natgillin/translations-raw huggingface dataset:
(i)Direktiva bi morala biti namenjena predvsem bolnikom, zato je treba spremeniti njeno žarišče: poudarek bi moral biti na pravici bolnikov do dostopa do informacij, ne pa na priložnosti farmacevtskih podjetij za njihovo širjenje. (ii) 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.
(i)The Directive should be made patient-centred and therefore its focus has to be shifted: emphasis should be put on the right of patients to access information and not on the opportunity for pharmaceutical companies to disseminate information . (ii) 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.
Člen 100 a – odstavek 1 a (novo)
Article 100 a – paragraph 1 a (new)
Zdravstveni delavci, ki dajejo informacije o zdravilih ali medicinskih napravah na javni prireditvi, v tisku ali radiu in televiziji, javno razglasijo svoje interese, na primer vse finančne vezi z imetniki dovoljenja za promet ali s tretjimi strankami, ki delajo v njihovem imenu.
Health professionals who deliver information on medicinal products or medical devices during a public event, in print or broadcast media shall declare publicly their interests, for example any financial ties with marketing authorisation holders or with third parties working on their behalf.
To vključuje tudi opravljanje svetovalnih storitev in tehničnega svetovanja o zadevnem(-ih) proizvodu(-ih).
This also includes the provision of consulting services and technical advice about the product(s) in question.
Člen 100 a – odstavek 1 b (novo)
Article 100 a – paragraph 1 b (new)
Organizirati bi bilo treba informacijske kampanje za večjo ozaveščenost širše javnosti in njenih članov o tveganju ponarejenih zdravil.
Information campaigns aimed at raising awareness among the general public and members thereof about the risks of falsified medicinal products should be organised.
Te informacijske kampanje lahko izvedejo pristojni nacionalni organi v sodelovanju z industrijo, zdravstvenimi delavci in organizacijami bolnikov.
Such information campaigns may be conducted by national competent authorities in collaboration with industry, healthcare professionals and patient organisations.
Da bi bolje zaščitili zdravje ljudi, bi lahko bile za bolnike zelo uporabne in koristne informacijske kampanje o tveganju ponarejenih zdravil, ki jih sprožijo nacionalni organi.
In order to better protect human health, information campaigns about the risks of falsified medicines, initiated by national authorities, could be very useful and beneficial to patients.
Da bi izboljšali kakovost teh informacijskih kampanj in zagotovili, da bodo dosegle bolnike na učinkovit način, bi morali nacionalni organi upoštevati strokovno znanje industrije, zdravstvenih delavcev in organizacij bolnikov o tej zadevi.
In order to increase the quality of these information campaigns and to ensure that they reach patients in an effective way, national authorities should take into consideration the expertise on the matter coming from the industry, health care professionals and patient organisations.
Člen 100 a – odstavek 2
Article 100 a – paragraph 2
Ta naslov ne vključuje:
This Title shall not cover the following:
(a) informacij v zvezi z zdravjem ljudi ali boleznimi pod pogojem, da ni nobenega napotila, tudi posrednega ne, na zdravila;
(a) information relating to human health or diseases, provided that there is no reference, even indirect, to medicinal products;
(a) 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, v pisnih izjavah in objavah ali poročilih) ter referenčnega gradiva za zdravila, na primer sprememb na ovojnini, opozoril o neželenih učinkih kot dela splošnih previdnostnih ukrepov, prodajnih katalogov, cenikov in povrnitve stroškov pod pogojem, da njihov namen ni oglaševanje določenega zdravila;
(a) 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 that they do not intend to promote an individual medicinal product;
(b) gradiva, ki ga imetnik dovoljenja za promet zagotovi zdravstvenim delavcem za posredovanje bolnikom.
(b) material provided by the marketing authorisation holder to healthcare professionals for distribution to patients.
(b) gradiva, ki ga zdravstveni delavci dobijo za lastno uporabo.
