natgillin/translations-raw huggingface dataset:
širšo javnost ali njene člane, izpolnjujeta naslednje pogoje:
or the general public or members thereof shall fulfil the following conditions:
morata biti objektivni in nepristranski; če se pri tem informacije sklicujejo na koristi zdravila, je treba navesti tudi njegova tveganja;
it must be objective and unbiased, and, in this regard, if the information refers to the benefits of a medicinal product, its risks shall also be stated;
biti usmerjena k bolniku, da bolje izpolnjujeta njihove potrebe
be patient oriented to better meet patients“
morata temeljiti na dokazih, biti preverljivi in vključevati izjavo o zanesljivosti dokazov;
it must be based on evidence, be verifiable and include a statement on the level of evidence;
morata biti posodobljeni in vsebovati datum objave ali zadnji pregled informacij;
it must be up to date and include the date of publication or last revision of the information;
morata biti zanesljivi, vsebovati točne podatke in ne biti zavajajoči;
it must be reliable, factually correct and not misleading;
morata biti razumljivi
it must be understandable
in jasno čitljivi
and perfectly legible
splošno javnost
the general public
njene člane
members thereof
s posebnim upoštevanjem starejših ljudi
, paying particular attention to elderly people
morata jasno navajati vir informacij z navedbo njegovega avtorja ter se sklicevati na vsak dokument, na katerem temeljijo informacije;
it must clearly state the source of the information indicating its author and giving references to any documentation that the information is based on;
ne smeta nasprotovati povzetku značilnosti zdravila, ovojnini in
it must not contradict the summary of product characteristics, labelling and
, kakor so jih odobrili pristojni organi.
of the medicinal product, as approved by the competent authorities.
Evropskemu parlamentu in Svetu predloži poročilo o oceni trenutnih pomanjkljivostih v povzetku glavnih značilnosti proizvoda in navodil bolnikom za uporabo ter predloge za njihovo izboljšanje, da bi bolje zadovoljili potrebe bolnikov in zdravstvenih delavcev.
, the Commission shall present to the European Parliament and the Council an assessment report on current shortcomings in the summary of product characteristics and the patient package leaflet and how they could be improved in order to better meet the needs of patients and healthcare professionals.
Komisija, če je to primerno, na temelju poročila in posvetovanja z ustreznimi udeleženci, pripravi predloge za izboljšanje berljivosti, predstavitve in vsebine teh dokumentov.
The Commission shall, if appropriate, and on the basis of the report, and after consultation with appropriate stakeholders, present proposals in order to improve the readability, layout and content of these documents.
Vse informacije vključujejo:
Any information shall include:
izjavo, da je zadevno zdravilo na voljo samo na recept in da so navodila navedena v
a statement that the medicinal product concerned is available on prescription only and that instructions for use appear on the
ali na zunanji ovojnini, kakor je ustrezno;
or on the outer packaging, as the case may be;
izjavo, da je namen informacij podpreti, in ne nadomestiti, odnos med bolnikom in zdravstvenim delavcem ter da mora bolnik, če potrebuje pojasnilo
a statement indicating that the information is intended to support, not to replace, the relationship between patient and healthcare professionals and that a healthcare professional should be contacted if the patient requires clarification
ali dodatne informacije
or further information
o zagotovljenih informacijah, stopiti v stik z zdravstvenim delavcem;
on the information provided;
izjavo, da informacije
a statement indicating that the information is
da na voljo poimensko naveden
made available
ali so dane na voljo v njegovem imenu
, or on behalf of,
bolniki in
patients and
člani širše javnosti sporočajo pripombe
members of the general public to send comments to
ali zahtevke za dodatne informacije
, or requests for further information from,
imetniku dovoljenja za promet.
the marketing authorisation holder.
Posredovane pripombe posameznikov in odgovore imetnikov dovoljenja za promet je treba primerno evidentirati in spremljati;
Comments sent by private individuals and the replies from marketing authorisation holders shall be duly recorded and monitored;
poštni ali elektronski naslov, na katerega lahko bolniki in člani širše javnosti sporočajo pripombe pristojnim nacionalnim organom;
a postal address or e-mail address allowing patients and members of the general public to send comments to the national competent authorities;
trenutno besedilo navodil bolnikom za uporabo ali navodila za dostop do tega besedila.
the text of the current patient package leaflet or an indication as to where that text may be found.
