natgillin/translations-raw huggingface dataset:
Države članice oblikujejo določbe, da se ukrepi iz odstavka 1 sprejmejo po pospešenem postopku z začasnim ali dokončnim učinkom.
Member States shall make provision for the measures referred to in paragraph 1 to be taken under an accelerated procedure either with interim effect or with definitive effect.
Med pritožbenim postopkom se dajanje na voljo informacij prekine, dokler pristojni organ ne sprejme drugačne odločitve.
During the appeal procedure the making available of information shall be suspended until a contrary decision is taken by the responsible body.
Člen 100j
Article 100j
Države članice zagotovijo, da imetniki dovoljenja za promet prek strokovne službe iz člena 98(1):
Member States shall ensure that marketing authorisation holders, through the scientific service referred to in Article 98(1):
dajo na voljo
keep available, for the
organom ali službam, odgovornim za nadzor informacij o zdravilih,
authorities or bodies responsible for monitoring information on medicinal products
ki te informacije odobrijo v naprej,
that have approved the information in advance
vzorec vseh informacij
, a sample of all information
na voljo
made available
v skladu s tem naslovom, ter informacije o količini
in accordance with this Title and information on its volume of
informacij, skupaj z izjavo, v kateri so navedene osebe, na katere so informacije naslovljene, način
, together with a statement indicating the persons to whom it is addressed, the method of
dajanja na voljo
making it available
ter datum
and the date
in nudijo pomoč, ki jo zahtevajo za izvajanje svojih pristojnosti;
and assistance they require to carry out their responsibilities;
zagotovijo, da se sklepi organov ali služb za spremljanje informacij o zdravilih, takoj in v celoti upoštevajo.
ensure that the decisions taken by the authorities or bodies responsible for monitoring information on medicinal products are immediately and fully complied with.
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 medicinal products.
Člen 100l
Article 100l
Ne glede na določbe tega naslova o informacijah, ki jih posreduje imetnik dovoljenja za promet, vsaka država članica zagotovi, da so bolnikom in širši javnosti ali njenim članom na voljo objektivne in nepristranske informacije o:
Notwithstanding the provisions of this Title on information by the marketing authorisation holder, each Member State shall ensure that objective, unbiased information is available to patients and the general public or members thereof on:
zdravilih, ki se prodajajo na trgu, ki se nahaja na ozemlju države članice.
medicinal products placed on the market on its territory.
Takšne informacije med drugim vključujejo najnovejšo različico povzetka značilnosti zdravila ter ovojnine in navodil bolnikom za uporabo, kakor so jih odobrili pristojni organi med postopkom izdaje ali podaljšanja dovoljenja za promet, ter najnovejšo javno dostopno različico poročila o oceni, ki jo pripravijo pristojni organi, in dopolnitve;
Such information shall include, but shall not be limited to, the most recent summary of product characteristics and labelling and patient package leaflet of the medicinal product as approved by the competent authorities during the course of marketing authorisation and its renewal, and the most recent, publicly accessible version of the assessment report as drawn up by the competent authorities, and updates thereof;
boleznih in zdravstvenih pogojih, za katere so namenjena zdravila, ki se prodajajo na trgu, ki se nahaja na ozemlju države članice; ter
the diseases and health conditions which are to be treated with medicinal products placed on the market on its territory; and
preprečevanju takšnih boleznih in pogojev.
the prevention of such diseases and conditions.
Informacije iz odstavka 1 so na razpolago tako v elektronski kot v tiskani obliki ter v formatu, ki je dostopen invalidnim osebam.
The information referred to in paragraph 1 shall be made available both in electronic and printed form and in a format accessible for people with disabilities.
posebnih spletnih mest, ki jih vzpostavi država članica ali organ, ki ga določi država članica, in ki jih spremlja pristojni nacionalni organ ali organ, ki ga določi pristojni nacionalni organ;
dedicated websites set up by the Member State or by a body assigned by the Member State, and monitored by the competent national authority or by a body assigned by the competent national authority;
tiskovin, ki so na razpolago bolnikom in širši javnosti;
printed materials made available to patients and the general public;
pisnih odgovorov na zahtevke po informacijah s strani bolnika in člana širše javnosti.
written answers to requests for information of patients and members of the general public.
Tri leta od začetka veljavnosti te direktive.
