FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: the maximum single dose, the maximum daily dose, the strength, the pharmaceutical form, certain types of packaging;
Slovenian: največjega enkratnega odmerka, največjega dnevnega odmerka, jakosti, farmacevtske oblike, nekaterih vrst pakiranja;
English: other circumstances of use which it has specified.
Slovenian: drugih okoliščin uporabe, ki jih podrobno navede.
English: If a competent authority does not designate medicinal products into sub-categories referred to in Article 70(2), it shall nevertheless take into account the criteria referred to in paragraphs 2 and 3 of this Article in determining whether any medicinal product shall be classified as a prescription-only medicine.
Slovenian: Če pristojni organ zdravil ne razvrsti v podskupine iz člena 70(2), mora kljub temu pri odločanju upoštevati merila iz odstavkov 2 in 3 tega člena, ali zdravilo razvrstiti kot zdravilo, ki se izdaja le na recept.
English: Medicinal products not subject to prescription shall be those which do not meet the criteria listed in Article 71.
Slovenian: Zdravila, ki niso predmet recepta, so tista zdravila, ki ne ustrezajo merilom iz člena 71.
English: The competent authorities shall draw up a list of the medicinal products subject, on their territory, to medical prescription, specifying, if necessary, the category of classification.
Slovenian: Pristojni organi pripravijo seznam zdravil, ki se na njihovem ozemlju izdajajo le na recept in, če je potrebno, podrobno navedejo skupino razvrstitve.
English: They shall update this list annually.
Slovenian: Seznam letno ažurirajo.
English: On the occasion of the five-yearly renewal of the marketing authorization or when new facts are brought to their notice, the competent authorities shall examine and, as appropriate, amend the classification of a medicinal product, by applying the criteria listed in Article 71.
Slovenian: Ob petletnem podaljšanju dovoljenja za promet z zdravilom ali ko so obveščeni o novih dejstvih, pristojni organi preučijo in, kot je primerno, spremenijo razvrstitev zdravil ob upoštevanju meril iz člena 71.
English: Each year, Member States shall communicate to the Commission and to the other Member States, the changes that have been made to the list referred to in Article 73.
Slovenian: Vsako leto države članice obvestijo Komisijo in druge države članic o spremembah seznama iz člena 73.
English: WHOLESALE DISTRIBUTION OF MEDICINAL PRODUCTS
Slovenian: PROMET Z ZDRAVILI NA DEBELO
English: Without prejudice to Article 6, Member States shall take all appropriate action to ensure that only medicinal products in respect of which a marketing authorization has been granted in accordance with Community law are distributed on their territory.
Slovenian: Brez poseganja v člen 6, države članice sprejmejo vse ustrezne ukrepe, da na svojem ozemlju zagotovijo distribucijo samo tistih zdravil, za katere je bilo izdano dovoljenje za promet v skladu z zakonodajo Skupnosti.
English: Member States shall take all appropriate measures to ensure that the wholesale distribution of medicinal products is subject to the possession of an authorization to engage in activity as a wholesaler in medicinal products, stating the place for which it is valid.
Slovenian: Države članice sprejmejo vse ustrezne ukrepe, da zagotovijo, da je promet z zdravili na debelo mogoč le na podlagi dovoljenja za promet z zdravilom, ki trgovcu na debelo omogoča vključitev v promet z zdravili na debelo z navedbo kraja, za katerega velja.
English: Where persons authorized or entitled to supply medicinal products to the public may also, under national law, engage in wholesale business, such persons shall be subject to the authorization provided for in paragraph 1.
Slovenian: Da se osebe, ki so po nacionalni zakonodaji pooblaščene za izdajo zdravil ali so jih upravičene izdajati širši javnosti, lahko vključijo v promet z zdravili na debelo, morajo pridobiti dovoljenje, predpisano v odstavku 1.
English: Possession of a manufacturing authorization shall include authorization to distribute by wholesale the medicinal products covered by that authorization.
Slovenian: Posedovanje dovoljenja za izdelavo zdravil vključuje dovoljenje za promet z zdravili na debelo, ki jih dovoljenje obsega.
English: Possession of an authorization to engage in activity as a wholesaler in medicinal products shall not give dispensation from the obligation to possess a manufacturing authorization and to comply with the conditions set out in that respect, even where the manufacturing or import business is secondary.
Slovenian: Posedovanje dovoljenja za opravljanje dejavnosti trgovca na debelo na področju zdravil ne daje oprostitve obveznosti posedovanja dovoljenja za proizvodnjo ter obveznosti prilagajanja za to določenim pogojem, četudi sta proizvodnja ali uvoz sekundarna.
