natgillin/translations-raw huggingface dataset:
(d) poštni ali elektronski naslov, na katerega lahko člani širše javnosti sporočajo pripombe imetniku dovoljenja za promet.
(d) a mail address or e-mail address allowing members of the general public to send comments to the marketing authorisation holder.
(d) poštni ali elektronski naslov, na katerega lahko člani širše javnosti sporočajo pripombe ali zahtevke za dodatne informacije imetniku dovoljenja za promet.
(d) a postal address or e-mail address allowing members of the general public to send comments to , or request s for further information from, the marketing authorisation holder .
Posredovane pripombe posameznikov in odgovore imetnikov dovoljenja za promet je treba primerno evidentirati in spremljati.
C omments sent by private individuals and the replies from marketing authorisation holders shall be duly recorded and monitored .
(Ne zadeva slovenske različice.)
The word 'postal' is better than ´mailing`.
Člen 100 d – odstavek 2 – točka d a (novo)
Article 100 d – paragraph 2 – point d a (new)
(da) poštni ali elektronski naslov, na katerega lahko člani širše javnosti sporočajo pripombe pristojnim nacionalnim organom;
( da) a postal address or e-mail address allowing members of the general public to send comments to the national competent authorities;
Širša javnost bi morala vedeti, na kateri organ se lahko obrne, če so informacije zavajajoče ali neustrezne.
The general public should know who to contact of the authorities if the information is misleading or inappropriate.
Člen 100 d – odstavek 2 – točka d b (novo)
Article 100d – paragraph 2 – point d b (new)
(db) trenutno besedilo navodil za uporabo ali navodila za dostop do tega besedila.
(d b ) t he text of the current package leaflet or an indication as to where that text may be found.
V primeru internetnih strani, ki so pod nadzorom imetnikov dovoljenja za promet in so namenjene izrecno državljanom ene ali več držav članic, vsebujejo povzetek značilnosti zadevnega zdravila in navodila za njegovo uporabo v uradnih jezikih držav članic, kjer imajo dovoljenje, če so informacije o zdravilu v teh jezikih.
In the case of Internet sites under the control of marketing authorisation holders that are directed specifically at citizens of one or more Member States, they shall contain the summary of product characteristics and the package leaflet of the medicinal products concerned in the official languages of the Member States where they are authorised if the information on medicinal products is presented in those languages.
Pomembno je, da ima bralec dostop do trenutnega besedila navodil.
It is important that the reader is able to access the current package leaflet text.
Zahteve v zvezi s spletnimi mesti sodijo bolj v ta odstavek kot med zahteve za spremljanje za države članice.
The requirement for Internet websites is better dealt with under this paragraph than as a monitoring requirement for Member States.
Člen 100 d – odstavek 2 – točka d c (novo)
Article 100 d – paragraph 2 – point d c (new)
dc) izjavo, v kateri se člane širše javnosti poziva, naj vse domnevne neželene učinke zdravil sporočijo svojemu zdravniku, lekarnarju, zdravstvenemu delavcu ali nacionalnemu pristojnemu organu, ter v kateri so navedeni ime, spletni naslov, poštni naslov in/ali telefonska številka nacionalnega pristojnega organa.
d c ) a statement indicating that members of the general public are encouraged to report all suspected adverse reactions of medicinal products to their doctor, pharmacist, healthcare professional, or to the national competent authority, and indicating the name and web-address, postal address and /or telephone number of that national competent authority.
Člen 100 d – odstavek 3 – točka a
Article 100 d – paragraph 3 – point a
a) primerjav med zdravili;
a) comparisons between medicinal products;
a) primerjav med zdravili glede njihove kakovosti, varnosti in učinkovitosti, če jih širi imetnik dovoljenja za promet, razen če :
a) comparisons between medicinal products regarding their quality, safety and efficiency, if disseminated by marketing authorisation holders except where those comparisons are :
– so primerjave del uradno odobrenih dokumentov, kot je povzetek značilnosti zdravil;
- included in officially approved documents, such as the Summary of Product Characteristics ;
– primerjave temeljijo na primerjalnih znanstvenih študijah, ki jih objavijo ustrezni nacionalni organi ali Evropska agencija za zdravila;
- based on comparative scientific studies published by the relevant national authorities or the European Medicines Agency;
– so primerjave iz povzetka evropskih javnih poročil o oceni zdravila iz člena 13 Uredbe (ES) št. 726/2004, ki navaja tudi druge možnosti zdravljenja in informacijo, ali ima novo zdravilo zdravilne prednosti.
