FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: Without prejudice to Article 88, all advertising to the general public of a medicinal product shall:
Slovenian: Brez poseganja v člen 88, se celotno oglaševanje širši javnosti zdravila:
English: be set out in such a way that it is clear that the message is an advertisement and that the product is clearly identified as a medicinal product;
Slovenian: pripravi tako, da je jasno, da gre za reklamno sporočilo ter, da je izdelek jasno predstavljen kot zdravilo;
English: include the following minimum information:
Slovenian: da vključuje najmanj naslednje podatke:
English: the name of the medicinal product, as well as the common name if the medicinal product contains only one active substance,
Slovenian: ime zdravila, kot tudi splošno ime, če zdravilo vsebuje samo eno zdravilno učinkovino,
English: the information necessary for correct use of the medicinal product,
Slovenian: informacije, potrebne za pravilno uporabo zdravila,
English: an express, legible invitation to read carefully the instructions on the package leaflet or on the outer packaging, as the case may be.
Slovenian: jasno čitljivo povabilo uporabniku, da natančno prebere navodila na navodilu za uporabo ali na zunanji ovojnini, odvisno od primera.
English: Member States may decide that the advertising of a medicinal product to the general public may, notwithstanding paragraph 1, include only the name of the medicinal product if it is intended solely as a reminder.
Slovenian: Države članice se lahko odločijo, da oglaševanje zdravila širši javnosti lahko, ne glede na odstavek 1, vključuje samo ime zdravila, če služi izključno kot opomnik.
English: The advertising of a medicinal product to the general public shall not contain any material which:
Slovenian: Oglaševanje zdravila širši javnosti ne sme vsebovati podatkov, ki:
English: gives the impression that a medical consultation or surgical operation is unnecessary, in particular by offering a diagnosis or by suggesting treatment by mail;
Slovenian: dajejo vtis, da sta posvet z zdravnikom ali kirurški poseg nepotrebna, zlasti z nudenjem diagnoze ali predlogom zdravljenja po pošti;
English: suggests that the effects of taking the medicine are guaranteed, are unaccompanied by adverse reactions or are better than, or equivalent to, those of another treatment or medicinal product;
Slovenian: nakazujejo, da so učinki jemanja zdravila zagotovljeni, da ni neželenih učinkov ali da je boljše kot ali enakovredno drugemu zdravljenju ali drugemu zdravilu;
English: suggests that the health of the subject can be enhanced by taking the medicine;
Slovenian: nakazujejo, da se zdravje osebe lahko izboljša z jemanjem zdravila;
English: suggests that the health of the subject could be affected by not taking the medicine;
Slovenian: nakazujejo, da bi zdravje osebe lahko bilo prizadeto brez jemanja zdravila;
English: this prohibition shall not apply to the vaccination campaigns referred to in Article 88(4);
Slovenian: ta prepoved se ne uporablja za kampanje o cepljenju iz člena 88(4);
English: is directed exclusively or principally at children;
Slovenian: je usmerjen izključno ali pretežno k otrokom;
English: refers to a recommendation by scientists, health professionals or persons who are neither of the foregoing but who, because of their celebrity, could encourage the consumption of medicinal products;
Slovenian: se sklicuje na priporočila znanstvenikov, zdravstvenih strokovnjakov ali oseb, ki niso ne eno ne drugo, pa bi zaradi svoje slave lahko spodbujali potrošnjo zdravil;
English: suggests that the medicinal product is a foodstuff, cosmetic or other consumer product;
Slovenian: nakazujejo, da je zdravilo živilo, kozmetični ali drug potrošniški izdelek;
English: suggests that the safety or efficacy of the medicinal product is due to the fact that it is natural;
Slovenian: nakazujejo, da se varnost in učinkovitost zdravila pripisuje dejstvu, da je naravnega izvora;
English: could, by a description or detailed representation of a case history, lead to erroneous self-diagnosis;
Slovenian: bi zaradi opisa ali podrobne predstavitve anamneze lahko privedel do napačne samodiagnoze;
English: refers, in improper, alarming or misleading terms, to claims of recovery;
Slovenian: ob uporabi neprimernih, vznemirljivih ali zavajajočih izrazov o možnostih okrevanja;
English: uses, in improper, alarming or misleading terms, pictorial representations of changes in the human body caused by disease or injury, or of the action of a medicinal product on the human body or parts thereof;
Slovenian: uporablja neprimerne, vznemirljive ali zavajajoče izraze, slikovne predstavitve sprememb v človeškem telesu, ki jih je povzročila bolezen ali poškodba, ali delovanje zdravila na človeško telo ali dele telesa;
English: mentions that the medicinal product has been granted a marketing authorization.
