natgillin/translations-raw huggingface dataset:
Države članice imetniku dovoljenja za promet omogočijo širjenje, neposredno ali posredno prek tretje stranke , informacij širši javnosti ali njenim članom o odobrenih zdravilih na recept pod pogojem, da so skladne z določbami tega naslova.
Member States shall allow the marketing authorisation holder to disseminate , either directly or indirectly through a third party, information to the general public or members thereof on authorised medicinal products subject to medical prescription provided that it is in accordance with the provisions of this Title.
Države članice imetniku dovoljenja za promet omogočijo širjenje informacij širši javnosti ali njenim članom o odobrenih zdravilih na recept pod pogojem, da so skladne z določbami tega naslova in da zdravila izpolnjujejo pogoje, pod katerimi se lahko tržijo.
Member States shall allow the marketing authorisation holder to disseminate information to the general public or members thereof on authorised medicinal products subject to medical prescription provided that it is in accordance with the provisions of this Title and provided that the medicinal products meet the conditions under which they may be marketed .
Takšne informacije se ne obravnavajo kot oglaševanje za namene uporabe naslova VIII, a bo zanje potrebna predhodna odobritev države članice, ko bo preverjeno, da so te informacije v skladu z zahtevami odobritve za trženje zdravila.
Such information shall not be considered advertising for the purposes of the application of Title VIII but it shall require prior authorisation by the Member State , after having checked that such information complies with the requirements for marketing authorisation for the medicinal product .
Zadevne informacije ne smejo vsebovati podatkov o razvojnih študijah o zdravilih, novih možnostih uporabe ali lastnostih, ki se preučujejo, ali drugih podatkov, ki bi lahko povzročili izkrivljanje ali dodajanje lastnosti ali rabe, ki se razlikujejo od tistih, ki so v veljavnih dovoljenjih za trženje zadevnega zdravila.
The information concerned may not contain any data on development studies for medicinal products, new prospects for their use or properties under investigation, or any other information which may create distortions or endow the medicinal product with properties or uses other than those contained in the current marketing authorisation for the medicinal product in question.
Potrebna je odobritev države, saj doslej ni bilo zgoščene pravne opredelitve informacij, pri katerih ne gre za oglaševanje.
authorisation is needed, since up to now there has been no legally useable definition of information as distinct from advertising.
Pomembno je, da lahko informacije širijo samo imetniki dovoljenja za promet, da bi preprečili težave pri pripisovanju odgovornosti v primeru kršitve predpisov.
It is important that only the marketing authorisation holder should be able to make information on the medicinal product available to the public in order to prevent problems in attributing responsibility in the event of an infringement of the regulations.
Člen 100a – odstavek 2 – točka (a)
Article 100a – paragraph 2 – point a
(a) informacij v zvezi z zdravjem ljudi ali boleznimi pod pogojem, da temeljijo na objektivnih, realističnih podatkih, ki jih dajejo pristojni organi, in da ni nobenega napotila, tudi posrednega ne, na zdravila;
(a) information relating to human health or diseases, provided that it is based on objective, realistic data supplied by the competent bodies and there is no reference, even indirect, to medicinal products;
Člen 100a – odstavek 2 – točka (b)
Article 100a – paragraph 2 – point b
(b) gradiva, ki ga imetnik dovoljenja za promet zagotovi zdravstvenim delavcem za posredovanje bolnikom , ki jih morajo izrecno odobriti države članice ob upoštevanju tega, kar je bilo odobreno v tehničnem povzetku.
(b) material provided by the marketing authorisation holder to healthcare professionals for distribution to patients , which must be explicitly authorised by the Member States, taking account of what was authorised in the technical summary .
Člen 100a – odstavek 2 – točka (b a) (novo)
Article 100a – paragraph 2 – point b a (new)
(ba) informativnih objav, ki niso promocijskega značaja, o dejstvih ter referenčnega gradiva v zvezi z zdravilom, na primer v zvezi s spremembami na ovojnini, opozorili o neželenih učinkih kot delu splošnih previdnostnih ukrepov, prodajnimi katalogi, ceniki in povrnitvijo stroškov, pod pogojem, da te objave in referenčno gradivo ne oglašujejo posameznega zdravila;
(ba) factual, informative, non- promotional announcements and reference material relating to a medicinal product, for example, relating to pack changes, adverse reaction warnings as part of general drug precautions, trade catalogues, prices lists and reimbursement, provided that such announcements and reference material do not intend to promote an individual medicinal product.