- contained in the summary of the European Public Assessment Reports referred to in Article 13 of Regulation (EC) No 726/2004, which shall list the other available therapeutic options and whether the new medicinal product brings about a therapeutic value.
Primerjave lahko najdemo v povzetku značilnosti zdravil in na navodilih za uporabo nekaterih zdravil.
Comparisons exist in the Summary of Product Characteristics (SmPC) and package leaflets of some medicines.
Če izključimo obstoječe primerjave, bi bile informacije, ki jih zagotovi imetnik dovoljenja za promet, nepopolne.
To exclude those existing comparisons would in effect require that information provided by marketing authorisation holders is incomplete.
To bi lahko ogrozilo tudi postopek odobritve.
This could also prejudice the approval process.
Neodvisnim nacionalnim organom in Evropski agenciji za zdravila ne bi smeli preprečevati, da opravljajo primerjalne znanstvene študije o kakovosti, varnosti in učinkovitosti različnih zdravil, saj so lahko dragocen vir informacij za potrošnike.
Comparative scientific studies on the quality, safety and efficiency of different medicinal products by independent National Authorities and the EMEA should not be discouraged as they can provide a valuable source for consumer information.
Člen 100 d – odstavek 3 – točka a a (novo)
Article 100 d - paragraph 3 - point a a (new)
(aa) kakršnega koli napeljevanja k uporabi zdravila ali njenega spodbujanja;
(aa) any inducement to, or promotion of , the consumption of the medicinal product ;
Bolj bi bilo treba poudariti razliko med informacijo in oglasom.
The distinction between information and advertisement should be further emphasised.
Čeprav člen 86 direktive opredeljuje oglaševanje in člen 88(1) prepoveduje oglase za zdravila na recept, bi bilo treba zaradi jasnosti poudariti, da ne sme biti na razpolago nobeno promocijsko gradivo za zdravila na recept.
Though Article 86 of the Directive sets the definition of advertising, and Article 88 (1) prohibits the advertisement of prescription-only medicines, for the sake of clarity it should underlined that no promotional material on prescription-only medicines could be made available.
Člen 100 d – odstavek 3 – točka b a (novo)
Article 100 d – paragraph 3 – point b a (new)
(ba) informacij o drugih zdravilih, za katera farmacevtska družba ni imetnik dovoljenja za promet.
( ba) information on other medicinal products for which the pharmaceutical company is not the marketing authorisation holder.
Napačne informacije tretjih družb o zdravilih, za katera so pristojni organi izdali dovoljenje za promet, je treba strogo prepovedati.
Misinformation campaigns by third party companies on medicinal products which have obtained a marketing authorisation from competent authorities must be prohibited by any means.
Prepoved je treba razširiti na oglaševanje in zagotavljanje informacij zdravstvenim delavcem.
The prohibition should be extended to advertising and information to healthcare professionals.
V predhodnem poročilu o preiskavi farmacevtskega sektorja so napačne informacije, ki jih na primer proizvajalci originalnega zdravila širijo javnosti o generičnih zdravilih, opredeljene kot ena od strategij zavlačevanja.
Misinformation campaigns from originator companies on generic medicines, for instance, towards the general public has been identified as one of the delaying strategies in the Preliminary Report of the Pharmaceutical Sector Inquiry.
Člen 100 d – odstavek 4
Article 100 d - paragraph 4
Komisija sprejme potrebne ukrepe za izvajanje odstavkov 1, 2 in 3.
The Commission shall adopt the measures necessary for the implementation of paragraphs 1, 2 and 3.
Da se zagotovi, da so širši javnosti na voljo kakovostne informacije in njenim članom, Komisija prek delegiranih aktov v skladu s členom 100 kb in pogoji iz členov 100 kc in 100 kd sprejme potrebne ukrepe za uporabo odstavkov 1, 2 in 3.
In order to ensure the quality of information made available to the general public and members thereof, the Commission shall adopt, by means of delegated acts in accordance with Article 100 kb and subject to the conditions of Articles 100 kc and 100 kd, the measures necessary for the application of paragraphs 1, 2 and 3.
Navedeni ukrepi, namenjeni spremembi nebistvenih določb te direktive z njeno dopolnitvijo, se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 121(2a).
Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 121(2a).
Člen 100 e – odstavek 1
Article 100 e – paragraph 1
Države članice zagotovijo, da so na spletnih straneh imetnika dovoljenja za promet za širjenje informacij o zdravilih, za katere velja zdravniški recept, povzetek značilnosti zdravila in navodila za uporabo zadevnih zdravil v uradnih jezikih držav članic, kjer so odobrena.