Slovenian: navaja, da je za zdravilo bilo izdano dovoljenje za promet z zdravilom.
English: Any advertising of a medicinal product to persons qualified to prescribe or supply such products shall include:
Slovenian: Oglaševanje zdravil osebam, usposobljenim za predpisovanje ali izdajanje zdravil, vsebuje:
English: essential information compatible with the summary of product characteristics;
Slovenian: osnovne informacije v skladu s povzetkom glavnih značilnosti zdravila,
English: the supply classification of the medicinal product.
Slovenian: razvrstitev zdravila glede na izdajanje.
English: Member States may also require such advertising to include the selling price or indicative price of the various presentations and the conditions for reimbursement by social security bodies.
Slovenian: Države članice lahko tudi zahtevajo, da oglaševanje zdravila osebam, usposobljenim za predpisovanje ali izdajanje zdravila, vključuje prodajno ceno ali okvirno ceno za različne oblike pakiranja ter pogoje za nadomestilo stroškov s strani organov socialnega varstva.
English: Member States may decide that the advertising of a medicinal product to persons qualified to prescribe or supply such products may, notwithstanding paragraph 1, include only the name of the medicinal product, if it is intended solely as a reminder.
Slovenian: Države članice se lahko odločijo, da oglaševanje zdravila osebam, usposobljenim za predpisovanje ali izdajanje zdravil, ne glede na odstavek 1, vključuje samo ime zdravila, če to služi izključno kot opomnik.
English: Any documentation relating to a medicinal product which is transmitted as part of the promotion of that product to persons qualified to prescribe or supply it shall include, as a minimum, the particulars listed in Article 91(1) and shall state the date on which it was drawn up or last revised.
Slovenian: Dokumentacija v zvezi zdravilom, ki se kot del njegove promocije pošilja osebam, usposobljenim za predpisovanje ali izdajanje zdravil, vsebuje najmanj podatke iz člena 91(1) in navaja datum, ko je bila pripravljena ali nazadnje revidirana.
English: All the information contained in the documentation referred to in paragraph 1 shall be accurate, up-to-date, verifiable and sufficiently complete to enable the recipient to form his or her own opinion of the therapeutic value of the medicinal product concerned.
Slovenian: Vse informacije v dokumentaciji iz odstavka 1, morajo biti točne, usklajene z zadnjim stanjem, preverljive in dovolj popolne, da prejemniku omogočijo, da si ustvari lastno mnenje o terapevtski vrednosti zadevnega zdravila.
English: Quotations as well as tables and other illustrative matter taken from medical journals or other scientific works for use in the documentation referred to in paragraph 1 shall be faithfully reproduced and the precise sources indicated.
Slovenian: Navedbe in preglednice ter ostalo slikovno gradivo iz medicinskih revij ali drugih znanstvenih del se v dokumentaciji iz odstavka 1 verodostojno povzame s točno navedbo virov.
English: Medical sales representatives shall be given adequate training by the firm which employs them and shall have sufficient scientific knowledge to be able to provide information which is precise and as complete as possible about the medicinal products which they promote.
