natgillin/translations-raw huggingface dataset:
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
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 into place by means of which marketing authorisation holders can be represented and heard in the course of the consideration of their case.
Spremljanje mora temeljiti na nadzoru informacij , preden se jih da na voljo , razen če so se pristojni organi že dogovorili o vsebini informacij ali če obstaja drugačen mehanizem za zagotavljanje ustreznega , učinkovitega in neodvisnega spremljanja.
Monitoring should be based on the control of information prior to its being made available , 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 adequate , effective and independent monitoring.
Predlog spremembe pojasnjuje področje uporabe direktive, tako da poudarja, da ta zakonodaja ne obsega zagotavljanja informacij o določenih vrstah ali skupinah zdravil.
This amendment clarifies the scope of the directive by reinforcing that the provision of information on certain types or groups of medicines is not covered by this legislation.
Za nekatere vrste informacij je težje določiti razliko med oglaševanjem in promocijskimi informacijami.
For certain types of information the distinction between advertising and promotional information is more difficult to establish.
Te vrste informacij bi zato morali pred širjenjem odobriti pristojni nacionalni organi.
Those types of information should therefore be subject to approval by the national competent authorities before its dissemination.
Treba je vzpostaviti mehanizme neodvisnega spremljanja pod nadzorom organov, tudi kadar spremljanje informacij prevzame drug institut.
Independent monitoring mechanisms controlled by authorities should be in place even when another institute takes over the monitoring of the information.
( - 1) V členu 59 se doda naslednji odstavek:
( - 1) I n Article 59 the following paragraph shall be inserted:
Navodila za uporabo ustrezajo dejanskim potrebam bolnikov.
The package leaflet shall correspond to the real needs of patients.
(-1a) V odstavku 1 člena 86 se po prvi alinei vstavi naslednja alinea:
(-1a) In paragraph 1 of Article 86, after the first indent, the following indent is inserted:
„– opozarjanje širše javnosti na zdravila z navedbo terapevtskih indikacij ali znakov in simptomov,“
“– drawing the attention of the general public to medicinal products by means of references to therapeutic indications or to signs and symptoms,”
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 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 ali v pisnih izjavah in objavah ali poročilih) ter referenčnega gradiva za zdravila , na primer v zvezi s spremembami na ovojnini, opozorili o neželenih učinkih kot delu splošnih previdnostnih ukrepov, prodajnimi katalogi , ceniki in povrnitvijo stroškov pod pogojem, da ne vključujejo promocijskih navedb o lastnostih 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 on a medicinal product relating , for example, to pack changes, adverse-reaction warnings as part of general drug precautions, trade catalogues, price lists and reimbursement , provided they include no promotional claims relating to medicinal products ;
Namen predloga spremembe je pojasniti področje uporabe te direktive.
This amendment aims to clarify the scope of the directive.
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 VIIIa.
– informacij , ki jih da na voljo imetnik dovoljenja za promet o zdravilih na recept za širšo javnost, za katere veljajo določbe naslova VIIIa.
– information made available 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.
Člen 100 a – odstavek 1
Article 100 a – paragraph 1
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 imetniku dovoljenja za promet omogočijo dajanje informacij na voljo širši javnosti ali njenim članom o odobrenih zdravilih na recept pod pogojem, da so skladne z določbami tega naslova.
Without prejudice to the importance of the role played by national competent authorities and healthcare professionals in better informing patients and the general public on authorised medicinal products subject to medical prescription, Member States shall allow the marketing authorisation holder to make available 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.
Imetniki dovoljenja za promet lahko nudijo dodatne informacije, ne morejo pa nadomestiti pristojnih nacionalnih organov in zdravstvenih delavcev.
Marketing authorisation holders can provide complementary information but cannot substitute themselves for national competent authorities and healthcare professionals.
Člen 100 a – odstavek 2 – točka b
Article 100a – paragraph 2 – point b
Tiskano gradivo, ki ga dobijo zdravstveni delavci za posredovanje bolnikom, mora izpolnjevati enaka merila kot druge oblike širjenja informacij.
Printed material provided to healthcare professionals for distribution to patients should respect the same criteria as the other means for disseminating information.
Zato bi bilo smiselno, da ta naslov vključuje tudi to vrsto gradiva.
It would be, therefore, reasonable that this kind of material is also covered by this Title.
Gradivo, ki vsebuje oglaševalske elemente, bi morda lahko vplivalo tudi na zdravstvene delavce.
Healthcare professionals might also be influenced by material containing advertising.
Ni objektivnega razloga, zakaj za gradivo, ki ga podjetja zagotovijo zdravstvenim delavcem za posredovanje bolnikom, ne bi veljale določbe iz tega naslova.
