogočajo identifikacije članov javnosti, ki imajo dostop do navedenih spletnih s trani , 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 identifikacije članov javnosti, ki imajo dostop do navedenih spletnih mest brez izrecnega predhodnega dovoljenja , ali pojava nezaželene vsebine na teh spletnih mestih , ki se 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 without their explicit prior consent, or the appearance therein of unsolicited content distributed to the general public or members thereof.
Spletna mesta lahko omogočajo video vsebine, če je to koristno za varno in učinkovito uporabo zdravila.
Internet websites may provide v ideo content if it is useful for promoting the safe and effective use of the medicine.
( i) Glede na obliko spletnega mesta, se lahko bolniki, ki ga redno obiskujejo, morda želijo prijaviti ali identificirati, da bi dostopali do informacij, ki so jih že kdaj iskali, ali do njih hitreje dostopali; to pa bi lahko bilo mogoče samo z njihovim predhodnim dovoljenjem. (ii) Pri nekaterih zdravilih (npr. inhalatorjih), drugem materialu in pripomočkih lahko kratek film pomaga prikazati pravilno uporabo zdravila.
( i) Depending on the design of the website, patients regularly visiting the site might wish to register/identify themselves in order to access information previously searched or to access information faster; this, however, could be done only with their explicit prior consent. (ii) For certain medicinal products (e.g. inhalers) other material and tools, for example a short film, is helpful to demonstrate the correct use of a medicinal product .
Člen 100 h – odstavek 2 – pododstavek 2 a (novo)
Article 100 h – paragraph 2 – subparagraph 2 a (new)
Ta registrirana spletna mesta imajo obvestilo na vrhu vsake spletne strani, s katerim se javnost obvešča, da informacije na teh straneh pripravlja imenovani imetnik dovoljenja za promet.
The registered websites shall display a notification at the top of each website page informing the public that the information contained therein is developed by a named marketing authorisation holder.
V to obvestilo je vključena tudi povezava na podatkovno zbirko o zdravilih EudraPharm.
A link to the EudraPharm database on medicinal products shall also be included in that notification.
Uporabniki spletnih strani, ki vsebujejo informacije o zdravilih na recept, morajo biti jasno obveščeni, da je te informacije pripravil imetnik dovoljenja za promet.
The users of Internet sites containing information on prescription medicines must be clearly informed that such information has been developed by a marketing authorisation holder.
S povezavo na podatkovno zbirko EudraPharm se zagotovi, da bodo imeli uporabniki neposreden in lahek dostop do primerljivih informacij o zdravilih na recept, ki jih zagotovi nekomercialen vir, s čimer je poskrbljeno za večjo preglednost.
The link to the EudraPharm database will ensure that users have direct and easy access to comparable information on prescription medicines provided by a non-commercial source, ensuring greater transparency.
Člen 100 h – odstavek 3
Article 100 h – 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 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.
Pomembna je natančnost, saj je mogoče, da velik del vsebine spletnega mesta ni povezan z zdravili na recept.
The precision is important as much of the website’s content could be unrelated to prescription medicinal products.
Člen 100 h – odstavek 4 – točka a
Article 100 h – paragraph 4 – point a
(a) Če država članica upravičeno dvomi, ali je prevod prikazanih informacij pravilen, lahko od imetnika dovoljenja za promet zahteva overjen prevod širjenih informacij na spletni strani , ki je registrirana pri pristojnih nacionalnih organih druge države članice.
(a) If a Member State has reasons for doubts as to whether the translation of the reproduced information is correct, it may require a marketing authorisation holder to provide for a certified translation of the information disseminated on the Internet website registered with the national competent authority of another Member State.
(a) Če država članica upravičeno dvomi, ali je prevod prikazanih informacij pravilen, lahko od imetnika dovoljenja za promet zahteva overjen prevod informacij , ki so jih odobrili pristojni organi, širjenih na spletnem mestu , ki je registrirano pri pristojnih nacionalnih organih druge države članice.
(a) If a Member State has reasons for doubts as to whether the translation of the reproduced information is correct, it may require a marketing authorisation holder to provide for a certified translation of the authority-approved information disseminated on the Internet website registered with the national competent authority of another Member State.
Člen 100 h – odstavek 4 – točka b
Article 100 h – paragraph 4 – point b
(b) Če država članica upravičeno dvomi, ali so informacije, ki se širijo na spletni strani , ki je registrirana pri pristojnih nacionalnih organih druge države članice, v skladu z zahtevami iz tega naslova, o razlogih za dvom obvesti navedeno državo članico.
