natgillin/translations-raw huggingface dataset:
(12) Informacije za širšo javnost o zdravilih na recept je treba zagotoviti samo preko posebnih kanalov komuniciranja, vključno s spletom, da se učinkovitost prepovedi oglaševanja nezaželenih informacij za javnost ne bi zmanjšala.
(12) Information to the general public on prescription-only medicinal products should only be provided through specific channels of communication, including Internet, to avoid that the effectiveness of the prohibition on advertising is undermined by unsolicited provision of information to the public.
Kadar se informacije dajejo na voljo prek televizije ali radia, časopisov, revij ali podobnih publikacij, bolniki pred takšnimi nezaželenimi informacijami niso zaščiteni, zato je treba takšno širjenje prepovedati.
Where information is made available via television, radio, newspapers, magazines and similar publications , patients are not protected against such unsolicited information and such dissemination should therefore not be allowed.
(14) S spremljanjem informacij o zdravilih na recept je treba zagotoviti, da imetniki dovoljenja za promet širijo zgolj informacije, ki so v skladu z Direktivo 2001/83/ES.
(14) Monitoring of information on prescription-only medicinal products should ensure that marketing authorisation holders only disseminate information which is in compliance with Directive 2001/83/EC.
Države članice morajo sprejeti predpise 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.
Spremljanje mora temeljiti na nadzoru informacij pred njihovim širjenjem, razen če so se pristojni organi že dogovorili o vsebini informacij ali če obstaja drugačen mehanizem za zagotavljanje enake ravni ustreznega in učinkovitega spremljanja .
Monitoring should be based on the control of information prior to its dissemination , unless the substance of the information has already been agreed by the competent authorities or if there is a different mechanism in place to ensure an equivalent level of adequate and effective monitoring .
(14) S spremljanjem informacij o odobrenih zdravilih na recept v skladu s to direktivo je treba zagotoviti, da imetniki dovoljenja za promet dajejo na voljo zgolj informacije, ki so v skladu z Direktivo 2001/83/ES.
(14) Monitoring of information on authorised prescription-only medicinal products under this Directive should ensure that marketing authorisation holders only make available information which is in compliance with Directive 2001/83/EC.
Te predpise je treba uskladiti na ravni Unije, da bi zagotovili doslednost.
These rules should be harmoni s ed at Union level so as to ensure consistency.
V primeru neskladnosti je 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 mora temeljiti na nadzoru informacij pred njihovim posredovanjem .
Monitoring should be based on the control of information prior to its being made available .
Posredovati se smejo samo informacije, ki jih predhodno odobrijo pristojni organi, in sicer samo v odobreni obliki.
Only information that has been approved in advance by the competent authorities should be provided and it should be provided in an approved form only .
(15) Ker ta direktiva prvič uvaja usklajene predpise o zagotavljanju informacij za širšo javnost o zdravilih na recept, mora Komisija oceniti njeno delovanje in potrebo po pregledu pet let po začetku njene veljavnosti.
(15) As this Directive introduces for the first time harmonised rules on the provision of information on medicinal products subject to medical prescription to the general public, the Commission should assess its operation and the necessity for a review five years after its entry into force.
Uvesti je treba tudi določbo, v skladu s katero Komisija pripravi smernice na podlagi izkušenj držav članic pri spremljanju informacij.
Provision should also be made for the drawing up of guidelines by the Commission based on Member States' experience in the monitoring of information.
Uvesti je treba tudi določbo, v skladu s katero Komisija v sodelovanju z organizacijami bolnikov in zdravstvenih delavcev pripravi smernice na podlagi izkušenj držav članic pri spremljanju informacij.
Provision should also be made for the drawing up of guidelines by the Commission based on Member States' experience , in cooperation with patient organisations and health care professionals , in the monitoring of information
Ker so te informacije namenjene pacientom, morajo biti njihove organizacije vključene v proces oblikovanja smernic.
As the information is targeted at patients, patients’ organizations have to be involved into the process of establishing the guidelines.
Pomembno je tudi gledišče zdravstvenih delavcev, saj morajo za bolnike ostati glavni vir informacij o zdravilih na recept.
The perspective of health professionals is also crucial as they are, and they should remain the main source of information to patients on prescribed medicines .
(15a) Komisija bi morala dobiti pooblastilo za sprejemanje delegiranih aktov v skladu s členom 290 Pogodbe o delovanju Evropske unije v zvezi s kakovostnimi merili informacij za splošno javnost in smernicami za spletno dostopnost.
(15a) 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 provided to the general public , and web accessibility guidelines.