There is no objective reason why material provided by companies to healthcare professionals for distribution to patients isn’t subject to the provisions of this Title.
Člen 100 a – odstavek 2 – točka b a (novo)
Article 100a – paragraph 2 – point b a (new)
(ba) informativnih objav o dejstvih (vključno z objavami ali izjavami, ki so na primer pripravljene za medijske organizacije kot odgovor na neposredno poizvedovanje ali so delničarjem in/ali zakonodajalcem posredovane na konferencah ali v pisnih izjavah in objavah ali poročilih) ter referenčnega gradiva za zdravila, na primer v zvezi s spremembami na ovojnini, opozorili o neželenih učinkih kot delu splošnih previdnostnih ukrepov, prodajnimi katalogi, ceniki in povračilom stroškov pod pogojem, da ne vključujejo promocijskih navedb o lastnostih zdravila;
(ba) factual, informative announcements, including announcements or statements 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 on a medicinal product relating, for example, to pack changes, adverse-reaction warnings as part of general drug precautions, trade catalogues, price lists and reimbursement, provided they include no promotional claims relating to medicinal product s ;
Člen 100 a – odstavek 2 – točka b b (novo)
Article 100a – paragraph 2 – point b b (new)
(bb) gradiva, ki ga zdravstveni delavci dobijo za lastno uporabo.
(bb) material provided to healthcare professionals for their own use.
Člen 100 b – uvodni del
Article 100b – introductory part
Imetnik dovoljenja za promet v zvezi z odobrenimi zdravili na recept da širši javnosti ali njenim članom na voljo povzetek značilnosti zdravila, ovojnino in navodilo za uporabo zdravila, kakor so jih odobrili pristojni organi, in javno dostopno različico poročila o oceni, ki ga pripravijo pristojni organi .
The marketing authorisation holder shall, in respect of authorised medicinal products subject to medical prescription , make available to the general public or members thereof a summary of the product characteristics, labelling and package leaflet of the medicinal product, as approved by the competent authorities, and the publicly accessible version of the assessment report drawn up by the competent authorities.
Te informacije je treba dati na razpolago tako v elektronski kot v tiskani obliki ter v formatu, ki je dostopen invalidom.
This information shall be made available both in electronic and in printed form and in a format accessible to people with disabilities.
Poleg tega lahko imetnik dovoljenja za promet širši javnosti ali njenim članom daje na voljo naslednje vrste informacij:
In addition, the following types of information may also be made available to the general public or members thereof by the marketing authorisation holder :
Zahteva se, da imajo bolniki najmanj dostop do povzetka značilnosti zdravila, navodil za uporabo in javno dostopne različice poročila o oceni tako v tiskani kot elektronski obliki.
As a minimum requirement, patients should have the right to access the SPC, the package leaflet, and the publicly accessible version of the assessment report in printed as well as electronic form.
Člen 100 b – točka a
Article 100 b – point a
V skladu s predlogom spremembe za člen 100b(1), kjer se razlikuje med informacijami, do katerih so bolniki upravičeni in te morajo biti na voljo, ter informacijami, ki jih je mogoče dati na voljo, kot je določeno v členu 100b(2).
In line with the amendment on Art. 100b(1), making a distinction between information to which patients have a right and which thus must be made available on the one hand, and on the other hand, information which may be made available as set out in Art. 100b(2).
Člen 100 b – točka b
Article 100b – point b
(a) informacije, ki ne presegajo prvin povzetka značilnosti zdravila, ovojnine in navodila za uporabo zdravila, in javno dostopna različica poročila o oceni, ki jo pripravijo pristojni organi, vendar jih predstavi na bolniku prijazen način , tako da so razumljive širši javnosti ali njenim članom, ne da bi to ogrozilo kakovost ali zanesljivost informacij, ki so dane na voljo, niti njihove izčrpnosti in nepristranskosti;
(a) information which does not go beyond the elements of the summary of product characteristics, labelling and the package leaflet of the medicinal product, and the publicly accessible version of the assessment report drawn up by the competent authorities, but presents them in a patient-friendly way that is comprehensible to the general public or members thereof without jeopardising the quality or reliability of the information made available, including its comprehensive and impartial nature ;
Treba je pojasniti, da bi morali z drugačnim podajanjem informacij okrepiti zmožnost bolnikov, da jih bolje razumejo, s čimer bi zagotovili, da bodo predstavljene na bolniku prijaznejši način.
It should be clarified that putting information in a different way must enhance patients’ ability to better understand the information, thus ensuring that it will be presented in a more patient-friendly way.