Slovenian: Podjetje, ki zaposluje strokovne sodelavce za prodajo zdravil, jim mora omogočati ustrezno usposabljanje; imeti morajo dovolj strokovnega znanja, da lahko posredujejo informacije, ki so v največji možni meri natančni in popolni podatki o zdravilu, ki je predmet njihove promocije.
English: During each visit, medical sales representatives shall give the persons visited, or have available for them, summaries of the product characteristics of each medicinal product they present together, if the legislation of the Member State so permits, with details of the price and conditions for reimbursement referred to in Article 91(1).
Slovenian: Ob vsakem obisku strokovni sodelavci za prodajo zdravil obiskanim osebam posredujejo ali jim dajo na voljo povzetke glavnih značilnosti zdravila za vsako predstavljeno zdravilo, skupaj s podrobnostmi o ceni in pogojih za nadomestilo plačila, navedenega v členu 91(1), če zakonodaja države članice to dovoljuje.
English: Medical sales representatives shall transmit to the scientific service referred to in Article 98(1) any information about the use of the medicinal products they advertise, with particular reference to any adverse reactions reported to them by the persons they visit.
Slovenian: Strokovni službi, navedeni v členu 98(1), strokovni sodelavci za prodajo zdravil prenesejo vse informacije o uporabi zdravil, ki jih oglašujejo, s posebno navedbo kakršnih koli neželenih učinkov, o katerih so jim poročale obiskane osebe.
English: Where medicinal products are being promoted to persons qualified to prescribe or supply them, no gifts, pecuniary advantages or benefits in kind may be supplied, offered or promised to such persons unless they are inexpensive and relevant to the practice of medicine or pharmacy.
Slovenian: Pri promocijah zdravil se ne sme dajati, ponujati ali obljubljati daril, denarnih ugodnosti ali nuditi materialne koristi osebam, usposobljenim za predpisovanje ali izdajanje zdravil, razen če so ti majhne vrednosti in se lahko uporabljajo za opravljanje zdravstvene ali lekarniške dejavnosti.
English: Hospitality at sales promotion shall always be reasonable in level and secondary to the main purpose of the meeting and must not be extended to other than health professionals.
Slovenian: Gostoljubnost med promocijskimi srečanji mora biti zmerna in sekundarnega pomena glede na glavni namen srečanja, deležni pa je smejo biti samo zdravstveni strokovnjaki.
English: Persons qualified to prescribe or supply medicinal products shall not solicit or accept any inducement prohibited under paragraph 1 or contrary to paragraph 2.
Slovenian: Osebe, usposobljene za predpisovanje ali izdajanje zdravil, se ne smejo potegovati za ali sprejemati kakršnih koli materialnih spodbud, ki so prepovedane na podlagi odstavka 1 ali so v nasprotju z odstavkom 2.
English: Existing measures or trade practices in Member States relating to prices, margins and discounts shall not be affected by paragraphs 1, 2 and 3.
Slovenian: Odstavki 1, 2 in 3 ne vplivajo na obstoječe ukrepe ali poslovno prakso držav članic v zvezi s cenami, maržami ali popusti.
English: The provisions of Article 94(1) shall not prevent hospitality being offered, directly or indirectly, at events for purely professional and scientific purposes;
Slovenian: Določbe člena 94(1) ne preprečujejo gostoljubnosti, neposredne ali posredne, ob dogodkih, katerih cilji so v celoti strokovni ali znanstveni;
English: such hospitality shall always be reasonable in level and remain subordinate to the main scientific objective of the meeting;
Slovenian: ponujeno gostoljubje mora biti zmerno in podrejeno glavnemu znanstvenemu cilju srečanja;
English: it must not be extended to persons other than health professionals.
Slovenian: deležni so ga lahko samo zdravstveni strokovnjaki.