Member States shall ensure that marketing authorisation holders' Internet websites for the dissemination of information on medicinal products subject to medical prescription reproduce the summary of product characteristics and the package leaflet of the medicinal products concerned in the official languages of the Member States where they are authorised.
Države članice zagotovijo, da je na spletnih mestih imetnika dovoljenja za promet objavljena zadnja posodobljena različica povzetka značilnosti zdravila in navodil za uporabo zdravil na recept, ki so ju odobrili pristojni organi in ki se tržijo v uradnih jezikih držav članic, kjer so odobrena.
Member States shall ensure that marketing authorisation holders' Internet websites reproduce the last updated version as approved by the competent authorities of the summary of product characteristics and of the package leaflet of the medicinal products subject to medical prescription that they commercialise in the official languages of the Member States where they are authorised.
Dokumente o zdravilih na recept, ki jih imetnik dovoljenja za promet objavi na svojem spletnem mestu, je treba posodabljati.
The documents on prescription-only medicinal products provided by marketing authorisation holders via their Internet websites should be up-to-date.
Člen 100 e – odstavek 1 a (novo)
Article 100 e – paragraph 1 a (new)
Države članice zagotovijo, da vsaka spletna stran spletnega mesta imetnika dovoljenja za promet, ki se nanaša na zdravila na recept, vsebuje povezavo na ustrezno spletno stran podatkovne zbirke Skupnosti iz členov 57(1)(l) in 57(2) Uredbe (ES) št. 726/2004 in na nacionalni spletni portal o varnosti zdravil ali takšen portal Skupnosti iz člena 106 Direktive 2001/83/ES ter člena 26 Uredbe (ES) št. 726/2004.
Member States shall ensure that each webpage from a marketing authorisation holders' website referring to a medicinal product subject to medical prescription includes a link to the corresponding webpage of the Community database referred to in Articles 57(1)(l) and 57(2) of Regulation EC 726/2004, and the national or Community safety web portal referred to in Article 106 of Directive 2001/83/EC , and Article 26 of Regulation (EC) No 726/2004.
Povezava na podatkovno zbirko EudraPharm bi izboljšala prepoznavnost tega pomembnega vira informacij za bolnike, ki ponuja široko paleto storitev in iskalnih pripomočkov.
A link to the Eudrapharm database would raise awareness of this useful source of information to patients, which offers a wide range of functionalities and search facilities.
Povezava na nacionalne spletne portale in na spletne portale Skupnosti o varnosti zdravil bi bolnikom omogočila, da dostopajo do dodatnih informacij o varnosti zdravil.
A link to the national and Community safety web portals would allow patients to access additional information about the safety of a medicinal product.
Člen 100 e – odstavek 1 b (novo)
Article 100 e – paragraph 1 b (new)
Povzetkom evropskih javnih poročil o oceni zdravila iz člena 13 Uredbe (ES) št. 726/2004 se dodajo spletne povezave na ustrezne študije iz podatkovne zbirke o kliničnih poskusih iz člena 11 Direktive 2001/20/ES (v nadaljevanju podatkovna zbirka EudraCT).
The summary of the European Public Assessment Reports referred to in Article 13 of Regulation (EC) No 726/2004 shall be hyperlinked with the corresponding studies in the clinical trials database provided for in Article 11 of Directive 2001/20/EC (hereinafter ‘the EudraCT database’).
Povezave na podatkovno zbirko EudraCT bi olajšale dostop do znanstvenih dognanj iz študij.
Such a link to the EudraCT database would facilitate access to the scientific results of studies.
Znanstvena dognanja iz študij so bistvena za razoj in razumevanje zanesljivih podatkov.
The scientific results of studies are essential to the development and to the understanding of reliable information.
Člen 100 e – odstavek 2
Article 100 e – paragraph 2
Države članice zagotovijo, da se lahko zahtevek za informacije o zdravilu na recept, ki ga član širše javnosti predloži imetniku dovoljenja za promet, sestavi v katerem koli od uradnih jezikov Skupnosti, ki so uradni jeziki v državah članicah, v katerih je zdravilo odobreno.
Member States shall ensure that requests for information to a marketing authorisation holder on a medicinal product subject to medical prescription by a member of the general public may be drafted in any of the official languages of the Community which are official languages in the Member States where the medicinal product is authorised.
Odgovor se sestavi v jeziku zahtevka.
