natgillin/translations-raw huggingface dataset:
Institucija, ki je začela notranji postopek za odločanje, ali naj se prenos pooblastila prekliče, si prizadeva, da o tem obvesti drugo institucijo in Komisijo, v doglednem času pred sprejetjem končnega sklepa, pri čemer navede prenesena pooblastila, ki bi lahko bila preklicana, ter morebitne razloge za preklic.
2.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 100 k d (novo)
Article 100 k d (new)
Člen 100kd
Article 100k d
Evropski parlament ali Svet lahko v treh mesecih od datuma uradnega obvestila nasprotujeta delegiranemu aktu.
The European Parliament or the Council may object to a delegated act within a period of three months from the date of notification.
Če po izteku obdobja iz odstavka 1 niti Evropski parlament niti Svet ne nasprotuje delegiranemu aktu, se ta objavi v Uradnem listu Evropske unije in začne veljati na tam navedeni datum.
If, on expiry of th e 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.
Delegirani akt se lahko objavi v Uradnem listu Evropske unije in začne veljati pred iztekom navedenega obdobja, če sta tako Evropski parlament kot Svet obvestila Komisijo o svoji nameri, da ne bosta ugovarjala.
The delegated act may be published in the Official Journal of the European Union and enter into force before the expiry of that period if the European Parliament and the Council have both informed the Commission of their intention not to raise objections.
Če Evropski parlament ali Svet ugovarjata delegiranemu aktu v roku iz odstavka 1, ta ne začne veljati.
If either the European Parliament or the Council objects to the delegated act within the period referred to in paragraph 1 , it shall not enter into force.
V skladu s členom 296 Pogodbe o delovanju Evropske unije institucija, ki nasprotuje, navede razloge za nasprotovanje delegiranemu aktu.
In accordance with Article 296 of the Treaty on the Functioning of the European Union, t he institution which objects shall state the reasons for objecting to the delegated act.
Člen 100 l
Article 100 l
Komisija najpozneje [vstaviti točen datum pet let po začetku veljavnosti direktive o spremembi] objavi poročilo o pridobljenih izkušnjah pri izvajanju tega naslova ter oceni potrebo po pregledu tega naslova.
By [insert specific date five years from the entry into force of amending directive] at the latest, the Commission shall publish a report on the experience acquired in the implementation of this Title 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.
Komisija najpozneje [vstaviti točen datum pet let po začetku veljavnosti direktive o spremembi], po posvetovanju z neodvisnimi organizacijami bolnikov, zdravstvenimi organizacijami in organizacijami potrošnikov ter pripadniki zdravstvenih poklicev , objavi poročilo o pridobljenih izkušnjah pri izvajanju tega naslova ter oceni potrebo po pregledu tega naslova.
By [insert specific date five years from the entry into force of amending directive] at the latest, the Commission shall publish a report on the experience acquired in the implementation of this Title after consulting independent patient, health and consumer organisations and the members of health care professions 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.
Člen 1 – točka 4a (novo)
Article 1 - point 4a (new)
Člen - 100 la (novo)
Article 100 la (new)
Člen 100 la (novo)
Article 100 la (new)
Ne glede na določbe naslova o informacijah, ki jih posreduje imetnik dovoljenja za promet države članice zagotovijo, da so širši javnosti in njenim članom na voljo objektivne in nepristranske informacije o:
Notwithstanding the provisions of this Title on information by the marketing authorisation holder, Member States shall ensure that objective, unbiased information is available to the general public and members thereof on
(a) zdravilih, ki se prodajajo na trgu, ki se nahaja na ozemlju države članice.
(a) medicinal products placed on the market on the territory of that Member State .
Takšne informacije med drugim vključujejo najnovejšo različico povzetka značilnosti zdravila ter ovojnine in navodila za uporabo zdravila, kakor so jih odobrili pristojni organi med postopkom izdaje ali podaljšanja dovoljenja za promet, ter najnovejšo 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 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 ;
(b) boleznih in zdravstvenih pogojih, za katere je namenjeno zdravilo iz točke a); ter
(b) the diseases and health conditions which are to be treated with the medicinal product referred to in point a); and
(c) preprečevanju takšnih boleznih in pogojev.
(c) the prevention of such diseases and conditions.
Te informacije so na razpolago tako v elektronski kot v tiskani obliki ter v formatu, ki je dostopen invalidnim osebam.
Such information shall be made available both in electronic and printed form and in a format accessible for people with disabilities.
Informacije so na voljo prek naslednjih kanalov:
The information shall be made available through the following channels:
(a) 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;
(a) 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;
(b) tiskovin, ki so na razpolago širši javnosti;
(b) printed materials made available to the general public;
(c) pisnih odgovorov na zahtevke po informacijah s strani člana širše javnosti.