V primeru spletnih mest, ki so pod nadzorom imetnikov dovoljenja za promet in so namenjene izrecno državljanom ene ali več držav članic, vsebujejo povzetek značilnosti zadevnega zdravila in navodila bolnikom za uporabo v uradnih jezikih držav članic, kjer imajo dovoljenje, če so informacije o zdravilu na voljo v teh jezikih;
In the case of internet websites under the control of marketing authorisation holders that are directed specifically at citizens of one or more Member States, they shall contain the summary of product characteristics and the patient package leaflet of the medicinal products concerned in the official languages of the Member States where they are authorised if the information on medicinal products is available in those languages;
izjavo, v kateri se bolnike in člane širše javnosti poziva, naj vse domnevne neželene učinke zdravil sporočijo svojemu zdravniku, lekarnarju, zdravstvenemu delavcu ali nacionalnemu pristojnemu organu, ter v kateri so navedeni ime, spletni naslov, poštni naslov in/ali telefonska številka nacionalnega pristojnega organa
a statement indicating that patients and members of the general public are encouraged to report all suspected adverse reactions of medicinal products to their doctor, pharmacist, healthcare professional, or to the national competent authority, and indicating the name and web-address, postal address and/or telephone number of that national competent authority
Informacije ne vsebujejo:
The information shall not include:
primerjav med zdravili
comparisons between medicinal products
glede njihove kakovosti, varnosti in učinkovitosti, če jih daje na voljo imetnik dovoljenja za promet, razen če:
regarding their quality, safety and efficiency, if the information is made available by marketing authorisation holders except where those comparisons are:
primerjave temeljijo na primerjalnih znanstvenih študijah, ki jih objavijo ustrezni nacionalni organi ali Agencija;
based on comparative scientific studies published by the relevant national authorities or the Agency;
so primerjave iz povzetka evropskih javnih poročil o oceni zdravila iz člena 13 Uredbe (ES) št. 726/2004, ki navaja tudi druge možnosti zdravljenja in informacijo, ali ima novo zdravilo zdravilne prednosti;
contained in the summary of the European Public Assessment Reports referred to in Article 13 of Regulation (EC) No 726/2004, which will list the other available therapeutic options and whether the new medicinal product brings about a therapeutic value;
kakršnega koli napeljevanja k uporabi zdravila ali njenega spodbujanja;
any inducement to, or promotion of, the consumption of the medicinal product;
kakršnega koli gradiva iz člena 90
any of the material referred to in Article 90
informacij o drugih zdravilih, za katera farmacevtska družba ni imetnik dovoljenja za promet
information on other medicinal products for which the pharmaceutical company is not the marketing authorisation holder
Da se zagotovi, da so bolnikom, širši javnosti ali njenim članom na voljo kakovostne informacije,
In order to ensure the quality of information made available to patients or the general public or members thereof,
prek delegiranih aktov v skladu s členom 100m in pogoji iz členov 100n in 100o
, by means of delegated acts in accordance with Article 100n, and subject to the conditions of Articles 100n and 100o,
sprejme potrebne ukrepe za
the measures necessary for the
odstavkov 1, 2, 3 in 4.
of paragraphs 1, 2, 3 and 4.
Člen 100e
Article 100e
objavljena zadnja posodobljena različica povzetka
last updated version as approved by the competent authorities
na recept, ki so ju odobrili pristojni organi in ki se tržijo
subject to medical prescription that they market
v uradnih jezikih držav članic, kjer so odobrena.
in the official languages of the Member States in which they are authorised.
Države članice zagotovijo, da vsaka spletna stran spletnega mesta imetnika dovoljenja za promet, ki se nanaša na zdravila na recept, vsebuje povezavo na ustrezno spletno stran baze podatkov Unije (v nadaljevanju: baza podatkov EudraPharm) iz členov 57(1)(l) in 57(2) Uredbe (ES) št. 726/2004 in na nacionalni spletni portal o zdravilih iz člena 106 te direktive ali evropski spletni portal o zdravilih iz člena 26 Uredbe (ES) št. 726/2004.