English: Free samples shall be provided on an exceptional basis only to persons qualified to prescribe them and on the following conditions:
Slovenian: Brezplačne vzorce se izjemoma daje samo osebam, usposobljenim za njihovo predpisovanje, pod naslednjimi pogoji:
English: the number of samples for each medicinal product each year on prescription shall be limited;
Slovenian: število vzorcev za vsako zdravilo na recept mora biti vsako leto omejeno;
English: any supply of samples shall be in response to a written request, signed and dated, from the prescribing agent;
Slovenian: vse vzorce se dostavi na pisno prošnjo, ki jo predpisovalec podpiše in opremi z datumom;
English: those supplying samples shall maintain an adequate system of control and accountability;
Slovenian: o prejetih vzorcih se vodi ustrezen sistem nadzora in odgovornosti;
English: each sample shall be identical with the smallest presentation on the market;
Slovenian: vsak vzorec mora biti popolnoma enak najmanjšemu pakiranju na trgu;
English: each sample shall be marked "free medical sample - not for sale" or shall show some other wording having the same meaning;
Slovenian: vsak vzorec mora biti označen z napisom "brezplačen zdravniški vzorec — ni za prodajo", ali z drugimi besedami z enakim pomenom;
English: each sample shall be accompanied by a copy of the summary of product characteristics;
Slovenian: vsem vzorcem je priložen izvod povzetka glavnih značilnosti zdravila;
English: no samples of medicinal products containing psychotropic or narcotic substances within the meaning of international conventions, such as the United Nations Conventions of 1961 and 1971, may be supplied.
Slovenian: ne sme se dajati vzorcev zdravil, ki vsebujejo psihotropne ali narkotične snovi v smislu mednarodnih konvencij, kot sta konvenciji Združenih narodov iz leta 1961 in 1971.
English: Member States may also place further restrictions on the distribution of samples of certain medicinal products.
Slovenian: Države članice lahko še dodatno omejijo razdeljevanje vzorcev nekaterih zdravil.
English: Member States shall ensure that there are adequate and effective methods to monitor the advertising of medicinal products.
Slovenian: Države članice zagotovijo ustrezne in učinkovite postopke za nadzor oglaševanja zdravil.
English: Such methods, which may be based on a system of prior vetting, shall in any event include legal provisions under which persons or organizations regarded under national law as having a legitimate interest in prohibiting any advertisement inconsistent with this Title, may take legal action against such advertisement, or bring such advertisement before an administrative authority competent either to decide on complaints or to initiate appropriate legal proceedings.
Slovenian: Postopki, ki lahko temeljijo na sistemu predhodnega preučevanja in presoje, v vsakem primeru vključujejo pravne predpise, na podlagi katerih osebe ali organizacije, ki se po zakonodaji države članice štejejo, da imajo pravno utemeljen interes za prepoved vsakega oglaševanja, ki je v neskladju s tem naslovom, lahko pravno ukrepajo proti tovrstnemu oglaševanju ali prijavijo tak oglas upravnemu organu, ki je pristojen za odločanje o pritožbah ali za sprožitev ustreznega sodnega postopka.
English: Under the legal provisions referred to in paragraph 1, Member States shall confer upon the courts or administrative authorities powers enabling them, in cases where they deem such measures to be necessary, taking into account all the interests involved, and in particular the public interest:
Slovenian: Po pravnih predpisih iz odstavka 1 države članice dodelijo sodiščem ali upravnim organom pristojnosti, ki jim omogočajo, da v primerih, kadar sodijo, da so taki ukrepi potrebni, in ob upoštevanju vseh vpletenih interesov, zlasti interesa javnosti:
English: to order the cessation of, or to institute appropriate legal proceedings for an order for the cessation of, misleading advertising, or
Slovenian: odredijo prenehanje oglaševanja, ali sprožijo ustrezen sodni postopek za izdajo odredbe o prenehanju zavajajočega oglaševanja, ali
English: if misleading advertising has not yet been published but publication is imminent, to order the prohibition of, or to institute appropriate legal proceedings for an order for the prohibition of, such publication,
Slovenian: če zavajajoči oglas še ni objavljen, se pa objava bliža, zahtevajo prepoved ali sprožijo ustrezen sodni postopek za prepoved take objave,
English: even without proof of actual loss or damage or of intention or negligence on the part of the advertiser.