Režim komitologije je treba prilagoditi sistemu delegiranih aktov, ki jih uvaja člen 290 Pogodbe o delovanju Evropske unije (Lizbonske pogodbe).
The comitology regime has to be aligned to the system of delegated acts introduced by Article 290 of the Treaty on the Functioning of the European Union (i.e. the Lisbon Treaty).
(15a) Komisija se mora o vprašanjih, povezanih z izvajanjem te direktive, in o tem, kako jo izvajajo države članice, posvetovati z neodvisnimi organizacijami bolnikov, zdravstvenimi organizacijami in organizacijami potrošnikov ter zdravstvenih delavcev.
(15a) The Commission should consult 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.
Upoštevati je treba tudi poglede zdravstvenih delavcev v zvezi z izvajanjem in uporabo te direktive.
Healthcare professionals` views related to the implementation and application of this Directive should also be taken into account.
Člen 1 – točka – 1 a (novo)
Article 1 – point – 1 a (new)
(-1a) V členu 1 se točka 26 nadomesti z:
(-1a) Article 1, point 26 shall be replaced by the following:
Navodila za bolnike : Zdravilu priložen listič s podatki, ki so namenjeni bolniku in ki ustrezajo dejanskim potrebam bolnikov .
Patient leaflet: A leaflet containing information for the patient which accompanies the medicinal product and which corresponds to patients' real needs.
Glej predlog spremembe k uvodni izjavi 2.
See amendment to Recital 2.
Člen 59 – odstavek 3 a (novo)
Article 59 – paragraph 3 a (new)
( - 1) V členu 59 se doda naslednji odstavek:
( - 1) I n Article 59 the following paragraph shall be added :
Navodila za uporabo ustrezajo dejanskim potrebam bolnikov.
The 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 Evropska agencija za zdravila.
To this end, patient organisations should be involved in developing and reviewing the information on medicinal products by national regulatory authorities and the European Medicines Agency.
Navodila 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 package leaflet shall include a short paragraph which sets out the benefit 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. ”
Študije, v katerih so sodelovali bolniki, so pokazale, da večina ljudi ne bere navodil za uporabo (npr. informacije so podane v napačnem vrstnem redu, najpomembnejše informacije ne izstopajo).
Studies involving patients show that often the package leaflets are not read by most people (e.g. information in the wrong order, most important information does not stand out).
Zaradi tega bi bilo treba navodila za uporabo pripraviti v sodelovanju s predstavniki bolnikov, kot je na primer leta 2005 predlagala delovna skupina za potrošnike v okviru Evropske agencije za zdravila.
Thus, patient leaflets should be developed in cooperation with patients’ representatives, as proposed e.g. by the EMA Patient and Consumer Working Group in 2005.
Delo te agencije za izboljšanje berljivosti bolniku prijaznih navodil za uporabo se mora nadaljevati, nacionalni regulativni organi pa bi ga morali posnemati kot zgled dobre prakse.
The EMA’s work to improve the readability and patient-friendliness of the leaflet should be continued and should be followed as a model of good practice for national regulatory authorities.
Člen 86 – odstavek 2 – alinea 1
Article 86 – paragraph 2 – indent 1
– označevanja in priloženega navodila za uporabo, kar urejajo določbe naslova V;
- the labelling and the accompanying package leaflets, which are subject to the provisions of Title V;
– označevanja , v katerem se vedno navede vsaj mednarodno nelastniško ime, in priloženega navodila za uporabo, kar urejajo določbe naslova V;
- the labelling , which shall always at least specify the International Non-proprietary Name , and the accompanying package leaflets, which are subject to the provisions of Title V;
Mednarodno nelastniško ime (ime zdravilne učinkovine, katere skupni koren določa terapevtsko skupino zdravil, v katero sodi učinkovina) je treba sistematično uporabljati, da bi okrepili ozaveščenost bolnikov (s tem bi prispevali k ozaveščenosti bolnikov o tem, katero zdravilno učinkovino jemljejo).
The International Non-proprietary Name (INN) (the name of the active substance which common stem identifies the therapeutic class the substance belongs to) should be systematically used to empower patients (it helps to raise awareness among patients of what active substance they are taking used).