The reply shall be drafted in the language of the request.
Odgovori so pristojnim nacionalnim organom na voljo za pregled, ko to zahtevajo.
The replies shall be kept available for inspections by national competent authorities.
Imetniki dovoljenja za promet morajo dajati na voljo vprašanja javnosti in odgovore, da bi se pristojnim organom, ki to zahtevajo, zagotovila možnost nadzora.
Marketing authorisation holder need to keep available the replies to allow easy control by the National Competent Authorities.
Člen 100 f – odstavek 2 – pododstavek 2
Article 100 f - paragraph 2 - subparagraph 2
Komisija lahko ta odstavek spremeni, da se upošteva tehnični napredek.
The Commission may amend this paragraph to take account of technical progress.
Ta ukrep, namenjen spreminjanju nebistvenih določb te direktive, se sprejme v skladu z regulativnim postopkom s pregledom iz člena 121(2a).
This measure, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 121(2a) .
Komisija lahko zaradi upoštevanja tehničnega napredka na podlagi delegiranih aktov v skladu s členom 100 kb in ob upoštevanju pogojev iz členov 100kc in 100kd sprejme potrebne ukrepe za uporabo tega odstavka .
In order to take account of technical progress, the Commission may adopt, by means of delegated acts in accordance with Article 100 kb and subject to the conditions of Articles 100 kc and 100 kd, measures necessary for the application of this paragraph .
Člen 100f – odstavek 2 a (novo)
Article 100f – paragraph 2 a (new)
Vzpostavi se usklajen postopek za določitev podlage, na kateri se regulirajo informacije, ki so na voljo na spletnih mestih in informacijskih točkah, da se zagotovita zanesljivost podatkov in njihova skladnost z dovoljenjem in registracijo zdravila, s čimer se potrošniku jamči, da sta spletno mesto in zadevna informacija točna in temeljita na dejstvih.
A harmonised procedure shall be established to determine the bases on which information provided on Internet websites and information points is regulated, in such a way as to guarantee the reliability of the data presented and its compliance with the authorisation and registration of the medicinal product, providing a guarantee for consumers that the site or information concerned is accurate and based on facts.
Uporablja se sistem certificiranja ali kvalifikacije odobrenih mest.
A certification or qualification system shall be applied with respect to authorised sites.
Prav tako se vodi seznam informacijskih strani in točk na internetu, ki imajo dovoljenje za informacije, obravnavane v tej direktivi.
A list shall also be kept of Internet web pages and information points authorised to provide the information referred to in this Directive.
Seznam se posodablja in je na voljo potrošnikom.
That list shall be kept up to date and shall be accessible to consumers.
Člen 100 g – odstavek 1 – pododstavek 1
Article 100 g – paragraph 1 – subparagraph 1
Države članice zagotovijo ustrezne in učinkovite metode spremljanja za preprečitev zlorab, kadar imetnik dovoljenja za promet širi informacije o odobrenih zdravilih na recept za širšo javnost ali njene člane .
Member States shall ensure that there are adequate and effective methods of monitoring to avoid misuse when information on authorised medicinal products subject to medical prescription is disseminated by the marketing authorisation holder to the general public or members thereof.
Države članice zagotovijo preprečitev zlorab tako, da omogočijo, da samo imetnik dovoljenja za promet posreduje informacije, in sicer tiste, ki so jih pristojni nacionalni organi odobrili za zdravila na recept ter v obliki, ki je bila odobrena za posredovanje širši javnosti ali njenim članom .
Member States shall ensure that misuse is avoided by ensuring that only the marketing authorisation holder supplies information, and only such information which has been approved by the competent authorities about approved medicines subject to medical prescription, and in the form which has been approved for the making available to the general public or members thereof.
Države članice lahko z odstopanjem nadaljujejo nadzornimi mehanizmi, ki so jih izvajale pred 31 december 2008.
By way of derogation Member States may continue those types of control mechanism which they have been implemented before 31 December 2008.
Komisija preveri in odobri te sisteme.
The Commission shall verif y and approve these systems.
Člen 100 g – odstavek 1 – pododstavek 3
Article 100 g – paragraph 1 – subparagraph 3
Metode lahko vključujejo prostovoljni nadzor informacij o zdravilih prek samoregulativnih ali koregulativnih organov in pritožbo na takšne organe, če so postopki pred takimi organi možni poleg sodnih ali upravnih postopkov, ki so na voljo v državah članicah.