Pojasnitev področja uporabe direktive, pravila trga vrednostnih papirjev na primer zahtevajo, da podjetja redno v celoti obveščajo vlagatelje o pomembnih dogodkih, zaposlene pa o poslovnem razvoju.
Clarification of scope, e.g. stock market rules require that companies keep investors fully informed of significant developments and employees must be kept informed of business developments.
Člen 100b – točka a
Article 100b – point a
(a) povzetek značilnosti zdravila, ovojnino in navodilo za uporabo zdravila, kakor so jih odobrili pristojni organi, in javno dostopna različica poročila o oceni, ki jo pripravijo pristojni organi;
(a) the summary of product characteristics, labelling and package leaflet of the medicinal product, as approved by the competent authorities, and the publicly accessible version of the assessment report drawn up by the competent authorities;
(a) povzetek značilnosti zdravila, ovojnino in navodilo za uporabo zdravila, kakor so jih odobrili pristojni organi, in javno dostopna različica poročila o oceni, ki jo pripravijo pristojni organi, ter druge razpoložljive izjave in dokumenti, ki jih objavijo pristojni organi;
(a) the summary of product characteristics, labelling and package leaflet of the medicinal product, as approved by the competent authorities, the publicly accessible version of the assessment report drawn up by the competent authorities and other available statements and documents published by the competent authorities ;
Evropsko javno poročilo o oceni zdravila (EPAR) in drugi dokumenti, ki jih objavijo pristojni organi, vsebujejo natančne informacije, ki so za nekatere bolnike pomembne.
The EPAR (European Product Assessment Report) and other documents published by the competent authorities include detailed information, which is of interest to certain patients.
Člen 100b – točka b
Article 100b – point b
(b) informacije, ki ne presegajo prvin povzetka značilnosti zdravila, ovojnine in navodila za uporabo zdravila, in javno dostopna različica poročila o oceni, ki jo pripravijo pristojni organi, vendar jih predstavi na drugačen način, pod pogojem, da vsebuje točno predstavitev tveganj in koristi zdravila; različica, dostopna javnosti, ne sme opisovati bistveno drugačnih značilnosti, lastnosti, učinkov in reakcij, ki bi jih lahko imelo zdravilo;
(b) information which does not go beyond the elements of the summary of product characteristics, labelling and the package leaflet of the medicinal product, and the publicly accessible version of the assessment report drawn up by the competent authorities, but presents them in a different way , provided that it clearly contains an accurate representation of the risks and benefits of the medicinal product ; this publicly accessible version may not constitute a substantial change in the characteristics, properties, effects and reactions that the medicinal product might have;
Zaradi večje razumljivosti je potrebna poenostavljena predstavitev informacij, ki jo razumejo tudi nestrokovnjaki.
It is beneficial for information to be presented in a simplified manner addressed to the general public, since this makes it easier to understand.
Vendar pa lahko taka poenostavitev povzroči spremembo konteksta in lahko pride do napačnega razumevanja tveganj in koristi, kar je treba preprečiti.
Nevertheless, this simplification may entail a change in the context of the information that may lead to a false understanding of the benefits and risks of the medicinal product, and this should be prevented.
Člen 100b – točka c
Article 100b – point c
(c) informacije o vplivu zdravila na okolje, cene in informativne objave o dejstvih ter referenčna gradiva, na primer v zvezi s spremembami na ovojnini, povrnitvijo stroškov ali opozorili o neželenih učinkih;
(c) information on the environmental impact of the medicinal product, prices and factual, informative announcements and reference material relating, for example, to pack changes , reimbursement or adverse-reaction warnings;
Povrnitev stroškov zdravljenja bi lahko vključili kot primer dejanskih informacij, ki bi morale biti dovoljene s to klavzulo.
It would be useful to include reimbursement status in the list as an example of factual information that should be permitted under this clause.
Člen 100b – točka d
Article 100b – point d
(d) informacije v zvezi z zdravilom o neintervencijskih znanstvenih študijah ali spremne ukrepe za preprečevanje in zdravljenje ali informacije, ki predstavljajo zdravilo v okviru stanja bolezni, ki ga je treba preprečiti ali zdraviti.
(d) medicinal product-related information about non-interventional scientific studies, or accompanying measures to prevention and medical treatment, or information which presents the medicinal product in the context of the condition to be prevented or treated.