Three years from the entry into force of this Directive.
Evropskemu parlamentu in Svetu posreduje poročilo o napredku držav članic pri izvajanju tega člena.
the Commission shall present a report to the European Parliament and the Council on the progress made by the Member States in applying this Article.
Člen 100m
Article 100m
Pooblastilo za sprejemanje delegiranih aktov iz členov 100d(5), 100f(2) in 100h(7) se prenese na Komisijo za obdobje petih let z začetkom od ...
The power to adopt delegated acts referred to in Articles 100d(5), 100f(2) and 100h(7) shall be conferred on the Commission for a period of five years from ...
Začetek veljavnosti te direktive.
The entry into force of this Directive.
Komisija pripravi poročilo o pooblastilu najpozneje šest mesecev pred koncem petletnega obdobja.
The Commission shall draw up a report in respect of the delegated power at the latest six months before the end of the five- year period.
Prenos pooblastila se samodejno podaljša za enako obdobje, razen če Evropski parlament ali Svet pooblastilo prekliče v skladu s členom 100n.
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 100n.
Pooblastilo za sprejemanje delegiranih aktov je prenešeneno na Komisijo pod pogoji, določenimi v členih 100n in 100o.
The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in Articles 100n and 100o.
Člen 100n
Article 100n
Pooblastilo iz členov 100d(5), 100f(2) in 100h(7) lahko kadar koli prekliče Evropski parlament ali Svet.
The delegation of power referred to in Articles 100d(5), 100f(2) and 100h(7) may be revoked at any time by the European Parliament or by the Council.
Institucija, ki je začela notranji postopek o morebitnem preklicu pooblastila, si prizadeva o tem obvestiti drugo institucijo in Komisijo v razumnem roku pred sprejetjem končne odločitve ter pri tem navede pooblastila, ki bi se lahko preklicala, in možne razloge za preklic.
The institution which has commenced an internal procedure for deciding whether to revoke the delegation of power shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated powers which could be subject to revocation and possible reasons for a revocation.
Člen 100o
Article 100o
Evropski parlament ali Svet lahko nasprotuje delegiranemu aktu v treh mesecih od datuma uradnega obvestila .
The European Parliament or the Council may object to a delegated act within a period of three months from the date of notification.
Na pobudo Evropskega parlamenta ali Sveta se navedeni rok podaljša za en mesec.
At the initiative of the European Parliament or the Council that period shall be extended by one month.
Če do izteka roka iz odstavka 1 niti Evropski parlament niti Svet ne nasprotuje delegiranemu aktu, se akt objavi v Uradnem listu Evropske unije in začne veljati na dan, ki je v njem določen.
If, on expiry of the period referred to in paragraph 1, neither the European Parliament nor the Council has objected to the delegated act it shall be published in the Official Journal of the European Union and shall enter into force at the date stated therein.
Člen 100p
Article 100p
objavi poročilo o pridobljenih izkušnjah pri izvajanju tega naslova ter oceni potrebo po pregledu tega naslova.
and shall also assess the need for a review thereof.
Komisija to poročilo predloži Evropskemu parlamentu in Svetu.‚
The Commission shall submit this report to the European Parliament and to the Council.
Izraza „navodilo za uporabo“ in „navodila za uporabo“ se v celotnem besedilu zamenjata z „navodilo bolnikom za uporabo“ in „navodila bolnikom za uporabo“.
The words ‘package leaflet’ and ‘package leaflets’ shall be replaced by ‘patient package leaflet’ and ‘patient package leaflets’ throughout the text.
Posvetovanje z zainteresiranimi stranmi
Consultation of stakeholders
Komisija se o vprašanjih, povezanih z izvajanjem te direktive, in o tem, kako jo izvajajo države članice, posvetuje z vsemi zadevnimi zainteresiranimi stranmi, kot so neodvisne organizacije bolnikov, zdravstvene organizacije in organizacije potrošnikov.
The Commission shall consult all relevant stakeholders, such as independent patient, health and consumer organisations on issues relating to the implementation of this Directive and its application by the Member States.
Države članice sprejmejo zakone in druge predpise, potrebne za uskladitev s to direktivo, najpozneje do ... * Eno leto po začetku veljavnosti te direktive.
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by ... * One year after the entry into force of this Directive.