Slovenian: tudi brez dokaza o dejanski izgubi ali škodi ali nameri ali malomarnosti s strani oglaševalca.
English: Member States shall make provision for the measures referred to in the second subparagraph to be taken under an accelerated procedure, either with interim effect or with definitive effect.
Slovenian: Države članice pripravijo določbe, da se ukrepi iz drugega pododstavka sprejmejo po pospešenem postopku z začasnim ali dokončnim učinkom.
English: It shall be for each Member State to decide which of the two options set out in the first subparagraph to select.
Slovenian: Države članice same odločijo, katero od obeh možnosti iz prvega pododstavka bodo izbrale.
English: Member States may confer upon the courts or administrative authorities powers enabling them, with a view to eliminating the continuing effects of misleading advertising the cessation of which has been ordered by a final decision:
Slovenian: S ciljem odstranitve nadaljnjih učinkov zavajajočega oglaševanja, za prenehanje katerega je bil izdan dokončen sklep, države članice lahko dodelijo sodiščem ali upravnim organom pristojnosti, ki jim omogočajo:
English: to require publication of that decision in full or in part and in such form as they deem adequate,
Slovenian: da zahtevajo objavo takega sklepa v celoti ali delno in v obliki, kakršni menijo, da je ustrezna,
English: to require in addition the publication of a corrective statement.
Slovenian: da dodatno zahtevajo objavo popravka.
English: Paragraphs 1 to 4 shall not exclude the voluntary control of advertising of medicinal products by self-regulatory bodies and recourse to such bodies, if proceedings before such bodies are possible in addition to the judicial or administrative proceedings referred to in paragraph 1.
Slovenian: Odstavki 1 do 4 ne izključujejo prostovoljnega nadzora oglaševanja zdravil, ki ga opravljajo samonadzorni organi in možnosti, da se zatečejo k takim organom, če je poleg sodnih ali upravnih postopkov iz odstavka 1, postopek pred takim organom možen.
English: The marketing authorization holder shall establish, within his undertaking, a scientific service in charge of information about the medicinal products which he places on the market.
Slovenian: Imetnik dovoljenja za promet z zdravilom v svojem podjetju vzpostavi strokovno službo, odgovorno za informacije o zdravilih, ki jih daje v promet.
English: The marketing authorization holder shall:
Slovenian: Imetnik dovoljenja za promet z zdravilom:
English: keep available for, or communicate to, the authorities or bodies responsible for monitoring advertising of medicinal products, a sample of all advertisements emanating from his undertaking together with a statement indicating the persons to whom it is addressed, the method of dissemination and the date of first dissemination,
Slovenian: da na voljo ali sporoči organom ali službam, odgovornim za nadzor oglaševanja zdravil, vzorec vsakega oglasa, ki prihaja iz njegovega podjetja skupaj z izjavo, v kateri so navedene osebe, na katere je oglas naslovljen, način razširjanja oglasa ter datum prvega oglaševanja,
English: ensure that advertising of medicinal products by his undertaking conforms to the requirements of this Title,
Slovenian: zagotovi, da je oglaševanje zdravil, ki ga izvaja podjetje, v skladu z zahtevami tega naslova,
English: verify that medical sales representatives employed by his undertaking have been adequately trained and fulfill the obligations imposed upon them by Article 93(2) and (3),
Slovenian: preveri, da so strokovni sodelavci za prodajo zdravil, ki jih podjetje zaposluje, ustrezno usposobljeni in izpolnjujejo zahteve iz člena 93(2) in (3),
English: supply the authorities or bodies responsible for monitoring advertising of medicinal products with the information and assistance they require to carry out their responsibilities,
Slovenian: organom ali službam za nadzor oglaševanja zdravil predloži zahtevane informacije in nudi pomoč, ki jo zahtevajo za izvajanje svojih pristojnosti,
English: ensure that the decisions taken by the authorities or bodies responsible for monitoring advertising of medicinal products are immediately and fully complied with.