Te informacije mora predhodno oceniti država članica, študije pa morajo biti vključene v registracijsko dokumentacijo zdravila.
This information must have been evaluated in advance by the Member State , and such studies must be included in the registration dossier for the medicinal product.
Znanstvene študije, ki niso bile izvedene v skladu z veljavnimi pravnimi zahtevami za klinične teste, ne smejo biti predložene.
Scientific studies may not be submitted if they were carried out without complying with the legal requirements in force for clinical trials.
Prav tako se ne smejo predložiti znanstvene študije o drugih lastnostih ali uporabah zdravila, ki jih država članica ni odobrila.
Scientific studies may also not be submitted if they relate to properties of the medicinal product or a use of that product other than those for which it is currently authorised in the Member State .
Člen 100c – uvodni del
Article 100c – introductory part
Informacije o odobrenih zdravilih na recept, ki jih imetnik dovoljenja za promet širi za širšo javnosti ali njene člane, niso na voljo na televiziji ali radiu.
Information on authorised medicinal products subject to medical prescription disseminated by the marketing authorisation holder to the general public or members thereof shall not be made available on television or radio.
Informacije o odobrenih zdravilih na recept, ki jih imetnik dovoljenja za promet širi za širšo javnosti ali njene člane, niso na voljo na televiziji, radiu, drugih sredstvih javnega obveščanja, vključno s spletnimi radijskimi in televizijskimi kanali, v časopisih in revijah ali v obliki njihovih dodatkov in prilog.
Information on authorised medicinal products subject to medical prescription disseminated by the marketing authorisation holder to the general public or members thereof shall not be made available on television , radio or any other instrument of dissemination to the general public, including Internet radio or television channels, or in general newspapers and magazines or in the form of inserts or supplements to them .
Člen 100c – točka a
Article 100c – point a
(a) publikacije v zvezi z zdravjem, kakor jih opredeli država članica publikacije, ob izključitvi nezaželenega gradiva, ki se aktivno razpošilja širši javnosti ali njenim članom;
(a) health-related publications as defined by the Member State of publication , to the exclusion of unsolicited material actively distributed to the general public or members thereof;
(a) tehnične in znanstvene revije s področja zdravja ali širši javnosti namenjene revije s pretežno zdravstveno vsebino, brošure, informativni listi in drugo tiskano informativno gradivo, ob izključitvi nezaželenega gradiva, ki se aktivno razpošilja širši javnosti ali njenim članom; publikacije v zvezi z zdravjem so tiste, za katere država članica jamči kot za take, da lahko potrošnik nedvoumno opredeli, da je zadevno publikacijo sprejela in odobrila država članica;
(a) technical and scientific magazines in the field of health, or magazines addressed to the general public whose main content is in the field of health, brochures, leaflets and other categories of printed information , to the exclusion of unsolicited material actively distributed to the general public or members thereof; health-related publications shall mean those certified as such by the Member State, so that consumers can clearly identify those publications as having been endorsed and authorised by the Member State;
Člen 100c – točka b
Article 100c – point b
(b) spletne strani o zdravilih, ki jih izrecno odobri in kot take opredeli država članica, ob izključitvi nezaželenega gradiva, ki se aktivno razpošilja širši javnosti ali njenim članom; države članice v ta namen uvedejo sistem odobritev, spremljanja in nadzora spletnih mest, ki bi lahko vseboval informacije, omenjene v tem členu; poleg tega se vzpostavi sistem zgodnjega opozarjanja med državami članicami za boj proti spletnim mestom, ki bodo kršila določbe te direktive; za neželeno razdeljevanje informativnega gradiva se vzpostavi dodaten sistem izdajanja odobritev in nadziranja;
(b) internet websites on medicinal products, explicitly authorised and regarded as such by the Member State, to the exclusion of unsolicited material actively distributed to the general public or members thereof; for this purpose, the Member States shall establish a system for authorising, supervising and monitoring Internet sites which may present the information referred to in this article; furthermore, an early warning system shall be set up among the Member States to combat Internet sites which violate the provisions of this Directive; an additional authorisation and monitoring system shall be established for the distribution of unsolicited material;
Člen 100c – točka c
Article 100c – point c
(c) pisni odgovori na zahtevke po informacijah s strani člana širše javnosti.
(c) written answers to requests for information of a member of the general public.