Člen 86 – odstavek 2 – alinea 1 a (novo)
Article 86 – paragraph 2 – indent 1 a (new)
– 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;
Člen 86 – odstavek 2 – alinea 2
Article 86 – paragraph 2 – indent 2
- informativnih objav o dejstvih ter referenčnega gradiva, na primer v zvezi s spremembami na ovojnini, opozorili o neželenih učinkih kot delu splošnih previdnostnih ukrepov, prodajnimi katalogi in ceniki pod pogojem, da ne vključujejo navedb o lastnostih zdravila;
- factual, informative announcements and reference material relating, for example, to pack changes, adverse-reaction warnings as part of general drug precautions, trade catalogues and price lists, provided they include no product claims;
- informativnih objav o dejstvih (vključno z informativnimi objavami ali izjavami, ki so na primer pripravljene za medijske organizacije kot odgovor na neposredno poizvedovanje ali so delničarjem in/ali zakonodajalcem posredovane na konferencah, v pisnih izjavah, objavah ali poročilih) ter referenčnega gradiva o zdravilu , na primer v zvezi z razpoložljivostjo, spremembami na ovojnini, opozorili o neželenih učinkih kot delu splošnih previdnostnih ukrepov, prodajnimi katalogi in ceniki, 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 pod pogojem, da takšne objave in referenčno gradivo ne vključujejo promocijskih navedb o lastnostih zdravila ter ne napeljujejo ali spodbujajo k jemanju zdravila ;
- factual, informative announcements (including announcements or statements such as those made to media organisations either in response to a direct enquiry or by dissemination of such information via conferences or written releases and announcements or reports to shareholders and/or regulators) and reference material relating to a medicinal product , for example, to availability, pack changes, adverse-reaction warnings as part of general drug precautions, trade catalogues, price lists, reimbursement and information on the environmental risk of the medicinal product and information relating to the disposal of unused medicinal product or waste derived from medicinal products as well as reference to any collection system in place, provided that such announcements and reference material include no product promotional claims and that they do not encourage or promote the consumption of the medicinal product ;
Člen 86 – odstavek 2 – alinea 3
Article 86 – paragraph 2 – indent 3
- informacij v zvezi z zdravjem ljudi ali boleznimi pod pogojem, da ni nobenega napotila, tudi posrednega ne, na zdravila;
- information relating to human health or diseases, provided that there is no reference, even indirect, to medicinal products;
– informacij v zvezi z zdravjem ljudi ali boleznimi pod pogojem, da ni nobenega napotila, tudi posrednega ne, na posamezna zdravila;
- information relating to human health or diseases, provided that there is no reference, even indirect, to individual medicinal products;
Pojasnitev področja uporabe direktive.
Clarification of scope of the Directive.
Podjetjem bi bilo treba še naprej dovoliti zagotavljanje nekaterih informacij.
Companies should be allowed to continue to provide certain information.
Pravila trga vrednostnih papirjev na primer zahtevajo, da podjetja redno v celoti obveščajo vlagatelje o pomembnih dogodkih, zaposlene pa o poslovnem razvoju.
For instance, stock market rules require that companies keep investors fully informed of significant developments and employees must be kept informed of business developments.
Izraz „navedbe o lastnostih zdravila“ bi lahko razumeli kot vsako izjavo o pozitivnih ali negativnih lastnostih proizvoda in bi tako nezavedno prepovedali izjave o negativnih reakcijah ali opozorila.
“Product claim” could be taken to mean any statement about the properties of a product, positive and negative, and might inadvertently prohibit statements about adverse reactions and warnings.
Direktiva 2001/83/ES2
Directive 2001/83/EC2
Člen 86 – odstavek 2 – alinea 4
Article 86 - paragraph 2 - indent 4
informacij imetnika dovoljenja za promet o zdravilih na recept za širšo javnost, za katere veljajo določbe naslova VIIIa.“
- information by the marketing authorisation holder to the general public on medicinal products subject to medical prescription, which is subject to the provisions of Title VIII a."
– informacij o zdravilih, ki izpolnjujejo merila kakovosti, ki so jih odobrili pristojni organi v državah članicah in ki jih imetnik dovoljenja za promet v odobreni obliki daje na voljo širši javnosti ter za katere veljajo določbe naslova VIIIa.
- information on medicinal products that meets the quality criteria , that has been approved by the competent authorities in the Member States and that has been made available to the general public in approved form by the marketing authorisation holder and that is subject to medical prescription, which is subject to the provisions of Title VIII a."
Informacije, ki se zagotavljajo bolnikom in širši javnosti, morajo izpolnjevati osnovna kakovostna merila, da se zagotovi varnost pacientov in varstvo javnega zdravja.
The information provided to patients and the general public needs to meet the core quality criteria in order to ensure patient safety and safeguard public health.
Člen 86 – odstavek 2 – alinea 4 a (novo)
Article 86 – paragraph 2 – indent 4 a (new)
– informativnih objav o dejstvih za vlagatelje in zaposlene o pomembnih spremembah v poslovnem razvoju pod pogojem, da ne promovirajo proizvoda širši javnosti.