(c) written answers to request for information of a member of the general public.
Komisija olajšuje izmenjavo izkušenj med državami članicami in sprejme smernice.
The Commission shall facilitate the sharing of best practices between Member States and shall adopt guidelines.
* UL: Vstaviti datum tri leta od začetka veljavnosti te direktive.
* OJ: Insert the date three years from the entry into force of the directive
Zato je bistveno, da se zagotovijo jasnejše določbe.
Therefore it is essential to create a increased clarity in the provisions.
§ Dajanje informacij na razpolago bi moralo temeljiti na „ načelu povpraševanja “, t.j. informacije bi morale biti na razpolago tistim bolnikom, ki jih sami iščejo.
§ The making available of information should be based on the "pull principle" , i.e. information should be made available to those patients who are searching for information themselves.
Bolniki in vsi zainteresirani bi morali biti sposobni poiskati natančne in nepristranske informacije o zdravem življenjskem slogu, preprečevanju bolezni in posebnih bolezni ter različnih možnostih zdravljenja.
Patients and everyone interested should be able to find accurate and unbiased information on healthy lifestyle, the prevention of illness and specific diseases, and various treatment options.
Poročevalec zato pričakuje, da bo Komisija v bližnji prihodnosti kot del take širše „strategije zagotavljanja informacij bolnikom“predstavila nov predlog ter dopolnila pričujočega.
The Rapporteur though expects the Commission to present a new proposal in a near future as a part of such wider "information to patients strategy" and to complement this one.
o predlogu Direktive Evropskega parlamenta in Sveta o spremembi Direktive 2001/83/ES o zakoniku Skupnosti o zdravilih za uporabo v humani medicini v zvezi z informacijami za širšo javnost o zdravilih na recept
on the proposal for a directive of the European Parliament and of the Council amending, as regards information to the general public on medicinal products subject to medical prescription, Directive 2001/83/EC on the Community code relating to medicinal products for human use
• zagotovijo ukrepi spremljanja in izvrševanja, s čimer se zagotovi, da posredovalci informacij izpolnjujejo merila kakovosti ter hkrati prepreči nepotrebna birokracija.
• Ensuring that monitoring and enforcement measures are in place to ensure that information providers comply with the quality criteria, while avoiding unnecessary bureaucracy.
Razčlemba posameznih ciljev
As to the individual aims:
Komisija je s predlogom te direktive pokazala, da se pacienti vedno bolj zanimajo za svoje zdravje in da želijo biti pri tem bolj vključeni.
By presenting this Directive, the Commission has recognised that patients are increasingly interested in their health and wish to be involved more actively in health-related processes.
EU si mora s certificiranimi informacijami prizadevati zagotoviti informacijsko protiutež zavajajočim oglasom, ki krožijo na internetu.
Through the provision of certified information, the EU must take action to provide an informative counterweight to the misleading advertising in circulation in the Internet.
Bistvo predloga Komisija je preoblikovati navodilo za uporabo.
The Commission proposal is therefore directed primarily at the redesigning of the package leaflet.
Pripravljavec mnenja ugotavlja zlasti, da je treba izboljšati opredelitev publikacij v zvezi z zdravjem in sankcij, kar bo obravnavano v okviru predlogov sprememb.
In particular, the author of the opinion identifies a need for improvement in relation to the definition of health-related publications and in relation to penalties.
(4) Izkušnje, pridobljene z uporabo obstoječega pravnega okvira, so prav tako pokazale, da so nekatere omejitve možnosti farmacevtskih družb za zagotavljanje informacij posledica dejstva, da se razlika med pojmoma oglaševanja in obveščanja v Skupnosti ne razlaga usklajeno.
(4) Experience gained from the application of the current legal framework has also shown that certain restrictions on the possibilities of pharmaceutical companies to provide information result from the fact that the distinction between the notions of advertising and information is not interpreted consistently across the Community.
Pravica državljanov do dostopa do informacij, vključno z informacijami o zdravilih na recept, je temeljno načelo demokratične družbe.
It is a fundamental principle in a democratic society that citizens have a right to access information, including on prescription medicines.
(8) Pristojni nacionalni organi in zdravstveni delavci morajo ostati pomemben vir informacij o zdravilih za širšo javnost.
(8) National competent authorities and health care professionals should remain important sources of information on medicinal product for the general public.
Države članice morajo olajšati dostop državljanov do kakovostnih informacij prek ustreznih kanalov.
Member States should facilitate the access of citizens to high-quality information through appropriate channels.