Slovenian: zagotovi, da se sklepi organov ali služb za nadzor oglaševanja zdravil, takoj in v celoti upoštevajo.
English: Article 99
Slovenian: Člen 99
English: Member States shall take the appropriate measures to ensure that the provisions of this Title are applied and shall determine in particular what penalties shall be imposed should the provisions adopted in the execution of Title be infringed.
Slovenian: Države članice sprejmejo ustrezne ukrepe, da zagotovijo, da se določbe tega naslova izvajajo ter določijo zlasti kazni za kršitev določb, sprejetih za izvajanje tega naslova.
English: Article 100
Slovenian: Člen 100
English: Advertising of the homeopathic medicinal products referred to in Article 13(2) and Article 14(1) shall be subject to the provisions of this Title with the exception of Article 87(1).
Slovenian: Za oglaševanje homeopatskih zdravil iz člena 13(2) in člena 14(1) se uporabljajo določila tega naslova, z izjemo člena 87(1).
English: However, only the information specified in Article 69(1) may be used in the advertising of such medicinal products.
Slovenian: Za oglaševanje homeopatskih zdravil se smejo uporabljati le informacije, navedene v členu 69(1).
English: Moreover, each Member State may prohibit in its territory any advertising of the homeopathic medicinal products referred to in Article 13(2) and Article 14(1).
Slovenian: Države članice na svojem ozemlju lahko prepovejo kakršno koli oglaševanje homeopatskih zdravil, navedenih v členu 13(2) in členu 14(1).
English: Article 101
Slovenian: Člen 101
English: The Member States shall take all appropriate measures to encourage doctors and other health care professionals to report suspected adverse reactions to the competent authorities.
Slovenian: Države članice sprejmejo vse ustrezne ukrepe za spodbujanje zdravnikov in drugih zdravstvenih strokovnjakov, da pristojnim organom poročajo o vseh domnevnih neželenih učinkih.
English: The Member States may impose specific requirements on doctors and other health care professionals, in respect of the reporting of suspected serious or unexpected adverse reactions, in particular where such reporting is a condition of the marketing authorization.
Slovenian: Države članice lahko uvedejo posebne zahteve do zdravnikov in drugih zdravstvenih strokovnjakov v zvezi s poročanjem o domnevnih resnih ali nepričakovanih neželenih učinkih, zlasti kadar je tovrstno poročanje pogoj pri izdaji dovoljenja za promet z zdravilom.
English: Article 102
Slovenian: Člen 102
English: In order to ensure the adoption of appropriate regulatory decisions concerning the medicinal products authorized within the Community, having regard to information obtained about adverse reactions to medicinal products under normal conditions of use, the Member States shall establish a pharmacovigilance system.
Slovenian: Da zagotovijo sprejetje ustreznih ureditvenih odločb o zdravilih, za katere je bilo izdano dovoljenje v Skupnosti, ter ob upoštevanju informacij o neželenih učinkih zdravila v predpisanih pogojih uporabe, države članice vzpostavijo sistem farmakovigilance.
English: This system shall be used to collect information useful in the surveillance of medicinal products, with particular reference to adverse reactions in human beings, and to evaluate such information scientifically.
Slovenian: Sistem se uporablja za zbiranje podatkov, koristnih pri nadzoru zdravil, s posebno navedbo neželenih učinkov pri ljudeh, ter za znanstveno ovrednotenje teh informacij.
English: Such information shall be collated with data on consumption of medicinal products.
Slovenian: Te informacije se primerja s podatki o porabi zdravil.