natgillin/translations-raw huggingface dataset:
samo kakovostne informacije, in za razlikovanje med nepromocijskimi informacijami in oglaševanjem, bi bilo treba opredeliti vrste informacij, ki se
only high-quality information and to distinguish non-promotional information from advertising, the types of information that
dajo na voljo
are made available
Imetnik dovoljenja za promet bi moral zagotoviti odobrene in najnovejše različice vsebine povzetkov značilnosti zdravil, ovojnino in navodila bolnikom za uporabo ter javno dostopno različico poročila o oceni.
Marketing authorisation holders should make available the approved and most recent contents of summaries of product characteristics, labelling and patient package leaflet and the publicly accessible version of the assessment report.
Zato je treba imetnikom dovoljenja za promet omogočiti, da
It is appropriate to allow marketing authorisation holders to
dajo na voljo
make available
druge natančno opredeljene informacije, povezane z zdravili.
other well-defined medicinal product-related information.
Pristojni organi bi morali med postopkom izdaje dovoljenja za promet odobriti povzetek značilnosti zdravil, ovojnino in navodila bolnikom za uporabo ter javno dostopno različico poročila o oceni ali katero koli posodobljeno različico teh dokumentov.
Approval should be required by the competent authorities, during the course of marketing authorisation, for the summary of product characteristics, labelling and patient package leaflet, and the publicly accessible version of the assessment report or any updated versions of these documents.
Zato ni bi smela biti potrebna dodatna odobritev pred objavo teh informacij v skladu s to direktivo.
This information should therefore not be subject to further approval prior to its being made available pursuant to this Directive.
Informacije za
Information to
širšo javnost o zdravilih na recept bi bilo treba zagotoviti samo prek posebnih kanalov komuniciranja, vključno s spletom ▌, da se učinkovitost prepovedi oglaševanja nezaželenih informacij za
the general public on prescription-only medicinal products should be provided only through specific channels of communication, including internet ▌, to avoid the effectiveness of the prohibition on advertising being undermined by unsolicited provision of information to
širšo javnost ne bi zmanjšala.
the general public.
Kadar se informacije
Where information is
prek televizije
via television
časopisov, revij ali podobnih publikacij,
newspapers, magazines and similar publications,
bolniki pred takšnimi nezaželenimi informacijami niso zaščiteni, zato bi bilo treba takšno
patients are not protected against such unsolicited information and
dajanje na voljo
the making available of
Splet je zelo pomemben z vidika zagotavljanja informacij bolnikom, njegov pomen pa še narašča.
The internet is of major importance with regard to the provision of information to patients and its importance is increasing.
Splet omogoča skoraj neomejen dostop do informacij ne glede na nacionalne meje.
The internet allows almost unlimited access to information disregarding national boundaries.
Treba bi bilo oblikovati posebne predpise o spremljanju spletnih mest, da se upošteva čezmejna narava informacij, ki se zagotavljajo prek spleta, in omogoči sodelovanje med državami članicami.
Specific rules on the monitoring of websites should be established to take account of the cross-border nature of information provided over the internet and to allow cooperation between the Member States.
S spremljanjem informacij o
Monitoring of information on
zdravilih na recept
prescription-only medicinal products
v skladu s to direktivo
under this Directive
bi bilo treba zagotoviti, da imetniki dovoljenja za promet
should ensure that marketing authorisation holders
dajejo na voljo
make available
zgolj informacije, ki so v skladu z Direktivo 2001/83/ES.
only information which is in compliance with Directive 2001/83/EC.
Države članice bi morale sprejeti pravila za vzpostavitev učinkovitih mehanizmov spremljanja in zagotavljanje učinkovitega izvrševanja v primeru neskladnosti.
Member States should adopt rules establishing effective monitoring mechanisms and allowing effective enforcement in cases of non-compliance.
Te predpise bi bilo treba uskladiti na ravni Unije, da bi zagotovili doslednost.
These rules should be harmonised at Union level so as to ensure consistency.
V primeru neskladnosti bi bilo treba vzpostaviti postopke, v okviru katerih so lahko pri obravnavi vsakega primera imetniki dovoljenja za promet zastopani in lahko izrazijo svoja stališča.
In cases of non-compliance, procedures should be put in place for marketing authorisation holders to be represented and heard in the course of the consideration of their case.