The methods may include the voluntary control of information on medicinal products by self-regulatory or co-regulatory bodies and recourse to such bodies, if proceedings before such bodies are possible in addition to the judicial or administrative proceedings available in the Member States.
Po mnenju številnih držav članic je prostovoljni sistem informiranja samoregulativnih in koregulativnih teles prešibak.
From many Member States’ points of view a voluntary system of control of information by self-regulatory or co-regulatory bodies is too weak.
Kljub temu nekatere države članice uporabljajo samoregulativni sistem.
Nevertheless, a few Member States practice self-regulatory systems.
Učinkovitost in uveljavitev samoregulativnih sistemov sta močno odvisni od kulturnega in pravnega pojmovanja družbe in ju zato ne bi bilo treba uporabljati v vseh državah članicah.
The effectiveness and the assertiveness of self-regulatory systems strongly depend on the cultural and judicial conception of a society and therefore should not be regulated for all Member States.
Člen 100 g – odstavek 2
Article 100 g - paragraph 2
Po posvetovanju z državami članicami Komisija pripravi smernice, ki zadevajo informacije, dovoljene na podlagi tega naslova, in vključujejo kodeks ravnanja za imetnike dovoljenja za promet, ki splošni javnosti ali njenim članom zagotavljajo informacije o odobrenih zdravilih na recept.
After consulting the Member States, the Commission shall draw up guidelines concerning information allowed under this Title and containing a code of conduct for marketing authorisation holders providing information to the general public or members thereof on authorised medicinal products subject to medical prescription.
Komisija pripravi te smernice ob začetku veljavnosti te direktive in jih redno posodablja na podlagi pridobljenih izkušenj.
The Commission shall draw up these guidelines on the entry into force of this directive and update them regularly on the basis of the experience gained.
Po posvetovanju z državami članicami , organizacijami bolnikov in zdravstvenimi delavci Komisija pripravi smernice, ki zadevajo informacije, dovoljene na podlagi tega naslova, in vključujejo kodeks ravnanja za imetnike dovoljenja za promet, ki splošni javnosti ali njenim članom zagotavljajo informacije o odobrenih zdravilih na recept.
After consulting the Member States, patient organi s ations and health care professionals, the Commission shall draw up guidelines concerning information allowed under this Title and containing a code of conduct for marketing authorisation holders providing information to the general public or members thereof on authorised medicinal products subject to medical prescription.
Smernice vsebujejo določbe, ki zagotovijo, da lahko člani javnosti vložijo pritožbo pri pristojnih organih v zvezi z zavajajočo prakso pri dajanju informacij na razpolago.
The guidelines shall contain provisions to ensure that members of the public may lodge complaints with competent authorities regarding misleading practices in the making available of information.
Pomembno je tudi gledišče zdravstvenih delavcev, saj morajo za paciente ostati glavni vir informacij o zdravilih na recept.
The perspective of health professionals is also crucial as they are and should remain the main source of information to patients on prescribed pharmaceuticals.
Člen 100 h – odstavek 1 – pododstavek 1
Article 100 h – paragraph 1 – subparagraph 1
Države članice zagotovijo, da imetniki dovoljenja za promet registrirajo spletne strani , ki vsebujejo informacije o zdravilih, pri pristojnih nacionalnih organih države članice, katere domena najvišje ravni z državno kodo se bo uporabila za zadevno spletno stran .
Member States shall ensure that marketing authorisation holders register Internet websites containing information on medicinal products with the national competent authorities of the Member State of the country code Top Level Domain used by the website concerned , prior to making it available to the general public.
Kadar se za spletno stran ne uporabi domena najvišje ravni z državno kodo, imetnik dovoljenja za promet izbere državo članico registracije.
Where the website does not use a country code Top Level Domain, the marketing authorisation holder shall select the Member State of registration.
Države članice zagotovijo, da imetniki dovoljenja za promet registrirajo spletna mesta pod njihovim nadzorom , ki so namenjena neposredno državljanom ene ali več držav članic in ki vsebujejo s strani organa odobrene informacije o zdravilih na recept, ki spadajo pod ta naslov , preden jih dajo na voljo širši javnosti .
Member States shall ensure that marketing authorisation holders register Internet websites under their control that are directed specifically at citizens of one or more Member States and that contain authority-approved information on prescription - only medicines covered by this Title , prior to making it available to the general public.
Kadar se za spletno mesto ne uporabi domena najvišje ravni z državno kodo, imetnik dovoljenja za promet izbere državo članico registracije.
Where the website does not use a country code Top Level Domain, the marketing authorisation holder shall select the Member State of registration.