- factual, informative announcements for investors and employees on significant business developments, provided they are not use d to promote the product to the general public;
Člen 86(2) obstoječe Direktive 2001/83/ES navaja specifične vire, ki so izvzeti iz opredelitve „oglaševanja“.
Article 86(2) of the existing Directive 2001/83/EC lists specific sources that are excluded from the definition of “advertising”.
Pri sedanji formulaciji se zastavlja vprašanje opredelitve oglaševanja in „informacij“, ki jih širi imetnik dovoljenja za promet.
The current wording raises the problem of the definition of advertising and “information” disseminated by the MAH.
Številne izjeme, ki jih predlaga Komisija, močno ogrožajo objektivnost „informacij“; v praksi bi lahko s preširoko opredelitvijo „informacij“ zajeli oglaševanje.
The numerous exceptions proposed by the Commission highly endanger the objectiveness of “information”: advertisings could de facto be covered by a too broad definition of “information”.
Zato se je bolje sklicevati na specifične „dokumente“ s strani imetnika dovoljenja za promet, kot so navedeni v naslovu VIII a.
It is therefore preferable to refer to specific “documents” produced by the MAH as listed in Title VIII a.
Člen 86 – odstavek 2 a (novo)
Article 86 – paragraph 2 a (new)
(1a) V členu 86 se doda naslednji odstavek:
(1a) In Article 86, the following paragraph shall be added :
“(2a) Kadar so na voljo izjeme od prepovedi oglaševanja iz odstavka 2, se opredeli imetnik dovoljenja za promet in vsaka tretja stran ter vsaka tretja stran, ki deluje v imenu imetnika dovoljenja za promet.“
“(2a) When exemptions to advertising referred to in paragraph 2 are 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 identified as such.”
Javnosti mora biti jasno, da je informacijo dalo na voljo farmacevtsko podjetje: če jo objavi kdo tretji, mora biti jasno, da deluje v imenu farmacevtskega podjetja.
It has to be clear for the public that information is made available by the pharmaceutical company: in case information is made available by a third party, it also has to be clear that the third party is acting on behalf of the pharmaceutical company.
Prepoved iz odstavka 1 se ne uporablja v primeru kampanj za cepljenje in drugih kampanj v interesu javnega zdravja , ki jih izvaja industrija in jih odobrijo pristojni organi držav članic.“
The prohibition set out in paragraph 1 shall not apply to vaccination campaigns and other campaigns in the interest of public health carried out by the industry and approved by the competent authorities of the Member States.
Prepoved iz odstavka 1 se ne uporablja v primeru kampanj za cepljenje, ki jih izvaja industrija in jih odobrijo pristojni organi držav članic.
The prohibition set out in paragraph 1 shall not apply to vaccination campaigns carried out by the industry and approved by the competent authorities of the Member States.
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, domnevnih 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 suspected adverse reactions and contra-indications of the vaccination.
Člen 1 – točka – 4 a (novo)
Article 1 – point – 4 a (new)
(4a) Člen 94(1) se nadomesti z naslednjim:
(4a) Article 94(1) shall be 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. "
Ne bi smeli dovoliti nobenih daril ali drugih ugodnosti, saj raziskave kažejo, da čut za povrnitev močno vpliva na vedenje tudi pri majhnih darilih.
There should be no gifts or other advantages whatsoever, as research evidence indicates that the instinct to reciprocate is a powerful influence on the behaviour even when small gifts are concerned.
Člen 100 a – odstavek 1
Article 100 a - paragraph 1
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.
Takšne informacije se ne obravnavajo kot oglaševanje za namene uporabe naslova VIII.
Such information shall not be considered advertising for the purposes of the application of Title VIII.
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 članice od imetnika dovoljenja za promet zahtevajo, da neposredno ali posredno prek tretje stranke , ki deluje v imenu imetnika dovoljenja za promet, posreduje informacije, ki jih je uradno odobril nacionalni ali evropski pristojni organ, širši javnosti ali njenim članom o odobrenih zdravilih na recept pod pogojem, da so informacije in način njihovega posredovanja skladni z določbami tega naslova.
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, Member States shall require the marketing authorisation holder to make available , either directly or indirectly through a third party acting on behalf of the marketing authorisation holder , information that has been officially approved by national or European competent authorities to the general public or members thereof on authorised medicinal products subject to medical prescription provided that such information and the manner in which it is made available is in accordance with the provisions of this Title.
Ko so takšne informacije dane na razpolago, 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 .