(b) If a Member State has reasons for doubts as to whether the information disseminated on an Internet website registered with the national competent authorities of another Member State complies with the requirements of this Title, it shall inform that Member State of the reasons for its doubts.
Zadevne države članice si po najboljših močeh prizadevajo doseči dogovor o potrebnih ukrepih.
The Member States concerned shall use their best endeavours to reach agreement on the action to be taken.
Če ne dosežejo dogovora v dveh mesecih, zadevo predajo farmacevtskemu odboru, ustanovljenemu s Sklepom 75/320/EGS.
If they fail to reach an agreement within two months, the case shall be referred to the Pharmaceutical Committee set up by Decision 75/320/EEC.
Vsi potrebni ukrepi se lahko sprejmejo šele potem, ko je navedeni odbor dal mnenje.
Any necessary measures may only be adopted after an opinion has been delivered by that Committee.
Države članice upoštevajo mnenja farmacevtskega odbora in obvestijo odbor o tem, kako se je njegovo mnenje upoštevalo.
Member States shall take account of opinions delivered by the Pharmaceutical Committee and shall inform the Committee of how its opinion has been taken into account.
(b) Če država članica upravičeno dvomi, ali so informacije, ki so jih odobrili pristojni organi in so na voljo na spletnem mestu , ki je registrirano pri pristojnih nacionalnih organih druge države članice, v skladu z zahtevami iz tega naslova, o razlogih za dvom obvesti navedeno državo članico.
(b) If a Member State has reasons for doubts as to whether the authority-approved information made available on an Internet website registered with the national competent authorities of another Member State complies with the requirements of this Title, it shall inform that Member State of the reasons for its doubts.
Člen 100 h – odstavek 5
Article 100 h – paragraph 5
Države članice od imetnikov dovoljenja za promet, ki so registrirali spletna mesta v skladu z odstavki 1 do 4, zahtevajo , da na vrh vsakega spletnega mesta vključijo obvestilo, s katerim se javnost obvešča, da informacije na teh mestih pripravlja imetnik dovoljenja za promet in se torej spletno mesto spremlja , da se na njem ne bi oglaševala zdravila na recept .
Member States shall require marketing authorisation holders which have registered Internet websites in accordance with paragraphs 1 to 4 to include a message at the top of each website page informing the public that information contained therein is developed by the marketing authorisation holder and is therefore subject to monitoring in order to avoid advertising of prescription medicines .
Izjava jasno navaja nacionalni pristojni organ, ki spremlja zadevno spletno mesto , ter imetnika dovoljenja za promet, ki je odgovoren za spletno mesto .
The statement shall clearly identify the national competent authority monitoring the website concerned and the marketing authorisation holder responsible for the website .
Prav tako navaja, da spremljanje spletnega mesta ne pomeni nujno, da so bile vse informacije na spletnem mestu predhodno odobrene, in vključuje povezavo na podatkovno zbirko EudraPharm s pojasnilom, da so v njej na voljo potrjene informacije .
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 and include a link to the EudraPharm database specifying that validated information is available there .
Dejstvo, da je spletno mesto registrirano in se spremlja v skladu z direktivo, nima za uporabnike nobene dodane vrednosti, lahko pa se zlorabi.
The fact that the website is registered and monitored in accordance with a Directive offers no added value for users, but can be misused.
Pomembno je, da se uporabniki jasno obvestijo, da se spletno mesto spremlja, da se na njem ne bi oglaševala zdravila na recept, saj se javnost ne zaveda dobro posameznih interesov.
It is important that the users are clearly informed that the website is “monitored in order to avoid advertising of prescription medicines” because the general public is not well aware of the notion of vested interests.
Povezava do podatkovne zbirke EudraPharm bo zagotovila, da bodo imeli uporabniki neposreden in lahek dostop do primerljivih informacij o zdravilih na recept, ki jih pripravi nekomercialen vir.
The link to the Eudrapharm database will ensure that users have direct and easy access to comparable information on prescription medicines provided by a non-commercial source.
Člen 100 i – odstavek 1 – pododstavek 1 a (novo)
Article 100 i – paragraph 1 – subparagraph 1 a (new)
Države članice zagotovijo možnost, da se objavi ime imetnika dovoljenja za promet, odgovornega za širjenje neustreznih informacij o zdravilu.
Member States shall provide for the possibility to publish the name of a marketing authorisation holder responsible for disseminating non-compliant information on a medicinal product.