English: At the request of the Commission or any Member State, Member States shall supply all appropriate information concerning the individual authorizations which they have granted under paragraph 1.
Slovenian: Na zahtevo Komisije ali katere koli države članice, države članice dostavijo vse ustrezne informacije o posameznih dovoljenjih, ki so jih izdale v skladu z odstavkom 1.
English: Checks on the persons authorized to engage in the activity of wholesaler in medicinal products and the inspection of their premises, shall be carried out under the responsibility of the Member State which granted the authorization.
Slovenian: Preverjanja oseb, ki so pooblaščene za opravljanje dejavnosti prometa z zdravili na debelo, ter inšpekcijski pregled njihovih prostorov je odgovornost države članice, ki je izdala dovoljenje.
English: The Member State which granted the authorization referred to in paragraph 1 shall suspend or revoke that authorization if the conditions of authorization cease to be met.
Slovenian: Država članica, ki je izdala dovoljenje iz odstavka 1, dovoljenje začasno prekliče ali ukine, če niso izpolnjeni pogoji dovoljenja.
English: It shall forthwith inform the other Member States and the Commission thereof.
Slovenian: Država članica o tem takoj obvesti ostale države članice in Komisijo.
English: Should a Member State consider that, in respect of a person holding an authorization granted by another Member State under the terms of paragraph 1, the conditions of authorization are not, or are no longer met, it shall forthwith inform the Commission and the other Member State involved.
Slovenian: Če država članica meni, da oseba, ki ima dovoljenje, ki ga je izdala druga država članica po pogojih odstavka 1, pogojev dovoljenja ne izpolnjuje, ali ne izpolnjuje več, o tem takoj obvesti Komisijo in vpleteno državo članico.
English: The latter shall take the measures necessary and shall inform the Commission and the first Member State of the decisions taken and the reasons for those decisions.
Slovenian: Ta sprejme potrebne ukrepe in obvesti Komisijo in prvo državo članico o sprejetih odločitvah ter razlogih zanje.
English: Member States shall ensure that the time taken for the procedure for examining the application for the distribution authorization does not exceed 90 days from the day on which the competent authority of the Member State concerned receives the application.
Slovenian: Države članice zagotovijo, da čas postopka za preučitev vloge za dovoljenje za promet z zdravili na debelo ne preseže 90 dni od dneva, ko pristojni organ zadevne države članice prejme vlogo.
English: The competent authority may, if need be, require the applicant to supply all necessary information concerning the conditions of authorization.
Slovenian: Če je potrebno, pristojni organ od vlagatelja lahko zahteva, da predloži vse potrebne informacije glede pogojev dovoljenja.
English: Where the authority exercises this option, the period laid down in the first paragraph shall be suspended until the requisite additional data have been supplied.
Slovenian: Če organ uporabi to možnost, rok, ki ga določa prvi odstavek, preneha teči do predložitve zahtevanih dodatnih informacij.
English: In order to obtain the distribution authorization, applicants must fulfil the following minimum requirements:
Slovenian: Za pridobitev dovoljenja za promet z zdravili na debelo morajo vlagatelji izpolnjevati naslednje minimalne zahteve:
English: they must have suitable and adequate premises, installations and equipment, so as to ensure proper conservation and distribution of the medicinal products;
Slovenian: imeti morajo ustrezne in primerne prostore, instalacije in opremo, tako da zagotovijo ustrezno shranjevanje in distribucijo zdravil;
English: they must have staff, and in particular, a qualified person designated as responsible, meeting the conditions provided for by the legislation of the Member State concerned;
Slovenian: imeti morajo osebje in zlasti usposobljeno osebo, ki je uradno imenovana kot odgovorna in izpolnjuje pogoje, predpisane z zakonodajo zadevne države članice;
English: they must undertake to fulfil the obligations incumbent on them under the terms of Article 80.
Slovenian: zagotavljati morajo izpolnjevanje pogojev, ki so njihova dolžnost po določbah člena 80.