Zakonodajna resolucija Evropskega parlamenta z dne 24. novembra 2010 o predlogu uredbe Evropskega parlamenta in Sveta o spremembi Uredbe (ES) št. 726/2004 o postopkih Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za humano in veterinarsko uporabo ter o ustanovitvi Evropske agencije za zdravila v zvezi z informacijami za širšo javnost o zdravilih na recept za uporabo v humani medicini ( KOM(2008)0662 – C6-0517/2008 – 2008/0255(COD) )
European Parliament legislative resolution of 24 November 2010 on the proposal for a regulation of the European Parliament and of the Council amending, as regards information to the general public on medicinal products for human use subject to medical prescription, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency ( COM(2008)0662 – C6-0517/2008 – 2008/0255(COD) )
ob upoštevanju predloga Komisije Evropskemu parlamentu in Svetu ( KOM(2008)0662 ),
having regard to the Commission proposal to the European Parliament and the Council ( COM(2008)0662 ),
ob upoštevanju členov 251(2) in 95 Pogodbe ES, na podlagi katerih je Komisija Parlamentu podala predlog ( C6-0517/2008 ),
having regard to Article 251(2) and Article 95 of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament ( C6-0517/2008 ),
ob upoštevanju členov 294(3), 114 in 168(4)(c) Pogodbe o delovanju Evropske unije,
having regard to Article 294(3), Article 114 and Article 168(4)(c) of the Treaty on the Functioning of the European Union,
ob upoštevanju poročila Odbora za okolje, javno zdravje in varnost hrane ter mnenj Odbora za industrijo, raziskave in energetiko ter Odbora za notranji trg in varstvo potrošnikov ( A7-0289/2010 ),
having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinions of the Committee on Industry, Research and Energy and the Committee on the Internal Market and Consumer Protection ( A7-0289/2010 ),
Komisija je 20. decembra 2007 predložila sporočilo z naslovom „Poročilo o obstoječi praksi glede zagotavljanja informacij o zdravilih bolnikom“.
On 20 December 2007, the Commission submitted a Communication entitled ‘Report on current practices with regard to the provision of information to patients on medicinal products’.
Poročilo ugotavlja, da so države članice sprejele različna pravila in prakse glede zagotavljanja informacij, kar vodi do situacije, v kateri imajo bolniki in širša javnost neenak dostop do informacij o zdravilih.
The report concludes that Member States have adopted divergent rules and practices with regard to the provision of information, resulting in a situation where patients and the public at large have unequal access to information on medicinal products.
Izkušnje, pridobljene pri uporabi sedanjega pravnega okvira, so prav tako pokazale razlike v razlagi pravil Unije o oglaševanju ter med nacionalnimi določbami o informacijah
Experience gained from the application of the current legal framework has also shown disparities in the interpretation of Union rules on advertising, and between national provisions on information
in nujno potrebo po pojasnitvi razlike med oglaševanjem in obveščanjem
, highlighting the urgent need for a more precise distinction between advertising and information
Uvedba novega naslova VIIIa v Direktivo 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini UL L 311, 28.11.2001, str.
The introduction of a new Title VIIIa in Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on a Community code relating to medicinal products for human use OJ L 311, 28.11.2001, p.
navedena vprašanja obravnava z različnimi določbami, katerih namen je zagotoviti razpoložljivost visoko kakovostnih, objektivnih, zanesljivih in nepromocijskih informacij o zdravilih na recept za uporabo v humani medicini
addresses those concerns through various provisions intended to ensure the availability of good-quality, objective, reliable and non promotional information on medicinal products for human use subject to prescription
ter poudariti pravice in interese bolnikov
and to place emphasis on the rights and interests of patients
Razlike pri zagotavljanju informacij o zdravilih za uporabo v humani medicini niso utemeljene v primeru zdravil, odobrenih v skladu z naslovom II Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta UL L 136, 30.4.2004, str.
Disparities in the provision of information on medicinal products for human use are not justified in the case of medicinal products authorised pursuant to Title II of Regulation (EC) No 726/2004 of the European Parliament and of the Council OJ L 136, 30.4.2004, p.
, za katere sta za celotno Unijo odobrena enoten povzetek karakteristik zdravil in enotna navodila za uporabo.
for which a single summary of the products characteristics and package leaflet are approved for the whole Union.