Oblikovanje potrebnega pravnega okvira za imetnike dovoljenja za promet bo okrepilo pravno gotovost farmacevtske industrije pri zagotavljanju posebnih oblik informacij o njihovih zdravilih javnosti.
Establishing the necessary legal framework for marketing authorisation holders will enhance legal certainty for the pharmaceutical industry in relation to the provision to the general public of specific types of information on their medicines.
Ta direktiva državam članicam nalaga, da morajo imetnikom dovoljenja za promet dovoliti, da javnosti prek določenih kanalov in ob ustreznem spremljanju zagotavljajo nekatere informacije o odobrenih zdravilih na recept.
This Directive requires Member States to permit, through certain channels and subject to appropriate monitoring, the provision by a marketing authorisation holder of certain information on authorised medicines subject to prescription to the public.
Če ne gre za oglaševanje, bi bilo treba dovoliti sporočila, ki ne spadajo pod naslov VIIIa.
Communications that do not fall within Title VIIIa should be permitted, provided that they do not constitute advertising.
Pojasnitev področja uporabe predloga direktive.
Clarification of the scope of the proposed Directive.
Pomembno je, da nova zakonodaja zaradi nepazljivosti ne prepove nekaterih sporočil, na primer odgovorov na poizvedovanja zdravstvenih delavcev o nelicenčni rabi.
It is important that new legislation does not inadvertently prohibit certain communications, e.g. responses to healthcare professionals’ enquiries on unlicensed uses.
(10) Uvesti je treba določbe, s katerimi se zagotovi, da se širijo samo kakovostne nepromocijske informacije o koristih in tveganjih zdravil na recept.
(10) Provisions should be established to ensure that only high-quality non-promotional information about the benefits and the risks of medicinal products subject to medical prescription may be disseminated .
Zato mora biti vsaka informacija za širšo javnost o zdravilih na recept skladna s sklopom meril kakovosti.
Therefore, any information to the general public on prescription-only medicinal products should comply with a set of quality criteria.
(10) Uvesti je treba določbe, s katerimi se zagotovi, da se dajo na razpolago samo kakovostne nepromocijske informacije o koristih in tveganjih odobrenih zdravil na recept.
(10) Provisions should be established to ensure that only high-quality non-promotional information about the benefits and the risks of authorised medicinal products subject to medical prescription may be made available .
Zagotavljanje več kakovostnih informacij o zdravilih bo državljanom EU omogočilo bolj razumno in primerno uporabo zdravil, rezultat tega pa bodo bolje obveščeni državljani in bolj zdrave družbe.
Providing EU citizens with more high quality information on medicines will enable them to make more rational and appropriate use of medicines, which will lead not only to better informed citizens but also to healthier societies.
Da bi to dosegli, morajo biti informacije za širšo javnost o odobrenih zdravilih na recept skladne s sklopom meril kakovosti.
To achieve this , information to the general public on authorised prescription-only medicinal products should comply with a set of quality criteria.
(Zamenjava izraza „širiti“ z „dati na razpolago“ velja za vse besedilo.
(Replacing the term 'disseminated' with 'made available' applies throughout the text.
Če bo ta predlog spremembe sprejet, bo treba ta izraz povsod nadomestiti.)
Adopting this amendment will necessitate corresponding changes throughout.)
V uvodnih izjavah se mora odražati tudi cilj predloga, ki je državljanom omogočiti ustrezno (razumnejšo in varnejšo) uporabo zdravil ter okrepiti upoštevanje navodil v zvezi s predpisanim zdravljenjem.
The recitals should also reflect the stated objective of the proposal to enable citizens to make proper (more rational and safer) use of medicines and to enhance adherence to prescribed treatments.
Po podatkih Svetovne zdravstvene organizacije več kot 50 % državljanov EU neustrezno uporablja zdravila.
According to WHO data, more than 50% of EU citizens use their medicines inappropriately.
Področje uporabe te direktive je omejeno na odobrena zdravila.
The scope of this directive is restricted to authorised medicinal products.
Informacij ne bi smeli širiti, ampak jih dati na razpolago javnosti, ko jih potrebuje.
The information should not be disseminated but made available to members of the public who require it.
To pomeni, da bi morale zadevne osebe te informacije dejavno iskati.
This implies that members of the public would play an active part in obtaining this information.
(11) Za nadaljnjo zagotovitev, da bodo imetniki dovoljenja za promet širili samo kakovostne informacije, in za razlikovanje med nepromocijskimi informacijami in oglaševanjem, je treba opredeliti vrste informacij, ki se smejo širiti.