English: Holders of the distribution authorization must fulfil the following minimum requirements:
Slovenian: Imetniki dovoljenja za promet z zdravili na debelo morajo izpolnjevati naslednje minimalne pogoje:
English: they must make the premises, installations and equipment referred to in Article 79(a) accessible at all times to the persons responsible for inspecting them;
Slovenian: prostori, instalacije in oprema iz člena 79(a) morajo biti vedno dostopni osebam, odgovornim za inšpekcijski pregled;
English: they must obtain their supplies of medicinal products only from persons who are themselves in possession of the distribution authorization or who are exempt from obtaining such authorization under the terms of Article 77(3);
Slovenian: z zdravili se smejo oskrbovati samo pri osebah, ki so tudi same imetniki dovoljenja za promet z zdravili na debelo ali pa jim v skladu z določbami člena 77(3) takega dovoljenja ni treba pridobiti;
English: they must supply medicinal products only to persons who are themselves in possession of the distribution authorization or who are authorized or entitled to supply medicinal products to the public in the Member State concerned;
Slovenian: zdravila smejo izdajati samo osebam, ki imajo tudi dovoljenje za promet z zdravili na debelo, ki imajo v zadevni državi članici uradno dovoljenje za izdajanje ali imajo pravico izdajati zdravila širši javnosti;
English: they must have an emergency plan which ensures effective implementation of any recall from the market ordered by the competent authorities or carried out in cooperation with the manufacturer or marketing authorization holder for the medicinal product concerned;
Slovenian: imeti morajo načrt ukrepov ob izrednih dogodkih, ki zagotavlja učinkovito izvajanje vsakega odpoklica zdravila iz prometa, ki ga odredi pristojni organ ali ga izvede v sodelovanju s proizvajalcem zdravila ali z imetnikom dovoljenja za promet z zadevnim zdravilom;
English: they must keep records either in the form of purchase/sales invoices, or on computer, or in any other form, giving for any transaction in medicinal products received or dispatched at least the following information:
Slovenian: voditi morajo dokumentacijo v obliki nabavnih/prodajnih računov, na računalniku ali v katerikoli drugi obliki, ki o vsakem izvršenem prejetju ali odpremi zdravil vsebuje najmanj naslednje podatke:
English: the date,
Slovenian: datum,
English: name of the medicinal product,
Slovenian: ime zdravila,
English: quantity received or supplied,
Slovenian: prejeta ali izdana količina,
English: name and address of the supplier or consignee, as appropriate;
Slovenian: ime in naslov dobavitelja ali prejemnika, kot je primerno;
English: they must keep the records referred to under (e) available to the competent authorities, for inspection purposes, for a period of five years;
Slovenian: dokumentacijo, navedeno pod (e), ki mora biti na voljo pristojnim organom za inšpekcijski pregled, morajo hraniti za obdobje petih let;
English: they must comply with the principles and guidelines of good distribution practice for medicinal products as laid down in Article 84.
Slovenian: ravnati morajo v skladu z načeli in smernicami dobre distribucijske prakse za zdravila, kot jih določa člen 84.
English: With regard to the supply of medicinal products to pharmacists and persons authorized or entitled to supply medicinal products to the public, Member States shall not impose upon the holder of a distribution authorization which has been granted by another Member State, any obligation, in particular public service obligations, more stringent than those they impose on persons whom they have themselves authorized to engage in equivalent activities.
Slovenian: V zvezi z dobavo zdravil farmacevtom in osebam z dovoljenjem za izdajo ali ki imajo pravico izdajati zdravila širši javnosti, države članice imetniku dovoljenja za promet z zdravili na debelo, ki mu ga je izdala druga država članica, ne nalagajo nobenih obveznosti, zlasti obveznosti javnih storitev, ki bi bile strožje od obveznosti, naloženih osebam, katerim so same izdale dovoljenje za opravljanje enakovrednih dejavnosti.
English: The said obligations should, moreover, be justified, in keeping with the Treaty, on grounds of public health protection and be proportionate in relation to the objective of such protection.
Slovenian: Omenjene odgovornosti morajo biti opravičljive, in v skladu s Pogodbo, na podlagi varovanja javnega zdravja in v sorazmerju s ciljem varovanja.
English: For all supplies of medicinal products to a person authorized or entitled to supply medicinal products to the public in the Member State concerned, the authorized wholesaler must enclose a document that makes it possible to ascertain:
Slovenian: K vsem dobavam zdravil osebi, ki ima dovoljenje ali pravico izdajati zdravila javnosti v zadevni državi članici, mora pooblaščeni trgovec na debelo priložiti dokument, na podlagi katerega je možno ugotoviti:
English: the name and pharmaceutical form of the medicinal product,
Slovenian: ime zdravila in farmacevtsko obliko,
English: the quantity supplied,
Slovenian: dobavljeno količino,
English: the name and address of the supplier and consignor.
Slovenian: ime in naslov dobavitelja in pošiljatelja.
English: Member States shall take all appropriate measures to ensure that persons authorized or entitled to supply medicinal products to the public are able to provide information that makes it possible to trace the distribution path of every medicinal product.