Spremljanje bi moralo temeljiti na nadzoru informacij pred njihovim
Monitoring should be based on the control of information prior to its
dajanjem na voljo
being made available
Ker ta direktiva prvič uvaja usklajene predpise o
As this Directive introduces for the first time harmonised rules on the
dajanju na voljo
making available
informacij za
of information on medicinal products subject to medical prescription to
širšo javnost o zdravilih na recept, bi morala Komisija oceniti njeno delovanje in potrebo po pregledu pet let po začetku njene veljavnosti.
the general public, the Commission should assess its operation and the necessity for a review five years after its entry into force.
Uvesti bi bilo treba tudi določbo, v skladu s katero Komisija
Provision should also be made for the drawing up of guidelines by the Commission based on Member States' experience
v sodelovanju z vsemi zadevnimi zainteresiranimi stranmi, kot so organizacije bolnikov in zdravstvenih delavcev,
, in cooperation with all relevant stakeholders, such as patient organisations and healthcare professionals,
pripravi smernice na podlagi izkušenj držav članic pri spremljanju informacij.
in the monitoring of information.
Komisija bi se morala o vprašanjih, povezanih z izvajanjem te direktive, in o tem, kako jo izvajajo države članice, posvetovati z vsemi zadevnimi zainteresiranimi stranmi, kot so neodvisne organizacije bolnikov, zdravstvene organizacije in organizacije potrošnikov ter zdravstvenih delavcev.
The Commission should consult all relevant stakeholders, such as independent patient, health and consumer organisations and healthcare professionals, on issues relating to the implementation of this Directive and its application by the Member States.
Komisijo bi bilo treba pooblastiti, da v skladu s členom 290 Pogodbe o delovanju Evropske unije sprejme delegirane akte v zvezi s Prilogo k tej direktivi v zvezi s kakovostnimi merili informacij za bolnike in širšo javnost in smernicami za spletno dostopnost.
The Commission should be empowered to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union in respect of the quality criteria of information made available to patients and the general public and web accessibility guidelines.
Ker cilja te direktive, zlasti uskladitve predpisov o informacijah o zdravilih na recept po vsej Uniji, države članice ne morejo zadovoljivo doseči in ker se ta cilj lahko bolje doseže na ravni Unije, lahko Unija sprejme ukrepe v skladu z načelom subsidiarnosti iz člena 5 Pogodbe o Evropski uniji.
Since the objective of this Directive, namely to harmonise the rules on information on medicinal products subject to prescription across the Union, cannot be sufficiently achieved by the Member States and can therefore be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union.
V skladu z načelom sorazmernosti iz navedenega člena ta direktiva ne presega tistega, kar je potrebno za doseganje navedenega cilja.
In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective.
Direktivo 2001/83/ES bi bilo treba ustrezno spremeniti –
Directive 2001/83/EC should be amended accordingly,
V členu 1 se točka 26 nadomesti z naslednjim:
In Article 1, point 26 is replaced by the following:
Navodila bolnikom za uporabo: Zdravilu priložen listič s podatki, ki so namenjeni bolniku in ki ustrezajo dejanskim potrebam bolnikov.
Patient package leaflet: A leaflet containing information for the patient which accompanies the medicinal product and which corresponds to patients' real needs.
V členu 59 se doda naslednji odstavek:
In Article 59, the following paragraph is added:
Navodila bolnikom za uporabo ustrezajo dejanskim potrebam bolnikov.
The patient package leaflet shall correspond to patients' real needs.
V ta namen bi morale organizacije bolnikov sodelovati pri razvoju in pregledovanju informacij o zdravilih, ki ga izvajajo nacionalni regulativni organi in Agencija.
To this end, patient organisations should be involved in developing and reviewing the information on medicinal products by national regulatory authorities and the Agency.
Navodila bolnikom za uporabo vsebujejo kratek odstavek, v katerem so navedene koristi in možni škodljivi učinki zdravila, pa tudi opis dodatnih informacij za varno in učinkovito uporabo zdravila.
The patient package leaflet shall include a short paragraph which sets out the benefits and potential harm of a medicinal product as well as a short description of further information aiming at safe and effective use of a medicinal product.
V členu 86 se odstavek 2 nadomesti z naslednjim: 2.
In Article 86, paragraph 2 is replaced by the following: 2.