To je učinkovit in odvračilen ukrep, ki bo prispeval k zagotavljanju skladnosti z zakonodajo.
This is an effective and dissuasive measure that would contribute to ensure the compliance with the legislation.
Člen 100 i – odstavek 1 – pododstavek 1 b (novo)
Article 100i – paragraph 1 – subparagraph 1 b (new)
Višina kazni se določi na ravni Skupnosti.
The level of penalties shall be determined at Community level.
Odločanja o višini kazni ne bi smeli prepustiti državam članicam.
It should not be a matter for Member States to determine the level of penalties.
Določitev višine kazni na ravni Skupnosti omogoči večjo pravno jasnost in zagotovi, da kazni jasno odvračajo od kršitev.
Setting of penalties by the Community provides more legal clarity and ensures that the sanctions have a clear deterrent effect in the event of violations.
Člen 100 i – odstavek 2 a (novo)
Article 100 i – 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, prisotni njihovi predstavniki in da lahko izrazijo svoja stališča.
Member States shall ensure that marketing authorisation 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 imajo glede vsake odločitve pravico do pritožbe pri sodnem ali drugem organu.
The marketing authorisation holders shall have the right to appeal to a judicial or other body against any decision.
Med pritožbenim postopkom se širjenje informacij prekine, dokler pristojni organ ne sprejme drugačne odločitve.
During the appeal procedure the dissemination of information shall be suspended until a contrary decision is taken by the responsible body.
Namen predloga spremembe je zagotoviti večjo učinkovitost in preglednost postopka.
This amendment aims to ensure greater efficiency and transparency in the process.
Imetniki dovoljenja za promet morajo imeti pravico, da se zagovarjajo, če menijo, da so obtožbe o neskladnosti neosnovane.
Market authorization holders should be given the right to defend themselves in case they consider that the charges of non-compliance are unfounded.
Da bi širšo javnost zaščitili pred informacijami, ki morda ne bi spoštovale določb iz tega naslova, je treba širjenje prekiniti takoj po odločitvi pristojnega organa.
In order to protect the general public from information that would possibly not respect the provisions of this Title, it is necessary that the dissemination is suspended right after the decision of the competent authority.
Širjenje se nadaljuje zgolj, če tako odloči pristojni organ, odgovoren za analiziranje pritožbe imetnikov dovoljenja za promet.
It should be resumed only in case the body responsible for analysing the marketing authorization holder’s appeal decides so.
Člen 100 j – točka a
Article 100 j – point a
a) dajo na voljo organom ali službam, odgovornim za nadzor informacij o zdravilih, vzorec vseh informacij , ki se posredujejo v skladu s tem naslovom, ter informacije o količini posredovanih informacij, skupaj z izjavo, v kateri so navedene osebe, na katere so informacije naslovljene, način širjenja ter datum prvega širjenja ;
a) keep available for the authorities or bodies responsible for monitoring information on medicinal products, a sample of all information disseminated in accordance with this Title and information on its volume of dissemination , together with a statement indicating the persons to whom it is addressed, the method of dissemination and the date of first dissemination ,
a) dajo na voljo pristojnim organom ali službam, odgovornim za nadzor informacij o zdravilih, ki te informacije odobrijo v naprej, vzorec vseh informacij na voljo v skladu s tem naslovom, ter informacije o količini zagotovljenih informacij, skupaj z izjavo, v kateri so navedene osebe, na katere so informacije naslovljene, način zagotavljanja ter datum prvega zagotavljanja ;
a) keep available for the competent authorities or bodies responsible for monitoring information on medicinal products that have approved the information in advance , a sample of all information made available in accordance with this Title and information on its volume of provision , together with a statement indicating the persons to whom it is addressed, the method of provision and the date of first provision ,
Člen 100 j – točka c
Article 100 j – point c
c) organom ali službam za spremljanje informacij o zdravilih predložijo zahtevane informacije in nudijo pomoč, ki jo zahtevajo za izvajanje svojih pristojnosti,
c) supply the authorities or bodies responsible for monitoring information on medicinal products with the information and assistance they require to carry out their responsibilities;
c) organom ali službam za spremljanje informacij o zdravilih zagotovijo zahtevane informacije ter finančna sredstva in nudijo pomoč, ki jo zahtevajo za izvajanje svojih pristojnosti,
c) provide the authorities or bodies responsible for monitoring information on medicinal products with the information , the financial resources and assistance they require to carry out their responsibilities;
Pristojnim organom je treba dati na razpolago ustrezna finančna sredstva za izpolnjevanje nalog.