Slovenian: Države članice sprejmejo ustrezne ukrepe, da zagotovijo, da so osebe, ki so pooblaščene za izdajanje ali imajo pravico izdajati zdravila širši javnosti, sposobne predložiti informacije, ki omogočajo sledljivost distribucijske poti vsakega zdravila.
English: The provisions of this Title shall not prevent the application of more stringent requirements laid down by Member States in respect of the wholesale distribution of:
Slovenian: Določbe tega naslova ne smejo preprečiti uporabe strožjih zahtev, ki jih države članice določijo v zvezi s prometom na debelo za:
English: narcotic or psychotropic substances within their territory,
Slovenian: narkotične ali psihotropne snovi na svojem ozemlju,
English: medicinal products derived from blood,
Slovenian: zdravila, pridobljena iz krvi,
English: immunological medicinal products,
Slovenian: imunološka zdravila,
English: radiopharmaceuticals.
Slovenian: radiofarmacevtske izdelke.
English: The Commission shall publish guidelines on good distribution practice.
Slovenian: Komisija objavi smernice o dobri distribucijski praksi.
English: To this end, it shall consult the Committee for Proprietary Medicinal Products and the Pharmaceutical Committee established by Council Decision 75/320/EEC(22).
Slovenian: V ta namen se posvetuje z Odborom za lastniška zdravila in Odborom za farmacijo, ustanovljenim z Direktivo Sveta 75/320/EGS [22].
English: The provisions of this Title shall apply to homeopathic medicinal products, with the exception of those referred to in Article 14(1).
Slovenian: Določbe tega naslova se uporabljajo za homeopatska zdravila, razen navedenih v členu 14(1).
English: ADVERTISING
Slovenian: OGLAŠEVANJE
English: For the purposes of this Title, "advertising of medicinal products" shall include any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products;
Slovenian: Za namen tega naslova izraz "oglaševanje zdravil" vključuje vse oblike obveščanja, vključno z obveščanjem od vrat do vrat, agitiranjem ali spodbujanjem z namenom, da se spodbuja predpisovanje, izdajanje, prodaja ali potrošnja zdravil;
English: it shall include in particular:
Slovenian: vključuje zlasti:
English: the advertising of medicinal products to the general public,
Slovenian: oglaševanje zdravil širši javnosti,
English: advertising of medicinal products to persons qualified to prescribe or supply them,
Slovenian: oglaševanje zdravil osebam, usposobljenim za predpisovanje ali izdajanje zdravil,
English: visits by medical sales representatives to persons qualified to prescribe medicinal products,
Slovenian: obiske strokovnih sodelavcev za prodajo zdravil pri osebah, usposobljenih za predpisovanje zdravil,
English: the supply of samples,
Slovenian: dajanje vzorcev,
English: the provision of inducements to prescribe or supply medicinal products by the gift, offer or promise of any benefit or bonus, whether in money or in kind, except when their intrinsic value is minimal,
Slovenian: določila glede spodbujanja k predpisovanju ali izdajanju zdravil z darili, ponujanjem ali obljubljanjem koristi ali premij, v denarju ali v naravi, razen če je dejanska vrednost daril majhna,
English: sponsorship of promotional meetings attended by persons qualified to prescribe or supply medicinal products,
Slovenian: sponzoriranje promocijskih srečanj, ki jih obiskujejo osebe, usposobljene za predpisovanje ali izdajanje zdravil,
English: sponsorship of scientific congresses attended by persons qualified to prescribe or supply medicinal products and in particular payment of their travelling and accommodation expenses in connection therewith.
Slovenian: sponzoriranje znanstvenih kongresov, ki se jih udeležujejo osebe, usposobljene za predpisovanje ali izdajanje zdravil, zlasti v obliki plačila stroškov njihovih potovanj in bivanja s tem v zvezi.
English: The following are not covered by this Title:
Slovenian: Naslov ne vključuje:
English: the labelling and the accompanying package leaflets, which are subject to the provisions of Title V,
Slovenian: označevanja in priloženega navodila za uporabo, kar urejajo določbe naslova V,
English: correspondence, possibly accompanied by material of a non-promotional nature, needed to answer a specific question about a particular medicinal product,
Slovenian: dopisovanja, po možnosti s priloženimi gradivi, ki niso promocijske narave in so potrebna kot odgovor na specifična vprašanja o določenem zdravilu,
English: 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,
Slovenian: informativnih objav o dejstvih ter referenčna gradiva, na primer v zvezi s spremembami na ovojnini, opozorili o neželenih učinkih kot delu splošnih previdnostnih ukrepov, prodajnih katalogov in cenikov, ki ne vključujejo navedb o lastnostih zdravila,
English: statements relating to human health or diseases, provided there is no reference, even indirect, to medicinal products.