(b) material provided to healthcare professionals for their own use.
Zaradi doslednosti in skladnosti z navedenimi cilji predloga in da bi bolje poskrbeli za to, da informacije ne bodo namenjene promociji, bi morale biti določbe iz točk a) in b) vključene v področje uporabe poglavja VIII.
For consistency and coherency with the stated aims of the proposal and to better ensure that information provided is not of promotional nature, of the directive points the provisions set our in point a) and b) should fall under the scope of Title VIII.
Predlog spremembe je v skladu s predlogom spremembe člena 86(2), njegov namen pa je pojasniti področje uporabe direktive.
This amendment is coherent with the amendment on article 86(2) and aims at clarifying the scope of the directive.
Imetnikom dovoljenja za promet bi moralo biti omogočeno, da zagotavljajo določene informacije.
Market authorization holders should be allowed to provide certain information.
Pravila trga vrednostnih papirjev zahtevajo, da podjetja redno v celoti obveščajo vlagatelje o pomembnih dogodkih, zaposlene pa o poslovnem razvoju.
Stock market rules require that companies keep investors fully informed of significant developments and employees must be kept informed of business developments.
To je treba jasno zapisati, da bi omogočili ustrezno zagotavljanje teh informacij.
It is necessary to specify this to allow appropriate provision of such information.
Treba je zagotoviti, da direktiva ne vključuje informacij, ki jih zdravstveni delavci dobijo za lastno uporabo.
It should be ensured that information provided to healthcare professionals for their own use is not covered by the Directive.
Člen 100 a – odstavek 2 a (novo)
Article 100 a - paragraph 2 a (new)
Določbe te direktive ne posegajo v pravico oseb ali organizacij, zlasti medijev, bolnikov ali organizacij bolnikov, da izrazijo svoje stališče o zdravilih, ki se izdajajo samo na recept, pod pogojem, da delujejo neodvisno, ne pa neposredno ali posredno v imenu imetnika dovoljenja za promet, po njegovih navodilih ali v njegovem interesu.
The provisions of this Directive shall be without prejudice to the right of any other person or organisation, in particular the press or patients and patient organisations, to express their views on prescription-only medicinal products , provided that they are acting independently and not directly or indirectly on behalf of, on the instructions of , or in the interest of the marketing authorisation holder.
Glede na nedavno dogajanje v sodni praksi je treba poudariti, da določbe te direktive v nobenem primeru ne vplivajo na pravico oseb, organizacij, zlasti medijev ali skupin bolnikov, da izrazijo svoje stališče o zdravilih, ki se izdajajo samo na recept, a pod pogojem, da ne delujejo v interesu ali v imenu farmacevtskih podjetij.
With reference to recent developments in the case law it has to be emphasised that the provisions of this Directive do not affect the right of any other person or organisation, in particular the press or patients' groups to express their views on prescription-only medicines as long as they are acting not in the interest of, or on behalf of the pharmaceutical companies .
Člen 100 b
Article 100b
Imetnik dovoljenja za promet lahko za širšo javnost ali njene člane širi naslednje vrste informacij o odobrenih zdravilih na recept:
The following types of information on authorised medicinal products subject to medical prescription may be disseminated by the marketing authorisation holder to the general public or members thereof:
Imetnik dovoljenja za promet daje na voljo širši javnosti ali njenim članom naslednje informacije o odobrenih zdravilih na recept:
The marketing authorisation holder shall, in respect of authorised medicinal products subject to medical prescription , make available to the general public or members thereof the following information:
(a) najnovejšo različico povzetka značilnosti zdravila , kot so jo odobrili pristojni organi med postopkom izdaje ali podaljšanja dovoljenja za promet;
(a) the most recent summary of product characteristics as approved by the competent authorities during the course of marketing authorisation and authorisation renewal;
(b) najnovejšo različico ovojnine in navodila za uporabo zdravila , kakor so ju odobrili pristojni organi med postopkom izdaje ali spremembe dovoljenja za promet; ter
(b) the most recent labelling and package leaflet as approved by the competent authorities during the course of marketing authorisation or authorisation variation; and
(c) najnovejšo javno dostopno različico poročila o oceni, ki jo pripravijo pristojni organi med postopkom izdaje ali spremembe dovoljenja za promet;
(c) the most recent, publicly accessible version of the assessment report as drawn up by the competent authorities during the course of marketing authorisation and authorisation updates .