Naslov ne vključuje:
The following are not covered by this Title:
, v katerem se vedno navede vsaj mednarodno nelastniško ime,
, which shall always at least specify the International Non-proprietary Name,
in priloženega
and the accompanying
navodila bolnikom za uporabo
patient package leaflets
, kar urejajo določbe naslova V,
, which are subject to the provisions of Title V;
dopisovanja, po možnosti s priloženimi gradivi, ki niso promocijske narave in so potrebna kot odgovor na specifična vprašanja o določenem zdravilu,
correspondence, possibly accompanied by material of a non-promotional nature, needed to answer a specific question about a particular medicinal product;
informativnih objav o dejstvih
factual, informative announcements
ter referenčnega gradiva
and reference material
o zdravilu
on a medicinal product,
, na primer v zvezi
relating, for example, to its
spremembami na ovojnini, opozorili o neželenih učinkih kot delu splošnih previdnostnih ukrepov, prodajnimi katalogi in ceniki
packaging changes, adverse-reaction warnings as part of general drug precautions, trade catalogues, price lists,
, povrnitvijo stroškov, informacijami o okoljevarstvenih tveganjih zdravila in o odlaganju neuporabljenih zdravil ali iz njih nastalih odpadnih snovi ter napotki v zvezi z uveljavljenim sistemom zbiranja teh snovi
reimbursement and information on the environmental risk of the medicinal product and information relating to the disposal of unused medicinal products or waste derived from medicinal products as well as reference to any collection system in place,
takšne objave in referenčno gradivo
that such announcements and reference material
ne vključujejo
include no
navedb o lastnostih zdravila
product claims
ter ne napeljujejo ali spodbujajo k jemanju zdravila
and that they do not encourage or promote the consumption of the medicinal product
informacij v zvezi z zdravjem ljudi ali boleznimi pod pogojem, da ni nobenega napotila, tudi posrednega ne, na
information relating to human health or diseases, provided that there is no reference, even indirectly, to
informativnih objav o dejstvih za vlagatelje in zaposlene o pomembnih spremembah v poslovnem razvoju pod pogojem, da ne promovirajo zdravila bolnikom ali širši javnosti
factual, informative announcements for investors and employees on significant business developments, provided they are not used to promote the medicinal product to patients or the general public
Kadar so odobrene izjeme od prepovedi oglaševanja iz odstavka 2, se opredeli imetnik dovoljenja za promet z zdravilom in vsaka tretja stran ter vsaka tretja stran, ki deluje v imenu imetnika dovoljenja za promet z zdravilom.
When exemptions to advertising referred to in paragraph 2 are granted, the marketing authorisation holder and any third party shall be identified, and any third party acting on behalf of the marketing authorisation holder shall be identified as such.
Takšne kampanje odobrijo pristojni organi držav članic samo, če se zagotovi, da industrija v okviru kampanje posreduje objektivne, nepristranske informacije o vzrokih bolezni, učinkovitosti cepiva, neželenih učinkih in kontraindikacijah za cepljenje.
Such campaigns shall be approved by the competent authorities of the Member States only if it is ensured that objective, non-biased information is provided in the frame of the campaign by the industry on the causes of the disease, the efficacy of the vaccine, the adverse reactions and contra-indications of the vaccination.
Naslov „NASLOV VIIIa Obveščanje in oglaševanje“ se črta.
The heading ‘TITLE VIIIa Information and advertising’ is deleted;
Črta se člen 88a.
Article 88a is deleted;
V členu 94 se odstavek 1 se nadomesti z naslednjim:
In Article 94, paragraph 1 is replaced by the following:
Pri neposrednih ali posrednih promocijah zdravil s strani imetnika dovoljenja za promet ali tretje strani, ki deluje v njegovem imenu ali po njegovih navodilih se ne sme dajati, ponujati ali obljubljati daril, denarnih ugodnosti ali nuditi materialne koristi osebam, usposobljenim za predpisovanje ali izdajanje zdravil.
Where medicinal products are being promoted directly or indirectly by a marketing authorisation holder or a third party acting on its behalf or following its instructions to persons qualified to prescribe or supply them, no gifts, pecuniary advantages or benefits in kind may be supplied, offered or promised to such persons.