Member States shall ensure that each webpage from a marketing authorisation holder's website referring to a medicinal product subject to medical prescription includes a link to the corresponding webpage of the Union database (hereinafter the “EudraPharm database”) referred to in Articles 57(1)(l) and 57(2) of Regulation (EC) No 726/2004, and the national medicines web-portals referred to in Article 106 of this Directive or the European medicines web-portal referred to in Article 26 of Regulation (EC) No 726/2004.
Povzetkom evropskih javnih poročil o oceni zdravila iz člena 13 Uredbe (ES) št. 726/2004 se dodajo spletne povezave na ustrezne študije iz evropske zbirke podatkov o kliničnih poskusih (v nadaljevanju: zbirka podatkov EudraCT) iz člena 11 Direktive 2001/20/ES .
The summary of the European Public Assessment Reports referred to in Article 13 of Regulation (EC) No 726/2004 shall be hyperlinked with the corresponding studies in the European database on information about clinical trials (the “EudraCT database”) provided for in Article 11 of Directive 2001/20/EC.
Države članice zagotovijo, da se lahko zahtevek za informacije o zdravilu na recept, ki ga
Member States shall ensure that requests for information to a marketing authorisation holder on a medicinal product subject to medical prescription by
bolnik ali
a patient or
član širše javnosti predloži imetniku dovoljenja za promet, sestavi v katerem koli od uradnih jezikov Unije, ki so uradni jeziki v državah članicah, v katerih je zdravilo odobreno.
a member of the general public may be drafted in any of the official languages of the Union which are official languages in the Member States in which the medicinal product is authorised.
Odgovori so pristojnim nacionalnim organom na voljo za pregled.
The replies shall be kept available for inspection by national competent authorities.
Člen 100f
Article 100f
Države članice brez ustvarjanja nesorazmernega bremena za imetnike dovoljenja za promet zagotovijo, da so informacije imetnikov dovoljenja za promet, zagotovljene v skladu s tem naslovom, dostopne invalidnim osebam.
Member States shall, without creating a disproportionate burden for the marketing authorisation holder, ensure that marketing authorisation holders make information provided in accordance with this Title accessible to persons with disabilities.
Za zagotavljanje dostopnosti informacij o zdravilu, ki jih zagotovijo imetniki dovoljenja za promet prek spleta, so zadevne spletne strani v skladu s smernicami ravni A verzije 1.0 za dostopnost do spletnih strani Konzorcija za svetovni splet (W3C).
To ensure accessibility of information on a medicinal product provided by marketing authorisation holders through the internet, the websites concerned shall conform to the World Wide Web Consortium's (W3C) Web Content Accessibility Guidelines version 1.0, Level A. The Commission shall make those guidelines publicly available.
Komisija navedene smernice javno objavi.
In order to take account of technical progress,
Komisija lahko
the Commission may
zaradi upoštevanja tehničnega napredka na podlagi delegiranih aktov v skladu s členom 100m in ob upoštevanju pogojev iz členov 100n in 100o sprejme potrebne ukrepe za uporabo tega odstavka
adopt, by means of delegated acts in accordance with Article 100m, and subject to the conditions of Articles 100n and 100o, measures necessary for the application of this paragraph
Člen 100g
Article 100g
Države članice zagotovijo ▌preprečitev zlorab
Member States shall ensure that ▌misuse ▌is
tako, da omogočijo, da samo
avoided by ensuring that only
imetnik dovoljenja za promet
the marketing authorisation holder
Države članice lahko z odstopanjem še naprej uporabljajo tiste vrste nadzornih mehanizmov, ki so jih izvajale pred 31. decembrom 2008, ne da bi izključile njihovo okrepitev.
By way of derogation, Member States may continue those types of control mechanism which they implemented before 31 December 2008 not excluding enhancements to such control mechanisms.
Komisija takšne mehanizme in njihovo okrepitev preveri in odobri, ob upoštevanju nasvetov pristojnih organov.
The Commission shall verify and approve such mechanisms and their enhancements, taking advice from the competent authorities.
temeljijo na nadzoru informacij pred njihovim
shall be based on the control of information prior to its
so pristojni organi že odobrili vsebino informacij; ali
the content of the information has already been approved by the competent authorities; or
se z različnimi mehanizmi zagotavlja enaka raven ustreznega in učinkovitega spremljanja.
an equivalent level of adequate and effective monitoring is ensured through a different mechanism.