(11) In order to further ensure that marketing authorisation holders disseminate only high-quality information and to distinguish non-promotional information from advertising, the types of information which may be disseminated should be defined.
Zato je treba imetnikom dovoljenja za promet omogočiti, da širijo vsebino odobrenih povzetkov značilnosti zdravila in navodil za uporabo, informacije, ki so skladne z navedenima dokumentoma, brez preseganja njunih ključnih prvin , in druge natančno opredeljene informacije, povezane z zdravili .
It is appropriate to allow marketing authorisation holders to disseminate the contents of the approved summaries of product characteristics and package leaflet, information that is compatible with those documents without going beyond their key elements , and other well-defined medicinal product-related information .
Zato je treba imetnikom dovoljenja za promet omogočiti, da širijo vsebino odobrenih povzetkov značilnosti zdravila in navodil za uporabo, informacije, ki so skladne z navedenima dokumentoma, brez preseganja njunih ključnih prvin.
It is appropriate to allow marketing authorisation holders to disseminate the contents of the approved summaries of product characteristics and package leaflet, information that is compatible with those documents without going beyond their key elements.
(13) Splet je zelo pomemben z vidika zagotavljanja informacij bolnikom, njegov pomen pa še narašča.
(13) 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 je oblikovati posebne predpise o spremljanju spletnih strani, 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.
Treba je oblikovati posebne predpise o spremljanju spletnih strani, ki so oblikovane posebej za državljane EU, da se upošteva čezmejna narava informacij, ki se zagotavljajo prek spleta, in omogoči sodelovanje med državami članicami.
Specific rules on the monitoring of websites that are directed specifically at EU citizens 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.
Člen 86 – odstavek 1 – alinea 1 a (novo)
Article 86 – paragraph 1 – indent 1 a (new)
(-1) V členu 86(1) se za prvo alineo doda naslednja alinea:
(-1) In Article 86(1), the following indent shall be inserted after the first indent:
–opozarjanje javnosti na posebna zdravila ob uporabi terapevtskih indikacij ali znakov in simptomov
"- drawing the general public's attention to a specific medicinal product, using therapeutic indications or signs and symptoms,"
Priporočanje zdravil na podlagi znakov in simptomov bolezni lahko spodbudi samodiagnozo, samozdravljenje in nepotrebno jemanje zdravil.
Suggesting medicinal products on the basis of signs and symptoms of diseases may encourage self-diagnosis, self-medication and the unnecessary taking of medicinal products.
To je treba preprečiti.
Action should be taken to prevent this.
–dopisovanja, po možnosti s priloženimi gradivi, ki ni promocijske narave in je potrebno kot odgovor na konkretna vprašanja o posameznem zdravilu;
- correspondence, possibly accompanied by all material of a non-promotional nature, needed to answer a specific question about a particular medicinal product ;
Nujno je, da „dopisovanje, po možnosti s priloženimi gradivi, ki niso promocijske narave in so potrebna kot odgovor na konkretna vprašanja o posameznem zdravilu“ ni niti oglaševanje iz naslova VIII niti informacije iz člena VIIIa.
It is essential that ‘correspondence, possibly accompanied by all material of a non-promotional nature, needed to answer a specific question about a particular medicinal product’ is neither advertising within the meaning of Title VIII nor information within the meaning of Title VIIIa.
Pravni status se glede na sedanje stanje ne more spremeniti.
The legal situation should not change from the status quo.
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 ter referenčnega gradiva v zvezi z zdravilom , na primer v zvezi s spremembami na ovojnini, opozorili o neželenih učinkih kot delu splošnih previdnostnih ukrepov, prodajnimi katalogi, ceniki in vračili kupnine, pod pogojem, da te objave in referenčno gradivo ne vključujejo promocijskih navedb o lastnostih zdravila;
- factual, informative announcements and reference material relating to a medicinal product , for example, relating to pack changes, adverse-reaction warnings as part of general drug precautions, trade catalogues , price lists and reimbursement , provided that such announcements and reference material include no product promotional claims;
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.
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 in drugih kampanj v interesu javnega zdravja, ki jih izvaja industrija in jih odobrijo pristojni organi držav članic, ki zagotovijo, da te kampanje ne služijo oglaševanju, pod pogojem, da služijo izključno zdravstvenim namenom.
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 , which shall ensure that such campaigns are not intended to serve as advertising, provided that these campaigns are carried out exclusively for medically necessary purposes .
Opisane kampanje smejo služiti samo zdravstvenim namenom in jih ne bi smeli zlorabiti za oglaševanje.
These campaigns should be carried out exclusively for medically necessary purposes and should not be misused for the purposes of advertising.
Člen 100a – odstavek 1
Article 100a – paragraph 1