Slovenian: izjave v zvezi z zdravjem ljudi ali boleznimi pod pogojem, da ni nobenega napotila, tudi posrednega, na zdravila.
English: Member States shall prohibit any advertising of a medicinal product in respect of which a marketing authorization has not been granted in accordance with Community law.
Slovenian: Države članice prepovejo vsakršno oglaševanje zdravila, za katerega dovoljenje za promet ni bilo pridobljeno v skladu z zakonodajo Skupnosti.
English: All parts of the advertising of a medicinal product must comply with the particulars listed in the summary of product characteristics.
Slovenian: Vsi elementi oglaševanja zdravila morajo biti v skladu s podrobnimi podatki, navedenimi v povzetku glavnih značilnostih zdravila.
English: The advertising of a medicinal product:
Slovenian: Oglaševanje zdravila:
English: shall encourage the rational use of the medicinal product, by presenting it objectively and without exaggerating its properties,
Slovenian: spodbuja smotrno uporabo zdravila, s tem da zdravilo predstavlja objektivno in brez pretiravanja o njegovih lastnostih,
English: shall not be misleading.
Slovenian: ni zavajajoče.
English: Member States shall prohibit the advertising to the general public of medicinal products which:
Slovenian: V državah članicah je prepovedano oglaševanje širši javnosti zdravil:
English: are available on medical prescription only, in accordance with Title VI,
Slovenian: ki se izdajajo le na recept, v skladu z naslovom VI,
English: contain psychotropic or narcotic substances, such as the United Nations Conventions of 1961 and 1971,
Slovenian: ki vsebujejo psihotropne ali narkotične snovi, kot so navedene v konvencijah Združenih narodov iz leta 1961 in 1971,
English: may not be advertised to the general public in accordance with the second subparagraph of paragraph 2.
Slovenian: s katerih lastnostmi se ne sme seznanjati širše javnosti v skladu z drugim pododstavkom odstavka 2.
English: Medicinal products may be advertised to the general public which, by virtue of their composition and purpose, are intended and designed for use without the intervention of a medical practitioner for diagnostic purposes or for the prescription or monitoring of treatment, with the advice of the pharmacist, if necessary.
Slovenian: Širši javnosti je dovoljeno oglaševati zdravila, ki so zaradi svoje sestave in namena, namenjena in oblikovana za uporabo brez posredovanja zdravnika za diagnostične namene ali za predpisovanje ali spremljanje zdravljenja, po nasvetu farmacevta, če je to potrebno.
English: Member States shall prohibit the mentioning in advertising to the general public of therapeutic indications such as:
Slovenian: Države članice v oglaševanju širši javnosti prepovejo omenjanje terapevtskih indikacij, kot so:
English: tuberculosis,
Slovenian: tuberkuloza,
English: sexually transmitted diseases,
Slovenian: spolno prenosljive bolezni,
English: other serious infectious diseases,
Slovenian: druge resne nalezljive bolezni,
English: cancer and other tumoral diseases,
Slovenian: rak in druge bolezni tumorskega izvora,
English: chronic insomnia,
Slovenian: kronična nespečnost,
English: diabetes and other metabolic illnesses.
Slovenian: sladkorna bolezen in druge presnovne bolezni.
English: Member States shall be able to ban, on their territory, advertising to the general public of medicinal products the cost of which may be reimbursed.
Slovenian: Državam članicam se omogoči, da na svojem ozemlju prepovejo oglaševanje zdravil širši javnosti, za katere je možno nadomestilo stroškov.
English: The prohibition referred to in paragraph 1 shall not apply to vaccination campaigns carried out by the industry and approved by the competent authorities of the Member States.
Slovenian: Prepoved iz prvega odstavka se ne uporablja za kampanje o cepljenju, ki jih izvaja industrija in jih odobrijo pristojni organi držav članic.
English: The prohibition referred to in paragraph 1 shall apply without prejudice to Article 14 of Directive 89/552/EEC.
Slovenian: Prepoved iz odstavka 1 se uporablja brez vpliva na člen 14 Direktive 89/552/EGS.
English: Member States shall prohibit the direct distribution of medicinal products to the public by the industry for promotional purposes;
Slovenian: Države članice prepovejo neposredno razdeljevanje zdravil javnosti s strani industrije v promocijske namene;
English: they may, however, authorize such distribution in special cases for other purposes.
Slovenian: tako razdeljevanje pa je lahko dovoljeno v posebnih primerih za druge namene.