Zato bi moral naslov VIIIa Direktive 2001/83/ES prav tako veljati za navedena zdravila.
Therefore Title VIIIa of Directive 2001/83/EC should also apply to those products.
Direktiva 2001/83/ES določa, da nacionalni pristojni organi držav članic nadzorujejo nekatere vrste informacij, preden se
Directive 2001/83/EC provides that certain types of information are subject to control by the Member States' national competent authorities prior to
dajo na voljo
being made available
V primeru zdravil za uporabo v humani medicini, odobrenih v skladu z naslovom II Uredbe (ES) št. 726/2004, bi morala Evropska agencija za zdravila (v nadaljnjem besedilu: Agencija) zagotoviti vnaprejšnje preverjanje nekaterih vrst informacij
In the case of medicinal products for human use authorised pursuant to Title II of Regulation (EC) No 726/2004, provision should also be made for certain types of information to be subject to prior vetting by the European Medicines Agency (hereinafter the ‘Agency’)
in nadzorovati ukrepe, ki jih bo proizvajalec sprejel, ter spremljati posodabljanje literature po poročanju o neželenih učinkih
, and for the Agency to monitor the measures to be taken by the manufacturer and to monitor the updating of the literature following the reporting of adverse reactions
Za primerno financiranje teh dejavnosti v zvezi z informacijami bi bilo treba zagotoviti zbiranje pristojbin, ki jih Agencija zaračuna imetnikom dovoljenj za promet.
To ensure the adequate funding of these activities related to information, provision should be made for the collection of fees charged to marketing authorisation holders by the Agency.
Če se izkaže, da so za Agencijo zaradi predhodnega preverjanja posameznih vrst informacij v skladu s to uredbo nastali dodatni stroški, ki se ne morejo pokriti iz prispevkov imetnikov dovoljenj za promet z zdravili, bi bilo treba preveriti višino prispevka Unije v proračun Agencije.
In the event that the additional costs incurred by the Agency as a result of its preliminary checking of certain types of information pursuant to this Regulation are not covered by the fees payable by the marketing authorisation holders for this purpose, the amount of the Union's contribution to the Agency's budget should be reviewed.
Tudi na ravni držav članic bi si bilo treba prizadevati za ustrezno prilagoditev prispevka Unije Agenciji.
Accordingly, efforts should be initiated at Member State level with a view to the possible amendment of the Union's contribution to the Agency.
Ker cilja te uredbe, zlasti zagotoviti posebna pravila za informacije o zdravilih na recept za uporabo v humani medicini, odobrenih v skladu z Uredbo (ES) št. 726/2004, 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 Regulation, namely to provide for specific rules on information on medicinal products for human use subject to prescription authorised pursuant to Regulation (EC) No 726/2004, cannot be sufficiently achieved by 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.
Uredbo (ES) št. 726/2004 bi bilo treba ustrezno spremeniti –
Regulation (EC) No 726/2004 should be amended accordingly,
Uredba (ES) št. 726/2004 se spremeni:
Regulation (EC) No 726/2004 is amended as follows:
V členu 9(4) se doda naslednja točka:
In Article 9(4), the following point is added:
povzetek Evropskega javnega poročila o oceni zdravila iz člena 13(3).
the summary of the European Public Assessment Report referred to in Article 13(3).
Naslov VIIIa Direktive 2001/83/ES se uporablja za zdravila, ki so odobrena v skladu s tem naslovom in se izdajajo na zdravniški recept.
Title VIIIa of Directive 2001/83/EC shall apply to medicinal products which are authorised under this Title and are subject to medical prescription.
Z odstopanjem od člena 100g(1) Direktive 2001/83/ES Agencija informacije v zvezi z zdravili iz člena 100b(d) navedene direktive preveri, preden se
By way of derogation from Article 100g(1) of Directive 2001/83/EC, medicinal product-related information referred to in Article 100b(d) of that Directive shall be subject to vetting by the Agency prior to its
dajo na voljo, razen če so te informacije objavljene na spletnem mestu, katerega vsebino bi morala v skladu s členom 100h Direktive 2001/83/ES spremljati posamezna država članica
being made available, unless this information appears on a website, the responsibility for monitoring the content of which rests with a Member State in accordance with Article 100h of Directive 2001/83/EC
Za namene odstavka 1 imetnik dovoljenja za promet Agenciji predloži model informacij, ki jih namerava
For the purposes of paragraph 1, the marketing authorisation holder shall submit to the Agency a mock-up of the information to be
dati na voljo
made available
Agencija lahko na podlagi razlogov, povezanih z neizpolnjevanjem določb naslova VIIIa Direktive 2001/83/ES, predloženim informacijam ali delom teh informacij ugovarja v
The Agency may object to the information submitted or parts thereof on grounds related to non-compliance with the provisions of Title VIIIa of Directive 2001/83/EC within
po prejemu obvestila.
after receipt of the notification.