Člen 100 b – točka c
Article 100b – point c
(c) informacije o vplivu zdravila na okolje, cene in informativne objave o dejstvih ter referenčna gradiva, na primer v zvezi s spremembami na ovojnini ali opozorili o neželenih učinkih;
(c) information on the environmental impact of the medicinal product , prices and factual, informative announcements and reference material relating, for example, to pack changes or adverse-reaction warnings;
(b) informacije o odlaganju neuporabljenih zdravil ali iz njih nastalih odpadnih snovi kot tudi napotitev na uveljavljen sistem zbiranja teh snovi ; informacije o cenah in informativne objave o dejstvih ter referenčna gradiva o zdravilu , na primer v zvezi s spremembami na ovojnini ali opozorili o neželenih učinkih;
(b) information relating to the disposal of unused medicinal products or waste derived from medicinal products , as well as reference to any collection system in place; information on prices and factual, informative announcements and reference material on a medicinal product, relating, for example, to pack changes or adverse-reaction warnings;
Zdravila vplivajo na okolje.
Medicines have an impact on the environment.
Te informacije so še posebej pomembne v zvezi s sistemi odlaganja in zbiranja, zato da se prepreči okoljska škoda.
Therefore, such information, especially with regard to disposal and collection systems, is important to prevent any environmental harm.
Člen 100 b – točka d
Article 100b – point d
Predlog spremembe se nanaša na informacije, ki jih pristojni organi niso odobrili pri registraciji zdravila, in gre dejansko za aktivno posredovanje informacij (push information).
The proposed amendment relates to information not approved by competent authorities during the registration of medicinal products and is in fact hidden “push” information.
Člen 100 b – točka d a (novo)
Article 100b – point d a (new)
(da) druge informacije o zdravilih na recept na podlagi tega naslova, kot so informacije o farmacevtskih in predkliničnih preizkusih ali kliničnih preskušanjih, ki izpolnjujejo pogoje iz člena 100d in ne oglašujejo nobenega posameznega zdravila.
(da) other information on medicinal products subject to medical prescription provided under this Title, such as information about the pharmaceutical and pre-clinical tests or clinical trials, that meets the criteria set out in Article 100d and does not promote any individual medicinal product.
Bolniki bi morali imeti možnost, da dobijo informacije o farmacevtskih in predkliničnih preizkusih ter kliničnih preskušanjih.
Patients should be given the opportunity to get information about the pharmaceutical and pre-clinical tests and the clinical trials.
Ker pa je narava teh preizkusov in preskušanj poslovno občutljiva, farmacevtskih družb ne bi smeli obvezati k temu, da dajejo na voljo tovrstno dokumentacijo; če pa jo želijo objaviti, jim je treba to omogočiti.
Considering, however, the commercial sensitivity of these tests and trials, pharmaceutical companies cannot be obliged to make such test and trial documentation available; they, however, should be allowed to make that documentation public if they so wish.
Člen 100 c – uvodni del
Article 100c – introductory part
Informacije o odobrenih zdravilih na recept, ki jih imetnik dovoljenja za promet širi za širšo javnosti ali njene člane , niso na voljo na televiziji ali radiu.
Information on authorised medicinal products subject to medical prescription disseminated by the marketing authorisation holder to the general public or members thereof shall not be made available on television or radio.
Informacije o odobrenih zdravilih na recept, ki jih imetnik dovoljenja za promet da na voljo širši javnosti ali njenim članom , niso na voljo na televiziji , radiu ali v tiskanih medijih .
Information on authorised medicinal products subject to medical prescription made available by the marketing authorisation holder to the general public or members thereof shall not be made available on television , radio or in the printed media .
Namen predloga spremembe je pojasniti, kaj je mišljeno s tiskanimi mediji.
The amendment aims at clarifying what is meant by printed media.
Kot kanali, po katerih se dajejo informacije na voljo javnosti, bi morali biti dovoljeni tudi informativni listi in brošure.
Booklets, leaflets etc. should be allowed as channels for making information available to patients.