Po posvetovanju z državami članicami
After consulting the Member States
in vsemi zadevnimi zainteresiranimi stranmi, kot so organizacije bolnikov in zdravstvenih delavcev,
and all relevant stakeholders, such as patient organisations and healthcare professionals
Komisija pripravi smernice, ki zadevajo informacije, dovoljene na podlagi tega naslova, in vključujejo kodeks ravnanja za imetnike dovoljenja za promet, ki
, 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
bolnikom in
patients and
širši javnosti ali njenim članom zagotavljajo informacije o odobrenih zdravilih na recept.
the general public or members thereof on authorised medicinal products subject to medical prescription.
Smernice vsebujejo določbe, ki zagotavljajo, da lahko bolniki in člani javnosti pri pristojnih organih vložijo pritožbo v zvezi z zavajajočo prakso pri dajanju informacij na voljo.
The guidelines shall contain provisions to ensure that patients and members of the public may lodge complaints with competent authorities regarding misleading practices in the making available of information.
Komisija pripravi te smernice do ... * Začetek veljavnosti te direktive.
The Commission shall draw up these guidelines by ... * The entry into force of this Directive.
in jih redno posodablja na podlagi pridobljenih izkušenj.
and update them regularly on the basis of the experience gained.
Člen 100h
Article 100h
Države članice zagotovijo, da imetniki dovoljenja za promet registrirajo spletna mesta
Member States shall ensure that marketing authorisation holders register internet websites
, preden jih dajo na voljo
, prior to making it available to
bolnikom ali
patients or
širši javnosti.
the general public.
Informacije so 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.
Po registraciji spletnega mesta lahko imetnik dovoljenja za promet informacije o zdravilu z navedenega spletnega mesta objavi na drugih spletnih mestih
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
, ki jih imetnik dovoljenja za promet v skladu z določbami prvega pododstavka prijavi
registered by the marketing authorisation holder in accordance with the provisions of the first subparagraph
po vsej Uniji, če je vsebina enaka.
throughout the Union if the contents are identical.
Po registraciji spletnega mesta se predlogi sprememb vsebine v zvezi z zdravilom na recept nadzirajo v skladu z odstavkom 4.
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 4.
Vsaka država članica sestavi in posodobi seznam registriranih spletnih mest.
Each Member State shall draw up and update a list of registered internet websites.
Ti seznami se dajo na voljo potrošnikom.
Those lists shall be made available to consumers.
Spletna mesta, registrirana v skladu z odstavkom 1, ne vsebujejo povezav na druga spletna mesta imetnika dovoljenja za promet, razen če so bila tudi ta registrirana v skladu z navedenim odstavkom.
Internet websites registered in accordance with paragraph 1 shall not contain links to other marketing authorisation holder websites unless they have also been registered in accordance with that paragraph.
Spletna mesta, registrirana v skladu z odstavkom 1, ne omogočajo identifikacije
Internet websites registered in accordance with paragraph 1 shall not allow the identification of
bolnikov ali
patients or
članov javnosti, ki imajo dostop do navedenih spletnih mest
members of the general public which have access to those websites
brez izrecnega predhodnega dovoljenja
without their explicit prior consent,
, ali pojava
or the appearance therein of unsolicited
na teh spletnih mestih, ki se aktivno razpošilja
distributed to
širši javnosti ali njenim članom.
the general public or members thereof.
Registrirana spletna mesta imajo obvestilo na vrhu vsake spletne strani, s katerim se bolnike in širšo javnost obvešča, da informacije na teh straneh pripravlja imenovani imetnik dovoljenja za promet.
Registered websites shall display a notification at the top of each webpage informing patients and the general public that the information contained therein is developed by a named marketing authorisation holder.
Država članica, v kateri je bilo registrirano spletno mesto, je odgovorna za spremljanje vsebine
The Member State in which the internet website has been registered shall be responsible for the monitoring of the contents
v zvezi z zdravili na recept, ki je na voljo
relating to medicinal products subject to medical prescription made available
na navedenem spletnem mestu.
on that website.