The competent authorities should be given the appropriate financial resources in order to fulfil their tasks.
Člen 1 – točka 5 (novo)
Article 1 – point 5 (new)
Člen 100 j – točka c a (novo)
Article 100 j – point c a (new)
ca) vzpostavijo sisteme za obravnavanje pritožb in učinkovite odškodninske mehanizme, ki bodo obravnavali pritožbe potrošnikov in žrtvam zagotovili pravično odškodnino,
ca) put in place complaint-handling systems and efficient redress mechanisms to deal with consumer complaints and to ensure fair compensation of victims.
Zavajajoče informacije o zdravilih na recept imajo lahko hude posledice za javno zdravje.
Misleading information on prescription medicine can have serious consequences for public health.
Treba je dodati sistem za pritožbe in odškodnine, ki bo varoval potrošnike in jim zagotovil orodje za uveljavljanje pravic ter odškodninskih zahtevkov v primeru zavajajočih informacij.
A complaint and redress system to protect consumers and provide them the tools to enforce their rights and seek compensation in case of misleading information needs to be added.
Člen 100k
Article 100k
Za informacije o homeopatskih zdravilih iz člena 14(1), ki so bila uvrščena kot zdravila samo na recept, veljajo določbe tega naslova.
Information on homeopathic medicinal products referred to in Article 14(1) that have been classified as prescription-only shall be subject to the provisions of this Title.
Enako velja za informacije o zdravilih iz zdravilnih zelišč ali drugih sestavin ali terapij, ki so razvrščena kot zdravila samo na recept.
The same shall apply to information on herbal medicinal products or any other compounds or therapies that have been classified as prescription-only.
Člen 100 k a (novo)
Article 100 k a (new)
Člen 100k
Article 100k a
Posvetovanje z neodvisnimi organizacijami bolnikov, zdravstvenimi organizacijami in organizacijami potrošnikov
Consultation with independent patient , health and consumer organisations
Komisija se o vprašanjih, povezanih z izvajanjem te direktive, in o tem, kako jo države članice izvajajo, posvetuje z neodvisnimi organizacijami pacientov, zdravstvenimi organizacijami in organizacijami potrošnikov.
The Commission shall consult independent patient , health and consumer organisations on issues relat ing to the implementation of this Directive and its application by the Member States.
Da bi pri vprašanjih izvajanja in uporabe te direktive upoštevali mnenje pacientov, bi se morala Komisija posvetovati z njihovimi organizacijami.
In order to make patients' voice heard on issues related to the implementation and application of this Directive, the Commission should consult the patients' organisations .
Člen 100 k b (novo)
Article 100 k b (new)
Člen 100kb
Article 100k b
Pooblastilo za sprejemanje delegiranih aktov iz členov 100d(4) in 100f(2) se Komisiji podeli za obdobje petih let po začetku veljavnosti te direktive.
The power to adopt delegated acts referred to in Articles 100d (4) and 100f (2) shall be conferred on the Commission for a period of 5 years following the entry into force of this Directive.
Komisija najpozneje šest mesecev pred iztekom petletnega obdobja pripravi poročilo glede prenesenih pooblastil.
The Commission shall draw up a report in respect of the delegated power at the latest 6 months before the end of the 5 year period.
Prenos pooblastil se samodejno podaljša za enako dolgo obdobje, razen če ga Evropski parlament ali Svet v skladu s členom 100kc ne prekliče.
The delegation of power shall be automatically extended for periods of an identical duration, unless the European Parliament and the Council revoke it in accordance with Article 1 00kc .
Pooblastilo za sprejemanje delegiranih aktov se Komisiji podeli pod pogoji iz členov 100kc in 100kd.
The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in Articles 100kc and 100kd.
V skladu s členom 290 Pogodbe o delovanju Evropske unije morajo biti v direktivi natančne določbe o prenosu pooblastil.
Pursuant to Article 290 of the Treaty on the Functioning of the European Union, detailed provisions on the delegation of powers have to be set out in the Directive.
Člen 100 k c (novo)
Article 100 k c (new)
Člen 100k
Article 100k c
Prenos pooblastil iz členov 100d(4) in 100f(2) lahko Evropski parlament ali Svet kadar koli prekličeta.
The delegation of power referred to in Articles 100d(4) and 100f(2) may be revoked at any time by the European Parliament or by the Council.