(a) povzetek značilnosti zdravila, ovojnino in navodilo za uporabo zdravila, kakor so jih odobrili pristojni organi, in javno dostopna različica poročila o oceni, ki jo pripravijo pristojni organi;
(a) the summary of 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.
Informacije morajo biti na voljo v obliki, ki verodostojno ponazarja uradno odobrene informacije, ki so jih pripravili pristojni organi.
That information shall be presented in a format that faithfully represents the officially approved information drawn up by the competent authorities.
Na voljo morajo biti v elektronski in tiskani obliki ter v oblikah, namenjenim slepim in slabovidnim osebam.
The information shall be made available both in electronic and printed form, and in formats appropriate for the blind and partially-sighted.
(b) 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 drugačen način;
(b) 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 different way;
Imetnik dovoljenja za promet daje na voljo širši javnosti ali njenim članom naslednje informacije o odobrenih zdravilih na recept:
The marketing authorisation holder may, in respect of authorised medicinal products subject to medical prescription, make available to the general public or members thereof the following information:
(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;
(a) informacije o vplivu zdravila na okolje poleg informacij o sistemu odlaganja in zbiranja v skladu s členom 54(j), ki se dajo na voljo v skladu s prvim odstavkom tega člena;
(a) information on the environmental impact of the medicinal product further to the information provided on the disposal and collection system pursuant to Article 54 (j) and made available pursuant to paragraph 1 of this Article;
(b) informacije o cenah;
(b) information on prices ;
(c) informacije o spremembah na ovojnini;
(c) information on pack changes ;
(d) opozorila o neželenih učinkih poleg informacij, zagotovljenih v skladu s členom 59(1) (e) in danih na voljo v skladu s prvim odstavkom tega člena;
(d) adverse-reaction warnings further to the information provided pursuant to Article 59 (1) (e) and made available pursuant to paragraph 1 of this Article ;
(f) farmacevtski in predklinični preizkusi ter klinična preskušanja zadevnih zdravil, ki jih vsebuje javno dostopna različica poročila o oceni iz odstavka 1;
(f) the pharmaceutical and pre-clinical tests and the clinical trials of the medicinal product concerned that are contained in the publicly accessible version of the assessment report referred to in paragraph 1;
(g) povzetek pogosto predloženih zahtev za posredovanje informacij v skladu s členom 100c(c) in odgovorov nanje.
(g) a summary of the frequently submitted requests for information pursuant to Article 100c (c), and the subsequent answers.
(d) informacije v zvezi z zdravilom o neintervencijskih znanstvenih študijah ali spremne ukrepe za preprečevanje in zdravljenje ali informacije, ki predstavljajo zdravilo v okviru stanja bolezni, ki ga je treba preprečiti ali zdraviti.
(d) medicinal product-related information about non-interventional scientific studies, or accomp a nying measures to prevention and medical treatment, or information which presents the medicinal product in the context of the condition to be prevented or treated.
Informacije v skladu s točkami (a) do (g) morajo biti na voljo v elektronski in tiskani obliki ter v oblikah, namenjenim slepim in slabovidnim osebam.
Information pursuant to points (a) to (g) shall be made available both in electronic and printed form, and in formats appropriate for the blind and partially-sighted.
Informacije v skladu s točkami (a) do (g) pred njihovo objavo za namene tega člena odobrijo pristojni organi ali agencija, v primeru izdaje dovoljenja za promet na ravni Skupnosti.