Država članica ne sprejme nobenega ukrepa v zvezi z vsebino spletnega mesta, ki prikazuje spletno mesto, registrirano pri pristojnih nacionalnih organih druge države članice, razen v naslednjih primerih:
A Member State shall not adopt any measure with regard to the content of an internet website which reproduces an internet website registered with the national competent authorities of another Member State, except on the following grounds:
na spletnem mestu, ki je registrirano pri pristojnih nacionalnih organih druge države članice.
on the internet website registered with the national competent authority of another Member State.
so jih odobrili pristojni organi in so na voljo
made available
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.
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.
Če ne dosežejo dogovora v dveh mesecih, zadevo predajo farmacevtskemu odboru iz člena 84.
If they fail to reach an agreement within two months, the case shall be referred to the Pharmaceutical Committee referred to in Article 84.
, da na
message at
spletnega mesta vključijo
information contained therein is developed by
in se
and is
, da se na njem ne bi oglaševala zdravila na recept
order to avoid advertising of prescription-only medicinal products
navaja nacionalni pristojni organ, ki spremlja zadevno spletno mesto
identify the national competent authority monitoring the website concerned
, ter imetnika dovoljenja za promet, ki je odgovoren za spletno mesto
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
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
, in vključuje povezavo na bazo podatkov EudraPharm s pojasnilom, da so v njej na voljo potrjene informacije
and shall include a link to the EudraPharm database specifying that validated information is available there
Komisija z delegiranimi akti v skladu s členom 100m in pod pogoji iz členov 100n in 100o določi podrobna pravila in pogoje za registracijo in spremljanje spletnih mest, o katerih govori ta naslov, in informacij, objavljenih na njih, da bi zagotovila zanesljivost tam predstavljenih podatkov in njihovo skladnost z dovoljenjem in registracijo zadevnega zdravila, s čimer se potrošnikom zagotovi jamstvo, da so zadevno spletno mesto oziroma informacije točni in temeljijo na dejstvih.
The Commission shall establish, by means of delegated acts in accordance with Article 100m and subject to the conditions of Articles 100n and 100o, the detailed rules and conditions for registration and monitoring of internet websites referred to in this Title and of information provided therein, with a view to guaranteeing the reliability of the data presented and their compliance with the authorisation and registration of the medicinal products concerned so as to provide a guarantee for consumers that the website or information concerned is accurate and based on facts.
Ta pravila in pogoji vključujejo merila certificiranja ali kvalifikacije, ki se uporabljajo za registrirana spletna mesta.
Those rules and conditions shall include certification or qualification criteria to be applied with respect to registered websites.
Člen 100i
Article 100i
Države članice sprejmejo ustrezne ukrepe za zagotovitev, da se določbe tega naslova izvajajo ter da se sprejmejo ustrezni in učinkoviti ukrepi za kaznovanje neskladnosti z navedenimi določbami.
Member States shall take appropriate measures to ensure that the provisions of this Title are applied and that adequate and effective measures are adopted to sanction non-compliance with those provisions.
Ti ukrepi vključujejo:
Such measures shall include the following:
določitev kazni, ki se uvedejo za kršitev določb, sprejetih za izvajanje tega naslova.
the determination of the penalties which are to be imposed should the provisions adopted for the implementation of this Title be infringed;
Te kazni so učinkovite, sorazmerne in odvračilne;
those penalties shall be effective, proportionate and dissuasive;
obveznost kaznovanja primerov neskladnosti;
the obligation to sanction cases of non-compliance;
dajanje pooblastil sodiščem ali upravnim organom, ki jim omogočajo odreditev prenehanja
the conferment of powers on the courts or administrative authorities enabling them to order the cessation of
dajanja na voljo
the making available
informacij, ki niso v skladu s tem naslovom, ali, če se takšne informacije še niso
of information that does not comply with this Title or, if such information has not been
dale na voljo
made available
, vendar so tik pred
but will be imminently, to prohibit the
dajanjem na voljo
making available
Države članice zagotovijo možnost, da se objavi ime imetnika dovoljenja za promet, odgovornega za dajanje na voljo neustreznih informacij o zdravilu.
Member States shall provide for the possibility to publish the name of a marketing authorisation holder responsible for making available non-compliant information on a medicinal product.