Člen 100d – odstavek 1 – točka (b)
Article 100d – paragraph 1 – point b
(b) morata upoštevati splošne potrebe in pričakovanja bolnikov;
(b) it must take into account the general needs and expectations of patients ;
(b) morata biti usmerjeni v boljše izpolnjevanje potreb bolnikov;
(b) it must be geared to the patient, to better meet his or her needs ;
Besedilo blje odraža cilj predloga: bolnikom dati podatki, ki jih potrebujejo, v najbolj razumljivi obliki.
This wording better reflects the objectives of the proposal: to provide patients with the information they need in a form which is more easily understood.
Člen 100d – odstavek 1 – točka (c)
Article 100d – paragraph 1 – point c
(c) morata temeljiti na dokazih, biti preverljivi in vključevati izjavo o zanesljivosti dokazov;
(c) it must be based on evidence, be verifiable and include a statement on the level of evidence;
(Ne zadeva slovenske različice.)
( Does not affect the English version)
Ne zadeva slovenske različice.
(Does not affect the English version.)
Člen 100d – odstavek 1 – točka (f)
Article 100d – paragraph 1 – point f
Člen 100d – odstavek 1 – točka (h a) (novo)
Article 100d – paragraph 1 – point h a (new)
(ha) morata biti predstavljeni tako, da je doziranje zdravila popolnoma razumljivo, s posebnim upoštevanjem tistih zdravil, ki imajo zapleteno pravilno uporabo.
(ha) it must be presented in such a way as to ensure that the dosage of the medicinal product is perfectly understandable, paying particular attention to those medicinal products whose correct administration is complex.
Informacije navajajo:
This information shall indicate:
(i) natančno doziranje za uporabo;
(i) the exact dosage to be taken;
(ii) način zdravljenja in instrumente, ki se za to uporabijo;
(ii) the way in which it is to be measured and the instruments to be used for this purpose;
(iii) časovni presledek med vsakim doziranjem;
(iii) the interval of time between each dose;
(iv) prilagoditev doziranja glede na posebno težo in starost uporabnika zdravila.
(iv) the adjustment of the dosage to the weight and age of the individual patient.
Člen 100d – odstavek 2 – točka (b)
Article 100d – paragraph 2 – point b
(b) izjavo, da je namen informacij podpreti, in ne nadomestiti, odnos med bolnikom in zdravstvenim delavcem ter da mora bolnik, če potrebuje pojasnilo o zagotovljenih informacijah, stopiti v stik z zdravstvenim delavcem;
(b) a statement indicating that the information is intended to support, not to replace, the relationship between patient and health professionals and that a health professional should be contacted if the patient requires clarification on the information provided;
(b) izjavo, da je namen informacij podpreti, in ne nadomestiti, odnos med bolnikom in zdravstvenim delavcem ter da mora bolnik, če potrebuje pojasnilo ali dodatne informacije o zagotovljenih informacijah, stopiti v stik z zdravstvenim delavcem;
(b) a statement indicating that the information is intended to support, not to replace, the relationship between patient and health professionals and that a health professional should be contacted if the patient requires clarification or further information on the information provided;
Člen 100d – odstavek 2 – točka (c)
Article 100d – paragraph 2 – point c
(c) izjavo, da informacije širi imetnik dovoljenja za promet, in ime imetnika dovoljenja ;
(c) a statement indicating that the information is disseminated by a marketing authorisation holder and naming the holder ;
Navedba je jasnejša in razumljivejša, saj ni nujno, da bi bil zapis „imetnik dovoljenja“ vsem razumljiv.
This information is clearer and more easily understood, since many readers may find the term 'marketing authorisation holder' confusing.
Člen 100d – odstavek 2 – točka (d)
Article 100d – paragraph 2 – point d
Člen 100d – odstavek 2 – točka (d a) (novo)
Article 100d – paragraph 2 – point d a (new)
(da) trenutno besedilo navodil za uporabo ali navodila za dostop do tega besedila.
(da) t he text of the current package leaflet or an indication as to where that text may be found.
Zahteve v zvezi s spletnimi stranmi sodijo bolj v ta odstavek kot med zahteve za spremljanje za države članice.
The requirement for Internet websites is better dealt with under this paragraph than as a monitoring requirement for Member States.