Information pursuant to points (a) to (g) shall be approved by the competent authorities, or in case of Community marketing authorisation, by the Agency, prior to its being made available for the purpose of this Article.
Člen 100 c
Article 100c
Informacije o odobrenih zdravilih na recept, ki jih imetnik dovoljenja za promet širi za širšo javnost 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.
Na voljo se dajo samo prek naslednjih kanalov:
It shall only be made available through the following channels:
Informacije o odobrenih zdravilih na recept, ki jih imetnik dovoljenja za promet da na razpolago za širšo javnost ali njene člane, niso na voljo na televiziji, radiu ali v časopisih, revijah in podobnih publikacijah .
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 newspapers, magazines and similar publications .
(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;
(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 o zdravilih, registranih in upravljanih v skladu s členom 100h, ob izključitvi nezaželenega gradiva, ki se aktivno razpošilja širši javnosti ali njenim članom;
(b) internet websites on medicinal products registered and managed in accordance with Article 100h , to the exclusion of unsolicited material actively distributed to the general public or members thereof;
(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 posebne zahtevke po informacijah o zdravilih s strani člana širše javnosti ;
(c) answers to specific requests for information about a medicinal product of a member of the general public ;
(ca) tiskovine o zdravilu, ki jih je pripravil imetnik dovoljenja za promet v skladu s členom 100b na posebno zahtevo člana širše javnosti.
(ca) printed materials about a medicinal product prepared by the marketing authorisation holder pursuant to Article 100b upon specific request by a member of the general public.
Člen 100 d – odstavek 1 – uvodni del
Article 100d – paragraph 1 – introductory part
Vsebina in predstavitev informacij o odobrenih zdravilih na recept, ki jih imetnik dovoljenja za promet širi za širšo javnost ali njene člane, izpolnjujeta naslednje pogoje:
The content and presentation of information on authorised medicinal products subject to medical prescription disseminated by the marketing authorisation holder to the general public or members thereof shall fulfil the following conditions:
Vsebina in predstavitev informacij o odobrenih zdravilih na recept, ki jih imetnik dovoljenja za promet da na voljo za širšo javnost ali njene člane, izpolnjujeta naslednje pogoje:
The content and presentation of information on authorised medicinal products subject to medical prescription made available by the marketing authorisation holder to the general public or members thereof shall fulfil the following conditions:
Informacij ne bi smel širiti imetnik dovoljenja za promet, saj bi to lahko pomenilo, da ima aktivno vlogo („push“) pri posredovanju informacij javnosti.
Information should not be disseminated by the marketing authorization holder as it may imply an active role (push) in passing information to the public.
Vendar pa imetnik dovoljenja za promet informacije lahko da na voljo javnosti: javnost mora imeti proaktivno vlogo pri iskanju teh informacij („pull“).
Information may, however, be made available to the public by the marketing authorization holder: the public must have a proactive role in seeking such information (pull).
Člen 100 d – odstavek 1 – točka b
Article 100d – paragraph 1 – point b
b) morata upoštevati splošne potrebe in pričakovanja bolnikov ;
b) it must take into account the general needs and expectations of patients ;
b) morata biti usmerjena k bolniku, da bolje izpolnjujeta njihove potrebe ;
b) it must be patient oriented to better meet patients' needs;
Preoblikovanje besedila, da se bolje odraža eden glavnih ciljev predloga, namreč da se omogočijo informacije, ki jih želijo bolniki in ki bolje izpolnjujejo njihove posebne potrebe.
Re-wording to better reflect one of the main objectives of the proposal, namely to provide information that patients want and that better meets their individual needs.