Za členom 100 se vstavi naslednji naslov:
The following Title is inserted after Article 100:
Naslov VIIIa – informacije za
Title VIIIa – Information to
širšo javnost o zdravilih na recept
the general public on medicinal products subject to medical prescription
Člen 100a
Article 100a
Ne glede na pomembno vlogo, ki jo imajo pristojni nacionalni organi in zdravstveni delavci pri boljšem obveščanju bolnikov in širše javnosti o odobrenih zdravilih na recept, lahko države
Without prejudice to the importance of the role that national competent authorities and healthcare professionals play in better informing patients and the general public on authorised medicinal products subject to medical prescription,
dovoljenja za promet
the marketing authorisation holder to
neposredno ali posredno prek tretje stranke,
, either directly or indirectly through a third party
širši javnosti ali njenim članom o odobrenih zdravilih na recept pod pogojem, da so
the general public or members thereof on authorised medicinal products subject to medical prescription provided that
informacije in način njihovega dajanja na voljo skladni
such information and the manner in which it is made available
z določbami tega naslova.
is in accordance with the provisions of this Title.
Takšne informacije se ne obravnavajo kot oglaševanje za namene uporabe naslova VIII.
Such information shall not be considered as advertising for the purposes of the application of Title VIII.
Ko so takšne informacije dane na voljo, se opredelijo imetnik dovoljenja za promet in tretje stranke, pa tudi vsaka tretja stranka, ki deluje v imenu imetnika dovoljenja za promet, se kot takšna jasno opredeli.
When such information is made available, the marketing authorisation holder and any third party shall be identified, and any third party acting on behalf of the marketing authorisation holder shall be clearly indentified as such.
Zdravstveni delavci, ki dajejo na voljo informacije o zdravilih ali medicinskih napravah na javni prireditvi, v tisku ali radiu in televiziji, javno razglasijo svoje interese, na primer vse finančne vezi z imetniki dovoljenja za promet ali s tretjimi strankami, ki delujejo v njihovem imenu.
Healthcare professionals who make available information on medicinal products or medical devices during a public event, in print or broadcast media shall declare publicly their interests, for example any financial ties with marketing authorisation holders or with third parties acting on their behalf.
To zajema tudi dajanje na voljo informacij o zdravilih ali medicinskih napravah med opravljanjem svetovalnih storitev in tehničnega svetovanja.
This also covers the making available of information on medicinal products or medicinal devices in the course of consulting services and technical advice.
Organizirati bi bilo treba informacijske kampanje za večjo ozaveščenost bolnikov, širše javnosti in njenih članov o tveganju ponarejenih zdravil.
Information campaigns aimed at raising awareness among patients and the general public and members thereof about the risks of falsified medicinal products should be organised.
informativnih objav o dejstvih (vključno z objavami ali izjavami, ki so na primer pripravljene za medijske organizacije kot odgovor na neposredno poizvedovanje ali so delničarjem in/ali zakonodajalcem dane na voljo na konferencah, v pisnih izjavah in objavah ali poročilih) ter referenčnega gradiva za zdravila, na primer sprememb na ovojnini, opozoril o neželenih učinkih kot dela splošnih previdnostnih ukrepov, prodajnih katalogov, cenikov in povrnitve stroškov pod pogojem, da njihov namen ni oglaševanje določenega zdravila
factual, informative announcements (including announcements or statements made to media organisations either in response to a direct enquiry or by making them available at conferences or by written releases and announcements or reports to shareholders and/or regulators) and reference material on a medicinal product relating, for example, to packaging changes, adverse-reaction warnings as part of general drug precautions, trade catalogues, price lists and reimbursement, provided that they do not intend to promote an individual medicinal product
gradiva, ki ga
material provided
Določbe te direktive ne posegajo v pravico oseb ali organizacij, zlasti medijev, bolnikov ali organizacij bolnikov, da izrazijo svoje stališče o zdravilih, ki se izdajajo samo na recept, pod pogojem, da delujejo neodvisno, ne pa neposredno ali posredno v imenu imetnika dovoljenja za promet, po njegovih navodilih ali v njegovem interesu.
The provisions of this Directive shall be without prejudice to the right of any other person or organisation, in particular the press or patients and patient organisations, to express their views on prescription-only medicinal products, provided that they are acting independently and not directly or indirectly on behalf of, on the instructions of, or in the interest of, the marketing authorisation holder.
Člen 100b
Article 100b
Imetnik dovoljenja za promet
The marketing authorisation holder shall, in respect of
njenim članom
patients and
najnovejšo različico povzetka
the most recent
najnovejšo različico
the most recent
ovojnine in
labelling and
kakor so ju odobrili pristojni organi med postopkom izdaje ali spremembe dovoljenja za promet;
during the course of marketing authorisation or authorisation variation;
med postopkom izdaje ali spremembe dovoljenja za promet
during the course of marketing authorisation and authorisation updates
Informacije iz točk (a), (b) in (c) so na voljo v obliki, ki verodostojno ponazarja uradno odobrene informacije, kot so jih pripravili pristojni organi.