Člen 100 c – točka a
Article 100c – point a
(a) publikacije v zvezi z zdravjem, kakor jih opredeli država članica publikacije , ob izključitvi nezaželenega gradiva, ki se aktivno razpošilja širši javnosti ali njenim članom;
(a) health-related publications as defined by the Member State of publication , to the exclusion of unsolicited material actively distributed to the general public or members thereof;
(a) brošure, informativni listi in drugo tiskano informativno gradivo, znanstvene in tehnične revije ali revije, namenjene širši javnosti s pretežno zdravstveno vsebino, vključno s publikacijami v zvezi z zdravjem, kakor jih opredeli Komisija v svojih smernicah o dovoljenih informacijah, ob izključitvi nezaželenega gradiva, ki se aktivno razpošilja širši javnosti ali njenim članom;
(a) booklets, leaflets, and other categories of printed information, scientific and technical journals or magazines aimed at the general public with mainly health-related content, including health-related publications as defined by the Commission’s guidelines concerning the information allowed , to the exclusion of unsolicited material actively distributed to the general public or members thereof;
Člen 100 c – točka b
Article 100c – point b
(b) spletne strani o zdravilih, ob izključitvi nezaželenega gradiva, ki se aktivno razpošilja širši javnosti ali njenim članom ;
(b) internet websites on medicinal products, to the exclusion of unsolicited material actively distributed to the general public or members thereof ;
(b) spletna mesta imetnikov dovoljenja za promet in drugi elektronski arhivi informacij o zdravilih ob izključitvi nezaželenega posredovanja državljanom prek sredstev množičnega obveščanja, kot so e-pošta in kratka sporočila (SMS), poslani več prejemnikom hkrati ;
(b) marketing authorisation holders’ internet websites and other electronic repositories containing information on medicinal products, to the exclusion of unsolicited distribution to citizens through mass communications such as e-mails and telephone text messages to multiple recipients ;
„Drugi elektronski arhivi informacij o zdravilih”: pojasnitev je potrebna, zato da se dovoli zagotavljanje visokokavostnih nepromocijskih informacij prek elektronskih arhivov, ki niso samo spletna mesta.
“other electronic repositories containing information”: A necessary clarification to allow provision of high-quality non-promotional information through electronic repositories that are not strictly Internet websites.
Poleg teh že obstajajo druga sredstva za elektronsko komuniciranje, prek katerih imajo lahko tisti, ki iščejo informacije, dostop do referenčnih informacij (na primer referenčne strani na videotekstu, dostopne prek televizijskih sprejemnikov ali telefonov).
There are already electronic communication media that are not websites but through which information seekers can access reference information (eg reference text pages made available through TV sets or via telephone systems.
Tudi internet postaja vse bolj dinamičen in presega statična spletna mesta.
The Internet is also becoming much more dynamic and is going beyond static websites.
Pomembno je, da je direktiva pripravljena na razvoj v prihodnosti.
It is important that the directive is fit for the future.
Člen 100 c – točka c
Article 100 c – point c
(c) pisni odgovori na zahtevke po informacijah s strani člana širše javnosti .
(c) written answers to requests for information of a member of the general public.
(c) odgovori na zahtevke člana širše javnosti po informacijah.
(c) answers to requests for information from a member of the general public.
Ustna vprašanja je treba zabeležiti.
Verbal questions must be recorded.
Člen 100 c a (novo)
Article 100c a (new)
Člen 100ca
Article 100ca
Države članice zagotovijo, da so obvezne informacije iz člena 100b(1) na voljo prek nacionalnih spletnih mest o zdravju v uradnem jeziku (uradnih jezikih) države članice, v kateri je spletno mesto registrirano.
Member States shall ensure that the mandatory information as referred to in Article 100b(1) shall be made available through national health websites in the official language(s) of the Member State where the website is registered.
Ta spletna mesta spremlja pristojni organ države članice ali telo, ki ga določi pristojni organ v skladu s členom 100g.
Such websites shall be monitored by a competent authority of the Member State or by a body assigned by the competent authority in accordance with Article 100g.
Spletna mesta se upravljajo in urejajo v sodelovanju z zainteresiranimi stranmi, kot so zdravstveni delavci in organizacije bolnikov.
The websites shall be administered and managed in cooperation with stakeholders such as healthcare professionals and patient organisations.
Informacije opisujejo tako koristi kot tveganja na jasen način, ki je bolniku prijazen in povezan z nacionalnimi spletnimi mesti o varnosti zdravil.
The information shall communicate both benefits and risks in a clear descriptive manner that is patient friendly and linked to the national medicinal products safety website.
Spletna mesta bolnikom dajejo obvezne informacije o vseh razpoložljivih zdravilih v tej državi članici, ki jih centralno odobri Evropska agencija za zdravila, lokalno pa ta država članica.
The websites shall provide patients with the mandatory information on all available medicinal products in that Member State both centrally approved by the European Medicines Agency and locally approved in that Member State.
Spletna mesta vključujejo tudi splošne informacije o zdravljenju različnih bolezni z zdravili in brez njih, vključno z redkimi boleznimi, da se spodbudi višja raven javnega zdravja.
The websites should also include general information about medicinal and non-medicinal treatment of various diseases, including rare diseases, in order to promote a high level of public health.
Vključujejo pa lahko tudi druge informacije, kot je navedeno v členu 100b(2) in opredeljeno v smernicah Komisije o dovoljenih informacijah.
They may also contain other information as referred to in Article 100b(2) and as defined by the Commission’s guidelines concerning information allowed.