Če Agencija ne ugovarja v
If the Agency does not object within
, se informacije štejejo za sprejete in se lahko objavijo.
, the information shall be deemed accepted and may be published.
Če Agencija zahteva spremembe informacij, ki jih je predložil imetnik dovoljenja za promet, in če ta ponovno predloži izboljšani model informacij v 30 delovnih dneh, Agencija nanj odgovori v 60 delovnih dneh.
If the Agency asks for changes to be made to information submitted by the marketing authorisation holder, and if the latter resubmits an improved mock-up of the information within 30 working days, the Agency shall communicate its response to the new proposal within 60 working days.
Za to oceno Agencija imetniku dovoljenja za promet zaračuna novo pristojbino.
The Agency shall charge the marketing authorisation holder an additional fee for this assessment.
Za predložitev informacij Agenciji v skladu z odstavki 1, 2, 3 in 4 se plača pristojbina v skladu z Uredbo Sveta (ES) št. 297/95 z dne 10. februarja 1995 o pristojbinah, ki se plačujejo Evropski agenciji za vrednotenje zdravil*.
The submission of information to the Agency in accordance with paragraphs 1, 2, 3 and 4 shall be subject to a fee payable in accordance with Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products*.
* UL L 35, 15.2.1995, str.
* OJ L 35, 15.2.1995, p.
ustvarjanje baze podatkov o zdravilih, ki naj bo dostopna javnosti, v vseh uradnih jezikih Unije, zagotavljanje njenega posodabljanja in upravljanja neodvisno od poslovnih interesov farmacevtskih podjetij.
creating a database on medicinal products, to be accessible to the general public, in all official languages of the Union, and ensuring that it is updated and managed independently of the commercial interests of pharmaceutical companies.
Baza podatkov olajša iskanje podatkov že odobrenih zdravil za navodila za uporabo; vključuje skupino podatkov o zdravilih, odobrenih za zdravljenje otrok, podatki za javnost pa se oblikujejo v primernem in razumljivem jeziku in so namenjeni nestrokovnjakom;
The database shall facilitate the search for information already authorised for package leaflets, it shall include a section on medicinal products authorised for the treatment of children, and the information provided to the public shall be worded in an appropriate and comprehensible manner designed for non-experts;
zagotavljanje mnenj o informacijah za širšo javnost o zdravilih na recept za humano uporabo;
delivering opinions on information to the general public on medicinal products for human use subject to medical prescription;
spodbujanje obstoječih virov neodvisnih zanesljivih zdravstvenih informacij.
promoting existing sources of independent reliable health information.
odstavek 2 se spremeni:
paragraph 2 is amended as follows:
prvi pododstavek se nadomesti z naslednjim:
The first subparagraph is replaced by the following:
Baza podatkov, predvidena v točki (l) odstavka 1, vključuje povzetke glavnih značilnosti zdravil, navodila za uporabo zdravila za bolnika ali uporabnika in podatke, prikazane na ovojnini.
The database provided for in point (l) of paragraph 1 shall include the summaries of product characteristics, the patient or user package leaflet and the information shown on the labelling.
Baza podatkov se razvija v stopnjah: prednost dobijo zdravila, odobrena po tej uredbi, in tista, ki so odobrena po poglavju 4 naslova III Direktive 2001/83/ES in poglavju 4 naslova III Direktive 2001/82/ES.
The database shall be developed in stages, priority being given to medicinal products authorised under this Regulation and those authorised under Chapter 4 of Title III of Directive 2001/83/EC and Chapter 4 of Title III of Directive 2001/82/EC.
Baza podatkov se bo širila, da bo vključevala vsa zdravila, dana v promet znotraj Unije.
The database shall subsequently be extended to include any medicinal product placed on the market within the Union.