Člen 100 d – odstavek 1 – točka f
Article 100d – paragraph 1 – point f
(f) morata biti razumljivi za splošno javnost ali njene člane;
(f) it must be understandable for the general public or members thereof;
(f) morata biti razumljivi in jasno čitljivi za splošno javnost in njene člane s posebnim upoštevanjem starejših ljudi ;
(f) it must be understandable and perfectly legible for the general public and members thereof , paying particular attention to elderly people ;
Člen 100 d – odstavek 1 a (novo)
Article 100 d - paragraph 1 a (new)
Komisija do ...* Evropskemu parlamentu in Svetu predloži poročilo o oceni trenutnih pomanjkljivostih v povzetku glavnih značilnosti proizvoda in navodil za uporabo ter predloge za njihovo izboljšanje, da bi bolje zadovoljili potrebe bolnikov in zdravstvenih delavcev.
By ...* , the Commission shall present to the European Parliament and the Council an assessment report on current shortcomings in the summary of product characteristics and the package leaflet and how they could be improved in order to better meet the needs of patients and healthcare professionals.
Komisija, če je to primerno, na temelju poročila in posvetovanja z ustreznimi udeleženci, pripravi predloge za izboljšanje berljivosti, predstavitve in vsebine teh dokumentov.“
The Commission shall, if appropriate, and on the basis of the report, and after consultation with appropriate stakeholders, present proposals in order to improve the readability, layout and content of these documents.
* UL: vstavite datum 24 mesecev po začetku veljavnosti te direktive
* OJ: Insert date 24 months after the entry into force of this Directive
Uskladitev z direktivo o farmakovigilanci.
Alignment to Directive on Pharmacovigilance.
Člen 100 d – odstavek 2 – točka b
Article 100d – paragraph 2 – point b
(b) izjavo, da je namen informacij podpreti, in ne nadomestiti, odnos med bolnikom in zdravstvenim delavcem ter da mora bolnik, če potrebuje pojasnilo o zagotovljenih informacijah , stopiti v stik z zdravstvenim delavcem;
(b) a statement indicating that the information is intended to support, not to replace, the relationship between patient and health professionals and that a health professional should be contacted if the patient requires clarification on the information provided;
(b) izjavo, da je namen informacij podpreti, in ne nadomestiti, odnos med bolnikom in zdravstvenim delavcem ter da mora bolnik, če potrebuje pojasnilo ali dodatne informacije o zagotovljenih informacijah , stopiti v stik z zdravstvenim delavcem;
(b) a statement indicating that the information is intended to support, not to replace, the relationship between patient and health professionals and that a health professional should be contacted if the patient requires clarification or further information on the information provided;
Predlog spremembe pojasnjuje, da mora bolnik stopiti v stik z zdravstvenim delavcem, če potrebuje dodatno pojasnilo.
To clarify in the statement that a health professional should be contacted if a patient requires further information.
Zdravstveni delavec sicer morda ne bo mogel odgovoriti na vprašanja v zvezi z informacijami, ki jih zagotovi proizvajalec.
The health professional may however not be in a position to answer specific questions relating to the information provided by the manufacturer.
Člen 100 d – odstavek 2 – točka c
Article 100 d – paragraph 2 – point c
(c) izjavo, da informacije širi imetnik dovoljenja za promet;
(c) a statement indicating that the information is disseminated by a marketing authorisation holder;
(c) izjavo, da informacije da na voljo poimensko naveden imetnik dovoljenja za promet ali so dane na voljo v njegovem imenu ;
(c) a statement indicating that the information is made available by , or on behalf of , a named marketing authorisation holder;
Lahko se zgodi, da tretja stranka širi informacije v imenu imetnika dovoljenja za promet.
A third party may undertake dissemination on behalf of the Marketing Authorisation Holder.
Bralci morda ne poznajo izraza „imetnik dovoljenja za promet”.
Readers of the statement may not be familiar with the term “marketing authorisation holder”.
Izjava, ki vsebuje ime imetnika dovoljenja za promet, je torej bolj smiselna in razumljivejša.
A statement bearing the name of the marketing authorisation holder is more meaningful and understandable.
Člen 100 d – odstavek 2 – točka d
Article 100 d – paragraph 2 – point d