The information referred to in points (a), (b) and (c) shall be presented in a format that faithfully represents the officially approved information drawn up by the competent authorities.
Na voljo se dajo v elektronski in tiskani obliki ter v oblikah, namenjenih slepim in slabovidnim osebam.
The information shall be made available both in electronic and printed form, and in formats appropriate for the blind and partially-sighted.
Imetnik dovoljenja za promet lahko daje na voljo bolnikom, širši javnosti ali njenim članom naslednje informacije o odobrenih zdravilih na recept:
The marketing authorisation holder may, in respect of authorised medicinal products subject to medical prescription, make available to patients and the general public or members thereof the following information:
informacije o vplivu zdravila na okolje
information on the environmental impact of the medicinal product
poleg informacij o sistemu odlaganja in zbiranja v skladu s členom 54(j), ki se dajo na voljo v skladu s prvim odstavkom tega člena;
further to the information provided on the disposal and collection system pursuant to Article 54(j) and made available pursuant to paragraph 1 of this Article.
informacije o spremembah
information on
na ovojnini
packaging changes
poleg informacij, zagotovljenih v skladu s členom 59(1)(e) in danih na voljo v skladu s prvim odstavkom tega člena
further to the information provided pursuant to Article 59(1)(e) and made available pursuant to paragraph 1 of this Article
navodila za uporabo poleg informacij, zagotovljenih v skladu s členom 59(1)(d) in danih na voljo v skladu z odstavkom 1 tega člena.
instructions for use of the medicinal product, further to the information provided pursuant to Article 59(1)(d) and made available pursuant to paragraph 1 of this Article.
Te informacije se lahko po potrebi dopolnijo z nepremičnimi ali premičnimi slikami tehnične narave, ki ponazarjajo pravilen način uporabe zdravila;
This information may be supplemented, where necessary, with still or moving images of a technical nature demonstrating the proper way of using the product;
povzetek pogosto predloženih zahtev za posredovanje informacij v skladu s členom 100c(b) in odgovorov nanje;
a summary of the frequently submitted requests for information pursuant to Article 100c(b), and the subsequent answers;
druge vrste informacij, ki jih je odobril pristojni organ in pomembno pripomorejo k primerni uporabi zdravila.
other types of information agreed by the competent authority that are relevant to supporting the appropriate use of the medicinal product.
Informacije iz točk (a) do (g) so na voljo v elektronski in tiskani obliki ter v oblikah, namenjenim slepim in slabovidnim osebam.
The information referred to in points (a) to (g) shall be made available both in electronic and printed form, and in formats appropriate for the blind and partially-sighted.
Informacije iz točk (a) do (g) pred njihovo objavo za namene tega člena odobrijo pristojni organi ali Agencija v primeru izdaje dovoljenja za promet na ravni Unije.
The information referred to in points (a) to (g) shall be approved by the competent authorities, or in case of Union marketing authorisation, by the Agency, prior to its being made available for the purposes of this Article.
Člen 100c
Article 100c
Informacije o odobrenih zdravilih na recept, ki jih imetnik dovoljenja za promet
Information on authorised medicinal products subject to medical prescription
da na voljo bolnikom ali
made available
širši javnosti ali njenim članom, niso na voljo na televiziji
by the marketing authorisation holder to
ali v časopisih, revijah in podobnih publikacijah
or newspapers, magazines and similar publications
Na voljo se dajo samo prek naslednjih kanalov:
It shall be made available only through the following channels:
spletna mesta o zdravilih,
internet websites
registrana in upravljana v skladu s členom 100h,
registered and managed in accordance with Article 100h
ob izključitvi nezaželenega gradiva, ki se aktivno razpošilja
, relating to medicinal products, to the exclusion of unsolicited material actively distributed to
širši javnosti ali njenim članom;
the general public or members thereof;
▌odgovori na
▌answers to
zahtevke po informacijah
requests for information
o zdravilih
about a medicinal product
s strani
of a
bolnika ali
patient or a
člana širše javnosti
member of the general public
Člen 100d
Article 100d
Vsebina in predstavitev informacij o odobrenih zdravilih na recept, ki jih imetnik dovoljenja za promet
The content and presentation of information, on authorised medicinal products subject to medical prescription,
da na voljo
made available