Člen 100d – odstavek 3 – točka (a)
Article 100d – paragraph 3 – point a
(a) primerjav med zdravili;
(a) comparisons between medicinal products;
(a) primerjav med zdravili, razen če so te primerjave del uradno odobrenih dokumentov, kot je povzetek značilnosti zdravil;
(a) comparisons between medicinal products , except where such comparisons are included in officially approved documents, such as the summary of product characteristics ;
Člen 100e – odstavek 1
Article 100e – paragraph 1
Države članice zagotovijo, da so na spletnih straneh imetnika dovoljenja za promet za širjenje informacij o zdravilih, za katere velja zdravniški recept, povzetek značilnosti zdravila in navodila za uporabo zadevnih zdravil v uradnih jezikih držav članic , kjer so odobrena.
Member States shall ensure that marketing authorisation holders' Internet websites for the dissemination of information on medicinal products subject to medical prescription reproduce the summary of product characteristics and the package leaflet of the medicinal products concerned in the official languages of the Member States where they are authorised.
Države članice zagotovijo, da so na spletnih straneh imetnika dovoljenja za promet za širjenje informacij o zdravilih, za katere velja zdravniški recept, povzetek značilnosti zdravila in navodila za uporabo zadevnih zdravil v uradnem jeziku države članice , kjer so odobrena in ki ji je spletna stran namenjena .
Member States shall ensure that marketing authorisation holders' Internet websites for the dissemination of information on medicinal products subject to medical prescription reproduce the summary of product characteristics and the package leaflet of the medicinal products concerned in the official language of the Member State where they are authorised and for which the website is intended.
Treba je pojasniti, da morajo biti povzetek značilnosti zdravila in navodila za uporabo zdravil, za katera velja zdravniški recept, le v uradnem jeziku države članice, kjer so informacije objavljene in ki ji je spletna stran namenjena.
It should be clarified that the summary of product characteristics and the package leaflet of a medicinal product subject to medical prescription should only be reproduced in the official language of the Member State where the information is published and where the website is intended for.
Če je stran na primer namenjena nemškemu trgu, morajo biti povzetek značilnosti zdravila in navodila za uporabo zdravil objavljena le v nemškem jeziku.
For example, if the website is intended for the German market the summary of product characteristics and the package leaflet need to be published in German language only.
Trenutno besedilo je v tem pogledu nejasno.
The current wording is unclear in this regard.
Člen 100e – odstavek 2 a (novo)
Article 100e – paragraph 2 a (new)
Nacionalni ali regionalni/lokalni organi, pristojni za zdravstveno upravljanje, morajo vzpostaviti posamezniku prilagojeno telefonsko storitev, ki jo bodo nudili zdravstveni delavci in bo omogočala posvetovanje o razlagi informacij v prospektu, združljivosti z drugimi zdravili ali z zdravstvenim stanjem pacienta.
The state or regional/local authorities responsible for health administration shall set up a telephone helpline providing individual advice to patients, staffed by healthcare professionals, that may be consulted on the interpretation of the information contained in the leaflet, and on compatibility with other medicinal products or with the patient's case history.
Vzpostavi se usklajen postopek za določitev podlage, na kateri se regulirajo informacije, ki so na voljo na spletnih straneh in informacijskih točkah, da se zagotovita zanesljivost podatkov in njihova skladnost z dovoljenjem in registracijo zdravila, s čimer se potrošniku jamči, da sta spletna stran in zadevna informacija točni in temeljita na dejstvih.
A harmonised procedure shall be established to determine the bases on which information provided on Internet websites and information points is regulated, in such a way as to guarantee the reliability of the data presented and its compliance with the authorisation and registration of the medicinal product, providing a guarantee for consumers that the site or information concerned is accurate and based on facts.
Seznam se posodablja in je potrošnikom na voljo.
That list shall be kept up-to-date and shall be accessible to consumers.
Člen 100g – odstavek 2
Article 100g – paragraph 2
Po posvetovanju z državami članicami in drugimi zainteresiranimi stranmi Komisija pripravi smernice, ki zadevajo informacije, dovoljene na podlagi tega naslova, in vključujejo 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 code of conduct for marketing authorisation holders providing information to the general public or members thereof on authorised medicinal products subject to medical prescription.
Pri pripravi kodeksa in smernic bi se bilo treba posvetovati z drugimi zainteresiranimi stranmi, kot so bolniki, zdravstveni delavci in industrija.
Other stakeholders such as patients, healthcare professionals and the industry should be consulted in drawing up the code and guidelines.